Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets

Pronunciation: KLOR-fen-IR-a-meen/SOO-doe-e-FED-rin/METH-skoe-POL-a-meen
Generic Name: Chlorpheniramine/Pseudoephedrine/Methscopolamine
Brand Name: Examples include Dallergy PSE and Relcof PSE

Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets are an antihistamine, decongestant, and anticholinergic combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets if:

• you are allergic to any ingredient in Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets


• you are pregnant or breast-feeding


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days


• you have severe heart blood vessel disease, severe high blood pressure, narrow-angle glaucoma, severe bleeding, severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia), peptic ulcer, a blockage of your stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), certain muscle problems (eg, myasthenia gravis), or uncontrolled bleeding


• you are unable to urinate or are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets:

Some medical conditions may interact with Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of diabetes, an enlarged prostate, bladder or kidney problems, high blood pressure, diarrhea, asthma, nerve problems, heart problems, blood clots, a hiatal hernia, an adrenal gland tumor, glaucoma, breathing problems during sleep, seizures, myasthenia gravis (muscle weakness), or an overactive thyroid

Some MEDICINES MAY INTERACT with Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, guanethidine, methyldopa, prazosin), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), furazolidone, or MAOIs (eg, phenelzine) because the risk of high or low blood pressure may be increased


• Alkalizers (eg, calcium or magnesium antacids), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, sodium bicarbonate, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets's side effects


• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets:

Use Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Do not take Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets at the same time as an antacid, certain medicines for diarrhea (eg, attapulgite, bismuth, kaolin, pectin), or ketoconazole. Take these medicines 2 or 3 hours before or after you take Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets.


• Swallow Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• If you miss a dose of Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets.

Important safety information:

• Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• If your symptoms do not get better within 7 days or if they get worse or you develop a high fever or persistent headache, check with your doctor.


• Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.


• Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Do not take diet or appetite control medicines while you are taking Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets without checking with your doctor.


• Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets.


• Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you are taking Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets.


• Tell your doctor or dentist that you take Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Use Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: It is not known if Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets while you are pregnant. Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets.

Possible side effects of Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing.

Proper storage of Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets:

Store Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets in a tightly closed container between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Chlorpheniramine/Pseudoephedrine/Methscopolamine Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Chlorpheniramine/Pseudoephedrine/Methscopolamine resources

• Chlorpheniramine/Pseudoephedrine/Methscopolamine Use in Pregnancy & Breastfeeding
• Chlorpheniramine/Pseudoephedrine/Methscopolamine Drug Interactions
• Chlorpheniramine/Pseudoephedrine/Methscopolamine Support Group
• 4 Reviews for Chlorpheniramine/Pseudoephedrine/Methscopolamine - Add your own review/rating

Compare Chlorpheniramine/Pseudoephedrine/Methscopolamine with other medications

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Trifluoperazine 5mg / 5ml Oral Solution

1. Name Of The Medicinal Product

Trifluoperazine 5mg/5ml Oral Solution

2. Qualitative And Quantitative Composition

Trifluoperazine Hydrochloride BP equivalent to trifluoperazine 5mg/5ml

3. Pharmaceutical Form

Oral solution

4. Clinical Particulars

4.1 Therapeutic Indications

Trifluoperazine is a piperazine phenothiazine tranquilliser with potent antipsychotic, anxiolytic and anti-emetic activity, and a pharmacological profile of moderate sedative and hypotensive properties, and fairly pronounced tendency to cause extrapyramidal reactions.

Low Dosage

Trifluoperazine is indicated as an adjunct in the short term management of anxiety states, depressive symptoms secondary to anxiety, and agitation. It is also indicated in the symptomatic treatment of nausea and vomiting.

High Dosage

Trifluoperazine is indicated for the treatment of symptoms and prevention of relapse in schizophrenia and in other psychoses, especially of the paranoid type, but not in depressive psychoses. It may also be used as an adjunct in the short term management of severe psychomotor agitation and of dangerously impulsive behaviour, for example, mental subnormality.

4.2 Posology And Method Of Administration

For oral administration only.

Adults

Low Dosage: 2- 4 mg a day given in divided doses, according to the severity of the patients condition. If necessary, dosage may be increased to 6mg a day but above this level, extrapyramidal symptoms are more likely to occur in some patients.

High dosage: The recommended starting dose for physically fit adults is 5mg twice a day; after a week this may be increased to 15mg a day. If necessary, further increases of 5mg may be made at three day intervals, but not more often. When satisfactory control has been achieved, dosage should be reduced gradually until an effective maintenance level has been established. As with all major tranquillisers, clinical improvement may not be evident for several weeks after starting treatment, and there may also be delay before recurrence of symptoms after stopping treatment. Gradual withdrawal from high dosage treatment is advisable.

Elderly

Reduce starting dose in elderly and frail patients by at least half.

Children

Low Dosage:	For children aged 3 - 5 years - up to 1mg a day given in divided doses.
	For children age 6 - 12 years - the dosage may be increased to a maximum of 4mg a day.
High Dosage:	For children aged under 12 years - the initial oral dosage should not exceed 5mg a day, given in divided doses. Any subsequent increase should be made with caution, at intervals of not less than three days and taking into account age, body weight and severity of symptoms.

4.3 Contraindications

Do not use Trifluoperazine in comatose patients, particularly if associated with other central nervous system depressants, or in those with existing blood dyscrasias or known liver damage, or in those hypersensitive to the active ingredient or related compounds. Patients with uncontrolled cardiac decompensation should not be given trifluoperazine.

4.4 Special Warnings And Precautions For Use

Trifluoperazine should be discontinued at the first sign of clinical symptoms of tardive dyskinesia and Neuroleptic Malignant Syndrome.

Patients on long term phenothiazine therapy require regular and careful surveillance with particular attention to tardive dyskinesia and possible eye changes, blood dyscrasias, liver dysfunction and myocardial conduction defects, particularly if other concurrently administered drugs have potential effects in these systems.

Care should be taken when treating elderly patients, and initial dosage should be reduced. Such patients can be specially sensitive, particularly to extrapyramidal and hypotensive effects. Patients with cardiovascular disease including arrhythmias should also be treated with caution. Because Trifluoperazine may increase activity, care should be taken in patients with angina pectoris. If an increase in pain is noted, the drug should be discontinued. Patients who have demonstrated bone marrow suppression or jaundice with a phenothiazine should not be re-exposed to trifluoperazine unless in the judgement of the physician the potential benefits of the treatment out weigh the possible hazards.

In patients with Parkinson's disease, symptoms may be worsened, and the effects of levodopa reversed. Since phenothiazines lower the convulsive threshold, patients with epilepsy should be treated with caution, and metrizamide avoided. Although Trifluoperazine has minimal anticholinergic activity, this should be borne in mind when treating patients with narrow angle glaucoma, myasthenia gravis or prostatic hypertrophy. Nausea and vomiting as a sign of organic disease may be masked by the anti-emetic action of Trifluoperazine.

An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. Trifluoperazine should be used with caution in patients with risk factors for stroke.

Caution should be used in patients with cardiovascular disease or family history of QT prolongation. Concomitant use of neuroleptics should be avoided.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Trifluoperazine and preventive measures undertaken.

Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of antipsychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable.

Phenothiazines should be used with care in extremes of temperature since they may affect body temperature control.

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Trifluoperazine is not licensed for the treatment of dementia-related behavioural disturbances.

Ingredients in the formulation

The medicine contains:

• sorbitol and maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

• Methyl and propyl hydroxybenzoate. These may cause allergic reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potentiation may occur if antipsychotic drugs are combined with CNS depressants such as alcohol, hypnotics and strong analgesics. Phenothiazines may antagonise the action of Guanethidine and Levodopa. Trifluoperazine may aggravate Parkinsonism and antagonise the action of levodopa. They may lower the convulsive threshold. Hence patients with epilepsy should be treated with caution.

Serum levels of phenothiazine can be reduced to non-therapeutic concentrations by concurrent administration of lithium. Dosage increases may be needed.

Desferrioxamine should not be used in combination with Trifluoperazine, since prolonged unconsciousness has occurred after combination with the related prochlorperazine.

Phenothiazines increase the risk of ventricular arrhythmias with drugs which prolong the Q-T interval, drugs causing electrolyte imbalances.

Trifluoperazine may diminish the effect of oral anticoagulants.

Severe extrapyramidal side-effects or neurotoxicity have been observed in patients concurrently treated with lithium and trifluoperazine. Sleep walking has been described in some patients taking phenothiazines and lithium.

Antacids can reduce the absorption of phenothiazines.

4.6 Pregnancy And Lactation

Trifluoperazine has been available since 1958. There are some animal studies that indicate a teratogenic effect, but results are conflicting. There is no clinical evidence (including follow-up surveys in over 800 women who had taken low-dosage Trifluoperazine during pregnancy) to indicate that trifluoperazine has a teratogenic effect in man. Nevertheless, drug treatment should be avoided in pregnancy unless essential, especially during the first trimester. Trifluoperazine passes into the milk of lactating dogs. Breast feeding should only be allowed at the discretion of the physician

4.7 Effects On Ability To Drive And Use Machines

Patients who drive or operate machinery should be warned of the possibility of drowsiness.

4.8 Undesirable Effects

Lassitude, drowsiness, dizziness, transient restlessness, insomnia, dry mouth, blurred vision, muscular weakness, anorexia, mild postural hypotension, skin reactions including photosensitivity reactions, weight gain, oedema and confusion may occasionally occur. Tachycardia, constipation, urinary hesitancy and retention and hyperpyrexia have been reported very rarely. Adverse reactions tend to be dose related and to disappear.

Hyperprolactinaemia may occur at higher dosages with associated effects such as galactorrhoea or amenorrhoea; certain hormone dependant breast neoplasms may be affected.

Phenothiazines can produce ECG changes with prolongation of the QT interval and T-wave changes; ventricular arrhythmias (VF, VT (rare)), sudden unexplained death; cardiac arrest and Torsades de pointes have been reported. Serious arrhythmias have been reported.

Such effects are rare with Trifluoperazine. In some patients, especially non-psychotic patients, Trifluoperazine even at low dosage may cause unpleasant symptoms of being dulled or paradoxically of being agitated. Extrapyramidal symptoms are rare at daily dosages of 6mg or less; they are considerably more common at higher dosage levels. These symptoms include Parkinsonism, akathisia with motor restlessness and difficulty in sitting still and acute dystonia or dyskinesia, which may occur early in treatment and may present with torticollis facial grimacing, trismus, tongue protrusion and abnormal eye movements including oculogyric crises. Such reactions may often be controlled by reducing the dosage or by stopping medication. In more severe dystonic reactions, an anticholinergic antiparkinsonism drug should be given.

Tardive dyskinesia of the facial muscles, sometimes with involuntary movements of the extremities, has occurred in some patients on long term high dosage and, more rarely, low dosage phenothiazine therapy, including Trifluoperazine. Symptoms may appear in the first time either during or after a course of treatment; they may become worse when treatment is stopped. The symptoms may persist for many months or even years, and while they gradually disappear in some patients, they appear to be permanent in others. Patients have most commonly been elderly, with organic brain damage. Particular caution should be observed in treating such patients. Periodic gradual reduction of dosage to reveal persisting dyskinesia has been suggested, so that treatment may be stopped if necessary. If tardive dyskinesia occurs, trifluoperazine should be discontinued. Anticholinergic antiparkinsonism agents may aggravate the condition. Since the occurrence of tardive dyskinesia may be related to length of treatment and dosage, Trifluoperazine should be given for as short a time and at as low a dosage as possible.

The neuroleptic malignant syndrome is a rare but occasionally fatal complication of treatment with various neuroleptic drugs, and is characterised by hyperpyrexia, muscle rigidity, altered consciousness and autonomic instability. Intensive symptomatic treatment should include cooling. Intravenous dantrolene has been suggested for muscle rigidity.

Mild cholestatic jaundice and blood dyscrasias such as agranulocytosis, pancytopenia, leucopenia and thrombocytopenia have been reported very rarely.

Signs of persistent infection should be investigated.

Very rare cases of skin pigmentation and lenticular opacities have been reported with Trifluoperazine.

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs – Frequency unknown

Withdrawal reactions have been reported in association with antipsychotic drugs (see 4.4).

4.9 Overdose

Signs and symptoms will be predominantly extrapyramidal; hypotension may occur. Treatment consists of gastric lavage together with supportive and symptomatic measures. Do not induce vomiting. Extrapyramidal symptoms may be treated with an anticholinergic antiparkinsonism drug. Treat hypotension with fluid replacement; if severe or persistent, noradrenaline may be considered. Adrenaline is contra-indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Trifluoperazine is one of the phenothiazine class of compounds and as such has many pharmacodynamic effects which relate to its therapeutic actions and side effects. The most notable action of phenothiazines is antagonism at dopamine receptors in the CNS. It is hypothesised that this action in the limbic system and associated areas of cerebral cortex is the basis of the antipsychotic action of phenothiazines, whilst in the medullary chemoreceptor trigger zone it appears to be responsible for the antiemetic effect of these agents. In addition, dopamine antagonism in the basal ganglia appears to be involved in some of the extrapyramidal side-effects of phenothiazines, whilst blockage of the dopaminergic inhibition of prolactin release from the anterior pituitary gland is thought to lead to hyperprolactinaemia.

Other central actions of phenothiazines include sedation and inhibition of the function of the hypothalmic heat regulatory centre. Phenothiazines also lower the seizure threshold. Central actions of phenothiazines also affect the cardiovascular system, as does their antagonism of peripheral α - adrenergic receptors, which can cause hypotension.

Phenothiazines also have anti – muscarinic activity which causes certain side effects.

Trifluoperazine is one of the piperazine sub–class of phenothiazine drugs whose members have fewer sedative, antimuscarinic and hypotensive side – effects but more extrapyramidal side effects than other types of phenothiazines.

5.2 Pharmacokinetic Properties

The pharmacokinetics for trifluoperazine are typical of phenothiazines such as chlorpromazine. It is readily absorbed from the gastrointestinal tract with peak plasma levels being reached from 1.5 to 6.0 hours after ingestion. A high interindividual variation in bioavailability has been consistently reported. In the blood, trifluoperazine is highly bound to plasma proteins. It probably penetrates the placental barrier and enters breast milk like chlorpromazine.

The elimination of trifluoperazine from the blood is multiphasic with an α phase elimination half-life of about 3.6 hours and a terminal elimination half-life of about 22 hours. Several metabolites of trifluoperazine have been identified, including an N-oxide, a sulphoxide and a 7-hydroxy derivative. The N-oxide is thought to be the main metabolite and possibly active. This and the sulphoxide metabolite are thought to be extensively metabolised pre-systemically (i.e. in the gut and/or liver), whilst the 7-hydroxy derivative appears to undergo no such metabolism.

Elimination occurs via bile and urine.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Propylhydroxybenzoate, methylhydroxybenzoate, propylene glycol, sorbitol solution 70%, liquid maltitol, ascorbic acid, lime and aniseed flavour, caramel E150 and purified water.

6.2 Incompatibilities

None

6.3 Shelf Life

12 months unopened

1 month after opening

6.4 Special Precautions For Storage

Store below 25°C, protected from light.

6.5 Nature And Contents Of Container

Bottles :-	Amber (Type III) glass
Closures:	a) Aluminium, EPE wadded roll-on pilfer proof
	b) HDPE EPE wadded, tamper evident
	c) HDPE EPE wadded, tamper evident, child resistant.
Capacities:	150ml, 200ml or 500ml

6.6 Special Precautions For Disposal And Other Handling

Keep out of the reach of children.

Administrative Data

7. Marketing Authorisation Holder

Rosemont Pharmaceuticals Limited

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

8. Marketing Authorisation Number(S)

00427/0118

9. Date Of First Authorisation/Renewal Of The Authorisation

12/7/2008

10. Date Of Revision Of The Text

20/07/2010

Palcaps

Generic Name: pancrelipase (Oral route)

AM-i-lase, LYE-pase, PROE-tee-ase

Commonly used brand name(s)

In the U.S.

• Creon


• Palcaps


• Pancreaze


• Pancrelipase


• Pangestyme EC


• Panocaps


• Ultracaps


• Zenpep

In Canada

• Viokase

Available Dosage Forms:

• Capsule, Delayed Release


• Capsule


• Tablet


• Tablet, Chewable


• Powder

Therapeutic Class: Enzyme Replacement

Pharmacologic Class: Enzyme

Uses For Palcaps

Pancrelipase is used to help improve food digestion in certain conditions (e.g., cystic fibrosis) where the pancreas is not working properly.

Pancrelipase contains the enzymes needed for the digestion of proteins, starches, and fats.

This medicine is available only with your doctor's prescription.

Before Using Palcaps

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pancrelipase in children.

Geriatric

No information is available on the relationship of age to the effects of pancrelipase in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to pork products—Use with caution. Pancrelipase contains pork proteins.

• Gout or


• Hyperuricemia (high uric acid in the blood) or


• Hyperuricosuria (high uric acid in the urine) or


• Intestinal (bowel) blockage, history of or


• Kidney disease or


• Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse.

Proper Use of pancrelipase

This section provides information on the proper use of a number of products that contain pancrelipase. It may not be specific to Palcaps. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Take this medicine with meals or snacks and enough liquid to swallow it completely, unless otherwise directed by your doctor.

When prescribing this medicine for your condition, your doctor may also prescribe a personal diet for you. Follow the special diet carefully. This is necessary for the medicine to work properly. It is also important to drink plenty of water while you are on this medicine.

For patients taking the tablets:

• Swallow the tablets quickly with some liquid, without chewing, to avoid mouth irritation.

For patients taking the delayed-release capsules:

• Swallow the capsule whole.


• Do not crush, break, or chew before swallowing. Do not hold the capsule in your mouth.


• When given to children, the capsule may be opened and sprinkled on a small amount of soft food that can be swallowed without chewing, such as applesauce, gelatin, pureed bananas, or pears. This mixture must be swallowed immediately and followed with a glass of water or juice. This will ensure complete swallowing of the contents of the capsule and avoid mouth irritation.


• When given to infants, the contents of the capsule may be put directly into the infant's mouth or mixed with a small amount of applesauce, pureed bananas, or pears, and given before each feeding.


• Do not mix the contents of the capsule with alkaline foods, such as milk, breast milk, formula, or ice cream. This could reduce the effect of the medicine.

Do not change brands or dosage forms of pancrelipase without first checking with your doctor. Different products may not work in the same way. If you refill your medicine and it looks different, check with your pharmacist.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• To help digestion:
  
  • For oral dosage form (capsules):
    
    • Older adults, adults, and teenagers—One to three capsules before or with meals and snacks. Your doctor may adjust your dose if needed.
    
    
    • Children—The contents of one to three capsules sprinkled on food at each meal. Your doctor may adjust your dose if needed.
    
    
  
  
  • For oral dosage form (delayed-release capsules):
    
    • Older adults, adults, teenagers, and children older than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 500 lipase units per kilogram (kg) of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
    
    
    • Children older than 12 months and younger than 4 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 1000 lipase units per kilogram (kg) of body weight per meal. However, the dose is usually not more than 2500 lipase units per kg of body weight per meal (or less than or equal to 10,000 lipase units per kg of body weight per day), or less than 4000 lipase units per gram (g) of fat ingested per day.
    
    
    • Infants younger than 12 months—
      
      • Creon®: 3000 lipase units per 120 milliliters (mL) of infant formula or per breastfeeding.
      
      
      • Zenpep®: 3000 lipase units per 120 mL of infant formula or per breastfeeding.
      
      
      • Pancreaze™: 2000 to 4000 lipase units per 120 mL of infant formula or per breastfeeding.
      
      
    
    
  
  
  • For oral dosage form (powder):
    
    • Older adults, adults, and teenagers—1/4 teaspoonful (0.7 gram) with meals and snacks. Your doctor may adjust your dose if needed.
    
    
    • Children—1/4 teaspoonful with meals. Your doctor may adjust your dose if needed.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Older adults, adults, and teenagers—One to three tablets before or with meals and snacks. Your doctor may adjust your dose if needed.
    
    
    • Children—One to two tablets with meals.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store Creon® capsules at room temperature for 30 days. Throw away any unused medicine after 30 days.

Store the delayed-release capsules in a tightly-closed container to protect them from moisture. Putting desiccant pouches in the container may also help to keep the capsules from getting moist.

Precautions While Using Palcaps

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

For patients taking the capsules containing the powder:

• If the capsules are opened to mix with food, be careful not to breathe in the powder. To do so may cause harmful effects such as stuffy nose, shortness of breath, troubled breathing, wheezing, or tightness in the chest.

For patients taking the powder form of this medicine:

• Avoid breathing in the powder. To do so may cause harmful effects such as stuffy nose, shortness of breath, troubled breathing, wheezing, or tightness in the chest.

Check with your doctor right away if you or your child have unusual or severe abdominal or stomach pain, trouble passing stool, nausea, or vomiting. These may be symptoms of a rare but serious bowel disorder called fibrosing colonopathy.

This medicine is made from the pancreas of pigs. The risk of getting a virus from medicines made of pig organs has been greatly reduced in recent years. This is the result of required testing for certain viruses, and testing during manufacture of these medicines. Although the risk of transmitting certain viruses to people who will use the medicine is low, talk with your doctor if you or your child have concerns.

This medicine may cause a serious type of allergic reaction, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you or your child are using this medicine.

Palcaps Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Skin rash or hives

With high doses

• Bowel blockage


• diarrhea


• nausea


• stomach cramps or pain

With very high doses

• Blood in the urine


• joint pain


• swelling of the feet or lower legs

With powder dosage form or powder from opened capsules - if breathed in

• Shortness of breath


• stuffy nose


• tightness in the chest


• troubled breathing


• wheezing

With tablets - if held in mouth

• Irritation of the mouth

Incidence not known

• Cough


• difficulty with breathing


• difficulty with swallowing


• dizziness


• fast heartbeat


• itching


• noisy breathing


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness of the skin


• severe stomach pain


• unusual tiredness or weakness


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Blurred vision


• dry mouth


• flushed, dry skin


• fruit-like breath odor


• headache


• increased hunger


• increased thirst


• increased urination


• sweating


• unexplained weight loss


• vomiting

Less common

• Abnormal feces


• anxiety


• bloated


• chills


• cold sweats


• coma


• confusion


• cool, pale skin


• depression


• excess air or gas in the stomach or intestines


• fever


• frequent bowel movements


• full feeling


• muscle aches


• nightmares


• passing gas


• runny nose


• seizures


• shakiness


• slurred speech


• sore throat

Incidence not known

• Difficulty having a bowel movement (stool)


• difficulty with moving


• muscle aching or cramping


• muscle pains or stiffness


• muscle spasm


• swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Palcaps side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Palcaps resources

• Palcaps Side Effects (in more detail)
• Palcaps Use in Pregnancy & Breastfeeding
• Drug Images
• Palcaps Drug Interactions
• Palcaps Support Group
• 10 Reviews for Palcaps - Add your own review/rating

Compare Palcaps with other medications

• Chronic Pancreatitis
• Cystic Fibrosis
• Pancreatic Exocrine Dysfunction

Torsemide Solution

Pronunciation: TORE-se-mide
Generic Name: Torsemide
Brand Name: Generic only. No brands available.

Torsemide Solution is used for:

Treatment of edema (swelling) associated with heart, kidney, or liver failure, or conditions in which there is excess body water. The injection is used when a rapid decrease of swelling is desired or when a tablet cannot be taken. It is also used alone or with other medicines to treat high blood pressure. It may also be used to treat certain conditions as determined by your doctor.

Torsemide Solution is a loop diuretic. It works by making the kidneys eliminate larger amounts of electrolytes (especially sodium and potassium salts) and water than normal (diuretic effect).

Do NOT use Torsemide Solution if:

• you are allergic to any ingredient in Torsemide Solution or to a sulfonylurea (eg, glyburide)


• you are unable to urinate

Contact your doctor or health care provider right away if any of these apply to you.

Before using Torsemide Solution:

Some medical conditions may interact with Torsemide Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have fluid in your abdomen, hearing impairment, diabetes mellitus, low urine output, high blood uric acid levels, a blood disorder, kidney disease, lupus, liver disease, or heart failure


• if you have had a heart attack


• if you are dehydrated

Some MEDICINES MAY INTERACT with Torsemide Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aminoglycosides (eg, gentamicin) or cisplatin because the risk of temporary or permanent hearing loss may be increased


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin) or probenecid because they may decrease Torsemide Solution's effectiveness


• Chloral hydrate, digitalis (eg, digoxin), lithium, or suramin because the risk of their side effects may be increased by Torsemide Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Torsemide Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Torsemide Solution:

Use Torsemide Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Torsemide Solution is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not use Torsemide Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Torsemide Solution should be given intravenously slowly over a period of at least 2 minutes or as a continuous infusion.


• Torsemide Solution may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


• Avoid eating licorice or Korean ginseng while taking Torsemide Solution.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Torsemide Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Torsemide Solution.

Important safety information:

• Torsemide Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Torsemide Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Torsemide Solution may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Tell your doctor or dentist that you take Torsemide Solution before you receive any medical or dental care, emergency care, or surgery.


• Torsemide Solution may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Torsemide Solution. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.


• Torsemide Solution is a strong "water pill" (diuretic). Using too much of Torsemide Solution can lead to serious water and mineral loss. Therefore, it is important that you be monitored by your doctor. Promptly notify your doctor if you become very thirsty, have a dry mouth, become confused, or develop muscle cramps/weakness.


• Diabetes patients - Torsemide Solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Weight should be monitored while taking this medication.


• Lab tests, including kidney function, electrolyte levels, and blood pressure, may be performed while you use Torsemide Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Torsemide Solution is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Torsemide Solution while you are pregnant. It is not known if Torsemide Solution is found in breast milk. If you are or will be breast-feeding while you use Torsemide Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Torsemide Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness or lightheadedness when sitting up or standing; excessive urination; headache; increased cough; nasal inflammation; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; diarrhea; dry mouth or unusual thirst; fever, chills, or persistent sore throat; hearing loss or ringing in the ears; loss of appetite; muscle pain or cramps; rapid or irregular heartbeat; rectal bleeding; red, swollen, blistered, or peeling skin; restlessness; unusual bruising or bleeding; unusual tiredness or weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Torsemide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; dizziness; dizziness or lightheadedness when sitting up or standing; dry mouth; excessive urination followed by a decrease in amount of urine, muscle cramps, weakness, and/or rapid or irregular heartbeat.

Proper storage of Torsemide Solution:

Store Torsemide Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light. Keep Torsemide Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Torsemide Solution, please talk with your doctor, pharmacist, or other health care provider.


• Torsemide Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Torsemide Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Torsemide resources

• Torsemide Side Effects (in more detail)
• Torsemide Use in Pregnancy & Breastfeeding
• Drug Images
• Torsemide Drug Interactions
• Torsemide Support Group
• 0 Reviews for Torsemide - Add your own review/rating

Compare Torsemide with other medications

• Ascites
• Edema
• Heart Failure
• High Blood Pressure
• Nonobstructive Oliguria
• Renal Failure

Tucks Hemorrhoidal Ointment

Pronunciation: pra-MOX-een
Generic Name: Pramoxine
Brand Name: Examples include Fleet Relief and Tucks Hemorrhoidal

Tucks Hemorrhoidal Ointment is used for:

Treating pain, soreness, burning, and itching of the anal area due to hemorrhoids and other anorectal disorders.

Tucks Hemorrhoidal Ointment is a topical anesthetic. It works by blocking pain signals from the nerve endings in the skin, which helps relieve discomfort.

Do NOT use Tucks Hemorrhoidal Ointment if:

• you are allergic to any ingredient in Tucks Hemorrhoidal Ointment

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tucks Hemorrhoidal Ointment:

Some medical conditions may interact with Tucks Hemorrhoidal Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Tucks Hemorrhoidal Ointment. Because little, if any, of Tucks Hemorrhoidal Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tucks Hemorrhoidal Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tucks Hemorrhoidal Ointment:

Use Tucks Hemorrhoidal Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tucks Hemorrhoidal Ointment is for use around the rectal area only.


• Wash your hands immediately after using Tucks Hemorrhoidal Ointment.


• Wash the affected area with soap and water, and gently pat dry.


• Apply Tucks Hemorrhoidal Ointment according to the instructions on the container unless directed otherwise by your doctor.


• If you miss a dose of Tucks Hemorrhoidal Ointment, apply it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tucks Hemorrhoidal Ointment.

Important safety information:

• If your symptoms do not improve within 7 days, or if they become worse, check with your doctor.


• Avoid getting Tucks Hemorrhoidal Ointment in your eyes. If you get Tucks Hemorrhoidal Ointment in your eyes, immediately flush them with cool tap water.


• Tucks Hemorrhoidal Ointment is not recommended for use in CHILDREN younger than 12 years of age, except under the advice of a doctor. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Tucks Hemorrhoidal Ointment during pregnancy. It is unknown if Tucks Hemorrhoidal Ointment is excreted in breast milk after topical use. If you are or will be breast-feeding while you are using Tucks Hemorrhoidal Ointment, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Tucks Hemorrhoidal Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding from the rectum; new or increasing redness, pain, swelling, irritation, or other symptoms.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tucks Hemorrhoidal side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Tucks Hemorrhoidal Ointment may be harmful if swallowed.

Proper storage of Tucks Hemorrhoidal Ointment:

Store in an upright position at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tucks Hemorrhoidal Ointment out of the reach of children and away from pets.

General information:

• If you have any questions about Tucks Hemorrhoidal Ointment, please talk with your doctor, pharmacist, or other health care provider.


• Tucks Hemorrhoidal Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tucks Hemorrhoidal Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tucks Hemorrhoidal resources

• Tucks Hemorrhoidal Side Effects (in more detail)
• Tucks Hemorrhoidal Use in Pregnancy & Breastfeeding
• Tucks Hemorrhoidal Support Group
• 9 Reviews for Tucks Hemorrhoidal - Add your own review/rating

Compare Tucks Hemorrhoidal with other medications

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• Hemorrhoids
• Pain
• Pruritus

Diamicron

diamicron

gliclazide

About your medicine

What is in your medicine?

The name of your medicine is Diamicron. Each tablet contains 80 mg of the active ingredient gliclazide. In addition, the tablet contains a number of inactive ingredients. These are necessary to add bulk and consistency to medicines. They improve the packaging, storage and handling characteristics of the tablets and make them easier to use. The inactive ingredients are: lactose monohydrate, maize starch, pregelatinized maize starch, talc, magnesium stearate. Diamicron tablets are white, circular compressed tablets with flat bevelled edges and cross scoring on one face and come in cartons of 60 tablets.

What type of medicine is Diamicron?

Diamicron is one of a group of medicines called sulphonylureas.

Who makes and distributes my medicine?

Diamicron is manufactured by

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy

France

Diamicron is distributed in the UK by

Servier Laboratories Ltd.

Gallions

Wexham Springs

Framewood Road

Wexham

Slough

SL3 6RJ

The Product Licence Holder is Servier Laboratories Ltd.

What is my medicine for?

Diamicron is used in the treatment of diabetes mellitus when insulin is not necessary and when diet alone fails to lower blood glucose (sugar).

Before taking your medicine

Diamicron should not be used :

• in pregnancy,


• when breast feeding,


• for the treatment of diabetes in children,


• when there is a known allergy to sulphonylureas and other related drugs,


• in diabetics undergoing surgery, after trauma or during serious infections


• in diabetics with severe kidney or liver disease


• if you experience symptoms of hypoglycaemia (low blood sugar) such as sweating, pallor, hunger, irregular heart beat


• in patients allergic to lactose or any of the inactive ingredients.

If you think any of these situations apply to you, or you have any questions or doubts about taking
Diamicron
, you should consult your doctor, pharmacist or nurse.

Precautions

As with any treatment for diabetes, your blood sugar level will become too low if your dietary intake is reduced. If you have an infection, an operation, or suffer a serious injury, inform your doctor that you take Diamicron.

Your concentration and therefore your ability to drive or use machines, may be affected if your diabetes is not satisfactorily controlled.

Drinking alcohol can alter the control of your treatment for diabetes.

Interactions with other medicines

The treatment of your diabetes with Diamicron may be affected by a number of other medicines you may have been prescribed or have bought from the chemist. The effect of Diamicron may be increased by salicylates (aspirin), phenylbutazone (used to treat arthritis), sulphonamides, coumarin drugs (used to thin the blood), MAOIs (a type of anti-depressant), beta blockers (used to treat high blood pressure), tetracycline compounds (a type of antibiotic),chloramphenicol (a type of antibiotic), disopyramide (used to treat irregular heart beat), miconazole (an oral treatment for fungus infection), clofibrate (used to reduce fat) and cimetidine (used to treat stomach ulcers). The effect of Diamicron may be lessened by oral contraceptives, steroids, thiazide diuretics (water tablets), phenothiazine derivatives (a type of sedative), thyroid hormone and in patients who overuse laxatives.

It is most important that you consult your doctor, pharmacist or nurse if you are taking any other medicine.

Taking your medicine

The total daily dose generally varies from one half to four tablets according to your response to treatment. The dose you need will be determined and adjusted by your doctor. When the total daily dose exceeds two tablets, it should be divided into two equal doses taken morning and evening.

Tablets should be swallowed with a glass of water before a meal.

Treatment for diabetes is usually life-long.

In the event of an overdose, contact your doctor or nearest hospital casualty department immediately.

The symptoms to be expected of overdose are those of hypoglycaemia (sweating, pallor, hunger pangs, tachycardia, malaise) and can be helped by taking glucose or sweet drinks.

If you forget to take one or more doses, take another as soon as you remember and then go on as prescribed. Do not take a double dose.

This medicine should not be taken after the expiry date which is clearly marked on the outside of the box.

Undesirable effects

Unfortunately, all medicines can produce side-effects and Diamicron is not different. Diamicron used in normal doses may cause unwanted effects in some people. These can include: nausea, diarrhoea, constipation, indigestion, headache, skin rashes, itching, hypoglycaemia, the symptoms of blood dyscrasias i.e. paleness, prolonged bleeding, bruising, sore throat and fever , abnormalities of liver function including yellow skin and eyes.

If you should suffer from any undesirable effect including any not listed above, you should report it to your doctor, pharmacist or nurse.

Storage

This medicine should be kept out of reach of children.

If your doctor decides to stop your treatment, return any tablets left over to the pharmacist.

Only keep them if your doctor tells you to.

IMPORTANT REMINDER: Do not give your tablets to anyone else, even if they suffer from the same condition as you. This medicine could be harmful to them or interfere with other treatments. Your medicine has been prescribed by your doctor specifically for you.

This package information leaflet was last revised in July 2005.

UK Product Licence Holder

Servier Laboratories Ltd

Gallions

Wexham Springs

Slough

SL3 6RJ

England

Nupercainal

Generic Name: dibucaine (Topical application route)

DYE-bue-kane

Commonly used brand name(s)

In the U.S.

• Nupercainal

Available Dosage Forms:

• Cream


• Ointment

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Amide

Uses For Nupercainal

Dibucaine is used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Dibucaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.

Before Using Nupercainal

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of dibucaine have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in children are not expected.

Geriatric

No information is available on the relationship of age to the effects of dibucaine in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection at or near the place of application or


• Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased.

Proper Use of Nupercainal

Use this medicine exactly as directed by your doctor or as directed in the package instructions. Do not use it for any other reason without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

Wash your hands with soap and water before and after using this medicine.

Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.

This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Be careful not to get any of this medicine in your nose, mouth, and especially in your eyes, because it can cause severe eye irritation. If any of the medicine does get on these areas, wash the area with water for at least 15 minutes and check with your doctor right away.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (ointment):
  
  • For pain and itching caused by minor skin conditions:
    
    • Adults—Apply to the affected area three or four times a day as needed. The largest amount that may be used in a 24-hour period is 30 grams (g), but much smaller amounts are usually enough.
    
    
    • Children 2 years of age and older—Apply to the affected area three or four times a day as needed. Do not use more than 7.5 g in a 24-hour period.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Nupercainal

If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.

After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. Dibucaine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

Stop using this medicine and check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.

Do not use cosmetics or other skin care products on the treated skin areas.

Nupercainal Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Chest pain


• fast or irregular heartbeat


• tightness in the chest


• unusual warmth or flushing of skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Diarrhea


• eye irritation


• nausea


• skin irritation


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Nupercainal side effects (in more detail)

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More Nupercainal resources

• Nupercainal Side Effects (in more detail)
• Nupercainal Use in Pregnancy & Breastfeeding
• Nupercainal Support Group
• 1 Review for Nupercainal - Add your own review/rating

• Nupercainal topical Concise Consumer Information (Cerner Multum)


• Nupercainal Monograph (AHFS DI)


• Nupercainal Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

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