Pimozide Tablets USP 4mg Taj Pharma

  1. Name of the medicinal product

Pimozide Tablets USP 1mg Taj Pharma
Pimozide Tablets USP 2mg Taj Pharma
Pimozide Tablets USP 4mg Taj Pharma

  1. Qualitative and quantitative composition

Each tablet contains pimozide 1mg, 2mg or 4mg.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Tablet

The tablet can be divided into equal doses.

  1. Clinical particulars

4.1 Therapeutic indications

Pimozide is an antipsychotic of the diphenylbutyl-piperidine series and is indicated in:

– Chronic schizophrenia, for the treatment of symptoms and prevention of relapse.

– Other psychoses, especially paranoid and monosymptomatic hypochondriacal psychoses (eg delusional parasitosis).

Pimozide is indicated in adults and children over 12 years old.

4.2 Posology and method of administration

Posology

Pimozide is intended for once daily oral administration in adults and children over 12 years of age.

Since individual response to antipsychotic drugs is variable, dosage should be individually determined and is best initiated and titrated under close clinical supervision. In determining the initial dose, consideration should be given to the patient’s age, severity of symptoms and previous response to other neuroleptic drugs. Dose increases should be made at weekly intervals or longer, and by increments of 2-4 mg in the daily dose.

The patient should be reviewed regularly to ensure the minimum effective dose is being used.

Chronic schizophrenia:

The dose ranges between 2 and 20 mg daily, with 2 mg as a starting dose. This may be increased according to response and tolerance to achieve an optimum response.

Other psychoses, paranoid states and monosymptomatic hypochondriacal psychoses (MHP):

An initial dose of 4 mg daily which may then be gradually increased, if necessary, according to response, to a maximum of 16 mg daily.

Use in elderly:

Elderly patients require half the normal starting dose of pimozide.

Paediatric population (less than 12 years old)

No data are available

Method of Administration

Oral use.

4.3 Contraindications

In common with several other neuroleptics, pimozide has been reported to prolong the QT interval. It is, therefore, contra-indicated in patients with a pre-existing congenital prolongation of QT, or with a history or family history of this syndrome, and in patients with a history of cardiac arrhythmias and a history of Torsades de pointes. Pimozide should not be used in the case of acquired long QT interval, such as that associated with the concomitant use of drugs known to prolong the QT interval (see section 4.5), known uncorrected hypokalaemia or hypomagnesaemia, or clinically significant cardiac disorders (eg recent acute myocardial infarction, uncompensated heart failure, arrhythmias treated with class IA and III antiarrhythmic medicinal products) or clinically significant bradycardia.

Pimozide is also contra-indicated in patients with severe central nervous system depression and in patients with a known hypersensitivity to pimozide or other diphenylbutyl-piperidine derivatives, or to any of the excipients listed in section 6.1. It should not be used in patients with depression or Parkinson’s syndrome.

The concomitant use of orally or parenterally administered cytochrome P450 CYP 3A4 inhibiting drugs such as azole antimycotics, antiviral protease inhibitors, macrolide antibiotics and nefazodone is contra-indicated. The concomitant use of CYP 2D6 inhibiting drugs such as quinidine is also contra-indicated. The inhibition of either or both of these cytochrome P450 systems may result in the elevation of pimozide blood concentration and increase the possibility of QT-prolongation.

Pimozide is contraindicated with concomitant use of serotonin uptake inhibitors such as sertraline, paroxetine, citalopram and escitalopram (see Section 4.5).

4.4 Special warnings and precautions for use

Please also refer to Drug Interactions section.

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.

Pimozide is not licensed for the treatment of dementia-related behavioral disturbances.

Cardiac monitoring (See also Section 4.3)

There have been very rare reports of QT prolongation, ventricular arrhythmias, and Torsade de Pointes in patients without risk factors for QT prolongation administered therapeutic doses of pimozide, and in the setting of overdose. Ventricular tachycardia and ventricular fibrillation (in some cases with fatal outcomes) have also been reported, in addition to very rare reports of sudden death and cardiac arrest.

As with other neuroleptics, cases of sudden unexpected death have been reported with pimozide at recommended doses and in the setting of overdose. An ECG should be performed prior to initiation of treatment with pimozide, as well as periodically during treatment. If repolarization changes (prolongation of QT interval, T-wave changes or U-wave development) appear or arrhythmias develop, the need for treatment with pimozide in these patients should be reviewed. They should be closely monitored and their dose of pimozide should be reduced or the drug discontinued. If QT or QTc exceeds 500 msec, pimozide should be discontinued.

As with other neuroleptics, caution is advised in patients with cardiovascular diseases.

Electrolyte disturbances should also be considered a risk factor (see Section 4.3 and Section 4.5) and periodic electrolyte monitoring is recommended.

Drugs which may cause electrolyte disturbances are not recommended in patients receiving long-term pimozide (please also refer to the Section 4.5).

Venous Thromboembolism (VTE)

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 Pimozide and preventive measures undertaken.

Liver disease

Caution is advised in patients with liver disease because pimozide is metabolized in the liver.

Kinetics of response/withdrawal

In schizophrenia, the response to antipsychotic drug treatment may be delayed. If drugs are withdrawn, recurrence of symptoms may not become apparent for several weeks or months.

Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia, have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic 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.

Extrapyramidal symptoms

In common with all neuroleptics, extrapyramidal symptoms may occur (see Section 4.8). Antiparkinsonian drugs of the anticholinergic type may be prescribed as required, but should not be prescribed routinely as a preventive measure (see tardive dyskinesia below).

Tardive dyskinesia

As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or after drug discontinuation. The syndrome is mainly characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw. The manifestations may be permanent in some patients.

The syndrome may be masked when treatment is reinstituted, when the dosage is increased or when a switch is made to a different antipsychotic drug. Treatment should be discontinued as soon as possible.

There is no known treatment for tardive dyskinesia. The antipsychotic drug may mask it, as may anticholinergic agents. Although the latter do not predispose to tardive dyskinesia, they should not be used routinely to mask the Parkinsonian effects of antipsychotic drugs as they may mask the early signs of tardive dyskinesia.

Neuroleptic malignant syndrome

In common with other antipsychotic drugs, pimozide has been associated with neuroleptic malignant syndrome: an idiosyncratic response characterized by hyperthermia, generalised muscle rigidity, autonomic instability, altered consciousness. Hyperthermia is often an early sign of this syndrome.

Antipsychotic treatment should be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted.

Seizures

As with other antipsychotic drugs, pimozide should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold (e.g. alcohol withdrawal or brain damage). In addition, grand mal convulsions have been reported in association with pimozide.

Body Temperature Regulation

Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing pimozide to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity or being subject to dehydration.

Endocrine Effects

Hormonal effects of antipsychotic neuroleptic drugs include hyperprolactinaemia, which may cause galactorrhoea, gynaecomastia, oligomenorrhoea or amenorrhoea, and erectile dysfunction.

Pimozide should only be used with great caution in patients with thyrotoxicosis.

Other

Caution is also advised in patients with renal failure, Parkinson’s disease and phaeochromocytoma.

Concomitant use of pimozide with other neuroleptics should be avoided.

4.5 Interaction with other medicinal products and other forms of interaction

Please also refer to the Precautions and Warnings and Contra-indications sections.

– As with other neuroleptics, Pimozide may increase the central nervous system depression produced by other CNS depressant drugs, including alcohol, hypnotics, sedatives or strong analgesics.

– Pimozide may impair the anti-Parkinson effect of levodopa. The dosage of anticonvulsants may need to be increased to take account of lowered seizure threshold.

– Concomitant use of pimozide with drugs known to prolong the QT interval is contra-indicated (see section 4.3). Examples include certain antiarrhythmics, such as those of Class IA (such as quinidine, disopyramide and procainamide) and Class III (such as amiodarone and sotalol), tricyclic antidepressants (such as amitriptyline), certain tetracyclic antidepressants (such as maprotiline), certain other antipsychotic medications (such as phenothiazines and sertindole), certain antihistamines (such as terfenadine), cisapride, bretylium and certain antimalarials such as quinine and mefloquine. This list is not comprehensive.

– There is an increased risk of extrapyramidal effects with anti-emetics such as metoclopramide.

– Avoid concomitant use with sibutramine due to an increased risk of CNS toxicity.

– Concomitant use with calcium channel blockers may result in an enhanced hypotensive effect.

– Concurrent treatment with neuroleptics should be kept to a minimum as they may predispose to the cardiotoxic effects of pimozide. Particular care should be exercised in patients who are using depot neuroleptics. Low potency neuroleptics such as chlorpromazine and thioridazine should not be used concomitantly with pimozide.

– Pimozide is metabolised mainly via the cytochrome P450 subtype 3A4 (CYP 3A4) enzyme system and, to a lesser extent, via the CYP 2D6 subtype. Concomitant use of pimozide with drugs known to be inhibitors of cytochrome P450 CYP 3A4 or CYP 2D6 is contraindicated (see Section 4.3).

– In vitro data indicate that highly potent inhibitors of the CYP 3A4 enzyme system, such as azole antimycotics, antiviral protease inhibitors, macrolide antibiotics and nefazodone will inhibit the metabolism of pimozide, resulting in markedly elevated plasma levels of pimozide.

– In vitro data also indicated that quinidine diminishes the CYP 2D6 dependent metabolism of pimozide.

– Elevated pimozide levels may enhance the risk of QT-prolongation.

– As grapefruit juice is known to inhibit the metabolism of CYP3A4 metabolised drugs, concomitant use of grapefruit juice with pimozide should be avoided.

– An in vivo study of pimozide added to steady state sertraline revealed a 40% increase in the pimozide AUC and Cmax (see Section 4.3).

– An in vivo study of co-administered pimozide and citalopram resulted in a mean increase of QTc values of approximately 10 milliseconds. Citalopram did not alter the AUC and Cmax of pimozide (see Section 4.3).

– An in vivo study of co-administered pimozide (a single 2 mg dose) and paroxetine (60 mg daily) was associated with mean increases of 151% in pimozide AUC and 62% in pimozide Cmax (see Section 4.3).

– As CYP1A2 may also contribute to the metabolism of pimozide, prescribers should be aware of the theoretical potential for drug interactions with inhibitors of this enzymatic system.

– Concurrent use of drugs causing electrolyte imbalance is not recommended. Diuretics, in particular those causing hypokalemia, should be avoided but, if necessary, potassium-sparing diuretics are preferred.

4.6 Fertility, pregnancy and lactation

Pregnancy

The safety of pimozide in pregnancy has not been established. Therefore, it should not be administered to women of child-bearing potential, particularly during the first trimester of pregnancy, unless, in the opinion of the physician, the expected benefits of the drug to the patient outweigh the potential risk to the foetus.

Studies in animals have shown reproductive toxicity but no teratogenic effects have been demonstrated (see section 5.3).

Neonates exposed to antipsychotic drugs (including pimozide) during the third trimester of pregnancy are at risk of adverse effects including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

Breastfeeding

Pimozide may be excreted in breast milk. If the use of Pimozide is considered essential, breast feeding should be discontinued.

4.7 Effects on ability to drive and use machines

Pimozide may impair alertness, especially at the start of treatment. These effects may be potentiated by alcohol. Patients should be warned of the risks of sedation and advised not to drive or operate machinery during treatment until their susceptibility is known.

4.8 Undesirable effects

The safety of PIMOZIDE was evaluated in 165 pimozide-treated subjects who participated in seven placebo-controlled trials of patients with schizophrenia, or patients with anxiety or behavioural disorders, and in 303 pimozide-treated subjects who participated in eleven active-comparator controlled clinical trials in patients with schizophrenia (10 trials, including chronic schizophrenia) or psychic fatigability (1 trial). Based on pooled safety data from these clinical trials, the most commonly reported (≥ 9% incidence) Adverse Drug Reactions (ADRs) were (with % incidence): Nervous System Disorders: Dizziness (11) and Somnolence (11), Extrapyramidal Disorder (9); Muscle Rigidity (9); Hyperhidrosis (13); Nocturia (12).

Including the above-mentioned ADRs, the following table (next page) displays ADRs that have been reported with the use of PIMOZIDE from either clinical-trial or post-marketing experiences. The displayed frequency categories use the following convention:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated form the available data)

System Organ Class Adverse Drug Reactions
Frequency Category
Very Common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Not Known
Endocrine Disorders Hyperglycaemia (in patients with pre-existing diabetes); Blood Prolactin Increased
Metabolism and Nutrition Disorders Anorexia Hyponatraemia
Psychiatric Disorders Depression; Insomnia; Agitation; Restlessness Libido Decreased
Nervous System Disorders Dizziness; Somnolence; Extrapyramidal Disorder; Akathisia; Headache; Tremor; Lethargy; Muscle Rigidity Bradykinesia; Cogwheel Rigidity; Dyskinesia; Dystonia; Dysarthria Neuroleptic Malignant Syndrome; Grand Mal Convulsion; Tardive Dyskinesia; Neck Rigidity
Eye Disorders Vision Blurred Oculogyric crisis
Cardiac Disorders Torsade de Pointes; Ventricular Tachycardia; Ventricular Fibrillation
Gastrointestinal Disorders Constipation; Dry Mouth; Vomiting; Salivary Hypersecretion
Skin and subcutaneous tissue disorders Hyperhidrosis Sebaceous Gland Overactivity Pruritus; Rash, Urticaria
Musculoskeletal and Connective Tissue Disorders Muscle Spasms
Renal and urinary disorders Nocturia Urinary frequency Glycosuria
Pregnancy, puerperium and perinatal conditions. Drug withdrawal syndrome neonatal (see 4.6)
Reproductive System and Breast Disorders Erectile Dysfunction Amenorrhoea Galactorrhoea; Gynaecomastia
General Disorders and Administration Site Conditions Extreme exhaustion Face oedema Body Temperature Dysregulation; Hypothermia
Investigations Weight increased Electrocardiogram QT Interval Prolonged; Electroencephalogram Abnormal

In addition to the above, cardiac arrest and sudden unexplained death have been reported with the use of pimozide. These events should be considered ADRs associated with the class of medicinal products, the D2, dopamine-antagonist neuroleptics.

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs (frequency unknown).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

In general, the signs and symptoms of overdose with Pimozide would be an exaggeration of known pharmacological effects, the most prominent of which would be severe extrapyramidal symptoms, hypotension or sedation. The risk of cardiac arrhythmias, possibly associated with QT-prolongation and ventricular arrhythmias including Torsade de Pointes, should be considered. The patient may appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state.

Treatment:

There is no specific antidote to pimozide. Establishment of a patent airway and if necessary, mechanically assisted respiration, are advised. Continuous electrocardiographic monitoring should be performed due to the risk of QT interval prolongation and ventricular arrhythmias including Torsade de Pointes and continued until the ECG returns to normal. Hypotension and circulatory collapse may be counteracted by the use of intravenous fluids, plasma or concentrated albumin, and vasopressor agents such as noradrenaline.

Adrenaline should not be used.

In cases of severe extrapyramidal symptoms, anti-Parkinson medication should be administered.

Because of the long half-life of pimozide, patients who have taken an overdose should be observed for at least 4 days.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pimozide is an orally active neuroleptic drug which blocks central dopaminergic receptors. Pimozide antagonises many of the actions of amphetamine and apomorphine.

5.2 Pharmacokinetic properties

The mean serum elimination half-life in schizophrenic patients is approximately 55 hours. This is highly variable and may be as long as 150 hours in some individuals. There is a 13-fold interindividual difference in the area under the serum pimozide concentration-time curve and an equivalent degree of variation in peak serum levels among patients studied. The significance of this is unclear since there are few correlations between plasma levels and clinical findings.

5.3 Preclinical safety data

The results of mutagenic studies indicate no genotoxicity. Carcinogenicity studies revealed no treatment related tumors in rats or male mice, but increased incidences of pituitary adenomas and mammary gland adenocarcinomas in female mice. These histopathology changes in the mammary gland and pituitary are thought to be prolactin-mediated and have been shown in rodents following hyperprolactinaemia by a variety of neuroleptic drugs with the relevance to humans being unknown. Due to the lack of toxicokinetic data in rodents the safety margin cannot be determined. Animal data has shown some embryo-toxicity at dose levels similar to the maximum human use level (MHUL). Fetal growth retardation and fetaltoxicity was observed at dose levels of approximately 6 times the MHUL on an mg/kg basis. Teratogenic effects have not been observed.

Pimozide has been shown in studies in vitro to block the cardiac hERG channel and to prolong the action potential duration in isolated perfused hearts. This effect on the hERG channel may be attenuated by pimozide’s blocking effect on the cardiac calcium L channel. In a number of in vivo animal studies intravenous or oral administration of pimozide has been shown to cause significant QTc prolongation. The doses which prolonged QTc did not cause arrhythmias.

  1. Pharmaceutical particulars

6.1 List of excipients

Calcium hydrogen phosphate dihydrate

Maize starch

Microcrystalline cellulose

Polyvidone K30

Talc

Cottonseed Oil Hydrogenated

Ferric oxide

Indigotindisulphonate – aluminium lake

Purified water*

* not in final product

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

PVC/aluminium foil blister packs, containing 28, 100 or 250 tablets.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Pimozide Tablets USP 1mg/2mg/4mg Taj Pharma

Pimozide

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

– Keep this leaflet. You may need to read it again.

– If you have any further questions, ask your doctor, pharmacist or nurse.

– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Pimozide is and what it is used for
  2. What you need to know before you take Pimozide
  3. How to take Pimozide
  4. Possible side effects
  5. How to store Pimozide
  6. Contents of the pack and other information

 

  1. What Pimozide is and what it is used for

The name of your medicine is Pimozide 4 mg tablets. They are called ‘Pimozide tablets’ or just ‘Pimozide’ in this leaflet.

Pimozide tablets contain a medicine called pimozide. This belongs to a group of medicines called ‘neuroleptics’.

Pimozide tablets are used for illnesses affecting the way you think, feel or behave. These illnesses may make you:

  • Feel confused
  • See, hear or feel things that are not there (hallucinations)
  • Believe things that are not true (delusions)
  • Feel unusually suspicious (paranoia)

Important – it may take some time before you feel the full effect of the medicine but it is important

that you carry on taking it for as long as your doctor has told you.

  1. What you need to know before you take Pimozide

Do not take Pimozide:

– if you are allergic to pimozide or any of the other ingredients of this medicine (listed in section 6).

– You are allergic to similar medicines

– You have ever had an irregular heart beat (arrhythmia) or unusually slow heart beat

(bradycardia)

– You have recently had a heart attack or have heart failure

– You suffer from a heart problem known as ‘QT-prolongation’. This problem sometimes runs in

families and can only be confirmed by an electrocardiogram (ECG). An ECG measures the

electrical activity of your heart

– You have lower than normal levels of minerals (electrolytes) in your blood. Your doctor will advise you

– You have Parkinson’s disease

– You are suffering from depression

– You are less aware of things around you or your reactions become slower

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or

pharmacist before using Pimozide tablets.

Warnings and precautions

Talk to your doctor or pharmacist before using Pimozide

– if you have a heart problem or anyone in your close family has died suddenly of heart problems

– if you have liver or kidney problems

– if you have epilepsy or any other problem that can cause fits (convulsions)

– if you have problems with your thyroid gland

– if you have a non-cancerous tumour of the adrenal gland (phaeochromocytoma)

– if you have a history of blood clots, or someone else in your family has (as medicines like this

have been associated with formation of blood clots)

– if you exercise hard, are going somewhere very hot or don’t drink enough

You may need to be more closely monitored, and the amount of Pimozide tablets you take may have to be altered.

Medical check ups

Your doctor may want to take an electrocardiogram (ECG) before or during your treatment with Pimozide

tablets. The ECG measures the electrical activity of your heart.

Blood tests

Your doctor may want to check the levels of minerals (electrolytes) in your blood.

Other medicines and Pimozide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

In particular, do not take this medicine and tell your doctor if you are taking any of the following

medicines:

– for fungal infections such as ketoconazole, itraconazole, miconazole, fluconazole

– certain antibiotics such as erythromycin, clarithromycin, azithromycin, troleandomycin

– antiviral protease inhibitors such as indinavir, ritonavir, saquinavir

– for the heart such as quinidine, disopyramide, procainamide, amiodarone, sotalol, bretylium

– for allergies such as terfenadine

– for some digestive problems such as cisapride

– for treating or preventing malaria such as mefloquine, quinine

– for depression such as nefazodone, amitriptyline, maprotiline, sertraline, paroxetine, citalopram,

escitalopram

– for mental illness such as chlorpromazine, thioridazine, sertindole

– for weight control such as sibutramine

Do not start taking Pimozide tablets and tell your doctor if you are taking any of the above.

Tell your doctor before taking any of the following medicines.

– Anxiety or help you to sleep (tranquillisers)

– Severe pain (strong painkillers)

– Parkinson’s disease

– Epilepsy or fits (convulsions)

– Sickness such as metoclopramide

– High blood pressure such as calcium channel blockers and diuretics

Tell your doctor before taking any of the above. They may need to alter the dose of Pimozide tablets or

your other medicine.

Pimozide with food, drink and alcohol

Do not drink grapefruit juice while taking Pimozide tablets.

Drinking alcohol while you are taking Pimozide tablets might make you feel drowsy and less alert. This

means you should be careful how much alcohol you drink.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

The following symptoms may occur in newborn babies of mothers that have used Pimozide in the last

trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness,

agitation, breathing problems and difficulty in feeding. If your baby develops any of these symptoms

you may need to contact your doctor.

You may still be able to take Pimozide tablets if your doctor thinks you need to.

Do not take this medicine if you are breast-feeding. This is because small amounts may pass into the mother’s milk.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines

This medicine may affect you being able to drive. Do not drive or use any tools or machines without

discussing this with your doctor first.

  1. How to take Pimozide

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

You can take Pimozide tablets with or without food. Swallow the tablets with some water.

How much should you take

Your doctor will tell you how many Pimozide tablets to take and for how long. Your doctor will adjust the

dose to suit you. It is very important you take the correct amount.

Your dose will depend on:

– Your age

– How serious your symptoms are

– How you have reacted to similar medicines in the past

Use in adults and children over 12 years old

– Your starting dose will normally be between 2 mg and 4 mg. You will take this once a day

– Your doctor may want to gradually increase this dose to find the dose which suits you best. The

maximum amount that you should take in one day is 20 mg

– Your doctor may reduce the dose of Pimozide  tablets when your symptoms begin to improve

Use in children under 12 years old

Not recommended.

Use in elderly people

– Elderly people are normally started on a lower dose

– The amount of Pimozide tablets you take will then be adjusted until the doctor finds the dose that

suits you best

The tablet can be divided into equal doses.

If you stop taking Pimozide tablets

Take the medicine for as long as your doctor has told you. It may be some time before you feel the full

effect of the medicine.

Unless your doctor tells you otherwise, you should stop taking Pimozide tablets gradually. Stopping

treatment suddenly may cause effects such as:

  • Feeling sick (nausea) or being sick (vomiting)
  • Difficulty sleeping
  • Sweating

Always follow your doctor’s instructions carefully.

If you take more Pimozide than you should

If you take more Pimozide tablets than you were told to or if someone else has taken any Pimozide tablets, talk

to a doctor or go to the nearest hospital casualty department straight away.

If you forget to take Pimozide

– If you forget to take a dose, take your next dose as usual. Then keep taking your medicine as

your doctor has told you

– Do not take a double dose to make up for a forgotten dose

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Pimozide tablets and tell your doctor straight away if you notice or suspect any of the

following. You may need urgent medical treatment.

– Rash, hives (also known as nettle rash or urticaria), severe irritation of your skin. These may be

signs of a severe allergic reaction. This only happens in a small number of people

– A serious problem called ‘neuroleptic malignant syndrome’. The signs may include:

  • Fast heart beat, changing blood pressure and sweating followed by fever
  • Faster breathing, muscle stiffness, reduced consciousness and coma
  • Raised levels of a protein in your blood (an enzyme called creatine phosphokinase)

– Your heart:

  • Beats abnormally (arrhythmia)
  • Flutters (fibrillates)
  • Beats unusually fast (tachycardia)

An arrhythmia can cause your heart to stop beating (cardiac arrest). Unexplained deaths have

occurred rarely in patients taking this type of medicine

– Jerky movements and problems such as slowness, muscle stiffness or spasm, shaking, trembling

or tremors, feeling restless and stiff neck. More saliva than normal, twitching or unusual

movements of the tongue, face, mouth, jaw or throat, difficulty speaking or rolling of the eyes.

If you get any of these effects, you may be given an additional medicine

– Low sodium levels in the blood which can cause tiredness and confusion, muscle twitching, fits or coma.

Tell your doctor or pharmacist straight away if you notice or suspect any of the following side effects:

Very common side effects (affects more than 1 in 10 patients)

  • Sweating more than usual
  • Urinating (passing water) at night
  • Feeling dizzy
  • Feeling sleepy

Common side effects (affects up to 1 in 10 patients)

  • Feeling agitated or restless
  • Feeling low or depressed
  • Difficulty sleeping
  • Feeling tired or lacking in energy
  • Loss of appetite
  • Dry mouth
  • Being sick
  • Constipation
  • Headache
  • Blurred vision
  • Very oily skin
  • Need to pass water (urine) more often than usual
  • In men, erection problems
  • Weight gain

Uncommon side effects (affects up to 1 in 100 patients)

  • In women, no monthly period
  • Swollen face

Not known (cannot be estimated from the available data)

  • Fits or seizures (convulsions)
  • Hormone changes which may lead to:
  • Some women unexpectedly producing breast milk
  • Some men experiencing swelling of their breast
  • Some people losing interest in sex
  • Body temperature changes

Test results:

  • Sugar in the urine
  • High blood sugar levels (if you already have diabetes)
  • Abnormal heart traces (electrocardiogram, ‘ECG’) or brain traces (electroencephalogram ‘EEG’)

Medicines similar to Pimozide  may cause blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing

chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately

Medicines similar to Pimozide used by mothers in the last trimester (last three months of pregnancy) have been associated with the following symptoms in newborn babies: shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking neuroleptics compared with those not receiving neuroleptics.

  1. How to store Pimozide

Keep this medicine out of the sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Pimozide contains

– The active substance is pimozide. The tablets contain 4 mg of pimozide.

– The other ingredients are calcium hydrogen phosphate dihydrate, maize starch, microcrystalline cellulose, polyvidone, talc, cottonseed oil- hydrogenated, ferric oxide and indigotindisulphonate sodium.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com