Chlorpromazine Hydrochloride Tablets 25mg Taj Pharma

1. Name of the medicinal product

Chlorpromazine Hydrochloride Tablets 10mg Taj Pharma
Chlorpromazine Hydrochloride Tablets 25mg Taj Pharma
Chlorpromazine Hydrochloride Tablets 50mg Taj Pharma
Chlorpromazine Hydrochloride Tablets 100mg Taj Pharma
Chlorpromazine Hydrochloride Tablets 200mg Taj Pharma

2. Qualitative and quantitative composition

a) Chlorpromazine Hydrochloride Tablets 10mg Taj Pharma
Each film-coated tablet contains:
Chlorpromazine Hydrochloride USP 10mg
Excipients: Q.S.

b) Chlorpromazine Hydrochloride Tablets 25mg Taj Pharma
Each film-coated tablet contains:
Chlorpromazine Hydrochloride USP 25mg
Excipients: Q.S.

c) Chlorpromazine Hydrochloride Tablets 50mg Taj Pharma
Each film-coated tablet contains:
Chlorpromazine Hydrochloride USP 50mg
Excipients: Q.S.

d) Chlorpromazine Hydrochloride Tablets 100mg Taj Pharma
Each film-coated tablet contains:
Chlorpromazine Hydrochloride USP 100mg
Excipients: Q.S.

e) Chlorpromazine Hydrochloride Tablets 200mg Taj Pharma
Each film-coated tablet contains:
Chlorpromazine Hydrochloride USP 200mg
Excipients: Q.S.

See 6.1 for excipients.

3. Pharmaceutical form

Film-coated tablet

Round, white, film-coated tablet.

4. Clinical particulars

• Therapeutic indications

Schizophrenia and other psychoses (especially paranoia), mania and hypomania. In anxiety, psychomotor agitation, excitement, violent or dangerously impulsive behaviour. Is used as an adjunct in the short-term management of these conditions.

Intractable hiccup.

Nausea and vomiting in terminal illness (where other drugs have failed or are not available).

Induction of hypothermia is facilitated by Chlorpromazine Taj Pharma Tablets which prevents shivering and causes vasodilatation.

Childhood schizophrenia and autism.

• Posology and method of administration

Dosages should be low to begin with and gradually increased under close supervision until the optimum dosage for the individual is reached. Individuals vary considerably and the optimum dose may be affected by the formulation used.

Dosage of chlorpromazine in schizophrenia, other psychoses, anxiety and agitation etc.

Adult:

Initially 25mg t.d.s. or 75mg at bedtime increasing by daily amounts of 25mg to an effective maintenance dose. This is usually in the range 75 to 300mg daily but some patients may require up to 1 g daily.

Children under 1 year:

Do not use unless need is life saving.

Children 1-5 years:

0.5mg/kg body weight every 4-6 hours to a maximum recommended dose of 40mg daily.

Children 6-12 years:

¹/₃-½ adult dose to a maximum recommended dose of 75mg daily.

Elderly or debilitated patients:

Start with ¹/₃-½ usual adult dose with a more gradual increase in dosage.

Hiccups

Adult:

25-50mg t.d.s. or q.d.s.

Children under 1 year:

No information available.

Children 1-5 years:

No information available.

Children 6-12 years:

No information available.

Elderly or debilitated patients:

As for adults.

Nausea and vomiting of terminal illness:

Adults:

10-25mg every 4-6 hours.

Children under 1 year:

Do not use unless need is life saving.

Children 1-5 years:

0.5mg/kg every 4-6 hours. Maximum daily dosage should not exceed 40mg.

Children 6-12 years:

0.5mg/kg every 4-6 hours. Maximum daily dosage should not exceed 75mg.

Elderly or debilitated patients:

Initially ¹/₃-½ adult dose. The physician should then use his clinical judgment to obtain control.

Method of administration: Oral

• Contraindications

• Hypothyroidism
• Cardiac failure
• Phaeochromocytoma
• Myasthenia gravis
• Hypersensitivity to chlorpromazine, phenothiazines or one of the other constituents.
• Risk of angle-closure glaucoma.
• Risk of urinary retention related to urethroprostatic disorders.
• History of agranulocytosis.
• Dopaminergic antiparkinsonism agents (see Section 4.5).
• Nursing mothers (see Section 4.6).
• Gluten allergy or intolerance (see Section 4.4).
• Citalopram, escitalopram.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

• Special warnings and precautions for use

Blood Dyscrasias: Agranulocytosis has been reported rarely, most commonly in the first three months of treatment, but occasionally later. Other blood dyscrasias including thrombocytopenia and haemolytic anaemia have occurred very rarely. All patients must be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment will be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the latter.

Neuroleptic malignant syndrome: treatment must be interrupted in the event of unexplained hyperpyrexia since this can be one of the signs of neuroleptic malignant syndrome (pallor, hyperthermia, disorders of autonomic function). Signs of autonomic instability, such as hyperhydrosis and irregular blood pressure, can precede the onset of hyperthermia and as such constitute premonitory signs of the syndrome. While this neuroleptic-related effect can be of idiosyncratic origin, certain risk factors such as dehydration and brain damage would seem to indicate a predisposition.

Neuroleptic phenothiazines may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and congenital or acquired (i.e. drug induced) QT prolongation. If the clinical situation permits, medical and laboratory evaluations should be performed to rule out possible risk factors before initiating treatment with a neuroleptic agent and as deemed necessary during treatment (see Section 4.8).

Where clinically possible, the absence of any factors favouring the onset of ventricular arrhythmias should be ensured before administration:

• bradycardia less than 55 beats per minute;
• hypokalaemia;
• congenital long QT interval;
• ongoing treatment with any drug which could induce marked bradycardia (<55 beats per minute), hypokalaemia, intracardiac conduction depression or QT prolongation (see Section 4.5).

With the exception of emergencies, it is recommended that the initial work up of patients receiving a neuroleptic should include an ECG.

Except under exceptional circumstances, this drug must not be administered to patients with Parkinson’s disease.

The concomitant use of chlorpromazine with lithium, other QT prolongation agents, and dopaminergic antiparkinsonism agents is not recommended (see Section 4.5). Anti-Parkinson agents should not be prescribed routinely, because of the possible risks of aggravating anticholinergic side effects of chlorpromazine, of precipitating toxic-confusional states or of impairing its therapeutic efficacy. They should only be given as required.

Cases of venous thromboembolism (VTE) sometimes fatal, have been reported with antipsychotic drugs. Therefore Chlorpromazine Taj Pharma Tablets should be used with caution in patients with risk factors for thromboembolism (see Section 4.8).

Stroke: In randomised clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patient cannot be excluded. Chlorpromazine Taj Pharma should be used with caution in patients with stroke risk factors.

Elderly Patients with Dementia: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5% compared to a rate of about 2.65 in the placebo group. Although the cause of death in clinical trials with atypical antipsychotics were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patient is not clear.

Chlorpromazine Taj Pharma commonly causes increased susceptibility to sunburn and patients should be warned to avoid excessive exposure. Phototoxic or photoallergic reactions may occur. Various skin rashes and reactions, including exfoliative dermatitis and erythema multiforme have been reported. Contact skin sensitivity may be produced by contact with chlorpromazine. The occurrence of antinuclear antibodies has been reported. SLE has very rarely occurred.

Chlorpromazine Taj Pharma impairs body temperature regulation and cases of severe hypothermia or hyperpyrexia have been reported, usually in association with moderate or high dosage. The elderly or hypothyroid patient may be particularly susceptible to hypothermia. The hazard of hyperthermia may be increased by especially hot or humid weather or by drugs, such as anti-Parkinson agents, which impair sweating. It has also been reported after intramuscular injections of chlorpromazine.

Hyperglycaemia or intolerance to glucose has been reported in patients treated with Chlorpromazine Taj Pharma Tablets. Patients with an established diagnosis of diabetes mellitus or with risk factors for the development of diabetes who are started on Chlorpromazine Taj Pharma Tablets should get appropriate glycaemic monitoring during treatment (see Section 4.8).

• The following populations must be closely monitored after administration of chlorpromazine.
• epileptics, since chlorpromazine may lower the seizure threshold. Treatment must be discontinued if seizures occur.
• elderly patients presenting with heightened susceptibility to orthostatic hypotension, sedation and extrapyramidal effects; chronic constipation (risk of paralytic ileus), and potentially prostatic hypertrophy.
• patients presenting with certain forms of cardiovascular disease, since this class of drug has quinidine-like effects and can induce tachycardia and hypotension.
• patients with severe liver and/or renal failure because of the risk of accumulation.
• Patients on long-term treatment should receive regular ophthalmological and haematological examinations.
• Patients are strongly advised not to consume alcohol and alcohol-containing drugs throughout treatment (see Section 4.5).
• Chlorpromazine Taj Pharma tablets contain lactose and therefore patients with rare hereditary problems of congenital galactosemia, glucose or galactose malabsorption syndrome, lactase deficiency, galactose intolerance or the Lapp lactase deficiency should not take this medicine.

Chlorpromazine Taj Pharma can rarely cause obstructive jaundice associated with stasis in biliary canaliculi. It has been thought to be a hypersensitivity reaction and some cases have shown premonitory fever and associated eosinophilia. It has normally been reversible on stopping the drug, but extremely rare cases of progressive liver disease have been reported. In most cases the jaundice has appeared between one to four weeks after the start of the treatment. Chlorpromazine Taj Pharma treatment should be withdrawn and not given again.

Transient abnormalities of liver function tests may occur in the absence of jaundice.

Faecal impaction, severe paralytic ileus or megacolon have been reported. The signs of intestinal obstruction may be obscured by the anti-emetic action of chlorpromazine. The onset of paralytic ileus, potentially indicated by abdominal bloating and pain must be treated as an emergency (see Section 4.8).

With long-term usage, chlorpromazine can cause increased melanin pigmentation of the skin, which eventually may develop a bluish-grey colouration. Pigment deposits also occur in the eye and other tissues. Permanent deposits, leading to impairment of vision, may develop in the lens. Epithelial keratopathy has been reported. Toxic pigmentary retinopathy, which may cause progressive loss of vision has occurred very rarely, with excessively high doses.

Acute withdrawal symptoms including nausea, vomiting and insomnia have rarely been described after abrupt cessation of high doses of chlorpromazine. Gradual withdrawal is advisable.

The elderly are especially susceptible to the sedative and hypotensive effects of Chlorpromazine Taj Pharma Tablets.

Chlorpromazine Taj Pharma Tablets are not licenced for the treatment of dementia-related behavioural disturbances.

• Interaction with other medicinal products and other forms of interaction

Combinations contraindicated

Dopaminergics (quinagolide, cabergoline), not including dopaminergic antiparkinsonism agents, are contraindicated (see Section 4.3): reciprocal antagonism of the dopaminergic agent and neuroleptic.

Combinations not recommended

Dopaminergic antiparkinsonism agents (amantadine, bromocriptine, cabergoline, levodopa, lisuride, pergolide, piribedil, ropinirole) are not recommended: reciprocal antagonism of the antiparkinsonism agent and neuroleptic (see Section 4.4). Neuroleptic-induced extrapyramidal syndrome should be treated with an anticholinergic rather than a dopaminergic antiparkinsonism agent (dopaminergic receptors blocked by neuroleptics).

Levodopa: reciprocal antagonism of levodopa and the neuroleptic. In Parkinson’s patients, it is recommended to use the minimal doses of each drug.

QT prolonging drugs: there is an increased risk of arrhythmias when chlorpromazine is used with concomitant QT prolonging drugs (including certain antiarrhythmics and other antipsychotics including sultopride) and drugs causing electrolyte imbalance (see Section 4.4).

Alcohol: alcohol potentiates the sedative effect of neuroleptics. Changes in alertness can make it dangerous to drive or operate machinery. Alcoholic beverages and medication containing alcohol should be avoided (see Section 4.4).

Lithium (high doses of neuroleptics): concomitant use can cause confusional syndrome, hypertonia and hyperreflexivity, occasionally with a rapid increase in serum concentrations of lithium (see Section 4.4).

Combinations requiring precautions

Antidiabetic agents: concomitant administration of high chlorpromazine doses (100mg/day), and antidiabetic agents can lead to an increase in blood sugar levels (decreased insulin release). Forewarn the patient and advise increased self-monitoring of blood and urine levels. If necessary, adjust the antidiabetic dosage during and after discontinuing neuroleptic treatment.

Topical gastrointestinal agents (magnesium, aluminium and calcium salts, oxides and hydroxides): decreased GI absorption of phenothiazine neuroleptics. Do not administer phenothiazine neuroleptics simultaneously with topical GI agents (administer more than 2 hours apart if possible).

Combinations to be taken into consideration

Antihypertensive agents: potentiation of the antihypertensive effect and risk of orthostatic hypotension (additive effects). Phenothiazines enhance the hypotensive effect of anaesthetics and calcium channel blockers. Severe postural hypotension may occur with concomitant administration of chlorpromazine and ACE inhibitors.

Atropine and other atropine derivatives: imipramine antidepressants, histamine H1-receptor antagonists, anticholinergic, antiparkinsonism agents, atropinic antispasmodics, disopyramide: build up of atropine-associated adverse effects such as urinary retention, constipation and dry mouth.

Other CNS depressants: morphine derivatives (analgesics, antitussives and substitution treatments), barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, antihypertensive agents increased central depression. Respiratory depression may occur. Changes in alertness can make it dangerous to drive or operate machinery.

The action of some drugs may be opposed by Chlorpromazine Taj Pharma Tablets; these include amphetamine, clonidine, guanethidine, adrenaline.

Anticholinergic agents may reduce the antipsychotic effect of Chlorpromazine Taj Pharma Tablets. Some drugs interfere with absorption of neuroleptic agents; antacids, anti-Parkinson. Documented clinically significant adverse interactions occur with alcohol, guanethidine and hypoglycaemic agents.

• Pregnancy and lactation

Pregnancy

A large amount of exposure to chlorpromazine during pregnancy did not reveal any teratogenic effect. However, there is evidence of harmful effects in animals, so like other drugs, it should be avoided in pregnancy unless the physician considers it essential. It may occasionally prolong labour and at such a time should be withheld until the cervix is dilated 3-4cm.

It is advised to keep an adequate maternal psychic balance during pregnancy in order to avoid decompensation. If a treatment is necessary to ensure this balance, the treatment should be started or continued at effective dose all through the pregnancy.

Neonates exposed to antipsychotics (including chlorpromazine) during the third trimester of pregnancy are at risk of adverse reactions 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.

Lactation

Chlorpromazine Taj Pharma being excreted in milk, breast-feeding is not recommended during treatment.

Fertility

A decrease in fertility was observed in female animals treated with chlorpromazine. In male animals data are insufficient to assess fertility.

In humans, because of the interaction with dopamine receptors, chlorpromazine may cause hyperprolactinaemia which can be associated with impaired fertility in women (see Section 4.8). In men, data on consequences of hyperprolactinaemia are insufficient with regard to fertility.

• Effects on ability to drive and use machines

The attention of patients, particularly drivers and machine operators, should be drawn to the risk of drowsiness with this medication especially at the start of treatment.

• Undesirable effects

¹ may be seen without evidence of clinical disease

² particularly at the start of treatment

³ particularly during long term treatment; may occur after the neuroleptic is withdrawn and resolve after reintroduction of treatment or if the dose is increased

⁴ in the anterior segment of the eye caused by accumulation of the drug but generally without any impact on sight

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Tardive dyskinesia may occur during administration or following withdrawal of Chlorpromazine Taj Pharma and other neuroleptic drugs. This syndrome is common among patients treated with moderate to high doses of antipsychotic drugs for prolonged periods of time and may prove irreversible, particularly in patients over the age of 50. It is unlikely to occur in the short-term when low or moderate doses of chlorpromazine are used as recommended, but since its occurrence may be related to duration of treatment as well as daily dose, chlorpromazine should be given in the minimal effective dose for the minimum possible time, unless it is established that long-term administration for the treatment of schizophrenia is required. The potential seriousness and unpredictability of tardive dyskinesia and the fact that it has occasionally been reported to occur when neuroleptic antipsychotic drugs have been prescribed for relatively short periods in low dosage means that the prescribing of such agents requires especially careful assessment of risks versus benefit. Tardive dyskinesia can be precipitated or aggravated by anti-Parkinson drugs. Short-lived dyskinesias may occur after abrupt drug 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. Neuroleptic malignant syndrome is rare but may occur with any neuroleptic.

Chlorpromazine Taj Pharma, even in low dosage in susceptible (especially non-psychotic) individuals, may cause unpleasant subjective feelings of being mentally dulled or slowed down, nausea, dizziness, headache, or paradoxical effects of excitement, agitation, or insomnia. Confusional states or epileptic fits can occur. The effects of chlorpromazine on the heart are dose related. ECG changes, with prolongation of the QT interval and T-wave changes have been commonly reported in patients treated with moderate to high dosage; they are reversible on reducing the dose. In a small number of cases, they have been reported to precede serious arrhythmias, including ventricular tachycardia and fibrillation, which have occurred after overdosage.

• Overdose

Symptoms of chlorpromazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, E.C.G. changes, ventricular arrhythmias and hypothermia. Severe extra-pyramidal dyskinesias may occur.

Treatment should by symptomatic with continuous respiratory and cardiac monitoring (risk of prolonged QT interval) until the patient’s condition resolves.

If the patient is seen up to 6 hours after ingestion of a toxic dose, gastric lavage may be attempted. Induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment is supportive.

Generalised vasodilatation may result in circulatory collapse; raising the patient’s legs may suffice, in severe cases, volume expansion by intravenous fluids may be needed; infusion fluids should be warmed before administration in order not to aggravate hypothermia.

Positive inotropic agents such as dopamine may be tried if fluid replacement is insufficient to correct the circulatory collapse. Avoid use of adrenaline. Ventricular or supraventricular tachyarrhythmia’s usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life threatening, appropriate antiarrhythmic therapy may be considered. Avoid lignocaine and, as far as possible, long acting antiarrhythmic drugs.

Central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions usually respond to procyclidine (5-10mg) or orphenedrine (20-40mg) administered intramuscularly or intravenously. Convulsions should be treated with intravenous diazepam. Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.

5. Pharmacological properties

• Pharmacodynamic properties

Chlorpromazine Taj Pharma has depressant actions on the Central Nervous System, with alpha-adrenergic blocking and anticholinergic activities. It inhibits Dopamine and Prolactin release-inhibitory factor, thus stimulating the release of Prolactin. It increases the turnover of Dopamine in the brain.

It has anti-emetic, anti-puritic, serotonin-blocking and weak anti-histamine properties and slight ganglion blocking activity. It inhibits the heat regulating centre in the brain, and is analgesic and can relax skeletal muscle.

Due to its action on the autonomic system it produces vasodilatation, hypotension and tachycardia.

Salivary and gastric secretions are reduced

• Pharmacokinetic properties

Chlorpromazine Taj Pharma is readily absorbed in the gastro-intestinal tract. It is subject to first pass metabolism in the gut wall. It is extensively metabolised in the liver and excreted in the urine and faeces. The plasma half-life is only a few hours but it has a prolonged terminal elimination phase of up to about 3 weeks. Chlorpromazine Taj Pharma is extensively bound to plasma proteins.

• Preclinical safety data

No additional data of relevance to prescriber

6. Pharmaceutical particulars

• List of excipients

Lactose

Maize Starch

Povidone

Sodium starch glycollate

Colloidal anhydrous silica

Magnesium stearate

In coating:

Hypromellose

Eththylcellulose 10 cps

Diethylphthalate

Titanium dioxide

• Incompatibilities

Chlorpromazine Taj Pharma can increase the central nervous system depression produced by other CNS-depressant drugs including alcohol, hypnotics, sedatives or strong analgesics.

It antagonises the action of adrenaline and other sympathomimetic agents and reverses the blood pressure lowering effects of adrenergic blocking agents such guanethidine and clonidine. It may impair the metabolism of tricyclic antidepressants, the anti-Parkinson effects of levodopa and the effects of anticonvulsants; it may possibly affect the control of diabetes, or the action of anticoagulants. Antacids can impair absorption. Tea and coffee may prevent absorption by causing insoluble precipitates.

Undesirable anticholinergic effects can be enhanced by anti-Parkinson or other anticholinergic drugs. It may enhance the cardiac-depressant effects of quinidine, the absorption of corticosteroids and digoxin, the effect of diazoxide and of neuromuscular blocking agents. Interactions with propanolol have been reported. The possibility of interaction with lithium should be bone in mind.

Further information: Chlorpromazine Taj Pharma is a phenothiazide with an aliphatic side-chain. Its pharmacological profile of activity includes pronounced sedative and hypotensive properties, with fairly marked anticholinergic and anti-emetic activity and a moderate tendency to cause extrapyramidal reactions.

• Shelf life

3 years

• Special precautions for storage

Do not store above 25°C. Store in the original package.

• Nature and contents of container

High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene wads.

250 micron PVC glass-clear/green rigid PVC (pharmaceutical grade). 20 micron hard-tempered aluminium foil coated on the dull side with 6-7 gsm heat seal lacquer and printed on the bright side.

Packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 & 1000 tablets

• Special precautions for disposal and other handling

Not applicable

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

Chlorpromazine Tablets USP 25mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorpromazine Taj Pharma

Read all of this leaflet carefully before you start taking 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Chlorpromazine Taj Pharma Tablets are and what they are used for
2. What you need to know before you take Chlorpromazine Taj Pharma Tablets
3. How to take Chlorpromazine Taj Pharma Tablets
4. Possible side effects
5. How to store Chlorpromazine Taj Pharma Tablets
6. Contents of the pack and other information

1. What Chlorpromazine Taj Pharma Tablets are and what they are used for

Chlorpromazine Taj Pharma tablets belong to a group of drugs known as phenothiazines, which act on the central nervous system. They are used to treat the following conditions: schizophrenia and other psychoses particularly paranoia (delusions and feelings of persecution), mania (overactive behaviour and hypomania (elated moods and excitability), anxiety, agitation and violent or dangerously impulsive behaviour.

Chlorpromazine Taj Pharma is also used for prolonged periods of hiccups, feeling or being sick (when other drugs have failed), to lower body temperature and for childhood schizophrenia and autism (learning and communication difficulties).

2. What you need to know before you take Chlorpromazine Taj Pharma Tablets

Do not take Chlorpromazine Taj Pharma Tablets and tell your doctor if you:

• are allergic(hypersensitive) to Chlorpromazine Taj Pharma, other phenothiazines or to any of the other ingredients in the tablets (see Section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• have a low number of blood cells (bone marrow depression)
• have an increased pressure in the eye (glaucoma)
• are taking a dopaminergic antiparkinsonism drug
• are breast-feeding
• are taking citalopram or escitalopram
• have a history of low white blood cell count
• have urine retention due to a prostate disorder.

Warnings and precautions

Talk to your doctor or pharmacist before taking Chlorpromazine Taj Pharma Tablets if you:

• or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
• have liver or kidneydisease
• have epilepsyor have had fits (seizures)
• have Parkinson’sdisease
• have hypothyroidism(reduced activity of the thyroid gland)
• have heart diseasesuch as heart failure
• have ever had a stroke
• have myasthenia gravis(a condition where muscles become easily tired and weak leading to difficulty breathing)
• have low levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these
• have phaeochromocytoma(high blood pressure due to a tumour near the kidney)
• have glaucoma(raised eyeball pressure)
• have diabetes and are taking drugsto reduce blood sugar (as Chlorpromazine Taj Pharma Tablets may reduce their effect)
• have enlargement of the prostate.
• have depression
• have ever had alcohol problems
• have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than normal you are elderly (65 years of age or older).

Other medicines and Chlorpromazine Taj Pharma Tablets

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

• medicines for indigestion and heartburn (antacids)
• medicines for diabetes
• medicines for high blood pressure or prostate problems such as doxazosin and terazosin
• medicines for Parkinson’s disease such as levodopa
• medicines for fits (epilepsy) such as carbamazepine or phenobarbital
• medicines to control your heartbeat such as amiodarone, disopyramide or quinidine
• medicines to help you sleep (sedatives)
• medicines for depression or amphetamines
• other medicines used to calm emotional and mental problems such as olanzapine or prochlorperazine
• some medicines used for high blood pressure such as guanethidine, clonidine or propranolol
• some medicines used for infections (antibiotics) such as moxifloxacin
• some medicines used for cancer (cytotoxics)
• medicines which can alter electrolytes (salt levels) in your blood
• amphetamines – used for Attention Deficit Hyperactivity Disorder (ADHD)
• anticholinergic medicines – includes some medicines used for irritable bowel syndrome, asthma or incontinence
• adrenaline – used for life threatening allergic reactions
• deferoxamine – used when you have too much iron in your blood
• lithium – used for some types of mental illness.

Chlorpromazine Taj Pharma Tablets with alcohol

Alcohol must not be used with Chlorpromazine Taj Pharma. This is because alcohol can increase the effects of Chlorpromazine Taj Pharma and cause serious breathing problems.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before having this medicine if you are pregnant, might become pregnant or think you may be pregnant. The following symptoms may occur in newborn babies of mothers that have used Chlorpromazine Taj Pharma 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.

Do not breast-feed if you are being given Chlorpromazine Taj Pharma. This is because small amounts may pass into the mother’s milk. If you are breast-feeding or planning to breast-feed talk to your doctor or pharmacist before taking this medicine.

Chlorpromazine Taj Pharma may make it difficult for a woman to get pregnant due to it reducing her fertility.

Driving and using machines

This medicine may cause some people, especially elderly patients, to become drowsy, dizzy, light-headed, clumsy, unsteady or less alert than normal. If you are affected, do not drive or operate dangerous machinery.

Chlorpromazine Taj Pharma Tablets contain lactose

If a doctor has told you that you have an intolerance to some sugars, check with your doctor before taking these tablets, as they contain a type of sugar called lactose.

3. How to take Chlorpromazine Taj Pharma Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You will be prescribed the lowest dose needed to control your symptoms. Do not stop taking your medicine or change the dose unless your doctor tells you to.

The tablets should be swallowed with a glass of water.

Dose for schizophrenia, other psychoses, anxiety and agitation

Adults: Start with 25mg three times a day or 75mg at bedtime.

This may be increased by 25mg a day to an effective dose. This is usually 75mg – 300mg daily, but some patients need up to 1000mg (1g) daily.

Elderly weak or infirm patients: Start with ⅓–½ usual adult dose with a more gradual increase in dose.

Children 6-12 years: ⅓-½ adult dose to a maximum daily dose of 75mg.

Children 1-5 years: 0.5mg per kg body weight every 4-6 hours to a maximum daily dose of 40mg.

Children under 1 year: Not to be used unless the need is life saving.

Dose for nausea and vomiting

Adults: 10mg-25mg every 4-6 hours.

Elderly weak or infirm patients: Start with ⅓-½ adult dose.

Your doctor will then increase the dose as needed.

Children 6-12 years: 0.5mg per kg bodyweight every 4-6 hours. Maximum daily dose 75mg.

Children 1-5 years: 0.5mg per kg bodyweight every 4-6 hours. Maximum daily dose 40mg.

Children under 1 year: Not to be used unless the need is life saving.

Dose for hiccups

Adults, elderly, weak or infirm patients: 25-50mg 3-4 times a day.

Children: Not recommended in children.

If you don’t feel better

If you don’t feel the tablets are working as well after you have taken them for a short time (3-4 days), do not increase the dose; instead check with your doctor.

If you take more Chlorpromazine Taj Pharma Tablets than you should

If you accidentally take more tablets or somebody else takes any tablets, contact a doctor or go to your nearest hospital casualty department at once. Take any remaining tablets with you and the container or packaging, so they can be identified.

If you forget to take Chlorpromazine Taj Pharma Tablets

If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Chlorpromazine Taj Pharma tablets

Withdrawal symptoms can occur after you stop treatment (see Section 4), so gradual withdrawal is advisable. Do not stop taking the tablets without talking to your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them. Do not be alarmed by this list of side effects. Most people take Chlorpromazine Taj Pharma without any problems

Tell your doctor or pharmacist or go to a hospital straight away if:

Very common (may affect more than 1 in 10 people)

• you have movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs
• trembling, muscle stiffness or spasm, slow movement, producing more saliva that usual or feeling restless

Common (may affect up to 1 in 10 people)

• you have a fit (seizure)
• alteration of the heart rhythm (called ‘prolongation of the QT interval’, seen on ECG, electrical activity of the heart).

Not known (frequency cannot be estimated from the available data)

• you have an allergic reaction. The signs may include: rash, itching, fever, difficulty in breathing or wheezing, chills, swollen eyelids, lips, tongue or throat
• you have a very fast, uneven or forceful heartbeat (palpitations). You may also have breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain. These could be signs of very serious life threatening heart problems
• you have joint aches and pains, swollen joints, feel tired or weak with chest pain and shortness of breath. These could be signs of an illness called ‘systemic lupus erythematosus’ (SLE)
• you have yellowing of the skin or eyes (jaundice) and your urine becomes darker in colour. These could be signs of liver damage
• you have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called ‘leucopenia’
• you have a high temperature, sweating or stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious but rare side effect called ‘neuroleptic malignant syndrome’
• you get a bloated feeling and cramping pain in the abdomen (stomach) be sick (vomit), have indigestion, heartburn, upset stomach, constipation, loss of appetite, dry mouth. This could be caused by an obstruction or blockage of the intestine
• you have pain in your abdomen with vomiting and diarrhoea
• you have a long lasting painful erection of the penis
• you bruise more easily than usual. This could be because of a blood disorder called ‘thrombocytopenia’
• you have 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.

Tell your doctor or pharmacist as soon as possible if you have any of the following side effects:

Very common (may affect more than 1 in 10 people)

• feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure).

Not known (frequency cannot be estimated from the available data)

• you are breathing more slowly or less deeply than normal
• changes in skin or eye colour after having Chlorpromazine Taj Pharma for a long time
• problems with eyesight
• rigid or stiff muscles, trembling or shaking, difficulty moving
• passing large amounts of urine, excessive thirst and having a dry mouth or skin. You may be more likely get infections such as thrush. This could be due to too much sugar in your blood (hyperglycaemia)
• unusual eye movements (including rolling of the eyes)
• your neck becomes twisted to one side
• your jaw is tight and stiff
• you have difficulty in passing water (urine)
• feeling tired, weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

Very common (may affect more than 1 in 10 people)

• dry mouth
• feeling drowsy or sleepy
• putting on weight.

Common (may affect up to 1 in 10 people)

• abnormal production of breast milk in men and women
• loss of menstrual periods
• feeling anxious.

Not known (frequency cannot be estimated from the available data)

• breast enlargement in men
• difficulty in getting or keeping an erection (impotence)
• reduced sexual desire in women
• difficulty sleeping (insomnia)
• feeling agitated
• being more sensitive to the sun than usual
• stuffy nose
• skin rashes
• tiredness, low mood.

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

Withdrawal effects: If this medicine is stopped suddenly nausea, vomiting and difficulty sleeping (insomnia), tremor (shaking), jerky body movements and the inability to control movements of the hands and body can occur.

If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Chlorpromazine Taj Pharma Tablets

Do not store above 25°C.Store in a dry place, protect from light. Keep the container tightly closed. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister 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.

6. Contents of the pack and other information

What Chlorpromazine Taj Pharma Tablets contain

The active ingredient (which makes the tablets work) is Chlorpromazine Hydrochloride. The Tablets Also Contain Lactose, Maize Starch, Povidone, Sodium Starch Glycollate, Colloidal Anhydrous Silica, Magnesium Stearate, Hypromellose, Purified Water, Ethylcellulose, Diethylphthalate and Titanium Dioxide.

What Chlorpromazine Taj Pharma Tablets look like and contents of the pack

The tablets are round, white, and film coated.

Available pack sizes are 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1,000 tablets.

Not all pack sizes may be marketed.

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