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CHLORPROMAZINE Film-coated tablet (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Chlorpromazine 100mg Tablets.

Qualitative and quantitative composition

Chlorpromazine Hydrochloride 100.00 mg. See 6.1 for excipients.

Pharmaceutical form

Film-coated tablet. Round, white, film-coated tablet market CPZ 100.

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 ...

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 ...

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 ...

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 ...

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 ...

Fertility, 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 ...

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

Very common (≥1/10) Common (≥1/100 to <1/10) Not known (cannot be estimated from available data) Blood and lymphatic system disorders Not known: Agranulocytosis, Leukopenia Immune system disorders Not ...

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 ...

Pharmacodynamic properties

Chlorpromazine 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 ...

Pharmacokinetic properties

Chlorpromazine 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. ...

Preclinical safety data

No additional data of relevance to prescriber.

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 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 ...

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 ...

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Dr. Reddys Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 0LD, UK

Marketing authorization number(s)

08553/0076

Date of first authorization / renewal of the authorization

17/10/2005

Date of revision of the text

14/12/2016

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