Prosulpin® 50 mg
tablets
![ProsulpinRR 50 mg](javascript:obrazek_big("http://promedcs.cz//en/../img/baleni/600_prosulpin50(1).jpg", "en"); "ProsulpinRR 50 mg")
- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Sulpiridum 50 mg in 1 tablet.
- Indication group:
- psychopharmaceutical, neuroleptic agent
The following information is for health professionals only.
READ CAREFULLY THIS NOTICE!
Characteristics:
Sulpiride, a derivative of benzamide, is a selective antagonist of dopamine receptors D2 and D3 with central and peripheral effects. In larger doses it exerts neuroleptic effects, in smaller ones (50-100 mg), anxiolytic and antidepressant effects are shown, and its influence on dopamine receptors in the smooth muscles of the GIT regulates motility of the digestive tract.
Indications:
Prosulpin® 50 mg tablets is intended for the treatment of psychosomatic diseases, mainly those which are manifested by functional digestive disorders (e.g., upper and lower functional dyspeptic syndrome, functional gastric and intestinal dyspepsia). It is also suitable for the treatment of hypochondria and neurotic complaints accompanied by restlessness, depression, anxious tension, and vertigo (particularly in geriatrics). In children, Prosulpin® 50 mg tablets is used for the treatment of psychosomatic restlessness, excessive fear, and enuresis.
Contraindications:
Hypersensitivity to sulpiride, acute intoxication with agents suppressing the CNS and alcohol, prolactin-dependent tumour diseases. Patients with epilepsy, Parkinson’s disease, pregnant and nursing women can be administered Prosulpin® 50 mg tablets only when it is really necessary.
Undesirable effects:
Most undesirable effects are less serious and of transitory character. They are, e.g., fatigue, drowsiness, vertigo, orthostatic hypotension, tremor of hands, motoric restlessness, rarely contractions of the facial and cervical muscles. Endocrine disorders (amenorrhoea, galactorrhoea, gynecomastia) may also occur. In hypersensitive persons, allergic skin reactions may develop.
Interactions:
Suppressive effect of Prosulpin® 50 mg tablets is potentiated by concomitantly administered CNS depressants (general anaesthetics, barbiturates, benzodiazepines, tricyclic antidepressants, H1 antihistaminines, some analgesics) and alcohol. Concomitant administration of antihypertensive agents with Prosulpin® 50 mg tablets may induce orthostatic hypotension. The effects of Prosulpin® 50 mg tablets and levodopa attenuate each other.
Caution:
The preparation may unfavourably affect activities requiring increased attention and rapid decision-making (car driving, work in heights). For the period of Prosulpin® 50 mg tablets administration, drinking alcohol is to be avoided.
Dosage:
Dosage is established individually by the physician. Adults usually take 1-2 tablets of Prosulpin® 50 mg tablets (50-100 mg) 3 times a day. Children’s dose is administered according to body weight, usually 5 mg/kg/day divided into 3 doses. In severe disorders of renal function and in the elderly, the lowest possible dosage should be administered.
Package:
30 or 60 tablets.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: December 13, 2006.
The preparation is available on medical prescription only.