Prosulpin® 200mg
tablets
- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Sulpiride 200 mg in 1 tablet.
- Indication group:
- psycho-active drug, neuroleptic
The following information is for health professionals only.
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Characteristics:
Sulpiride, a derivative of benzamide, belongs to a subgroup of atypical neuroleptic drugs. It is also effective in the so-called negative symptoms of schizophrenia (flattening of affect, social withdrawal). The risk of extrapyramidal undesirable effects is minimal, in long-term therapy it does not cause tardive dyskinesia and shows an antidepressive effect.
Indications:
Psychotic depression with delusions and hallucination, schizophrenia (in particular if connected with depression symptoms), reactive depression, anorexia nervosa, withdrawal symptoms, aggressivity, hypochondria, hysteria, obsedant neurosis, neuropsychic disorders (especially in geriatrics and in children), psychosomatic complains in neurosis.
Contraindications:
Hypersensitivity to sulpiride, pheochromocytoma, acute intoxication by CNS suppressing drugs. Patients with Parkinson disease, prolactin -dependent tumors,epilepsy. Prosulpin tbl. can be administered in pregnancy and lactation only if really necessary.
Undesirable effects:
Prosulpin® tbl. is usually well tolerated. Most of the undesirable effects are mild and reversible. The include, for example: increased sweating, salivation or dryness in the mouth, nausea, hypotension, general excitation or sleep disorders, sexual disorders, gain of weight. Endocrine disorders (amenorrhea, galactorrhea, gynecomastia) can also appear. Allergic rashes can appear in hypersensitive individuals. Extrapyramidal syndrome (with involuntary muscle movements, tremor and disturbed movement co-ordination) can appear rarely.
Interactions:
The suppressive effect of Prosulpin® tbl. is enhanced by concomitantly given CNS suppressing drugs (barbiturates, benzodiazepines, tricyclic antidepressives, some analgesics, alcohol). The effect of Prosulpin® tbl. and levodopa is mutually reduced. Concomitant use of the antihypertensives with Prosulpin® tbl. can cause orthostatic hypotension.
Caution:
During Prosulpin® tbl. therapy, driving of vehicles, work with machines and work in heights are strictly forbidden. Alcohol in any form must be avoided.
Dosage:
The dose and the length of therapy are strictly determined by the physician in each individual case and it depends on the type and severity of illness. Adults are administered usually 400 - 800 mg daily (2x 1 or 2x 2 tablets daily). The dose can be increased up to a maximum of 1 200 mg daily. In elderly people and in patients with significantly reduced renal function half doses are recommended. Lower doses (100-400 mg)daily are recommended in neurosis and psychosomatic syndrome. Average daily dose of sulpiride in children is 5 mg/kg body weight.
Package:
30 tablets.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: December 3, 2006.
The preparation available on medical prescription only.
