DOLMATIL 200 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
SULPIRIDE
Available from:
B & S Healthcare
ATC code:
N05AL01
INN (International Name):
SULPIRIDE
Dosage:
200 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Antipsychotics
Authorization status:
Authorised
Authorization date:
2012-02-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dolmatil 200mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg sulpiride.
Excipient: Lactose 23mg/tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Product imported from the UK:
Plain white round tablets with ‘D200’ on one side and a breakline on the other. The scoreline is only to facilitate
breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute and chronic schizophrenia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
A starting dose of 400 mg to 800 mg daily, given as one or two tablets daily (morning and early evening) is recommended.
Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to
higher doses, and a starting dose of at least 400 mg twice daily is recommended, increasing if necessary up to a suggested
maximum of 1200 mg twice daily. Increasing the dose beyond this level has not been shown to produce further
improvement.
Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy), as well as depression, respond
to doses below 800 mg daily; therefore, a starting dose of 400 mg twice daily is recommended. Reducing this dose
towards 200 mg twice daily will normally increase the alerting effect of Dolmatil.
Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400-
600 mg twice daily.
CHILDREN
Clinical experience in children under 14 years of age is insufficient to permit specific recommendations.
ELDERLY
The same dose ranges may be required in the elderly, but should be reduced if there is evidence of rena
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