DOGMATIL TABLET 200 mg

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

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23-09-2014

Werkstoffen:

SULPIRIDE

Beschikbaar vanaf:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC-code:

N05AL01

Dosering:

200 mg

farmaceutische vorm:

TABLET

Toedieningsweg:

ORAL

Prescription-type:

Prescription Only

Geproduceerd door:

SANOFI WINTHROP INDUSTRIE

Autorisatie datum:

1988-05-13

Bijsluiter

                                 
DOGMATIL
®
 200MG 
SULPIRIDE 
 
[sanofi logo] 
 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Sulpiride……………………………………200mg 
 
PHARMACEUTICAL FORM 
Scored Tablets 
 
CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Acute and chronic psychoses. 
 
POSOLOGY AND METHOD OF ADMINISTRATION 
Oral route. 
 
Psychoses with prominent deficit 
200-600mg (1-3 tablets) a day 
 
Pyschoses with prominent productive symptoms: 
800-1600mg (4-8 tablets) a day 
 
Dogmatil should be administered 3 times daily 
 
YOU SHOULD COMPLY STRICTLY WITH YOUR DOCTOR’S PRESCRIPTION 
 
CONTRAINDICATIONS 
This medicine is CONTRAINDICATED in the following situations: 
-  hypersensitivity to sulpiride or to one of the other
ingredients of the product, 
-  prolactin-dependent tumours (for example, pituitary gland
prolactinomas and breast cancer), 
-  known or suspected pheochromocytoma, 
- acute porphyria, 
-  in combination with: 
- non-antiparkinsonian dopamine agonists (cabergoline and
quinagolide) and ropinirole. (see 
Interactions with other medicinal products and other forms of
interaction).  
 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
 
SPECIAL WARNINGS: 
Potentially fatal neuroleptic malignant syndrome: in the event
of unexplained fever, treatment must 
absolutely be discontinued since this may be one of the signs of
neuroleptic malignant syndrome (pallor, 
hyperthermia, autonomic disorders, impaired consciousness disorders,
,muscular rigidity). 
 
Signs of autonomic dysfunction, such as perspiration and unstable
blood pressure, may precede the 
onset of hyperthermia and thus represent early warning signs. 
 
Although this neuroleptic syndrome may be of idiosyncratic origin,
there are a number of predisposing risk 
factors, such as dehydration and  organic brain damage. 
 
Prolonged QT interval: sulpiride gives rise to dose-dependent
prolongation of the QT interval. This effect, 
which is known to p
                                
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