DOGMATIL CAPSULE 50 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

SULPIRIDE

Tilgængelig fra:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC-kode:

N05AL01

Dosering:

50 mg

Lægemiddelform:

CAPSULE

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

SANOFI WINTHROP INDUSTRIE

Autorisation dato:

1988-05-13

Indlægsseddel

DOGMATIL
®
 50mg 
Sulpiride 

Sanofi logo 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Sulpiride……………………………………50mg 

PHARMACEUTICAL FORM 
Capsules 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Short-term symptomatic treatment of anxiety in adults when the usual
therapeutic measures have 
failed. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Oral route. 
The objective is to reach the minimum effective dose. If the
patient’s clinical condition so allows, 
treatment will be initiated at a low dose, followed by gradual
increments  
In adults 
Short-term symptomatic treatment of anxiety in adults when the usual
therapeutic measures have 
failed: 
The daily dose is 50 to 150 mg for a maximum period of 4 weeks. 

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, 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