Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
SULPIRIDE
SANOFI-AVENTIS SINGAPORE PTE. LTD.
N05AL01
50 mg
CAPSULE
ORAL
Prescription Only
SANOFI WINTHROP INDUSTRIE
1988-05-13
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 Read the complete document