국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SULPIRIDE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
SULPIRIDE
12Tablet Tablets
SANOFI WINTHROP INDUSTRIE
_ _ 1 _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DOGMATIL ® TABLET _ _ Sulpiride (200 mg) _ _ WHAT IS IN THIS LEAFLET 1. What Dogmatil is used for 2. How Dogmatil works 3. Before you use Dogmatil 4. How to use Dogmatil 5. While you are using it 6. Side effects 7. Storage and Disposal of Dogmatil 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT DOGMATIL IS USED FOR • Acute and chronic psychotic disorders, such as - schizophrenia - chronic non-schizophrenia delusions (a belief that is not true) - paranoid delusions - chronic hallucinatory psychosis (hearing voices or seeing things which are not there) HOW DOGMATIL WORKS Dogmatil tablets belongs to a group of medicines known as neuroleptic antipsychotics. It is a type of medicine known as a benzamide. BEFORE YOU USE DOGMATIL If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. - _ When you must not use it _ Do not take Dogmatil if: • You are allergic to sulpiride or any of the other ingredients of this medicine (listed at the end of this leaflet). • You have pheochromocytoma (excessive growth of the adrenal glands around the kidneys, releasing substances that cause high blood pressure). • You have a prolactin-dependent tumour (prolactin is a hormone that stimulates milk production), e.g. breast cancer or pituitary disorders. • You are taking another medicine, check that combined use with Dogmatil tablet is not contraindicated (see information under the heading “ _Taking _ _other _ _medicines_ ”). • You have a blood disease characterised by accumulation of pigments in the body (acute porphyria). If you are unsure of anything, do not hesitate to ask your doctor or pharmacist for advice. _- Before you start to use it _ Talk to your doctor or pharmacist before taking Dogmatil tablet. • Your doctor may ask you to have an electrocardiogram (ECG) before starting treatment. This is because this medicine can cause hear 전체 문서 읽기
MY/DOG200/0421/CCDSv14 15 16 DRAFT PACKAGE INSERT NAME OF THE MEDICINAL PRODUCT DOGMATIL ® 200 MG, SCORED TABLETS QUALITATIVE AND QUANTITATIVE COMPOSITION Sulpiride base .................................................................................................................. 200.00 mg For one scored tablet. PHARMACEUTICAL FORM Scored tablets. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS • Acute psychotic disorders. • Chronic psychotic disorders (schizophrenia, chronic non-schizophrenic delusions: paranoid delusions, chronic hallucinatory psychosis). POSOLOGY AND METHOD OF ADMINISTRATION Oral use. FOR USE IN ADULTS ONLY. The minimum effective dose should always be used. If the patient’s clinical condition allows, treatment should be initiated at a low dose, then gradual dosage titration may be used. The daily dose is 200 to 1000mg. CONTRAINDICATIONS This medicinal product must never be used in the following situations: • hypersensitivity to the active substance or to any of the excipients, • prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer, • known or suspected pheochromocytoma, • in combination with: • non-antiparkinsonian dopamine agonists (cabergoline, quinagolide), • citalopram, escitalopram, hydroxyzine, domperidone and piperaquine, • acute porphyria. SPECIAL WARNINGS AND PRECAUTIONS FOR USE SPECIAL WARNINGS • A neuroleptic malignant syndrome, a potentially fatal complication reported with antipsychotics, is characterized by hyperthermia, pallor, autonomic dysfunction, altered consciousness, muscle rigidity, rhabdomyolysis, elevated serum creatine phosphokinase levels and dysautonomia. Cases with atypical features, such as hyperthermia without muscle rigidity or hypertonia, have been observed. In case of hyperthermia of undiagnosed origin, which may be considered either as an early sign/symptom of neuroleptic malignant syndrome or an atypical neuroleptic malignant syndrome, sulpiride and all other antipsychotics should be discontinued promptly, u 전체 문서 읽기