Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
TETRABENAZINE
NEOPHARM LTD, ISRAEL
N07XX06
TABLETS
TETRABENAZINE 25 MG
PER OS
Required
RECIPHARM FONTAINE, FRANCE
TETRABENAZINE
TETRABENAZINE
Movement disorders, associated with organic central nervous system conditions, e.g. Huntington's chorea, hemiballismus and senile chorea.Moderate to severe tardive dyskinesia, which is disabling and/or socially embarrassing. The condition should be persistent despite a switch to atypical antipsychotic medication and/or reduction in dosage of antipsychotic medication, when withdrawal of antipsychotic medication is not a realistic option.
2014-11-30
Xenazine tab. PIL vr 01A 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is dispensed by doctor ’s prescription only XENAZINE ® 25 MG, TABLETS ACTIVE INGREDIENT: EACH TABLET CONTAINS: Tetrabenazine 25 mg Inactive ingredients and allergens: see section 2, ‘Important information about some of this medicine’s ingredients’ and section 6, ’ Additional information. ’ READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult with your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. Xenazine 25 mg affects several chemical substances that are released in the brain and help to control abnormal and involuntary movements of the body. 1. WHAT IS THIS MEDICINE INTENDED FOR? Xenazine 25 mg is prescribed to treat diseases that cause sudden uncontrollable abnormal movements, such as Huntington's chorea, senile chorea, tardive dyskinesia and hemiballismus. THERAPEUTIC GROUP: medicines acting on the central nervous system. 2. BEFORE USING THIS MEDICINE SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE USING XENAZINE 25 MG, TELL YOUR DOCTOR IF: • You have been diagnosed with depression or have suicidal thoughts or have attempted to commit suicide. • You have had depression at any time. • You start showing angry or aggressive behavior. • You have a heart problem known as Long QT syndrome. Caution should be exercised when using tetrabenazine concomitantly with other medicines known to prolong QT syndrome (listed under ‘Drug interactions’ ) and by patients with congenital QT syndromes and a history of cardiac arrhythmias. • You have a recent history of chest pain or heart disease. • You have ever had hand tremors and jerky movements in your arms and legs at any time, which is known as Parkinson ’s disease Lesen Sie das vollständige Dokument
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 . TRADE NAME OF THE MEDICINAL PRODUCT XENAZINE® 25 MG 2 . QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg tetrabenazine. Excipient: Each tablet also contains 64 mg of lactose monohydrate. For a full list of excipients, see Section 6.1 . 3 . PHARMACEUTICAL FORM Tablet Yellowish-buff, circular, bevel- edged tablets with ‘CL25’ on one face and a single scoreline on the other. The tablet can be divided into equal halves . 4 . CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Movement disorders, associated with organic central nervous system conditions , e.g. Huntington's chorea, hemiballismus and senile chorea . Moderate to severe tardive dyskinesia, which is disabling and/or socially embarrassing. The condition should be persistent despite a switch to atypical antipsychotic medication and/or reduction in dosage of antipsychotic medication, when withdrawal of antipsychotic medication is not a realistic option . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablets are for oral administration . Organic Central Nervous System Movement Disorders Adults Dosage and administration are variable and only a guide is given. An initial starting dose of 25 mg three times a day is recommended. This can be increased by 25 mg a day every three or four days until 200 mg a day is being given or the limit of tolerance, as dictated by unwanted effects, is reached, whichever is the lower dose . If there is no improvement at the maximum dose in seven days, it is unlikely that the compound will be of benefit to the patient, either by increasing the dose or by extending the duration of treatment . Tardive Dyskinesia Recommended starting dose of 12.5 mg a day, subsequently titrated according to response. Medication should be discontinued if there is no clear benefit or if the side- effects cannot be tolerated . The elderly Page 2 of 12 No specific studies have been performed in the elderly, but tetrabenazine has been administered to elderly patients in standard dosage Lesen Sie das vollständige Dokument