Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
FLUPENTIXOL AS DIHYDROCHLORIDE
LUNDBECK ISRAEL LTD
N05AF01
TABLETS
FLUPENTIXOL AS DIHYDROCHLORIDE 3 MG
PER OS
Required
LUNDBECK A/S, DENMARK
FLUPENTIXOL
FLUPENTIXOL
Schizophrenia, mania.
2010-07-31
0660 190x600 925644 Black IL-067-22-3-134 / 133662 IL-626002 (067-02) / 119778 2014-11-28 / 14:17 / MOVB 2 3 Do not exceed the recommended dosage. consult the doctor or pharmacist. How to take Fluanxol Swallow with a drink of water. Do not chew the tablets. There is no information about crushing or splitting of the tablet. Duration of treatment As with other antipsychotic medicines it may take a few weeks before you feel any improvement. Continue to take the tablets for as long as your doctor recommended. Even if your medical situation has improved, do not stop taking the medicine without consulting the doctor or the pharmacist. If you stop your treatment too soon your symptoms may return. If you mistakenly took higher dosage If you think that you or anyone else may have taken too many Fluanxol tablets contact your doctor or the nearest hospital immediately. Do this even if there are no signs of discomfort or poisoning. Take the Fluanxol container with you if you go to a doctor or hospital. Symptoms of overdose may include: • Drowsiness • Unconsciousness • M • Convulsions • Low blood pressure, weak pulse, fast heart rate, pallor, restlessness • High or low body temperature • Changes in heart rate including irregular heart beat or slow heart rate has been seen when Fluanxol has been given in overdose together with medicines known If you forget to take Fluanxol If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet If you stop taking Fluanxol Do not stop taking Fluanxol even if you begin to feel better, unless you are told to do so by your doctor. Do not take medicines in the dark. Check the label and the dose each time you take a medicine. Wear glasses if you need them. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. SIDE EFFCTS You should contact your doctor or go to the hospital straight away if you experience any of the following symptoms: • Unusual movements of the mouth and Pročitajte cijeli dokument
1 . Physician Prescribing Information- Fluanxol tabs 3 mg SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fluanxol 3 mg coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fluanxol 3 mg: Each tablet contains 3 mg flupentixol (as 3.504 mg flupentixol dihydrochloride) Excipients with known effect: Lactose monohydrate 3 mg: Sunset yellow FCF (E110), For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Coated tablet 3mg: Round,slightly biconvex, ochre-, film coated tablet. 4. CLINICAL PARTICULARS 1.4 THERAPEUTIC INDICATIONS Schizophrenia and mania 1.4 POSOLOGY AND METHOD OF ADMINISTRATION Adults Schizophrenia and Dosage should be individually adjusted according to the patient's condition. In general, small doses should be used initially and increased to the optimal effective level as rapidly as possible based on the therapeutic response. The maintenance dose can usually be given as a single morning dose. Initially 3-15 mg/day divided in two or three daily doses, increased, if necessary, to 40 mg/day. Maintenance dose usually is 5-20 mg/day. Older patients Older patients usually should receive dosages in the lower end of the dosage range. Reduced renal function Flupentixol can be given in usual doses to patients with reduced renal function. Reduced liver function Careful dosing and, if possible, a serum level determination is advisable . Children Flupentixol is not recommended for use in children due to lack of clinical experience. 2 Method of administration The tablets are swallowed with water. 1.4 CONTRA-INDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma. 1.1 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neur Pročitajte cijeli dokument