Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
ILOPERIDONE
MEGAPHARM LTD
N05AX14
TABLETS
ILOPERIDONE 4 MG
PER OS
Required
PATHEON INC, CANADA
ILOPERIDONE
ILOPERIDONE
FANAPT is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults.
2017-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS - 1986 This medicine is dispensed with a physician’s prescription only FANAPT TABLETS 1 MG FANAPT TABLETS 2 MG FANAPT TABLETS 4 MG FANAPT TABLETS 6 MG FANAPT TABLETS 8 MG FANAPT TABLETS 10 MG FANAPT TABLETS 12 MG COMPOSITION: ACTIVE INGREDIENT: Iloperidone 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg Each 1 mg tablet contains 53.82 mg lactose Each 2 mg tablet contains 85.07 mg lactose Each 4 mg tablet contains 83.07 mg lactose Each 6 mg tablet contains 110.10 mg lactose Each 8 mg tablet contains 166.14 mg lactose Each 10 mg tablet contains 183.50 mg lactose Each 12 mg tablet contains 220.20 mg lactose For a list of inactive and allergenic ingredients, see section 6 - “Additional information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, consult your physician 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. WARNING: INCREASED RISK OF DEATH IN ELDERLY PERSONS SUFFERING FROM DEMENTIA ELDERLY PATIENTS SUFFERING FROM DEMENTIA-RELATED PSYCHOSIS AND TREATED WITH ANTIPSYCHOTIC MEDICINES ARE AT INCREASED RISK OF DEATH. THIS MEDICINE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. 1. WHAT IS THIS MEDICINE INTENDED FOR? FANAPT is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. Schizophrenia is a disorder with symptoms of hearing, seeing and sensing things that are not real, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech and behavioral and emotional flatness. Patients with schizophrenia may also feel depressed, anxious, guilty and tense. Treatment with FANAPT TABLETS has been shown to reduce the severity and occurrence of these symptoms. THERAPEUTIC GROUP: Antipsychotic medicines. 2. BEFORE USING THE MEDICIN Прочитайте повний документ
Page 1 of 19 1. NAME OF THE MEDICINAL PRODUCT FANAPT TABLETS 1 mg, 2 MG, 4 MG, 6 MG, 8 MG, 10 MG, 12 MG. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FANAPT TABLETS 1 MG, each 1 mg tablet contains 1 mg iloperidone, oral tablets. FANAPT TABLETS 2 MG, each 2 mg tablet contains 2 mg iloperidone, oral tablets. FANAPT TABLETS 4 MG, each 4 mg tablet contains 4 mg iloperidone, oral tablets. FANAPT TABLETS 6 MG, each 6 mg tablet contains 6 mg iloperidone, oral tablets. FANAPT TABLETS 8 MG, each 8 mg tablet contains 8 mg iloperidone, oral tablets. FANAPT TABLETS 10 MG, each 10 mg tablet contains 10 mg iloperidone, oral tablets . FANAPT TABLETS 12 MG, each 12 mg tablet contains 12 mg iloperidone, oral tablets. For the full list of excipients and allergens, see section 6.1 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. FANAPT TABLETS IS NOT APPROVED FOR USE IN PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. 3. PHARMACEUTICAL FORM FANAPT tablets are available in the following strengths: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. The tablets are white, round, flat, beveled-edged without a score line and identified with a logo “ ” debossed on one side and tablet strength “1”, “2”, “4”, “6”, “8”, “10”, or “12” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FANAPT tablets is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION USUAL DOSE: FANAPT tablets must be titrated slowly from a low starting dose to avoid orthostatic hypotension due to its alpha-adrenergic blocking properties. The recommended starting dose for FANAPT tablets is 1 mg orally twice daily. Dose increases to reach the target range of 6-12 mg twice daily (12_24 mg/day) may be made with daily dosage adjustments not to exceed 2 mg twice daily (4 mg/day). The maximum recommended dose is 12 Прочитайте повний документ