देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
ZUCLOPENTHIXOL AS DIHYDROCHLORIDE
LUNDBECK ISRAEL LTD.
N05AF05
FILM COATED TABLETS
ZUCLOPENTHIXOL AS DIHYDROCHLORIDE 10 MG
PER OS
Required
H.LUNDBECK A/S, DENMARK
ZUCLOPENTHIXOL
ZUCLOPENTHIXOL
Acute schizophrenia .Other acute psychoses.
2020-04-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is marketed only with prescription _ _ CLOPIXOL CLOPIXOL CLOPIXOL CLOPIXOL Drops COMPOSITION (active ingredient): Zuclopenthixol (as dihydrochloride ) 20 mg/ml (1 drop = 1 mg) 2 MG Tablets COMPOSITION (active ingredient): Zuclopenthixol (as dihydrochloride ) 2 mg 10 MG Tablets COMPOSITION (active ingredient): Zuclopenthixol (as dihydrochloride ) 10 mg 25 MG Tablets COMPOSITION (active ingredient): Zuclopenthixol (as dihydrochloride ) 25 mg Inactive ingredients: See section 6 - READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask your doctor or pharmacist. - This medicine was prescribed to treat your illness. Do not pass it to others. It may harm them even if it seems to you that their illness is similar to you own. - This medicine is not intended to be used by children. 1. WHAT IS THE MEDICINE BEING USED FOR? CLOPIXOL can be taken to treat acute schizophrenia and other acute psychoses. THERAPEUTIC GROUP: anti-psychotic drugs, Thioxanthene derivative. CLOPIXOL contains the active substance zuclopenthixol. It belongs to the antipsychotic drug group (which is also called the neuroleptic group). These medicines affect certain neural pathways in the brain and helps correct certain cases of chemical imbalance in the brain that cause your symptoms. 2. BEFORE USING THIS MEDICINE DO NOT TAKE THIS MEDICINE IF - You are sensitive (allergic) to the active ingredient (zuclopenthixol) or any of the other ingredients of Clopixol (listed in section 6). - If you are affected by alcohol, strong pain medication (morphine), or anti- epileptic drugs (phenobarbital). - If you have a severe drop in blood pressure or heart failure. - Please note: Unconscious patients should not be given Clopixol. WARNINGS AND PRECAUTIONS BEFORE USING CLOPIXOL, TELL YOUR DOCTOR IF: - You have a liver disease. - You suffe पूरा दस्तावेज़ पढ़ें
1/10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clopixol 2 mg tablets Clopixol 10 mg tablets Clopixol 25 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clopixol 2 mg Each tablet contains 2 mg zuclopenthixol (as 2.364 mg zuclopenthixol dihydrochloride) Clopixol 10 mg Each tablet contains 10 mg zuclopenthixol (as 11.82 mg zuclopenthixol dihydrochloride) Clopixol 25 mg Each tablet contains 25 mg zuclopenthixol (as 29.55 mg zuclopenthixol dihydrochloride) Excipients with known effect: Clopixol 2 mg contains 17.4 mg lactose monohydrate. Clopixol 10 mg contains 21.6 mg lactose monohydrate. Clopixol 25 mg contains 22.0 mg lactose monohydrate. Hydrogenated castor oil For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Tablets, film-coated Description of the tablets: 2 mg: Round, biconvex, pale red, film-coated tablet. 10 mg: Round, biconvex, light red-brown film-coated tablet. 25 mg: Round, biconvex, red-brown, film-coated tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute schizophrenia, other acute psychoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ _ADULTS _ Dosage should be individually adjusted according to the condition of the patient. 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 dose at bedtime. _Acute schizophrenia and other acute psychoses: _ 2/10 Usually 10-50 mg/day. In moderate to severe cases initially 20 mg/day increased, if necessary, by 10- 20 mg every 2 to 3 days to 75 mg or more daily. Maximum dosage per single dose is 40 mg and a total of 150 mg/day. _ _ _OLDER PATIENTS _ Older patients should receive dosages in the lower end of the dosage range. _ _ _CHILDREN _ Clopixol is not recommended for use in children due to lack of clinical experience. _ _ _REDUCED RENAL FUNCTION _ Clopixol can be given in usual doses to patients with reduced renal function. _ _ _REDUCED LI पूरा दस्तावेज़ पढ़ें