Land: Israel
Språk: engelsk
Kilde: Ministry of Health
ZUCLOPENTHIXOL AS DIHYDROCHLORIDE
LUNDBECK ISRAEL LTD.
N05AF05
SOLUTION
ZUCLOPENTHIXOL AS DIHYDROCHLORIDE 20 MG/ML
PER OS
Required
H.LUNDBECK A/S, DENMARK
ZUCLOPENTHIXOL
ZUCLOPENTHIXOL
Acute schizophrenia and 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 Les hele dokumentet
1/10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Clopixol Drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 20 mg zuclopenthixol (as 23,64 mg zuclopenthixol dihydrochloride) 1 drop = 1 mg. Excipients with known effect: Ethanol. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Oral drops, solution Oral drops, clear, nearly colourless to yellowish solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute schizophrenia and 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. _ 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. 2/10 _REDUCED LIVER FUNCTION _ Careful dosing and, if possible, a serum level determination is advisable. _METHOD OF ADMINISTRATION _ The drops are easily administered mixed in e.g. water, orange juice or apple juice. Turn the bottle completely upside down. If no drops come out, tap the bottle lightly to start the flow. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or to any of the excipients, listed in section 6.1. Impaired consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), circulatory collapse, coma. 4.4 SPECIAL WARNINGS AND PRECA Les hele dokumentet