Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CHLORPROMAZINE HYDROCHLORIDE
Clonmel Healthcare Ltd
N05AA; N05AA01
CHLORPROMAZINE HYDROCHLORIDE
100 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Phenothiazines with alipathic side-chains
Phenothiazines with aliphatic side-chain; chlorpromazine
Chlorpromazine belongs to a group of drugs known as antipsychotics, which act on the central nervous system. Clonactil Tablets are used for: – The treatment of behavioural disturbances, including schizophrenia, mania and hypomania – The short-term treatment of anxiety, agitation and violent or impulsive behaviour – The treatment of persistent hiccup and nausea and vomiting associated with terminal illness.
Marketed
1977-04-01
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER CLONACTIL 25MG FILM-COATED TABLETS CLONACTIL 50MG FILM-COATED TABLETS CLONACTIL 100MG FILM-COATED TABLETS CHLORPROMAZINE HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Clonactil is and what it is used for 2. What you need to know before you take Clonactil Tablets 3. How to take Clonactil Tablets 4. Possible side effects 5. How to store Clonactil Tablets 6. Contents of the pack and other information 1. WHAT CLONACTIL IS AND WHAT IT IS USED FOR Clonactil tablets contain the active substance chlorpromazine. Chlorpromazine belongs to a group of drugs known as antipsychotics, which act on the central nervous system. CLONACTIL TABLETS ARE USED FOR: – The treatment of behavioural disturbances, including schizophrenia, mania and hypomania – The short-term treatment of anxiety, agitation and violent or impulsive behaviour – The treatment of persistent hiccup and nausea and vomiting associated with terminal illness. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLONACTIL TABLETS DO NOT TAKE CLONACTIL TABLETS – if you are allergic to chlorpromazine or any of the other ingredients of this medicine (listed in section 6) if you have a low blood cell count (bone marrow depression) if you have prostate trouble if you have glaucoma (painful eyes with blurred vision) if you are breast-feeding if you are in or have ever previously been in a comatose state while taking barbiturates (medicines to treat fits, e.g., p Read the complete document
Health Products Regulatory Authority 24 November 2019 CRN00969X Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clonactil 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg Chlorpromazine Hydrochloride. Excipient with known effect: Lactose monohydrate: 286mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated Tablet (Tablets). White, circular, biconvex film-coated tablet engraved with 'CZ3' on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (i) In the management of anxiety and tension states, agitation, depression and behavioural disturbances. (ii) In the management of schizophrenia and other psychoses including mania and hypomania, and psychopathy, and in the control of the central effects of such drugs as LSD. (iii) In the management of terminal illness and intractable hiccup. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended Dosage There is a large inter and intra-individual variation in the kinetics of chlorpromazine, dosage must be on an individual basis. Initial dosage should be low and gradually increased under close supervision to the optimum level. ANXIETY, AGITATION & PSYCHOSES, BEHAVIOURAL DISTURBANCE Adults The recommended total daily dosage is 75 to 300 mg in divided doses, but in the management of psychoses, dosage may be as high as l g daily. Paediatric population 6-12 Years of age 1 / 3 to ½the adult dose to a maximum recommended dose of 75mg/day. 1-5 years 0.5 mg/kg every 4-6 hours to a maximum recommended dose of 40 mg/day. Health Products Regulatory Authority 24 November 2019 CRN00969X Page 2 of 10 Older people 10-25 mg once or twice daily is usually adequate in the control of agitated states. For other conditions, 1 / 3 to ½ the usual adult dose with a gradual titration upwards. INTRACTABLE HICCUP Adults 10-25 mg 6 to 8 hourly, increasing to 25-50 mg, 6-8 hourly if necessary. TERMINAL ILLNESS Adults 10-25 mg, 4-6 hourly. Paediatric population 1-5 years: 0.5 mg/kg 4-6 Read the complete document