Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlorpromazine hydrochloride
Teva UK Ltd
N05AA01
Chlorpromazine hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5017007112518
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER CHLORPROMAZINE 25 MG TABLETS CHLORPROMAZINE 50 MG TABLETS CHLORPROMAZINE 100 MG TABLETS Active substance: Chlorpromazine Hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Chlorpromazine is and what it is used for 2. Before you take Chlorpromazine tablets 3. How to take Chlorpromazine tablets 4. Possible side effects 5. How to store Chlorpromazine tablets 6. Further information 1. WHAT CHLORPROMAZINE IS AND WHAT IT IS USED FOR Chlorpromazine belongs to a group of drugs known as antipsychotics, which act on the central nervous system. CHLORPROMAZINE 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. BEFORE YOU TAKE CHLORPROMAZINE TABLETS _ _ DO NOT TAKE CHLORPROMAZINE TABLETS IF YOU: - Are allergic (hypersensitive) to - Chlorpromazine - Any of the other ingredients Chlorpromazine tablets (see section 6 “Further information”) - Have a low blood cell count (bone marrow depression) CHECK WITH YOUR DOCTOR BEFORE TAKING CHLORPROMAZINE TABLETS IF YOU: - Suffer from liver or kindey problems - Suffer from epilepsy (fits) - Have had, or any member of your family has had, any disease that has affected the heart or blood circulation. - Or someone else in your family has a history of blood clots, as medicines like this have been assoicated with formation of b Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlorpromazine Tablets BP 25 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorpromazine Hydrochloride BP 25 mg 3 PHARMACEUTICAL FORM Sugar Coated Tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chlorpromazine is a phenothiazine neuroleptic and is indicated in the following conditions. 1. Psychotic conditions (especially paranoid) including schizophrenia, mania and hypomania. 2. As an adjunct in the short term management of anxiety psychomotor agitation excitement, violent or dangerously impulsive behaviour. 3. Nausea or vomiting associated with terminal illness, where other agents are ineffective or unavailable. 4. Induction of hypothermia to prevent shivering and cause vasolidation. 5. Intractable hiccup. 6. Childhood schizophrenia and autism. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of Administration: Tablets are to be taken orally with a drink of water. Posology: Dosage: Dosage varies both with the individual and with the purpose for which the drug is being used. The dosage should be low to begin with and increased, gradually, under close supervision until the optimum level of control is achieved. Dosage in Schizophrenia, Other Psychoses Anxiety and Agitation etc: Adults: Initially 25mg three times daily or 75mg at bedtime, increasing by daily amounts of 25mg to the effective maintenance dose. The usual maintenance dose is in the range of 75 to 300mg daily, although some patients may require up to 1.0g daily. Children: (i) Aged under 1 year: Chlorpromazine should generally not be used unless the need is life-saving. (ii) Age 1 to 5 years: 0.5mg/kg every 4 to 6 hours to a maximum daily dosage of 40mg. (ii) Age 6 to 12 years: One-third to half the adult dose to a maximum daily dosage of 75mg. Elderly or Debilitated Patients: Initially one-third to half the usual adult dose with a more gradual increase in dosage. Dosage in Hiccup: Adults: 25-50mg three to four times daily Children: No information available. Elderly: One-third Lees het volledige document