国: マルタ
言語: 英語
ソース: Medicines Authority
CHLORPROMAZINE HYDROCHLORIDE
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
N05AA01
CHLORPROMAZINE HYDROCHLORIDE 100 mg
FILM-COATED TABLET
CHLORPROMAZINE HYDROCHLORIDE 100 mg
POM
PSYCHOLEPTICS
Authorised
2006-11-27
mt-pl-chlorpromazine-fc-tabs-a1 Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CHLORPROMAZINE 25 MG FILM-COATED TABLETS CHLORPROMAZINE 100 MG 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 any further questions, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Chlorpromazine is and what it is used for 2. What you need to know before you take Chlorpromazine 3. How to take Chlorpromazine 4. Possible side effects 5. How to store Chlorpromazine 6. Contents of the pack and other information 1. WHAT CHLORPROMAZINE IS AND WHAT IT IS USED FOR Chlorpromazine contains the active substance chlorpromazine hydrochloride. Chlorpromazine belongs to the group of medicines that are called phenothiazines which act on the central nervous system. They are used to treat the following conditions: schizophrenia and other psychoses particularly paranoia (delusions and feelings of persecution), mania (overactive behaviour) and hypomania (elated moods and excitability), anxiety, agitation and violent or dangerously impulsive behaviour. Chlorpromazine is also used for prolonged periods of hiccups, nausea and vomiting (when other drugs have failed), to lower body temperature and for childhood schizophrenia and autism (learning and communication difficulties). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORPROMAZINE DO NOT TAKE CHLORPROMAZINE : • if you are allergic (hypersensitive) to chlorpromazine, other phenothiazines or to any of the other ingredients in the tablets (listed in section 6). Signs of an allergic reaction include: a 完全なドキュメントを読む
mt-spc-chlorpromazine-fc-tabs-v03-r00-a2 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS _ _ 1. NAME OF THE MEDICINAL PRODUCT Chlorpromazine 25 mg film-coated tablets Chlorpromazine 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Chlorpromazine _ _25 mg _ _film-coated _ _tablets:_ Each film-coated tablet contains 25 mg chlorpromazine hydrochloride. Excipient(s) with known effect: This product contains 38 mg lactose. _Chlorpromazine _ _100 mg _ _film-coated _ _tablets:_ Each film-coated tablet contains 100 mg chlorpromazine hydrochloride. Excipient(s) with known effect: This product contains 151.9 mg lactose. For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Film-coated tablet. White, round, film-coated tablets. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Schizophrenia and other psychoses (especially paranoia), mania and hypomania. In anxiety, psychomotor agitation, excitement, violent or dangerously impulsive behaviour. Chlorpromazine is used as an adjunct in the short-term management of these conditions. Intractable hiccup. Nausea and vomiting in terminal illness (where other drugs have failed or are not available). Induction of hypothermia is facilitated by Chlorpromazine tablets which prevents shivering and causes vasodilatation. Childhood schizophrenia and autism. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION mt-spc-chlorpromazine-fc-tabs-v03-r00-a2 Page 2 of 15 Dosages should be low to begin with and gradually increased under close supervision until the optimum dosage for the individual is reached. Individuals vary considerably and the optimum dose may be affected by the formulation used. Posology Dosage of chlorpromazine in schizophrenia, other psychoses, anxiety and agitation etc. _Adult: _ Initially 25 mg three times a day or 75 mg at bedtime increasing by daily amounts of 25 mg to an effective maintenance dose. This is usually in the range 75 to 300 mg daily but some patients may require up to 1 g daily. _Children under 1 year: _ Chlorpromazi 完全なドキュメントを読む