国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlorpromazine hydrochloride
Rosemont Pharmaceuticals Ltd
N05AA01
Chlorpromazine hydrochloride
20mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5016119003899
CHLORPROMAZINE HYDROCHLORIDE 100MG/5ML ORAL SYRUP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE - BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. n Keep this leaflet. You may need to read it again. n If you have any further questions, ask your doctor or pharmacist. n 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. n If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Chlorpromazine Syrup is and what it is used for 2. What you need to know before you take Chlorpromazine Syrup 3. How to take Chlorpromazine Syrup 4. Possible side effects 5. How to store Chlorpromazine Syrup 6. Contents of the pack and other information PACKAGE LEAFLET: INFORMATION FOR THE USER _Continued overleaf_ n A PROLONGED PAINFUL ERECTION. If this happens to you, go to your nearest hospital n yellowing of the skin and whites of your eyes (jaundice) with fever and possible liver damage. IF YOU GET ANY OF THE FOLLOWING SIDE EFFECTS, SEE YOUR DOCTOR AS SOON AS POSSIBLE: n blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice IMMEDIATELY n feeling depressed, agitated, lack of emotion n fits n blood problems. You may notice signs such as high temperature or chills, sore throat, ulcers in your mouth or throat and unusual tiredness n heart changes including fast heart beats, unusual heart beats, heart attack. Symptoms of a heart attack are chest pain which may spread to the shoulders, neck or arms and shortness of breath. If you get these see a doctor straight away. Unexplained deaths have been reported but it is not proven that they were caused by chlorpromazine n low body temperature n low blood pressure. 阅读完整的文件
OBJECT 1 CHLORPROMAZINE HYDROCHLORIDE 100MG/5ML ORAL SYRUP Summary of Product Characteristics Updated 06-Aug-2013 | Rosemont Pharmaceuticals Limited 1. Name of the medicinal product Chlorpromazine Hydrochloride 100mg/5ml Oral Syrup 2. Qualitative and quantitative composition Chlorpromazine Hydrochloride 100mg/5ml 3. Pharmaceutical form Brown-red syrup with odour and taste of mint and apricot for oral administration 4. Clinical particulars 4.1 Therapeutic indications Chlorpromazine is a phenothiazine neuroleptic. It is indicated in the following conditions: - Schizophrenia and other psychoses (especially paranoid), mania and hypomania; - In severe anxiety, psychomotor agitation, excitement and violent or dangerously impulsive behaviour. Chlorpromazine is used as an adjunct in the short term management of these conditions; - Nausea and vomiting of terminal illness (where other drugs have failed or are not available); - Childhood schizophrenia and autism; - Intractable hiccups. 4.2 Posology and method of administration Posology For oral administration only. Dosage should be low to begin with and gradually increased under close supervision until the optimum dosage within the recommended range is reached. Individual response and dosage requirements may vary greatly. DOSAGE FOR SCHIZOPHRENIA, OTHER PSYCHOSES, MANIA, HYPOMANIA, ANXIETY, PSYCHOMOTOR AGITATION, EXCITEMENT, VIOLENT OR DANGEROUSLY IMPULSIVE BEHAVIOUR _Adults_: Initially 25mg three times daily or 75mg at bedtime increasing daily by 25mg to an effective maintenance dose. This maintenance dose is usually 70 to 300mg daily, but may be up to 1g daily in some patients. _Children under 1 year_: Not recommended unless the need is life saving. _Children 1 - 5 years: _0.5mg/Kg bodyweight every 4 - 6 hours to a maximum recommended dose of 40mg daily. _Children 6 - 12 years:_ 1/3 to 1/2 the adult dose up to a maximum recommended dose of 75 mg daily. _Elderly or disabled patients_: Start with 1/3 to 1/2 the usual adult dose with a more gradual increase in dosage. DOSAGE 阅读完整的文件