Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlordiazepoxide hydrochloride
Phoenix Healthcare Distribution Ltd
N05BA02
Chlordiazepoxide hydrochloride
5mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200
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, 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. THIS LEAFLET CONTAINS 1. WHAT CHLORDIAZEPOXIDE IS FOR 2. BEFORE YOU TAKE CHLORDIAZEPOXIDE PACKAGE LEAFLET: INFORMATION FOR THE USER CHLORDIAZEPOXIDE 5 MG & 10 MG TABLETS 1. WHAT CHLORDIAZEPOXIDE IS FOR 2. BEFORE YOU TAKE CHLORDIAZEPOXIDE 3. HOW TO TAKE CHLORDIAZEPOXIDE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CHLORDIAZEPOXIDE 6. FURTHER INFORMATION Chlordiazepoxide belongs to a group of medicines called benzodiazepines. It can be used in the SHORT-TERM (2-4 weeks only) treatment of: IN ADULTS: severe anxiety, occurring alone or in association with insomnia (difficulty in sleeping), stress or a loss of control with reality (psychosis) muscle spasms the symptoms of alcohol withdrawal. Chlordiazepoxide tablets are NOT FOR USE IN CHILDREN. If you are not sure why you have been prescribed this medicine then please ask your doctor. DO NOT TAKE CHLORDIAZEPOXIDE AND TELL YOUR DOCTOR IF YOU: are allergic to Chlordiazepoxide, any of the other ingredients in the tablets (listed in section 6 of this leaflet) or to other benzodiazepines have severe liver, lung or breathing problems have muscle weakness sometimes causing difficulty breathing (myasthenia gravis) suffer from breathing problems whilst asleep (sleep apnoea) suffer from depression, mental health problems, irrational fears (phobias) or obsessions are pregnant, planning to become pregnant or are breast-feeding, (see ‘Pregnancy and breast-feeding’ below) TAKE SPECIAL CARE WITH CHLORDIAZEPOXIDE Tell your doctor BEFORE you take this medicine if you: have a h Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlordiazepoxide 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlordiazepoxide Hydrochloride 5.6 mg Also contains lactose and sunset yellow E110, for a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet Mid-green, round, biconvex film-coated tablets with MP3 engraved on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For short-term (2-4 weeks only) use: • symptomatic relief of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness. • Muscle spasm of varied aetiology • Symptomatic relief of acute alcohol withdrawal Not for use: • Long term (i.e. longer than 4 weeks) • For mild anxiety • In children 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral Treatment to be given • under close medical supervision • at the lowest effective dose • for the shortest possible duration (not exceeding 4 weeks) Extension of use should not take place without further clinical evaluation Chronic use not recommended (little is known of the long term safety and efficacy: potential for dependence - see section 4.4). When treatment is started it may be useful to inform the patient that treatment will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product has been discontinued. Anxiety Adults: The starting dose should be 5 mg daily increasing to a usual dose of up to 30 mg in divided doses, but up to a maximum dose of 100 mg daily, in divided doses adjusted on an individual basis. Treatment should always be as short as possible and should not continue at full dose for more than 2 weeks with a 2 week tapering off pro Read the complete document