Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlordiazepoxide hydrochloride
Dr Reddy's Laboratories (UK) Ltd
N05BA02
Chlordiazepoxide hydrochloride
10mg
Oral tablet
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200
PACKAGE LEAFLET: INFORMATION FOR THE USER CHLORDIAZEPOXIDE 5MG & 10MG FILM-COATED TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU STARTS 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 are Chlordiazepoxide film-coated Tablets and what they are used for 2. What you need to know before you take Chlordiazepoxide film-coated Tablets 3. How to take Chlordiazepoxide film-coated Tablets 4. Possible side effects 5. How to store Chlordiazepoxide film-coated Tablets 6. Contents of the pack and other information 1. WHAT CHLORDIAZEPOXIDE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient (which makes the tablets work) is chlordiazepoxide hydrochloride. It belongs to a group of drugs known as benzodiazepines and has a calming effect. Chlordiazepoxide film-coated Tablets are used for the short-term relief (2-4 weeks only) OF SEVERE OR DISABLING ANXIETY occurring alone or along with sleeping problems, MUSCLE SPASM OF VARIED CAUSES and for the RELIEF OF SYMPTOMS OF SUDDEN ALCOHOL WITHDRAWAL. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORDIAZEPOXIDE FILM-COATED TABLETS DO NOT TAKE CHLORDIAZEPOXIDE TABLETS if you: • have had any UNUSUAL OR ALLERGIC REACTIONS to chlordiazepoxide, other benzodiazepine medicines or to any of the other ingredients in the tablets (see Section 6). • have a disorder known as MYASTHENIA GRAVIS a condition where muscles become easily tired and weak leading to difficulty breathing • have SEVERE LIVER DISEASE • suffer from lung disease or BREATHING DIFFICULTIES • have a condition called SLEEP APNOEA wher Perskaitykite visą dokumentą
CHLORDIAZEPOXIDE 10MG FILM-COATED TABLETS Summary of Product Characteristics Updated 22-Mar-2016 | Dr. Reddy's Laboratories (UK) Ltd 1. Name of the medicinal product Chlordiazepoxide 10 mg Film-coated Tablets 2. Qualitative and quantitative composition Chlordiazepoxide hydrochloride equivalent to 10mg Chlordiazepoxide For a full list of excipients, see section 6.1 3. Pharmaceutical form Film-coated tablet Plain, biconvex, mid-green, film coated tablets 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 (ie longer than 4 weeks) • For mild anxiety • In children 4.2 Posology and method of administration Route of administration: oral Posology: Treatment to be given • under close medical supervision • at the lowest effective dose • for the shortest possible duration (not exceeding 4 weeks) The dosage and duration of treatment should be determined on an individual basis dependent by the patient's response and severity of the disorder. Given that chlordiazepoxide is a long-acting benzodiazepine, the patient should be monitored regularly at the start of the treatment to decrease, if necessary, the dose or frequency of administration to prevent overdose due to accumulation. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. 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 the patient should be informed that • treatment will be of limited duration • the dosage will Perskaitykite visą dokumentą