Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlordiazepoxide hydrochloride
Phoenix Healthcare Distribution Ltd
N05BA02
Chlordiazepoxide hydrochloride
5mg
Oral capsule
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200
Product: Chlordazepoxide 5mg & 10mg Item Code: P0971T Size: 210 x 297 mm Min. Point size: 8.5pt O. Artwork: 19/09/19 Proof No. 7 Amendment Date 11/05/20 Process Black Keyline - Does not print Colours Used PATIENT INFORMATION LEAFLET CHLORDIAZEPOXIDE Capsules 5mg & 10mg 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 Chlordiazepoxide Capsules are and what they are used for 2. What you need to know before you take Chlordiazepoxide Capsules 3. How to take Chlordiazepoxide Capsules 4. Possible side effects 5. How to store Chlordiazepoxide Capsules 6. Contents of the pack and other information This medicine belongs to the group of medicines known as benzodiazepines. These are used for depressing the central nervous system (CNS) (medicines that slow down the nervous system). This medicine is used for the short term relief of severe anxiety, treatment of insomnia (trouble in sleeping), control of muscle spasms and symptomatic relief of acute alcohol withdrawal. This medicine should be used for as short a time as possible and should not be used for more than four weeks. If used for too long without a break, there is a risk of becoming dependent or of having problems when you stop taking it. The risk of dependence (a need to keep taking the medicine) increases with dose and length of treatment period and is greater if you have ever had a history of alcohol or drug abuse, or in patients with personality disorders. Your doctor will monitor you whilst you are taking this medicine and will withdraw Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlordiazepoxide 5mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlordiazepoxide Hydrochloride 5 mg 3 PHARMACEUTICAL FORM Capsule. 4.1. THERAPEUTIC INDICATIONS FOR SHORT TERM USE (2 – 4 WEEKS ONLY) • 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 Chlordiazepoxide is not recommended; for long term use (i.e. longer than 4 weeks), mild anxiety or for use in children. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY: ANXIETY _Adults _ Starting dose 5mg daily: usual dose up to 30mg in divided doses. For severe symptoms 20mg, 2-4 times a day. Maximum dose up to 100mg daily, in divided doses, adjusted on an individual basis. Treatment should not continue as full dose for more than 4 weeks including 2 week tapering off process. INSOMNIA ASSOCIATED WITH ANXIETY _Adults _ 10 – 30 mg at bedtime Treatment would normally vary from a few days to two weeks with a maximum of four weeks, including two weeks tapering off. MUSCLE SPASM _Adults _ 10mg to 30mg daily in divided doses SYMPTOMATIC RELIEF OF ACUTE ALCOHOL WITHDRAWAL _Adults _ 25 to 100mg, repeated if necessary in 2 to 4hrs SPECIAL POPULATIONS Elderly or debilitated patients, patients with organic brain damage, respiratory impairmentshould normally not exceed half of the doses normally recommended. _ _ _Patients with impaired hepatic or renal function _ Dosage should not exceed half the adult dose and steps should be taken to ensure that there is no accumulation of plasma chlordiazepoxide Contraindicated in severe hepatic insufficiency (see section 4.3) _Paediatric patients_ Chlordiazepoxide Capsules are not for paediatric use. Treatment should be given at the lowest effective dose. The dosage and duration of treatment should be determi Прочитайте повний документ