Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlordiazepoxide hydrochloride
Actavis UK Ltd
N05BA02
Chlordiazepoxide hydrochloride
10mg
Oral capsule
Oral
Schedule 4 (CD Benz)
Valid as a prescribable product
BNF: 04010200
PATIENT INFORMATION LEAFLET- KENT & ALMUS CHLORDIAZEPOXIDE 5MG AND 10MG CAPSULES 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 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 OR NURSE. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4. 1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR The name of your medicine is Chlordiazepoxide 5mg Capsules or Chlordiazepoxide 10mg Capsules. Chlordiazepoxide is a member of a group of medicines called benzodiazepine anxiolytics. Your medicine can be used for the short-term relief (2-4 weeks treatment only) of: muscle spasm of varied cause. symptoms of alcohol withdrawal anxiety causing distress or insomnia (difficulty sleeping) anxiety occurring with mental health problems 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE YOUR MEDICINE DO NOT TAKE YOUR MEDICINE IF YOU: are allergic to chlordiazepoxide or any of the other ingredients in chlordiazepoxide capsules. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue have reduced blood flow to the lungs- symptoms may include coughing and shortness of breath have any problems with your breathing have anxiety disorders due to unreasonable thoughts and fears (obsessional states) havea long-term mental condition causing hallucinations and delusions etc. have sleep apnoea (stopping breathing while asleep) have a severe liver disorder have a muscle weakness disorder known as myasthenia gravis suffer from depression that is not being treated. Chlordiazepoxide capsules are not to be used in anyone under 18 years of age. WHAT IS IN THIS Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlordiazepoxide 10mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlordiazepoxide Hydrochloride Ph. Eur. 10 mg Excipient with known effect: Each capsule contains 100mg Lactose For the full list of excipients, see section 6.1. 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 _ Usual dose 10mg, 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 OF VARIED AETIOLOGY _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 impairment should 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 pae Прочитайте повний документ