Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Alimemazine tartrate
Zentiva Pharma UK Ltd
R06AD01
Alimemazine tartrate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5000283653936
-1- 11503686-02 PACKAGE LEAFLET: INFORMATION FOR THE USER ALIMEMAZINE TARTRATE 10MG FILM COATED TABLETS 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 symptoms 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 alimemazine tablets are and what they are used for 2. What you need to know before you take alimemazine tablets 3. How to take alimemazine tablets 4. Possible side effects 5. How to store alimemazine tablets 6. Contents of the pack and other information 1. WHAT ALIMEMAZINE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Alimemazine Tartrate 10mg Film Coated Tablets (called alimemazine throughout this leaflet). It contains the active ingredient alimemazine tartrate and belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed. WHAT ALIMEMAZINE TABLETS ARE USED FOR • To treat itching (pruritus) or an itchy, lumpy rash (urticaria) • As a sedative for children aged between 2 and 7 years. This is a medicine given to reduce awareness or make the child feel relaxed and at ease before an operation 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALIMEMAZINE TABLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: You are allergic (hypersensitive) to: − alimemazine tartrate or any of the other ingredients of this medicine (listed in section 6) − any other similar medicines (phenothiazines) such as chlorpromazine The signs of an allergic reaction include: a rash, swallo Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alimemazine Tartrate 10mg Film Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Alimemazine tartrate 10mg For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Circular, film coated biconvex tablet with bevelled edge, dark blue in colour, one face impressed V/10. The reverse side is plain 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alimemazine has a central sedative effect comparable to that of chlorpromazine but largely devoid of the latter’s anti adrenaline action. In adults and children of 3 years and over: - Pre-medication before general anaesthesia and before stressful or painful process. - Second-line treatment of the signs and symptoms of allergic rhinitis, conjunctivitis and urticaria - Second-line treatment in symptomatic relief of allergic and pruritic dermatological disorders _4.2 _ _POSOLOGY AND METHOD OF ADMINISTRATION _ Posology Not recommended for children less than 3 years old (see also sections 4.3 and 4.4). DO NOT exceed the recommended dose (see also section 4.9). Urticaria and pruritus Adults: 10 mg (approx. 6.5 ml) two or three times daily; up to 100 mg per day have been used in intractable cases. Elderly: Dose should be reduced to 10 mg (approx. 6.5 ml) once or twice daily. Children over 3 years of age: 2.5 – 5 mg (approx. 1.7 – 3.3 ml) three or four times daily. Sedative premedication before general anaesthesia Children aged 3 – 7 years: The maximum dosage recommended is 2 mg (approx. 1.3 ml) per kg bodyweight 1 – 2 hours before the operation. Method of administration For oral administration. 4.3 CONTRAINDICATIONS Alimemazine is contraindicated in patients with: • Known hypersensitivity to phenothiazines or to any of the excipients listed in section 6.1. • Hepatic or renal dysfunction • Epilepsy • Parkinson’s disease • Hypothyroidism • Phaeochromocytoma • Myasthenia gravis • History of narrow angle glaucoma • History of agranulocytosis • Prostatic hypertrophy. Прочитать полный документ