Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
TRIMEPRAZINE (ALIMEMAZINE) TARTRATE
Mercury Pharmaceuticals (Ireland) Ltd
R06AD01
TRIMEPRAZINE (ALIMEMAZINE) TARTRATE
30 MG/5ml
Syrup
Product subject to prescription which may be renewed (B)
alimemazine
Not Marketed
2015-01-30
PACKAGE LEAFLET: INFORMATION FOR THE USER ALIMEMAZINE TARTRATE 7.5MG/5ML & 30MG/5ML SYRUP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. WHAT IS IN THIS LEAFLET: 1. What Alimemazine is and what it is used for 2. What you need to know before you take Alimemazine 3. How to take Alimemazine 4. Possible side effects 5. How to store Alimemazine 6. Contents of the pack and other information 1. WHAT ALIMEMAZINE IS AND WHAT IT IS USED FOR The name of your medicine is Alimemazine tartrate 7.5mg/5ml or 30mg/5ml Syrup (called Alimemazine throughout this leaflet). This 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 IS USED FOR: to treat itching (pruritus) or an itchy, lumpy rash (urticaria) as a sedative before anaesthesia for children aged between 2 and 7 years. This medicine is given to reduce awareness or make the child feel relaxed and at ease before an operation. (Alimemazine tartrate 30mg/5ml Syrup only). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALIMEMAZINE DO NOT TAKE ALIMEMAZINE 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, swallowing or breathing problems, swelling of your lips, face, throat or tongue. Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alimemazine tartrate 30mg/5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml dose contains 6mg of Alimemazine tartrate. Also contains Sucrose 680 mg/ml Sodium sulphite anhydrous (E221) 1.0 mg/ml Sodium metabisulphite (E223) 1.0 mg/ml Ethanol 40.2 mg/ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup. Clear, colourless to pale yellow, syrupy liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alimemazine has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and pruritus. Alimemazine tartrate 7.5mg / 5ml syrup should be used for this indication in children. Alimemazine may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years. Alimemazine tartrate 30 mg / 5ml syrup can be used for the specific indication of pre-anaesthesia sedation in children (see Section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Alimemazine is not recommended for children less than 2 years old. Do NOT exceed the recommended dose (see also section 4.9). _Urticaria and pruritus_ Adults and adolescents 12-17 years: 10mg (approx. 1.6ml) two or three times daily. Elderly: Dosage should be reduced to 10mg (approx. 1.6ml) once or twice daily. Children less than 12 years of age should be prescribed alimemazine in a lower strength (7.5 mg/5 ml) syrup formulation for the indication of urticaria and pruritus. _As a sedative before anaesthesia_ (Children aged 2-7 years:) the maximum dosage recommended is 2mg (approx. 0.33 ml) per kg bodyweight 1-2 hours H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Baca dokumen lengkapnya