Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ALIMEMAZINE TARTRATE
Lexon Pharmaceuticals (Ireland) Limited
R06AD01
ALIMEMAZINE TARTRATE
10 milligram(s)
Film-coated tablet
alimemazine
Marketed
2020-12-18
PACKAGE LEAFLET KEY PHARMACEUTICALS LTD. ALIMEMAZINE TARTRATE 10MG FILM-COATED TABLETS PL 34424/0054 PA23176/009/001 Version: 06 (March 2021)_MM Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER Alimemazine tartrate 10 mg film-coated tablets alimemazine tartrate Your medicine is called Alimemazine tartrate 10 mg film-coated tablets, but it will be referred to as Alimemazine tablets throughout this leaflet. 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 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 Alimemazine tablets contain 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) in adults 2. WHAT DO 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 Read the complete document
Health Products Regulatory Authority 03 February 2022 CRN00CS1D Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alimemazine tartrate 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of alimemazine tartrate Excipients with known effect Each film-coated tablet contains 38 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Blue, round, biconvex film-coated tablets, debossed with "A" on one side and "1" on other side, approximately 6.5 mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aliememazine tartrate 10 mg film-coated tablets is used for second-line treatment in the symptomatic relief of urticaria and pruritus in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults:_ 10 mg two or three times daily. _Elderly:_ Dose should be reduced to 10 mg once or twice daily. _Paediatric population:_ Children over 3 years of age: The use of Alimemazine Syrup is recommended. Children less than 3 years of age: Contraindicated (see sections 4.3 and 4.4) Method of administration: The product is administered orally. DO NOT exceed the recommended dose (see also section 4.9). 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 Health Products Regulatory Authority 03 February 2022 CRN00CS1D Page 2 of 6 Alimemazine is contraindicated for use in children less than 3 years of age (see section 4.4). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients are strongly advised not to consume alcoholic beverages or medicines containing alcohol throughout treatment (see section 4.5). Exposure to sunlight should be avoided during Read the complete document