Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Alimemazine tartrate
Primegen Limited
R06AD01
Alimemazine tartrate
10mg
Film-coated tablets
Oral use
28 tablets
Product subject to prescription which may be renewed (B)
Phenothiazine derivatives
It has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and pruritus. It may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years
Authorised
2015-07-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alimemazine tartrate 10mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10mg of alimemazine tartrate. Also contains lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets Dark blue, circular, biconvex and film coated tablet. One side of tablet is marked with AL and other side is plain. 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 may be used in pre-medication as a sedative before anaesthesia in children aged between 2 to 7 years. The alimemazine syrup formulation is suitable for these indications in children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Not recommended for infants less than 2 years old. Do NOT exceed the recommended dose (see also section 4.9). _Urticaria and pruritus_ Adults: 10mg two or three times daily. Elderly: Dosage should be reduced to 10mg once or twice daily. Children over 2 years of age: The use of Alimemazine Syrup is recommended. _As a sedative before anaesthesia_ The use of Alimemazine Syrup is recommended. 4.3 CONTRAINDICATIONS Use in patients with hepatic or renal dysfunction, epilepsy, Parkinson's disease, hypothyroidism, phaeochromocytoma, myasthenia gravis, and prostatic hypertrophy. Use in patients known to be hypersensitive to phenothiazines or to any of the excipients listed in section 6.1. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 31/07/2015_ _CRN 2165723_ _page number: 1_ Use in patients with a history of narrow angle glaucoma. Use i Read the complete document