Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlorphenamine maleate
Crescent Pharma Ltd
R06AB04
Chlorphenamine maleate
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5017123094132
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlorphenamine Tablets 4 mg Numark Antihistamine and Allergy Relief 4mg Tablets Allerief 4 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4.00 mg chlorphenamine maleate. Excipient(s) of known effect: Lactose 105.0 mg per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Yellow, normal convex tablet engraved with company logo on one side, and a breakline and B094 on the other side. 4.1 THERAPEUTIC INDICATIONS Chlorphenamine tablets are indicated for symptomatic control of all allergic conditions responsive to antihistamines, including hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergy, drug and serum reactions, pruritis and vulvae, and insect bites. Also indicated for the symptomatic relief of itch associated with chickenpox. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS AND CHILDREN 12 YEARS AND OVER: 1 tablet every 4-6 hours. Maximum daily dose 24 mg (6 tablets) in any 24 hours. ELDERLY: The elderly are more likely to experience neurological anticholinergic effects. Consideration should be given to using a lower daily dose (e.g. a maximum daily dose of 12mg (3 tablets) in any 24 hours). CHILDREN AGED 6–12 YEARS: ½ tablet every 4-6 hours. Maximum daily dose 12 mg (3 tablets) in any 24 hours. CHILDREN UNDER 6 YEARS: Not recommended. Method of administration: Oral Do not exceed the stated dose or frequency of dosing Minimum dosing interval: 4 hours. Do not use continuously for more than two weeks without consulting a doctor Populations Patients with renal or hepatic impairment should seek doctor’s advise prior to taking this medicine. (See Section 4.4 Special warnings and precautions for use). 4.3 CONTRAINDICATIONS Hypersensitivity to other antihistamines, chlorphenamine maleate or any of the other tablet ingredients. The anticholinergic properties of chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Chlorphenamine tablets are t Đọc toàn bộ tài liệu