Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlorphenamine maleate
Arrow Generics Ltd
R06AB04
Chlorphenamine maleate
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5060034831129
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlorphenamine 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg Chlorphenamine Maleate. Also contains lactose and sunset yellow (E110). For the full list of excipients see 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow, circular normal convex tablets with a breakline embossed C / 4 on one face and PV on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The symptomatic control of allergic conditions which respond to anti- histamines including hay fever, urticaria, vasomotor rhinitis, angioneurotic oedema, food allergies, drug and serum reactions, pruritis vulvae, pruritis ani, and insect bites. Also indicated for the symptomatic relief of itch associated with chickenpox. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use Adults and children over 12 years: 4mg (one tablet) every 4 to 6 hours (maximum 24 mg daily). Children: Aged 6 –12 years: 2mg (equivalent to half a tablet) every 4 to 6 hours (Maximum 12mg daily) Not recommended for children under 6 years of age. Elderly: As for adults but such patients are prone to confusional psychosis and other neurological anticholinergic effects. Consideration should be given to using a lower daily dose (e.g. a maximum of 3 tablets (12mg in total) in any 24 hours, taken 1 tablet 4 to 6 hourly. 4.3 CONTRAINDICATIONS 1. Use in patients hypersensitive to Chlorphenamine or any of the excipients in the tablet. 2. Coma or pre-coma states. 3. Known brain damage or epilepsy. The anticholinergic properties of Chlorphenamine are intensified by monoamine oxidase inhibitors (MAOIs). Chlorphenamine is therefore contraindicated in patients who have been treated with MAOIs within the last fourteen days. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The anticholinergic properties of Chlorphenamine may cause drowsiness, dizziness, blurred vision and psychomotor impairment in some patients, which may seriously affect ability to drive and use machinery. Chlorphenamine, in common wit Lugege kogu dokumenti