Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Chlorphenamine maleate
Almus Pharmaceuticals Ltd
R06AB04
Chlorphenamine maleate
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100
PATIENT INFORMATION LEAFLET CHLORPHENAMINE 4MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 • You must talk to a doctor if you do not feel better or if you feel worse. IN THIS LEAFLET: 1. What Chlorphenamine is and what it is used for 2. What you need to know before you take Chlorphenamine 3. How to take Chlorphenamine 4. Possible side effects 5. How to store Chlorphenamine 6. Contents of the pack and other information 1. WHAT CHLORPHENAMINE IS AND WHAT IT IS USED FOR This medicine contains Chlorphenamine maleate which belongs to a group of medicines called antihistamines, which act to relieve the symptoms of allergies. It can be used to relieve the symptoms of allergic reactions including hayfever, raised, red itchy skin (symptoms of urticaria, which is often known as hives or nettle rash), allergic reactions to foods or medicines, insect bites, runny nose and swelling of the face or throat due to fluid build up and itching caused by chickenpox. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORPHENAMINE DO NOT TAKE CHLORPHENAMINE IF YOU: • are allergic to Chlorphenamine or any other antihistamines or any of the other ingredients of this medicine (listed in section 6). This medicine contains sunset yellow E110 and can cause allergic type reaction, including asthma (allergy tends to be more common in people who are sensitive to aspirin) • have taken monoamine oxidase inhibitor (MAOI) antidepressant treatment in the past 14 days • have known brain damage or epilepsy • are comatose or in pre-comatose state WARNINGS AND PRECAUTIONS Talk Olvassa el a teljes dokumentumot
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 Olvassa el a teljes dokumentumot