Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CHLORPHENIRAMINE MALEATE
DUOPHARMA (M) SDN. BHD.
CHLORPHENIRAMINE MALEATE
100 Tablet Tablets; 1000 Tablet Tablets; 5000 Tablet Tablets
DUOPHARMA (M) SDN. BHD.
_Consumer Medication Information Leaflet (RIMUP) _ KOTAMIN TABLET Chlorpheniramine Maleate 4mg WHAT IS IN THE LEAFLET? 1. What KOTAMIN is used for 2. How KOTAMIN works 3. Before you use KOTAMIN 4. How to use KOTAMIN 5. While you are using it 6. Side effects 7. Storage and Disposal of KOTAMIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT KOTAMIN IS USED FOR KOTAMIN is used to treat allergies. It relieves the itchiness, redness, swelling, tenderness and irritation associated with many skin problems. KOTAMIN also relieves the sneezing and itching, watery eyes and nose associated with hay fever. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. HOW KOTAMIN WORKS The name of your medicine is KOTAMIN. It contains the active ingredient chlorpheniramine maleate which is an antihistamine. Histamine is a chemical released into the body during an allergic reaction. It causes itching and inflammation. KOTAMIN works by blocking the effects of histamine, calming down the body's allergic reaction and starting to relieve the symptoms. BEFORE YOU USE KOTAMIN _When you must not use it _ Do not take this medicine if: • You are hypersensitive to, or have had an allergic reaction to chlorpheniramine or any of the ingredients listed at the end of this leaflet. • You are taking a class of medicine known as ‘monoamine oxidase inhibitors’ (MAOIs) (often taken for depression). • The expiry date (EXP) printed on the pack has passed. • The packaging is torn, shows signs of tampering or it does not look quite right. _Before you start to use it _ You must tell your doctor if: • you have a known allergy to KOTAMIN or any of the ingredients listed at the end of this leaflet. • you are pregnant or intend to become pregnant. • you are breast-feeding or plan to breast-feed. • you have epilepsy, glaucoma (eye disease causing optic nerve damage which can lead to vision l Lue koko asiakirja
[DUOPHARMA (M) SDN BHD] Page 1 of 1 [REVISION DATE: 10.08.2020] KOTAMIN TABLET 4MG DESCRIPTION: A 7mm round, scored tablet, yellow colour with marking ‘duo’. COMPOSITION: Each tablet contains Chlorpheniramine Maleate 4mg. PHARMACODYNAMICS: Antihistamine. KOTAMIN is a member of the alkylamine group of antihistamines, which are among the most active H 1 blockers. They are effective in low dosage, have a wide safety margin, and a very low incidence of side effects such as dizziness and drowsiness. PHARMACOKINETICS: Chlorpheniramine maleate is absorbed relatively slowly from the gastro-intestinal tract, peak plasma concentrations occurring about 2.5 to 6 hours after administration by mouth. Bioavailability is low, values of 25 to 50% having been reported. Chlorpheniramine appears to undergo considerable first pass metabolism. About 70% of chlorpheniramine in the circulation is bound to plasma proteins. Chlorpheniramine is widely distributed in the body, including passage into the CNS. Chlorpheniramine maleate is extensively metabolized. Metabolites include desmethyl- and didesmethylchlorpheniramine. Unchanged drug and metabolites are excreted primarily in the urine; excretion is dependent on urinary pH and flow rate. Only trace amounts have been found in the faeces. Duration of action of 4 to 6 hours has been reported; this is shorter than may be predicted from pharmacokinetic parameters. More rapid and extensive absorption, faster clearance, and a shorter half-life have been reported in children. INDICATION: For all conditions requiring antihistamine therapy such as hay fever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergies, drug and serum reactions, atopic and contact dermatitis, allergic eczema, pruritus ani et vulvae, insect bites. RECOMMENDED DOSAGE: TABLET: ADULTS – One tablet, up to four times daily as required. CHILDREN – 6 -12years: 2-4mg t.d.s or q.i.d. ROUTE OF ADMINISTRATION: Oral CONTRAINDICATIONS: Hypersensitivity to chlorpheniramine. Traditional antihistamines such as chlorp Lue koko asiakirja