Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; Paracetamol
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; Paracetamol
100 Tablets
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
_Consumer Medication Information Leaflet (RiMUP)_ FEBRICOL TABLET Paracetamol/Pseudoephedrine hydrochloride/Chlorpheniramine maleate (500mg/30mg/2mg) 1 WHAT IS IN THIS LEAFLET : 1. What is Febricol used for 2. How Febricol works 3. Before you use Febricol 4. How to use Febricol 5. While you are using Febricol 6. Side effects 7. Storage and disposal of Febricol 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS FEBRICOL USED FOR It is used to relief symptoms of headache, muscular ache, fever, sneezing, nose congestion, itchy and watery eyes associated with flu, common colds and allergic rhinitis (inflammation of the mucous membrane inside the nose). HOW FEBRICOL WORKS Paracetamol treats minor pain and reduces fever by inhibiting prostaglandin which is produce during inflammation. Pseudoephedrine is a decongestant. It works by narrowing the blood vessels in the nose to decrease swelling and congestion. Chlorpheniramine Maleate helps to reduce secretion in the nose by blocking histamine, a natural substance produced in the body during allergic reactions. BEFORE YOU USE FEBRICOL_ _ - _When you must not use it_ Do not use Febricol Tablet if you are allergic to any ingredients in this medicine. are going to use it for children below 12 years old. - _Before you start to use it_ Tell your doctor or pharmacist before using Febricol if you: have glaucoma (increased pressure inside the eye) are pregnant or plan to get pregnant. are breast-feeding or plan to start breast-feeding. are taking other medicines containing Paracetamol. are taking drugs for antidepressant, e.g. MAOIs (monoamine oxidase inhibitors) or within two weeks after stopping the treatment. have heart, kidney or metabolic problems, e.g. high blood pressure, high blood sugar, overactive of thyroid gland. have prostate enlargement _ _ _- Taking other medicines_ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharm Baca dokumen lengkap
- - - FEBRICOL ® TABLETS COMPOSITION Each tablet contains Paracetamol Pseudoephedrine HCI Chlorpheniramine Maleate 500 mg 30 mg 2 mg PHARMACOLOGY AND PHARMACOKINETICS FEBRLCOL contains a combination of an antihistamine, decongestant and a n t i p y r e t i c a n a l g e s i c . T h e a n a l g e s i c a n d a n t i p y r e t i c a c t i o n s of Paracetamol are similar to those of the salicylates. Paracetamol is only a w e a k i n h i b i t o r o f p r o s t a g l a n d i n s y n t h e s i s . A n a l g e s i a i s mediated p e r i p h e r a l l y a n d a l s o c e n t r a l l y , whereas a n t i p y r e s i s i s p r o d u c e d by a central action on the hypothalamic regulatory center. C h l o r p h e n i r a m i n e maleate is a histamine H , - b l o c k e r s and is generally effective in relatively low doses. It acts by occupying receptor sites on the effector cell, to the exclusion of histamine antagonist molecules, without inhibiting histamine production nor inactivates them. The antagonism is competitive and reversible. P s e u d o e p h e d r i n e H y d r o c h l o r i d e i s a s y m p a t h o m i m e t i c a g e n t that stimulates alpha,-adrenergic receptors in vascular smooth muscle. This causes vasoconstriction, resulting in an increase in nasal airway patency. It has action similar to ephedrine but less active as a central nervous s t i m u l a n t . I t h a s a l p h a - a n d beta-adrenergic a c t i v i t i e s a n d causes brochodilation. All the active ingredients are readily and effectively absorbed from the gastrointestinal tract. Paracetamol is metabolised in the liver and excreted i n t h e u r i n e m a i n l y a s t h e g l u c u r o n i d e a n d s u l p h a t e conjugates. Chlorpheniramine maleate is also extensively metabolised in the liver and excreted mainly as metabolites in the urine. Pseudoephedrine is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. INDICATIONS FEBRICOL is indicate Baca dokumen lengkap