Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol
IDAMAN PHARMA MANUFACTURING SDN BHD
Paracetamol
1000 Tablets; 100 Tablets
IDAMAN PHARMA MANUFACTURING SDN BHD
FEPRIL TABLET 500MG Paracetamol (500mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What FEPRIL is used for 2. How FEPRIL works 3. Before you use FEPRIL 4. How to use FEPRIL 5. While you are using FEPRIL 6. Side effects 7. Storage and disposal of FEPRIL 8. Product description 9. Product Registration Holder & Manufacturer 10. Date of revision WHAT FEPRIL IS USED FOR FEPRIL is used for relief of mild to moderate pain and to reduce fever. It provides symptomatic relief only; additional therapy to treat the cause of the pain or fever should be instituted when necessary. HOW FEPRIL WORKS FEPRIL has analgesic (pain relief) and antipyretic (anti-fever) properties. BEFORE YOU USE FEPRIL - _When you must not use it _ Do not take FEPRIL if you are allergic to Paracetamol or Acetaminophen. Do not take FEPRIL if you are pregnant, trying to get pregnant or think you may be pregnant without discussing with your doctor first. Do not take FEPRIL if you are breast- feeding. If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist. - _Before you start to use it _ Tell your doctor if you have allergies to Paracetamol or Acetaminophen. Your doctor needs to know before you take FEPRIL if you have kidney or liver problem. FEPRIL should be given with care to patients with impaired kidney or liver function. FEPRIL should also be given with care to patients taking other drugs that affect the liver. Your doctor needs to know if you are intolerant of aspirin. Patient intolerant of aspirin may not be intolerant of FEPRIL, however mild bronchospastic reactions with FEPRIL have been reported in some aspirin-sensitive asthmatics. Discuss with your doctor or pharmacist first if you are pregnant or breastfeeding. - _Taking other medicines _ Tell your doctor or pharmacist before taking FEPRIL, if you are taking any other medicines, including any that you buy without a prescription from pharmacy, supermarket or health food shop. The effects of some medicines may be affe Đọc toàn bộ tài liệu
IDAMAN PHARMA MANUFACTURING FEPRIL TABLET 500MG PRODUCT DESCRIPTION Round and biconvex tablets with one side scored. White to off white in colour. Each tablet contains: Paracetamol 500mg _Preservative:- _ Potassium Sorbate: 0.58mg ROUTE OF ADMINISTRATION Oral PHARMACODYNAMICS Paracetamol is a centrally acting analgesic and antipyretic with minimal anti-inflammatory properties. Analgesic The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (specifically cyclooxygenase (COX)-2) and, to a lesser extent, through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation. Antipyretic Paracetamol act centrally on the hypothalamic heat-regulating center to produce peripheral vasodilatation resulting in increased blood flow through the skin, sweating and heat loss. Paracetamol reduces fever by inhibiting the formulation and release of prostaglandins in the CNS and by inhibiting endogenous pyrogens at the hypothalamic thermoregulator center. PHARMACOKINETICS Absorption After oral administration Paracetamol is rapidly and almost completely absorbed. Peak plasma concentrations are reached after 30 minutes to 2 hours. Distribution Paracetamol is distributed rapidly throughout all tissues. Concentrations are comparable in blood, saliva and plasma. The volume of distribution of Paracetamol is approximately 1 L/kg bodyweight. At therapeutic doses protein binding is negligible. Metabolism In adults, paracetamol is conjugated in the liver with glucuronic acid (~60%), sulphate (~35%) conjugates. The latter route is rapidly saturated at doses higher than the therapeutic dose. A minor route, catalyzed by the cytochrome P450, results in the formation of an intermediate reagent (N acetyl-p-benzoquinoneimine) which un Đọc toàn bộ tài liệu