Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol
Y.S.P. INDUSTRIES (M) SDN BHD
Paracetamol
5Units Units; 10Units Units; 100Units Units
Y.S.P. INDUSTRIES (M) SDN BHD
_Consumer Medication Information Leaflet (RiMUP)_ _ _ 1 | PORO SUPPOSITORY Paracetamol (Acetaminophen) (125mg, 250mg) WHAT IS IN THIS LEAFLET 1. What PORO SUPPOSITORY is used for 2. How PORO SUPPOSITORY works 3. Before you use PORO SUPPOSITORY 4. How to use PORO SUPPOSITORY 5. While you are using it 6. Side effects 7. Storage and disposal of PORO SUPPOSITORY 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PORO SUPPOSITORY IS USED FOR PORO SUPPOSITORY is used for the symptomatic relief of fever, minor aches, pain and headaches. HOW PORO SUPPOSITORY WORKS PORO SUPPOSITORY consists of analgesic- antipyretic (an agent that relieves pain and reduces fever) effect. BEFORE YOU USE PORO SUPPOSITORY _-When you must not use it _ Do not use PORO suppository if you are allergic to paracetamol or other ingredients in it. _-Before you start to use it _ Tell your doctor or pharmacist if - you are allergic to any medicines, foods, preservatives or dyes; - you have any other medical conditions such as heart, liver or kidney problems; - you have alcohol abuse problems - you are allergic to Paracetamol. Paracetamol may cause severe skin reactions. - you are taking other Paracetamol containing products _-Taking other medicines _ Do not take other paracetamol containing medicines at the same time. Avoid taking Aspirin with paracetamol as it may increase blood concentrations of unhydrolysed Aspirin. Besides, you must also inform them about all the medicines you are taking, including those without a prescription. HOW TO USE PORO SUPPOSITORY _-How much to use _ To be inserted deep into rectum every 4 hours as needed, up to four times daily. Children 1-2 years: 1 suppository of 125mg. Children 2-6 years: 1-2 suppositories of 125mg. Children 6-12 years: 1-2 suppositories of 250mg. _-When to use it _ PORO SUPPOSITORY should be taken according to the time advised by your doctor or pharmacist. It can be taken with or without food. _-How long to use it _ PORO SUPPOSITORY should be inserted into Прочетете целия документ
PORO ® SUPPOSITORY INGREDIENT(S): Poro suppository 125mg Each suppository contains: Paracetamol(Acetaminophen) ………..……….................…………...…… 125mg Poro suppository 250mg Each suppository contains: Paracetamol(Acetaminophen) ………..……………..……..................…… 250mg PHARMACOLOGY (SUMMARY OF PHARMACODYNAMIC AND PHARMACOKINETIC): 1. Paracetamol may act by inhibiting prostaglandin synthesis in the central nervous system and through a peripheral action by blocking pain impulse generation. The peripheral action may also be due to inhibition of the synthesis of prostaglandins which sensitize pain receptors to mechanical or chemical stimulation. 2. Paracetamol produces antipyresis by acting centrally on the hypothalamic heat-regulation center to produce peripheral vasodilation resulting in increase blood flow through the skin, sweating and heat loss. The central action probably involved inhibition of prostaglandin synthesis in the hypothalamus. 3. Paracetamol is uniformly distributed throughout most body fluids, the apparent volume of distribution is 1 to 1.2 L/kg. Paracetamol can cross the placenta and is excreted in milk. At therapeutic plasma levels no protein binding occurs. Paracetamol is metabolised by the hepatic microsomal enzyme system. In adults at therapeutic doses, paracetamol is mainly conjugated with glucuronide (45-55%) or sulphate (20-30%). A minor propor- tion (less than 20%) is metabolised to catechol derivatives, and mercapturic acid compounds via oxidation. Paracetamol is metabolized differently by infants and children compared to adults, the sulphate conjugate being predominant. Paracetamol is excreted by active tubular secretion: 85-90% of the administered dose is eliminated in the urine within 24 hours of administration. Paracetamol has a half-life of 1 to 3.5 hours. INDICATION(S): For the symptomatic relief of fever and pain (headache, muscle ache) associated with common cold. DOSAGE AND ADMINISTRATION: Children 1-2 years: 1 suppository of 125 Прочетете целия документ