Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol
Vitamode Sdn.bhd
Paracetamol
8 x 12 Tablets; 1x12 Tablets
BEXIMCO PHARMACEUTICAL LTD
NAPA EXTEND (PARACETAMOL 665MG ER TABLET) Paracetamol ER (665mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _Napa Extend_ is used for 2. How _Napa Extend _ works 3. Before you use _Napa Extend_ 4. How to use _Napa Extend_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Napa _ _Extend_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _NAPA EXTEND_ IS USED FOR Napa Extend Tablet is used for the relief of fever and the relief of mild to moderate pain including: headache, migraine, toothache, pain after dental procedures, neuralgia, muscular aches and joint pains, pain of osteoarthritis (inflammation of joints), rheumatic pain, period pain, pain after vaccination, sore throat and the discomfort from colds and influenza. HOW _NAPA EXTEND _WORKS Paracetamol is a para-aminophenol derivative that exhibits analgesic (pain relief) and antipyretic (reduce fever) activity. The mechanism of action of paracetamol is believed to include the inhibition of prostaglandin synthesis, primarily within the central nervous system. It does not possess anti- inflammatory activity. It provides relief from mild to moderate pain and fever. The combination of immediate release and sustained release paracetamol provides pain relief, which may last up to 8 hours. BEFORE YOU USE _NAPA EXTEND _ This preparation contains paracetamol. Do not take any other paracetamol containing medicines at the same time. _ _ - _When you must not use it _ Do not use _Napa Extend _ if you are allergic to paracetamol or to any of the other ingredients of this medicine. _ _ _ _ _Pregnancy and lactation_ _Napa Extend _ can be used in pregnancy and breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. _ Before you start use it _ Tell your doctor or pharmacist if: • You are taking other paracetamol- containing medication. • You have liver or kidney disease • You are severely malnourished, anorexic (loss of appetite for food) read_full_document
NAPA® EXTEND Paracetamol 665 mg ER Tablet PRODUCT DESCRIPTION A bi-layer white colored caplet shaped film coated tablet, engraved BPL on one side and plain on the other. Each modified release tablet contains 665 mg paracetamol. PHARMACODYNAMICS Paracetamol is a para-aminophenol derivative that exhibits analgesic and antipyretic activity. The mechanism of action of paracetamol is believed to include the inhibition of prostaglandin synthesis, primarily within the central nervous system. It does not possess anti-inflammatory activity. It provides relief from mild to moderate pain and fever. The combination of immediate release and sustained release paracetamol provides pain relief, which may last up to 8 hours. PHARMACOKINETICS Absorption Napa Extend are bilayer tablets incorporating an immediate release and a sustained release dose of paracetamol. The sustained release layer is formulated in such a manner that it rapidly hydrates to form a gel layer at the matrix periphery; the drug is then released from the matrix by a combination of diffusion and erosion of the gel layer. Napa Extend releases drug at a rate which ensures that therapeutically active plasma paracetamol concentrations are rapidly attained and maintained until up to 8 hours after administration. Distribution Paracetamol is distributed into most body tissues. Binding to the plasma proteins is minimal at therapeutic concentrations but increases with increasing doses. Metabolism Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulfate conjugates. The metabolites of paracetamol include a minor hydroxylated intermediate which has hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with glutathione, however, it can accumulate following paracetamol overdosage (more than 150 mg/kg or 10 g total paracetamol ingested) and if left untreated can cause irreversible liver damage. Paracetamol is metabolised differently by premature infants, newborns, infants and young child read_full_document