Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol; CODEINE PHOSPHATE
DYNAPHARM (M) SDN BHD
Paracetamol; CODEINE PHOSPHATE
100 Tablets; 1000 Tablets
DYNAPHARM (M) SDN BHD
PARADEINE TABLET Paracetamol / Codeine Phosphate (500mg / 8mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Paradeine Tablet is used for 2. How Paradeine Tablet works 3. Before you use Paradeine Tablet 4. How to use Paradeine Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Paradeine Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PARADEINE TABLET IS USED FOR For the relief of mild to moderately severe pain. HOW PARADEINE TABLET WORKS Paracetamol and codeine phosphate are painkillers that work together in different ways to relieve pain. BEFORE YOU USE PARADEINE TABLET - _When you must not use it _ - Hypersensitivity to Paracetamol or Codeine. - In children below the age of 12 years for the symptomatic treatment of colds due to an increased risk of developing serious and life-threatening adverse reactions. - In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to increased risk of developing serious and life- threatening adverse reactions. - In women who are breastfeeding. - In individuals for whom it is known they are CYP2D6 ultra-rapid metabolisers. This preparation contains Paracetamol. Do not take other Paracetamol containing medicines at the same time. _Pregnancy and lactation _ _ _ Do not take Paradeine Tablet if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Paradeine Tablet if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it _ Tell your doctor if: - You are patients with impaired kidney or liver function. - You are taking other drugs which affect the liver. - You have underactive thyroid, Addison’s disease and enlargement of the prostate gland or constriction of the urethra. - _Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a p Læs hele dokumentet
PARADEINE TABLET MAL19913256AZ DESCRIPTION: TABLET Colour : White Shape : Round, Flat and Scored Marking : “P” EACH TABLET CONTAINS: Paracetamol .................................................................................... 500 mg Codeine Phosphate ............................................................................... 8 mg PHARMACODYNAMICS: Codeine Phosphate is a narcotic analgesic that acts in the central nervous system to alter the perception of pain and emotional response to pain. Codeine also has antitussive action by the suppression of the cough reflex by a direct central action, probably in the medulla or pons. Codeine also has antidiarrhoeal action. Paracetamol has analgesic and antipyretic actions. PHARMACOKINETICS: Codeine Phosphate is well absorbed after oral administration and after injection. After an oral dose of 15 mg, peak plasma concentrations of 30 ng/ml are attained within 2 hours. It is widely distributed throughout the body and crosses the placenta. It is metabolised in the liver by O-demethylation to form morphine, N-demethylation to form narcodeine, and conjugation to form glucuronides and sulphates of both unchanged drug and its metabolites. After an oral dose, about 86% is excreted in the urine in 24 hours; of the excreted material, 40 to 70% is free or conjugated Codeine, 5 to 15% is free or conjugated morphine, 10 to 20% is free or conjugated normorphine; some of the dose is excreted in the bile and trace amounts are found in the faeces; unchanged drug accounts for 6 to 8% of the dose in urine in 24 hours which may be increased to about 10% when the urinary pH is decreased; after an intramuscular dose, 15 to 20% is excreted unchanged in acid urine in 24 hours. Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glycoronide and sulphate conjugates. Less than 5% is excreted as unchanged Paracetamol. The Læs hele dokumentet