Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
Paracetamol
100 ml; 90 ml; 60 ml; 120 ml; 60 ml; 90 ml; 100 ml; 100 mL; 90 mL; 60 mL; 120 mL; 60 mL; 90 mL; 100 mL
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ MILI SUSPENSION 250MG/5ML (RASPBERRY FLAVOUR) Paracetamol (250mg/5ml) 1 WHAT IS IN THIS LEAFLET 1. What Mili is used for 2. How Mili works 3. Before you use Mili 4. How to use Mili 5. While you are using Mili 6. Side effects 7. Storage and disposal of Mili 8. Product description 9. Manufactured by and Product Registration Holder 10. Date of revision WHAT MILI IS USED FOR For fever & relief of mild to moderate pain. HOW MILI WORKS Mili contains paracetamol, a medicine which works by relieving pain and reducing high temperature and fever. BEFORE YOU USE MILI _-When you must not use it _ Do not take Mili if allergic to paracetamol or to other ingredients in it. Do not take any other Paracetamol containing medicine at the same time. Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away. _-Before you start to use it_ Caution if you have impaired kidney or liver function. _Pregnancy and lactation_ Talk to you doctor before taking this medicine if you are pregnant, might become pregnant or are breastfeeding. _ _ _-Taking other medicines _ Inform your doctor or pharmacist before taking this medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Some medicine and Mili may interfere with each other. They may be affected by Mili or may affect how well it works especially: Enhance anticoagulant effect of warfarin (prevent heart attacks, strokes, and blood clots) and other coumarins with increased risk of bleeding. HOW TO USE MILI _-How much to use _ Always use Mili exactly as your doctor has prescribed. You should check with your doctor or pharmacist if in doubt. The usual dose: 1 to 5 years : 2.5 - 5 ml / dose 6 to 12 years : 5 - 10 ml / dose Above 12 years & adult : 10 - 20 ml / dose These doses may be repeated every 4-6 h Baca dokumen lengkapnya
MILI SUSPENSION 250MG/5ML (RASPBERRY FLAVOUR) NAME AND STRENGTH OF ACTIVE INGREDIENT (S) Each 5 ml contains: Paracetamol BP …………………………………….. 250 mg Preservatives: Methyl Paraben …………………………...……… 0.1% w/v Propyl Paraben ……………………...………...… 0.01% w/v PRODUCT DESCRIPTION Pink suspension with raspberry flavour. PHARMACODYNAMICS Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life of paracetamol varies from about 1 to 3 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine) which is usually produced in very small amounts by mixed-function oxidases in the liver and kidney and which is usually detoxified by conjugation with glutathione may accumulate following paracetamol overdosage and cause tissue damage. PHARMACOKINETICS Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. INDICATIONS For fever & relief of mild to moderate pain. RECOMMENDED DOSE 1 to 5 years : 2.5 - 5 ml / dose 6 to 12 years : 5 - 10 ml / dose Above 12 years & adult : 10 - 20 ml / dose These doses may be repeated every 4-6 hours when necessary. Maximum of 4 doses in 24 hours. ROUTE OF ADMINISTRATION Oral. CONTRAINDICATIONS It is contraindicated in patients with known hyper-sensitivity to paracetamol or any of the other ingredients/components. WARNING AND PRECAUTIONS This preparation contains Paracetamol. Do not take any other Paracetamol containing medicines at the same time. Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assis Baca dokumen lengkapnya