Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol; ORPHENADRINE CITRATE
SUNWARD PHARMACEUTICAL SDN. BHD.
Paracetamol; ORPHENADRINE CITRATE
1000 Tablet Tablets; 100 Tablet Tablets; 1000 Tablet Tablets; 500 Tablet Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
SUNITON TABLET Orphenadrine Citrate / Paracetamol (35mg / 450mg) 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Suniton Tablet is used for 2. How Suniton Tablet works 3. Before you use Suniton Tablet 4. How to use Suniton Tablet 5. While you are using it 6. Side effects 7. Storage and disposal of Suniton Tablet 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SUNITON TABLET IS USED FOR Suniton Tablet is used for the relief of painful muscle ache and headache. HOW SUNITON TABLET WORKS Orphenadrine is a skeletal muscle relaxant that acts in the nervous system to produce muscle relaxant effects. Paracetamol is an analgesic (pain killer) and antipyretic (relieve fever). BEFORE YOU USE SUNITON TABLET _- When you must not use it _ Do not take Suniton Tablet if you: are hypersensitive to chlorpheniramine citrate, paracetamol or any of the other ingredients of this medicine (listed in Product Description). _ _ have glaucoma (increase pressure in eyes). have gastric outflow obstruction. have ulcer in stomach. have enlargement of prostate or bladder neck obstruction. have severe muscle weakness. have liver problem or kidney problem. _- Before you start to use it _ Tell your doctor before taking this medicine if you have: rapid heart rate or other heart disease. impaired liver or kidney function. This preparation contains Paracetamol. Do not take any other paracetamol containing medicines at the same time. _Pregnancy and breastfeeding _ You should check with your doctor if you are or think you may be pregnant, planning to become pregnant or if you are breastfeeding. _ _ _Laboratory _ Tell your doctor that you are taking Suniton Tablet before doing any medical tests. _- Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. You should talk to your doctor or pharmacist if you are ta Прочитайте повний документ
INTERACTIONS WITH OTHER MEDICAMENTS: Orphenadrine has been shown to induce enzymatic systems involving the metabolism of aminopyrine, steroidal contraceptives, griseofulvin, hexobarbital and phenylbutazone. Orphenadrine will potentiate other anticholinergic agents. Paracetamol should also be given with care to patients taking other drugs that affect the liver. Paracetamol hepatotoxicity has been reported to be enhanced by phenobarbitone, alcohol and doxorubicin. PREGNANCY AND LACTATION: Orphenadrine has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformations or other direct or indirect harmful effects on the human fetus having been observed. Since safety of the use of this preparation in pregnancy and during lactation has not been established, use of the drug in such patients requires that the potential benefits of the drug be weighed against its possible hazard to the mother and child. SIDE EFFECTS: Adverse effects are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses. Side-effects of paracetamol are usually mild, though haematological reactions such as agranulocytosis, thrombocytopenia and pancytopenia have been reported. Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis have been reported. Other allergic reactions occur occasionally. SYMPTOMS AND TREATMENT OF OVERDOSE: Symptoms of orphenadrine overdosage are excitement, confusion and d Прочитайте повний документ