Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol
IDAMAN PHARMA MANUFACTURING SDN BHD
Paracetamol
1000 Tablets
IDAMAN PHARMA MANUFACTURING SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ IDAMOL TABLET 500MG Paracetamol (500mg) 1 WHAT IS IN THIS LEAFLET 1. What IDAMOL is used for 2. How IDAMOL works 3. Before you use IDAMOL 4. How to use IDAMOL 5. While you are using it 6. Side effects 7. Storage and disposal of IDAMOL 8. Product description 9. Product Registration Holder and Manufacturer 10. Date of revision WHAT IDAMOL IS USED FOR IDAMOL is used for relief of mild to moderate pain including headache, toothache, sore throat and period pain. They are also used to reduce fever HOW IDAMOL WORKS Paracetamol works as a painkiller by affecting chemicals in the body called prostaglandins. Prostaglandins are substances released in response to illness or injury. Paracetamol blocks the production of prostaglandins, making the body less aware of the pain or injury. Paracetamol reduces temperature by acting on the area of the brain that is responsible for controlling temperature. BEFORE YOU USE IDAMOL - _When you must not use it _ Should not be used by person with allergic to paracetamol or any other ingredients listed at the end of this leaflet. Should not be used by person with severe and active liver impairment. _Pregnancy and lactation _ Consult with your doctor before taking IDAMOL if you are pregnant or think you may be pregnant. It can be considered as choice for analgesic in pregnancy and it considered to be safe even though it crosses placenta. Consult with your pharmacist if you are breast feed your child since it excreted in breast milk. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it _ Care should be taken if you having alcohol dependence, severe liver or urinary impairment when taking IDAMOL. - _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. Some medicine might have interaction when taking together with IDAMOL. This include: - Warfarin (medicine for blood thinning Baca dokumen lengkap
PREGNANCY AND LACTATION _Use in pregnancy:_ • Considered to be the analgesic of choice in pregnant patients. • Although it crosses placenta, paracetamol is considered to be safe in normal therapeutic doses for short-term use as a minor analgesic/antipyretic in pregnancy. If paracetamol is clinically needed during pregnancy, it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency. _Use in lactation:_ • Excreted in breast milk but not in a clinically significant amount. • Maternal ingestion of paracetamol in normal therapeutic doses does not appear to present a risk to the nursing infant. ADVERSE EFFECTS / UNDESIRABLE EFFECTS Adverse effects of paracetamol are rare and usually mild, although haematological reactions have been reported. Cutaneous hypersensitivity reactions including skin rashes, angioedema, Steven Johnson Syndrome/ Toxic Epiderma Necrolysis have been reported. * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs OVERDOSE AND TREATMENT _Symptoms:_ Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors. Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolicacidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia,cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. _Risk factors_ a) If the patient is on long term treat Baca dokumen lengkap