Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol BP
UNIMED SDN BHD
Paracetamol BP
2x5 Suppositories; 20X5 Suppositories
Bliss GVS Pharma Ltd
GACET (PARACETAMOL SUPPOSITORIES) Paracetamol (125mg, 250mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Gacet is used for 2. How Gacet works 3. Before you use Gacet 4. How to use Gacet 5. While you are using it 6. Side effects 7. Storage and Disposal of Gacet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT GACET IS USED FOR Gacet is used for the treatment of mild to moderate pain and fever in children. Gacet suppositories may be especially useful in patients unable to take oral forms of paracetamol e.g post operatively or with nausea and vomiting. HOW GACET WORKS Paracetamol had been thought to work by inhibiting the production of a compound in the central nervous system. Recently, is was found that paracetamol may have been acting via interaction in spinal cord pathways and inhibition of spinal substance. BEFORE YOU USE GACET - _When you must not use it_ _ _ Do not use Gacet if you are hypersensitive to Paracetamol or any other ingredients in the product. Do not use Gacet if you have any of the following conditions: • Serious liver disorder • Bleeding or swelling of the rectal (contraindication related directly to the administration route of the medicine). _ _ _Pregnancy and lactation _ Ask your doctor or pharmacist for advice before using Gacet if you are pregnant, trying to get pregnant or think you may be pregnant or if you are breast-feeding. _ _ _ _ _ _ _ _ _ _ - _Before you start to use it _ Paracetamol should be taken with care to if you have impaired liver or kidney function. In the event of uric acid or sugar content tests, you may be advised to disclose your intake of paracetamol. If the pain persists for more than 5 days or the fever for more than 3 days, or in the event of worsening, stop taking paracetamol without seeking advice from the doctor. Gacet contains paracetamol. Do not take any other paracetamol containing medicines at the same time. Allergy alert: Paracetamol may cause severe skin reactions. Sym Прочитайте повний документ
DRUG INTERACTIONS : Drugs which include hepatic microsomal enzymes such as alcohol, Rifampicin, barbiturates and other anti-convulsants may increase the hepatotoxicity of Paracetamol particularly after overdosage. The therapeutic effects of Paracetamol may also be decreased. DOSAGE: GACET-125 SUPPOSITORY: 1-5years (10-20kg): 1-2 Suppositories GACET-250 SUPPOSITORY: 6-12years (20-40kg): 1-2 Suppositories METHOD OF ADMINISTRATION: These doses may be repeated up to a maximum of 4 times in 24 hours. The dose should not be repeated more frequently than every 4 hours. The recommended dose should not be exceeded. Higher doses do not produce any increase in analgesic effect. Only whole suppositories should be administered – do not break suppository before administration. OVERDOSAGE: In the event of overdosage or accidental ingestion of a very high dose (150mg/kg), the doctor should be immediately consulted. Specific antidote is N Acetyl Cysteine. PREGNANCY AND LACTATION : Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk but not in clinically significant amounts. Available published data does not contraindicate breast feeding. FOR RECTAL ADMINISTRATION ONLY. NOT TO BE TAKEN ORALLY. STORAGE: Store in a dry place, below 30ºC. Protect from light. Keep medicine out of reach of children. Jauhkan daripada capaian kanak-kanak. PRESENTATION: Pack of 2 x 5 & 20 x 5 Suppositories packed in a carton along with leaflet. DATE OF REVISION: 08/2020. HOW TO USE SUPPOSITORY The suppositories should be inserted deeply in to the anus, if possible after having the bowels open. 1. When practical, clean the area around the rectum with mild soap and warm water, and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth. 2. Detach one suppository from the strip. 3. Remove wrapper before inserting suppository by holding suppository Прочитайте повний документ