Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Paracetamol
IDAMAN PHARMA MANUFACTURING SDN BHD
Paracetamol
60 ml; 60 ml; 60 ml
IDAMAN PHARMA MANUFACTURING SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ ACTIMOL SUSPENSION 250MG/5ML _ _ Paracetamol (250mg/5ml) Page 1 of 3 WHAT IS IN THIS LEAFLET 1. What ActiMol Suspension is used for 2. How ActiMol Suspension works 3. Before you use ActiMol Suspension 4. How to use ActiMol Suspension 5. While you are using ActiMol Suspension 6. Side effects 7. Storage and disposal of ActiMol Suspension 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT ACTIMOL SUSPENSION IS USED FOR ActiMol Suspension is used for the relief of fever including fever after vaccination, additionally to treat headache and symptoms of cold and flu. Besides that, it also reduces pain of toothache and discomfort of teething. HOW ACTIMOL SUSPENSION WORKS ActiMol Suspension works as analgesic (pain relief) and antipyretic (anti-fever) with minimal anti- inflammatory properties. BEFORE YOU USE ACTIMOL SUSPENSION _ _ _ _ _ _ _ _ _ _ ALLERGY ALERT: Paracetamol may cause severe skin reactions. Symptom 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. _- When you must not use it _ You must not take this medicine and should talk to your doctor or pharmacist if: • You are allergic to Paracetamol or to other ingredients in it. • You are not sure whether you should start taking this medicine. _ _ _- Before you start to use it _ Tell your doctor if: • You have allergies to Paracetamol • You have kidney or liver problem. ActiMol Suspension should be given with care to patients with impaired kidney or liver function. ActiMol Suspension should also be given with care to patients taking other drugs that affect the liver. _Pregnancy and lactation _ This product is intended to be used in children. Talk to your doctor or your pharmacist before taking this medicine if you are pregnant, thinking of becoming pregnant or are breastfeeding. _- Taking other medicines _ Tell your doctor or p Belgenin tamamını okuyun
ACTIMOL SUSPENSION 250MG/5ML PRODUCT DESCRIPTION An orange suspension with a mentholated sweet and sour orange taste. COMPOSITION Each 5ml contains: • Active Ingredient: Paracetamol 250 mg • Preservatives: Methylparaben 9 mg and Propylparaben 1 mg PHARMACODYNAMICS ATC Code: N02 BE01. Pharmacotherapeutic group: Other Analgesics and Antipyretics (Anilides). Mechanism of Action Paracetamol is an analgesic and antipyretic. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system. Pharmacodynamic effects The lack of peripheral prostaglandin inhibition confers important pharmacological properties such as the maintenance of the protective prostaglandins within the gastrointestinal tract. Paracetamol is, therefore, particularly suitable for: patients with a history of disease or patients taking concomitant medication, where peripheral prostaglandin inhibition would be undesirable (such as, for example, those with a history of gastrointestinal bleeding or the elderly). PHARMACOKINETICS Absorption Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Distribution Binding to plasma proteins is minimal at therapeutic concentrations. Metabolism Paracetamol is metabolized in the liver and excreted in the urine mainly as glucuronide and sulfate conjugates. Elimination Less than 5% is excreted as unchanged paracetamol. INDICATIONS ActiMol Suspension 250mg/5ml is used for the relief of: • Fever • Headache and symptoms of cold and flu • Toothache and discomfort of teething • Fever after vaccination SYSTEM ORGAN CLASS FREQUENCY PROLONGED USAGE OR OVERDOSAGE SIGNIFICANT RARE POTENTIALLY FATAL NOT KNOWN Gastrointestinal disorders Nervous system disorders Blood and lymphatic disorders Skin and subcutaneous tissue Angioedema Thrombocytopenia, Leukopenia, Neutropenia, Pancytopenia, Methaemoglobi naemia, Agranulocytosis Acute renal tubular necrosis Hepatotoxicity Hepatic necrosis Nephrotoxicity Hypersensitivity reactions Belgenin tamamını okuyun