Land: Armenien
Sprache: Englisch
Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paracetamol
S.C. Europharm S.A.
N02BE01
paracetamol
500mg
tablets film-coated
(12/1x12/) blister
OTC
Registered
2015-05-15
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Panadol Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500.0 mg 3. PHARMACEUTICAL FORM Film-coated tablets White, film-coated and capsule-shaped tablets with flat edges with PANADOL embossed on one side and a break line on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic therapy of pain: headache (including migraine and tension headache, toothache, sore throat, backache, muscle and rheumatic pains, dysmennorhoea, and for relieving the fever (as antipyretic). In case of increased body’s temperature associated with cold and flu. Medicine is intended for pain decrease at the time of using and has no influence for progressive disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration only. Adults (including the elderly) and children over 12 years aged: 1-2 tablets taken every 4 to 6 hours as required. Minimum dosing interval: 4 hours. Maximum daily dose: 8 tablets (4000 mg). Children, 6 to 12 years: ½-1 tablet taken every 4 to 6 hours as required. Minimum dosing interval: 4 hours. Maximum daily dose: 4 tablets. Maximum daily dose: 60mg/kg presented in divided doses of 10 – 15 mg/kg throughout the 24 hour period. Maximum duration of continued use without medical advice: 3 days. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol or any of the other constituents; Children under the age of 6 years. Care is advised in the administration of paracetamol to patients with renal or hepatic failure, benign hyperbilirubinemia (including Gilber’s syndrome), virus hepatitis, hereditary absence of glucose-6-phosphate dehydrogenase, alcohol-induced liver failure, alcohol dependence, the elderly age, during pregnancy and lactation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. Do not exceed the stated dose. Do not take with any other paracetamol - containing Lesen Sie das vollständige Dokument