Country: Armenja
Lingwa: Ingliż
Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paracetamol
GlaxoSmithKline Dungarvan Limited
N02BE01
paracetamol
500mg
tablets film-coated
(12/1x12/) in blister
OTC
Registered
2023-03-21
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Panadol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500.0 mg 3. PHARMACEUTICAL FORM Film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short-term relief of pain and antipyretic including: Headache Musculoskeletal pain. Dysmennorhoea Toothache. Cold and flu symptoms It can also be used for symptomatic relief of pain from mild to moderate intensity in osteoarthritis diagnosed by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. Adults (including the elderly) and children aged 16 years and over: 1-2 tablets up to 4 times daily as required. Children 10 - 15 years: 1 tablet up to 4 times daily as required. Maximum duration of continued use without medical advice: 3 days. Minimum dosing interval: 4 hours. No more than four doses in any 24 hour period. Children: Not recommended for children under the age of 10 years. Patients with renal / hepatic impairment: Patients with severe hepatic or severe renal insufficiency are not recommended to use the drug. Patients who have been diagnosed with kidney/liver impairment must seek medical advice before taking this medication. Do not exceed the stated dose. The lowest dose necessary to achieve efficacy should be used. _ _ _ _ 4.3 CONTRAINDICATIONS Previous history of hypersensitivity to paracetamol or any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE CONTAINES PARACETAMOL . Do not use with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which can lead to liver transplant or death. Underlying liver disease increases the risk of paracetamol-related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. Cases of hepatic dysfunction/failure has been reported in patients with deplete Aqra d-dokument sħiħ