Pays: Arménie
Langue: anglais
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paracetamol, caffeine
Famar A.V.E. Anthoussa Plant
N02BE51
paracetamol, caffeine
500mg+ 65mg
tablets soluble
(12/2x6/) in strip
OTC
Registered
2019-12-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Solpadeine Active 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500.0 mg and Caffeine 65.0 mg. 3. PHARMACEUTICAL FORM Soluble tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT OF MILD TO MODERATE INTENSITY PAIN AND RELIEF OF FEVER INCLUDING: Headache Migraine Muscle ache Dysmennorhoea Sore throat Musculoskeletal pain Fever and pain after vaccination Pain after dental procedures/ tooth extraction Toothache Pain of osteoarthritis _For Colds and Flu:_ For the relief of symptoms of the common cold and influenza for example headache, fever, sore throat, muscular aches and pains reduced alertness and drowsiness. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Oral administration only. Should be dissolved in at least half a tumbler of water. Adults (including the elderly) and children aged 12 years and over: 1-2 tablets every 4 to 6 hours as required. Do not exceed 8 tablets in 24 hours. Minimum dosing interval: 4 hours. The lowest dose necessary to achieve efficacy should be used. Children: not recommended for children under the age of 12 years. Do not exceed the stated dose. If symptoms continue consult the doctor. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol, caffeine or 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 depleted glutathione levels, such as those who are severely malnourished, anorexic, have low body mass index or are chronic heavy users of alcohol. Lire le document complet