Nazione: Svezia
Lingua: svedese
Fonte: Läkemedelsverket (Medical Products Agency)
ibuprofen
Zentiva k.s.
M01AE01
ibuprofen
400 mg
Filmdragerad tablett
ibuprofen 400 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 40 tabletter; Blister, 10 tabletter; Blister, 100 tabletter; Blister, 12 tabletter; Blister, 20 tabletter; Blister, 24 tabletter; Blister, 250 tabletter; Blister, 30 tabletter; Blister, 36 tabletter; Blister, 48 tabletter; Blister, 50 tabletter
Godkänd
2021-05-04
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ibuprofen Zentiva 400 mg film-coated tablets Ibuprofen Zentiva 600 mg film-coated tablets Ibuprofen Zentiva 800 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each400 mg film-coated tablet contains ibuprofen 400 mg. Each Leggi il documento completo600 mg film-coated tablet contains ibuprofen 600 mg. Each 800 mg film-coated tablet contains ibuprofen 800 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 400 mg film-coated tablet: white to off-white rounded film-coated tablets with diameter 12 mm. 600 mg film-coated tablet: white to off-white oblong (17 x 10 mm) film-coated tablets. 800 mg film-coated tablet: light yellow to beige oblong (20 x 10 mm) film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [ 400 mg, 600 mg and 800 mg film-coated tablets] Rheumatic conditions such as arthritic diseases (e.g. rheumatoid arthritis including juvenile rheumatoid arthritis), non-articular rheumatic conditions, other muscular and joint disorders, and soft tissue injuries. 400 mg and 600 mg is recommended for adults and adolescents from 40 kg bodyweight (over 12 years). 800 mg is recommended for adults only (see section 4.2). [ 400 mg film-coated tablets] In addition, 400 mg is intended for short-term symptomatic treatment of mild to moderate pain, migraine, primary dysmenorrhea and/or fever. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The treatment should start with the lowest dose anticipated to be effective, which can subsequently be adjusted, depending on the therapeutic response and any undesirable effects. The maximum single dose should not exceed 800 mg of ibuprofen for adults and 600 mg of ibuprofen for adolescents. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to con