TROGE Ibuprofen 200mg film-coated tablets

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Virkt innihaldsefni:

ibuprofen

Fáanlegur frá:

Medopharm

INN (Alþjóðlegt nafn):

ibuprofen

Skammtar:

200mg

Lyfjaform:

tablets film-coated

Gerð lyfseðils:

OTC

Vara einkenni

Summary of Product
Characteristics
1. NAME OF THE MEDICINAL PRODUCT
TROGE
®
IBUPROFEN 200 mg film coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS:
PER TABLET:
Ibuprofen BP
200 mg
3. PHARMACEUTICAL FORM
Film-coated tablets for oral administration.
Description:
Bright pink coloured, film-coated tablets, slightly biconvex, circular
TROGE MEDICAL GMBH · HAMBURG · GERMANY
SPC_Ibuprofen_200mg_Tabs_MP_Armenien_14-05-07 .doc
page 2 of 7
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Ibuprofen is indicated for its analgesic and anti-inflammatory effects
in the treatment of rheumatoid
arthritis (including juvenile rheumatoid arthritis or Still's
disease), ankylosing spondylitis, osteoarthritis
and other non-rheumatoid (seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions, Ibuprofen is
indicated in periarticular conditions
such as frozen shoulder (capsulitis), bursitis, tendonitis,
tenosynovitis and low back pain; Ibuprofen can
also be used in soft tissue injuries such as sprains and strains.
Ibuprofen is also indicated for its analgesic effect in the relief of
mild to moderate pain such as
dysmenorrhoea, dental and post-operative pain and for symptomatic
relief of headache, including
migraine headache.
4.2. POSOLOGY AND METHOD OF ANALYSIS
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
ADULTS
The recommended dosage of Ibuprofen is 1200-1800 mg daily in divided
doses. Some patients can be
maintained on 600-1200 mg daily. In severe or acute conditions, it can
be advantageous to increase the
dosage until the acute phase is brought under control, provided that
the total daily dose does not exceed
2400 mg in divided doses.
CHILDREN
The daily dosage of Ibuprofen is 20 mg/kg of body weight in 3-4
divided doses.
In juvenile rheumatoid arthritis, up to 40 mg/kg of body weight daily
in divided doses may be taken.
Not recommended for children weighing less than 7 kg.