Brufen Retard tablets film-coated prolonged-release

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

ibuprofen

Доступна с:

FAMAR A.V.E. ANTHOUSSA PLANT

код АТС:

M01AE01

ИНН (Международная Имя):

ibuprofen

дозировка:

800mg

Фармацевтическая форма:

tablets film-coated prolonged-release

Штук в упаковке:

20(2x10) in blister

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2021-03-18

Характеристики продукта

Brufen Retard - Summary of Product Characteristics (SmPC)
Page 1 of 8
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
Brufen Retard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Ibuprofen – 800 mg
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brufen Retard 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,
Brufen
Retard
is
indicated
in
periarticular conditions such as
frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis
and low back pain; Brufen Retard can also be used in
soft-tissue injuries such as sprains and
strains.
Brufen Retard 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 ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to
control symptoms (see section 4.4).
Adults and children over 12 years of age: Two tablets taken as a
single daily dose, preferably in
the early evening well
before retiring to bed. The tablets should be swallowed whole with
plenty
of fluid and not chewed, broken, crushed or
sucked on to avoid oral discomfort and throat
irritation. In severe or acute conditions, total daily dosage may be
increased to three tablets in
two divided doses.
Children: Not recommended for children under 12 years.
Elderly: The elderly are at increased risk of serious consequences of
adverse reactions. If an
NSAID is considered
necessary, the lowest effective dose should be used and for the
shortest
possible duration. The patient should