Brufen Rapid capsules soft

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

ibuprofen

Доступна с:

Geltec Private Limited

код АТС:

M01AE01

ИНН (Международная Имя):

ibuprofen

дозировка:

400mg

Фармацевтическая форма:

capsules soft

Штук в упаковке:

(20/2x10/) in blister

Тип рецепта:

OTC

Статус Авторизация:

Registered

Дата Авторизация:

2020-11-20

Характеристики продукта

                                _Confidential _
_ _
_Module 1 _
SUMMARY OF PRODUCT CHARACTERISTICS
IBUPROFEN SOFT GELATIN CAPSULES 400 MG
1.
NAME OF THE MEDICINAL PRODUCT:
Brufen
®
Rapid, ibuprofen capsules 400 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Capsules 400 mg:
Each Soft Gelatin Capsule Contains:
Ibuprofen Ph. Eur.
Excipients q.s.
Please refer point no. 6.1 for detail list of inactive ingredients
3.
PHARMACEUTICAL FORM:
Capsules 400 mg:
The drug product is a Pale yellow colored, 14 minims, oval shaped,
transparent soft
gelatin capsules with clear fill material, printed with # in white
colour ink.
4.
CLINICAL PARTICULARS:
4.1
THERAPEUTIC INDICATIONS:
Adults, elderly, and children over 12 years of age:
Brufen
®
Rapid 400 mg, capsules, is indicated for short-term symptomatic
treatment of
non-severe
forms
of
arthritis,
rheumatic
pain,
back
and
muscle
pain,
neuralgia,
migraine, headache, toothache, dysmenorrhea, flu symptoms and colds.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
For oral administration and short-term use only. The capsules should
be taken with
water.
_Adults, elderly, children and adolescents from 12 to 18 years:_
Adverse reactions when taking the drug can be reduced
by using the minimum
effective dose for the shortest period necessary to relieve symptoms
(see section
"precautions").
If a child or teenager needs to take this medicine for more than 3
days or symptoms
worsen. The doctor should be consulted.
_Children and adolescents aged 12 to 18 years: _
1-2 capsules, but no more than 3 capsules per day as needed.
_Adults: _
1 capsule, but no more than 3 capsules per day as needed. The capsules
should be taken
with water.
It is necessary to observe an interval of at least 4 hours between
doses of the drug. Do
_Confidential _
_ _
_Module 1 _
not take more than 3 capsules within 24 hours.
4.3
CONTRAINDICATIONS:

Hypersensitivity to ibuprofen or any of the constituents in the
product.

Ibuprofen
is
contra-indicated
in
patients
who
have
previously
shown
hypersensitivity
reactions (e.g. asthma, rhinitis, angiodema or 
                                
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