Ibuprofen-Asteria 400mg tablets film-coated

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

ibuprofen

Доступна с:

Hankook Korus Pharm Co.

код АТС:

M01AE01

ИНН (Международная Имя):

ibuprofen

дозировка:

400mg

Фармацевтическая форма:

tablets film-coated

Штук в упаковке:

(20/2x10/) and (100/10x10/), in blister

Тип рецепта:

OTC

Статус Авторизация:

Registered

Дата Авторизация:

2015-10-28

тонкая брошюра

IBUPROFEN -ASTERIA TAB. 400MG (IBUPROFEN)
COMPOSITION
Each film coated tablets contains:
Active ingredient
Ibuprofen 400mg
Excipients
INDICATIONS & USAGE
Relief of the signs and symptoms of rheumatoid arthritis and
osteoarthritis, mild to moderate pain, and treatment of primary
dysmenorrheal and for fever reduction.
DOSAGE & ADMINISTRATION
The usual adults dose for painful conditions is 1.2g to 1.8g daily in
divided doses although maintenance doses of 600mg to 1.2g daily
may be effective in some patients. If necessary the dose may be
increased; in the UK the maximum recommended dose is 2.4g daily
whereas in the USA it is 3.2g daily. Patients with rheumatoid
arthritis generally require higher doses of ibuprofen than those with
osteoarthritis. If gastrointestinal complains occur administer
ibuprofen tablets with meals or milk. The recommended dose for fever
reduction is 200 to 400mg every 4-6hours. Maximum dose is 1.2g daily.
Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the
earliest onset of such pain, ibuprofen children's suspension should
be given in a dose of 400 mg every 4 hours as necessary for the relief
of pain.
Pediatric use: children 12 to 18 years- 200mg to 400mg 3 or 4 times
daily increased, if necessary, to a maximum of 2,4g daily.
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
urticaria) in response to aspirin or other non- steroidal
anti-inflammatory drugs. Active or previous peptic ulcer (two or more
episodes of
proven ulceration or bleeding). History of upper gastrointestinal
bleeding or perforation, related to previous NSAID therapy. Patients
with
severe hepatic failure, renal failure or heart failure. Use in last
trimester of pregnancy. Children under 12years of age.
UNDESIRABLE EFFECTS
The most frequent type of adverse reaction occurring with ibuprofen is
gastrointestinal. In controlled clinical trials, t

Характеристики продукта

Summary of Product Characteristics insert company logo
1. NAME OF THE MEDICINAL PRODUCT
Ibuprofen -Asteria Tab. 400mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/g
Use
1
Ibuprofen
400mg
Active ingredient
Excipient(s)
No.
Chemical Name
Quantity/Tab.
Use
1
Lactose
50.0 mg
Diluent
2
Corn starch
40.0 mg
Diluent
3
Polyvinylpyrolidone K-30
4.0 mg
Diluent
4
Colloidal silicone dioxide
2.0 mg
Diluent
5
Talc
2.0 mg
Lubricant
6
Magnesium stearate
4.0 mg
Lubricant
7
Hydroxypropylmethylcellulose 2910
6.0 mg
Coating agent
8
Polyethylene glycol 6000
3.0 mg
Coating agent
9
Titanium Oxide
2.0 mg
Coating agent
10
Diacetylatedmonoglycerides
1.0 mg
Coating agent
11
Sunset yellow FCF
q.s
Coating agent
12
Red. No. 3
q.s
Coating agent
3. PHARMACEUTICAL FORM
Film-coated tablets
Summary of Product Characteristics insert company logo
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Relief of the signs and symptoms of rheumatoid arthritis and
osteoarthritis, mild to moderate
pain, and treatment of primary dysmenorrheal and for fever reduction.
4.2 Posology and method of administration
The usual adults dose for painful conditions is 1.2g to 1.8g daily in
divided doses although
maintenance doses of 600mg to 1.2g daily may be effective in some
patients. If necessary the
dose may be increased; in the UK the maximum recommended dose is 2.4g
daily whereas in the
USA it is 3.2g daily. Patients with rheumatoid arthritis generally
require higher doses of
ibuprofen
than
those
with
osteoarthritis.
If
gastrointestinal
complains
occur
administer
ibuprofen tablets with meals or milk. The recommended dose for fever
reduction is 200 to
400mg every 4-6hours. Maximum dose is 1.2g daily.
Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the
earliest onset of such
pain, ibuprofen children's suspension should be given in a dose of 400
mg every 4 hours as
necessary for the relief of pain.
Pediatric use: children 12 to 18 years- 200mg to 400mg 3 or 4 times
daily increased, if necessary,
to a maximum o