Ibufene suspension oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ibuprofen

Available from:

Medical Horizon Ltd

ATC code:

M01AE01

INN (International Name):

ibuprofen

Dosage:

20mg/ml

Pharmaceutical form:

suspension oral

Units in package:

glass bottle 100ml and measuring cup

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2019-05-31

Patient Information leaflet

INSTRUCTION FOR MEDICINAL USE
(FOR PATIENTS)
IBUFENE
ORAL SUSPENSION 100 ML
TRADE NAME
IBUFENE
INTERNATIONAL NON-PROPRIETARY NAME (INN)
Ibuprofen
COMPOSITION
Each 5 ml contains active ingredients: 100 mg Ibuprofen, inactive
ingredients: Propylene glycol, Glycerine,
Methylparaben, Propylparaben, Sunset yellow, Sorbitol liquid,
Polysorbate 80, Orange flavour, Saccharose, Aerosol
200, Xanthan, Purified water.
DOSAGE FORM
Oral paediatric suspension with orange flavour.
PARMACOLOGICAL GROUP
Nonsteroidal anti-inflammatory drugs
ATC CODE
M01AE01
PHARMACOLOGOCAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Ibuprofen inhibits prostaglandin synthesis by decreasing the activity
of the enzyme, cyclooxygenase, which
results in decreased formation of prostaglandin precursors.
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 particular conditions such as
frozen shoulder (capsulitis), bursitis,
tendinitis, tenosynovitis, and low back pain; Ibuprofen can also be
used in soft-tissue injuries such as sprains
and strains. Ibuprofen is indicated for its analgesic effect in the
relief of mild to moderate pain such as
dysmenorrhea, dental and post-operative pain and for the symptomatic
relief of headache including
migraine headache. Ibuprofen is also indicated for its antipyretic
properties especially for children.
PHARMACOKINETIC PROPERTIES
Ibuprofen is absorbed from the gastrointestinal tract and peak plasma
concentrations occur about 1 to 2
hours after ingestion. Ibuprofen is also absorbed following rectal
administration. There is some absorption
following topical application to the skin. For example, some
manufacturers report that percutaneous
absorption from topical gel is about 5 % of that obtained following
administration of an oral dose

Summary of Product characteristics

PRODUCT –
IBUFENE ORAL SUSPENSION
Page 1 of 6
SUMMARY PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
IBUFENE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 100mg/5ml.
For excipients, see 6.1
3. PHARMACEUTICAL FORM
Oral Suspension 100ml
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IBUFENE suspension is indicated for children from 6 months to 12
years, but for infants 3-6 month only after
medical prescription, taking into account baby’s weight over 5 kg.
As antipyretic: acute respiratory diseases, flu, paediatric
infections, post-vaccination period, and diseases which
proceed with high temperature.
As analgesic: mild to moderate pain such as: dentation, headache,
toothache, earache, throat ache, traumatic and
post-operative pains, neuralgia and migraine.
As anti-inflammatory: juvenile rheumatoid arthritis, osteoarthritis,
bursitis, tendovaginitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage depends on children age and weight. Single dose of IBUFEN
suspension varies between 5-10mg/kg per
body weight, maximum daily dose is 30mg/kg per body weight. IBUFEN
suspension can be given 3-4 times during
24 hours. The medicine is effective until 8 hours.
AGE
AVERAGE WEIGHT
SINGLE DOSE
MAXIMUM DAILY DOSE
3-6 month
By medical advise
6 month-1year
7-10 kg
2.5 ml (mg)
200 mg
1-3 year
10-16 kg
2.5-5 ml (50-100 mg)
300 mg
4-6 year
18-22 kg
7.5 ml (150 mg)
450 mg
7-9 year
24-28 kg
10 ml (200 mg)
600 mg
10-12 year
30-36 kg
15 ml (300 mg)
900 mg
-
It is not recommended to use IBUFEN suspension for more than 5 days as
analgesic
-
And for more than 3 days as antipyretic
PRODUCT –
IBUFENE ORAL SUSPENSION
Page 2 of 6
4.3 CONTRAINDICATIONS
-
Infants above 3 month
-
Hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory
agents
-
Bronchial asthma, urticarial
-
Gastro-intestinal ulcer in children
-
Gastro-intestinal bleeding
-
Colon inflammation
-
Blood disease leucopenia, haemophilia
-
Liver or kidney insufficiency
-
Last trimester of pregnancy
4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE
Care