Brufen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ibuprofen 600mg

Available from:

Abbott Laboratories (NZ) Ltd

INN (International Name):

Ibuprofen 600 mg

Dosage:

600 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Ibuprofen 600mg Excipient: Chalk Colloidal silicon dioxide Hypromellose Maize starch Opacode black S-1-8152HV Opaspray white M-1-7111B Pregelatinised maize starch Stearic acid

Units in package:

Bottle, plastic, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

BASF Corporation

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1976-06-29

Summary of Product characteristics

Page 1 of 15
NEW ZEALAND DATA SHEET
BRUFEN

_ _
1. PRODUCT NAME
Brufen

400 mg and 600 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400 mg film-coated tablet contains 400 mg of ibuprofen.
Each 600 mg film-coated tablet contains 600 mg of ibuprofen.
Excipients with known effect: contains sulfites and sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Brufen 400 mg and 600 mg tablets are white, pillow-shaped, film-coated
tablets.
Do not halve the tablets._ _
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
•
Rheumatoid arthritis
•
Osteoarthritis
•
Juvenile rheumatoid arthritis
•
Primary dysmenorrhoea
•
Pyrexia
Brufen is also indicated for the relief of acute and/or chronic pain
states in which there is an
inflammatory component.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
After assessing risk/benefit ratio in each individual patient, the
lowest effective dose for the shortest
duration should be used.
ADULTS
The recommended initial dosage of Brufen is 1200 mg - 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, providing that
the total daily dosage does not exceed 2400 mg in divided doses.
Page 2 of 15
_PRIMARY DYSMENORRHOEA _
The initial dose is 400-800 mg at the first sign of pain or menstrual
bleeding, then 400 mg 4-6 hourly
with a maximum total daily dose of 1,600 mg._ _
_MAINTENANCE DOSE _
In all indications the dose should be adjusted for each patient and
the smallest dose that results in
acceptable control of the symptoms employed. In general, patients with
rheumatoid arthritis and
osteoarthritis tend to require higher doses than patients with other
conditions.
SPECIAL POPULATIONS
_ELDERLY _
In elderly patients receiving 600 - 1,200 mg daily ibuprofen appeared
to be well tolerated. However,
since elderly patients may have a degree of impaired liver or renal
f