Ibuprofen

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Ibuprofen 200mg;  

Verfügbar ab:

Viatris Limited

INN (Internationale Bezeichnung):

Ibuprofen 200 mg

Dosierung:

200 mg

Darreichungsform:

Film coated tablet

Zusammensetzung:

Active: Ibuprofen 200mg   Excipient: Colloidal silicon dioxide Opadry Whilte; OY-58900 Maize starch Purified water Stearic acid

Einheiten im Paket:

Blister pack, PVC/Al 12 tablets/sheet, 12 tablets

Klasse:

General sale

Verschreibungstyp:

General sale

Hergestellt von:

Strides Shasun Limited

Produktbesonderheiten:

Package - Contents - Shelf Life: Blister pack, PVC/Al 12 tablets/sheet - 12 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al 24 tablets/sheet - 24 tablets - 24 months from date of manufacture stored at or below 30°C

Berechtigungsdatum:

2009-06-02

Fachinformation

Page 1 of 15
NEW ZEALAND DATA SHEET
IBUPROFEN
1. PRODUCT NAME
IBUPROFEN 200 mg film coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 200 mg of ibuprofen.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
IBUPROFEN 200 mg tablets are white, circular, biconvex, film coated
tablet, with "IBU 200"
embossed on one side and plain on the other side.
Do not halve tablets.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
•
Rheumatoid arthritis
•
Osteoarthritis
•
Juvenile rheumatoid arthritis
•
Primary dysmenorrhoea
•
Pyrexia
Ibuprofen 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 _
DOSE
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the
shortest duration should be used (see section 4.4).
_ADULTS _
The recommended initial dosage of Ibuprofen is 1200 -1800 mg per day
in divided doses. Some
patients can be maintained on 600 -1200 mg per day. In severe of acute
conditions it can be
advantageous to increase the dosage until the acute phase is brought
under control, providing that
the total daily dose 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 _
PAEDIATRIC
The daily dosage of Ibuprofen is 20 mg per kg of body weight in
divided doses. In juvenile rheumatoid
arthritis, up to 40 mg per kg of bodyweight in divided doses may be
given. In children weighing less
than 30 kg the total dose shoul