Brufen

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Ibuprofen 400mg;  ;  ;  

Tilgængelig fra:

Viatris Limited

INN (International Name):

Ibuprofen 400 mg

Dosering:

400 mg

Lægemiddelform:

Film coated tablet

Sammensætning:

Active: Ibuprofen 400mg       Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Methylated spirits Microcrystalline cellulose Opadry white 06A28611 Opaspray white M-1-7111B Purified talc Purified water Sodium laurilsulfate

Enheder i pakken:

Blister pack, PVC/PVDC/Al Starter, 10 tablets

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Strides Shasun Limited

Terapeutiske indikationer:

Juvenile rheumatoid arthritis

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al Starter - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al Starter - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC or PVC/PVDC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 40 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE Starter pack - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 50 tablets - 36 months from date of manufacture stored at or below 25°C

Autorisation dato:

2000-03-30

Indlægsseddel

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BRUFEN
®
_IBUPROFEN FILM-COATED TABLET 400 MG _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Brufen
This leaflet answers some common
questions about Brufen.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Brufen
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT BRUFEN IS USED
FOR
Brufen relieves pain and reduces
inflammation (swelling or redness)
that may occur:
•
in different types of arthritis
including rheumatoid
arthritis, osteoarthritis and
juvenile rheumatoid arthritis
•
in muscle and bone injuries
such as sprains, strains,
low back pain (lumbago),
rheumatism, and tendonitis,
such as tennis elbow
•
from swelling and pain after
setting broken or dislocated
bones
•
menstrual cramps (period
pain)
•
following surgery
•
due to dental pain.
Brufen also relieves fever (high
temperature).
Although Brufen can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
Brufen contains the active
ingredient ibuprofen. Ibuprofen
belongs to a group of medicines
called non-steroidal anti-
inflammatory drugs (or NSAIDs).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
Many medicines used to treat
headache, period pain and other
aches and pains contain aspirin or
NSAID medicines. If you are not
sure if you are taking any of these
medicines, ask your pharmacist.
This medicine is available only with
a doctor’s prescription.
Brufen is not addictive.
BEFORE YOU TAKE
BRUFEN
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE BRUFEN IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
ibuprof

Produktets egenskaber

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