Brufen

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Ibuprofen 200mg;  ;  

Disponível em:

Viatris Limited

DCI (Denominação Comum Internacional):

Ibuprofen 200 mg

Dosagem:

200 mg

Forma farmacêutica:

Film coated tablet

Composição:

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

Unidades em pacote:

Blister pack, PVC/Al 10 tablets/strip, 100 tablets

Classe:

Pharmacy only

Tipo de prescrição:

Pharmacy only

Fabricado por:

Strides Shasun Limited

Indicações terapêuticas:

for the temporary relief of pain and/or inflammation associated with: · headache · period pain · dental pain · migrain headache · tension headach · cold and flu symptoms · muscular pain · back pain · arthritic pain

Resumo do produto:

Package - Contents - Shelf Life: Blister pack, PVC/Al 10 tablets/strip - 30 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al 10 tablets/strip - 60 tablets - 24 months from date of manufacture stored at or below 30°C - Blister pack, PVC/Al 10 tablets/strip - 100 tablets - 24 months from date of manufacture stored at or below 30°C

Data de autorização:

2008-09-01

Folheto informativo - Bula

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BRUFEN
®
_IBUPROFEN FILM-COATED TABLET 200 MG _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start 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.
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 provides temporary relief
of pain and reduces inflammation
(swelling or redness) that occur
with:
•
headache
•
migraine headache
•
tension headache
•
dental pain
•
backache
•
muscular pain
•
period pain
•
arthritic pain
•
sinus pain
•
cold and flu symptoms.
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).
This medicine is available from
pharmacies without a prescription.
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 or
doctor.
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
ibuprofen
•
any of the ingredients listed
at the end of this leaflet
•
aspirin or any other NSAID
medicine.
Some of the symptoms of an
allergic reaction may include:
•
asthma, wheezing or
shortness of breath
•
swelling of the face, lips,
tongue which may cause
difficulty in swallowing or
breathing
•
hives, itching or skin rash
•
stomach ache, fever, chills,
nausea and vomiting
•
fainting.
IF YOU ARE ALLERGIC TO ASPIRIN OR
NSAID MEDICINES A

Características técnicas

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