Brufen SR

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Ibuprofen 800mg;  

Предлага се от:

Viatris Limited

INN (Международно Name):

Ibuprofen 800 mg

дозиране:

800 mg

Лекарствена форма:

Modified release tablet

Композиция:

Active: Ibuprofen 800mg   Excipient: Colloidal silicon dioxide Hydroxymethylcellulose Hypromellose Methylated spirits Povidone Purified talc Purified water Stearic acid Titanium dioxide Xanthan gum

Броя в опаковка:

Blister pack, Opaque PVC/PVDC/Al, Physican's sample, 4 tablets

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Strides Shasun Limited

Терапевтични показания:

Juvenile rheumatoid arthritis

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, Opaque PVC/PVDC/Al, Physican's sample - 4 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Opaque PVC/PVDC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Opaque PVC/PVDC/Al - 40 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Opaque PVC/PVDC/Al - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Opaque PVC/PVDC/Al - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, Physican's sample - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Дата Оторизация:

1990-10-03

Листовка

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BRUFEN
®
SR
_IBUPROFEN MODIFIED RELEASE TABLET 800 MG _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Brufen SR.
This leaflet answers some common
questions about Brufen SR.
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 SR
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 SR IS
USED FOR
Brufen SR 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 SR also relieves fever (high
temperature).
Although Brufen SR can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
Brufen SR 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 SR is not addictive.
BEFORE YOU TAKE
BRUFEN SR
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE BRUFEN SR IF YOU
HAVE AN ALLER

Данни за продукта

Page 1 of 14
NEW ZEALAND DATA SHEET
BRUFEN
 SR
_ _
1. PRODUCT NAME
Brufen

SR 800 mg modified release tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains 800 mg of ibuprofen.
Excipient with known effect: contains sulfites
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Brufen SR tablets are white, pillow-shaped, film coated tablets.
These tablets are not capable of providing a divided dose. Do not
halve the tablets.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
•
Rheumatoid arthritis
•
Osteoarthritis
•
Juvenile rheumatoid arthritis
•
Primary dysmenorrhoea
•
Pyrexia
Brufen SR 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.
DOSE
_ADULT _
The recommended daily dosage is two Brufen SR tablets taken as a
single dose, preferably in the
early evening, well before retiring to bed. The tablets should be
swallowed whole with plenty of
fluids.
In severe or acute conditions, the total daily dosage may be increased
to three tablets taken as two
tablets in the early evening and an additional tablet in the morning.
Page 2 of 14
_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
function the adult dosage should
be used with caution.
HEPATIC IMPAIRMENT
Ibuprofen should be used with caution in patients with impaired liver
function (see section 4.4).
RENAL IMPAIRMENT