Ibuprofen SR BNM

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ibuprofen 800mg

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

Dosage:

800 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Ibuprofen 800mg Excipient: Colloidal silicon dioxide Hypromellose Opadry white 03A580003 Povidone Stearic acid Xanthan gum

Prescription type:

Prescription

Therapeutic indications:

Rheumatoid arthritis

Product summary:

Package - Contents - Shelf Life: Blister pack, Al/PVC/PVdC - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP screw cap - 160 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2018-03-22

Patient Information leaflet

1
IBUPROFEN SR BNM
Consumer Medicine Information
IBUPROFEN SR BNM
_IBUPROFEN_
_ _
Modified release tablet 800 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Ibuprofen
SR BNM.
This leaflet answers some common questions about Ibuprofen SR BNM. It
does not
contain all the available information. The most up-to-date Consumer
Medicine Information
can be downloaded from www.medsafe.govt.nz.
Reading this leaflet 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
Ibuprofen SR BNM against the benefits this medicine is expected to
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 want to read it again.
WHAT IBUPROFEN SR BNM IS USED FOR
Ibuprofen SR BNM contains ibuprofen. Ibuprofen belongs to a group of
medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen SR BNM relieves pain and reduces inflammation (swelling or
redness) that may
occur:

in different types of arthritis, a disease that mainly affect the
joints with pain and
swelling. These include rheumatoid arthritis, osteoarthritis and
juvenile rheumatoid
arthritis

in menstrual cramps (period pain)

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

following surgery

due to dental pain.
Ibuprofen SR BNM also relieves fever (high temperature).
2
IBUPROFEN SR BNM
Although Ibuprofen SR BNM can relieve the symptoms of pain and
inflammation, it will not
cure your condition.
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR
YOU.
Ibuprofen SR BNM is only available with a doctor's prescription.
Ibuprofen SR BNM is not addictive.
BEFORE YOU TAKE IBUPROFEN SR BNM
Ibuprofen SR BNM

Summary of Product characteristics

1
IBUPROFEN SR BNM
IBUPROFEN MODIFIED RELEASE TABLETS 800 MG
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
IBUPROFEN SR BNM
800 mg modified release tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains 800 mg of ibuprofen.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White to off white, pillow shaped film coated tablets plain on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Rheumatoid arthritis
•
Osteoarthritis
•
Juvenile rheumatoid arthritis
•
Primary dysmenorrhoea
•
Pyrexia
Ibuprofen SR BNM 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 the 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 Ibuprofen SR BNM 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.
2
IBUPROFEN SR BNM
IBUPROFEN MODIFIED RELEASE TABLETS 800 MG
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.
_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 _
Ibuprofen should be used with ca