NAPROSYN SR 750 naproxen 750 mg sustained release tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

naproxen, Quantity: 750 mg

Available from:

Atnahs Pharma Australia Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: sunset yellow FCF; hypromellose; purified water; magnesium stearate

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and the relief of chronic pain states in which there is an inflammatory component.

Product summary:

Visual Identification: Peach-coloured capsule-shaped tablet debossed with NPR SR-750 on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-07-19

Patient Information leaflet

NAPROSYN SR
®
N
A
P
R
O
S
Y
N
S
R
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NAPROSYN SR?
NAPROSYN SR contains the active ingredient naproxen. NAPROSYN SR is
used to relieve pain and reduces inflammation
(swelling, redness and soreness) that may occur in different types of
arthritis including rheumatoid arthritis, osteoarthritis and
ankylosing spondylitis. For more information, see Section 1. Why am I
using NAPROSYN SR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NAPROSYN SR?
Do not use if you have ever had an allergic reaction to naproxen,
aspirin or any other NSAID medicines, or any of the ingredients
listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY
OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more
information, see Section 2. What should I know before I
use NAPROSYN SR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NAPROSYN SR and affect how it works.
A list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE NAPROSYN SR?
•
Your doctor will tell you how many NAPROSYN SR tablets to take each
day. The usual dose is one tablet once a day.
•
More instructions can be found in Section 4. How do I use NAPROSYN SR?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NAPROSYN SR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
NAPROSYN SR.
•
Tell your doctor if you get an infection while using NAPROSYN SR.
•
Tell your doctor if you feel the tablets are not helping your
condition.
•
Call your doctor straight away if you become pregnant while taking
NAPROSYN SR.
THINGS YOU
SHOULD NOT DO
•
Do not give NAPROSYN SR to anyone else, even if they have the same
condition as you.
•
Do not use NAPROSYN SR to treat other compl

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – NAPROSYN
® SR
(NAPROXEN)
1. NAME OF THE MEDICINE
naproxen
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NAPROYSN SR 750 is available as a sustained release tablet containing
750 mg of naproxen.
NAPROYSN SR 1000 is available as a sustained release tablet containing
1000 mg of naproxen.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
NAPROYSN SR 750 sustained release tablets are available as a
peach-coloured capsule-shaped tablet
debossed with NPR SR-750 on one side.
NAPROYSN SR 1000 sustained release tablets are available as a
peach-coloured oblong tablet, debossed
NPR SR-1000 on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NAPROSYN SR is indicated for the treatment of rheumatoid arthritis,
osteoarthritis, ankylosing spondylitis
and for the relief of 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
possible duration should be used.
The total required daily dose of naproxen can be achieved by the
administering the appropriate single daily
dose i.e. NAPROSYN SR 750 mg or NAPROSYN SR 1000 mg.
The total daily dose of naproxen should not exceed 1000 mg. NAPROSYN
SR tablets should be taken whole
and not chewed.
NAPROSYN SR TABLETS ARE NOT INTENDED FOR PATIENTS REQUIRING SHORT-TERM
TREATMENT FOR ACUTE INDICATIONS.
Patients on long term treatment should be reviewed regularly with
regards to efficacy, risk factors and
ongoing need for treatment.
PREGNANCY
See Section 4.6 FERTILITY, PREGNANCY AND LACTATION.
4.3 CONTRAINDICATIONS
NAPROSYN SR is contraindicated in patients:
•
who are hypersensitive to naproxen or naproxen sodium or in whom
acetylsalicylic acid (aspirin) or
other non-steroidal anti-inflammatory/analgesic agents induce allergic
manifestations, e.g. asthma,
nasal polyps, rhinitis and urticaria. Severe anaphylactic-like
reactions to naproxen have been
rep