Naprosyn SR

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Naproxen 1000mg

Available from:

Clinect NZ Pty Limited

INN (International Name):

Naproxen 1000 mg

Dosage:

1000 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Naproxen 1000mg Excipient: Hypromellose Magnesium stearate Purified water Sunset yellow FCF

Units in package:

Blister pack, Physician sample pack, 7 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Industrias Quimicas Falcon De Mexico SA de CV

Therapeutic indications:

Naprosyn SR is indicated for its anti-inflammatory and analgesic action in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and other musculoskeletal disorders,

Product summary:

Package - Contents - Shelf Life: Blister pack, Physician sample pack - 7 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, plastic, - 90 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Calendar pack, - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

1985-10-06

Patient Information leaflet

NAPROSYN SR
®
1
NAPROSYN SR
®
PRONOUNCED NAP-ROW-SIN S-R
_naproxen _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NAPROSYN SR
tablets.
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 NAPROSYN
SR tablets 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 NAPROSYN SR
IS USED FOR
NAPROSYN SR belongs to a family
of medicines called Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs).
NAPROSYN SR relieves pain and
reduces inflammation (swelling,
redness and heat) associated with:
•
different types of arthritis
including rheumatoid arthritis,
osteoarthritis
•
ankylosing spondylitis (a disease
of the joints in the spine)
•
general muscle and bone ailments
such as sprains, strains, lower
back pain (lumbago) etc.
Although NAPROSYN SR can
relieve the symptoms of pain and
inflammation, it will not cure your
condition.
Your doctor may have prescribed
NAPROSYN SR for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY NAPROSYN SR HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
NAPROSYN SR is not addictive.
BEFORE YOU TAKE
NAPROSYN SR
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NAPROSYN SR IF YOU
HAVE AN ALLERGY TO:
•
NAPROSYN SR OR ANY
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
•
ASPIRIN OR ANY OTHER NSAID
MEDICINE INCLUDING OTHER
NAPROXEN CONTAINING MEDICINES
SUCH AS SYNFLEX®, NAXEN® OR
NAPROGESIC®.
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.
Symptoms of an allergic reaction to
these medicines may include:
•
asthma, wheezing or shortness of

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1
NAPROSYN SR (SUSTAINED RELEASE TABLETS)
Naprosyn® SR 750 mg sustained release (SR) tablets.
Naprosyn® SR 1000 mg sustained release (SR) tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sustained release tablet contains 750 mg or 1000 mg of naproxen.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Sustained release tablets
_750 mg:_ Peach, capsule shaped tablet, with marking NPR SR-750 on one
side.
_1000 mg:_ Peach, oblong tablet, with marking NPR SR-1000 on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naprosyn SR is indicated for its anti-inflammatory and analgesic
action in the treatment of rheumatoid arthritis,
osteoarthritis, ankylosing spondylitis and other musculoskeletal
disorders.
4.2
DOSAGE AND ADMINISTRATION
_DOSE _
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the shortest
possible duration should be used (see Section 4.4).
The total required daily dose of naproxen can be achieved by
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
ARE
NOT
INTENDED
FOR
PATIENTS
REQUIRING
SHORT-TERM
TREATMENT FOR ACUTE INDICATIONS.
The dose of naproxen may be adjusted up or down depending on the
clinical response of the patient. A lower
daily dose may suffice for long-term administration. In patients who
tolerate lower doses well, the dose may
be increased to 1000 mg per day when a higher level of
anti-inflammatory/analgesic activity is required. When
treating patients with naproxen 1000 mg/day, the physician should
observe sufficient increased clinical benefit
to offset the potential increased risk (see Section 4.4).
A lower dose should be considered in patients with renal or hepatic
impairment or in elderly patients (see
Section 4.4).
_Cardiovascular _
Patients on long-term treatment should be reviewed regularly with
regards to efficacy, risk factors and ongoing
need for t