Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Naproxen 750mg
Clinect NZ Pty Limited
Naproxen 750 mg
750 mg
Modified release tablet
Active: Naproxen 750mg Excipient: Hypromellose Magnesium stearate Purified water Sunset yellow FCF
Blister pack, Physician Sample pack, 7 tablets
Prescription
Prescription
Industrias Quimicas Falcon De Mexico SA de CV
Naprosyn SR is indicated for its anti-inflammatory and analgesic action in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and other musculoskeletal disorders,
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
1985-10-06
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 Lire le document complet
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 Lire le document complet