Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
naproxen, Quantity: 250 mg
Atnahs Pharma Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: croscarmellose sodium; iron oxide yellow; povidone; magnesium stearate
Oral
50 tablets
(S4) Prescription Only Medicine
For the treatment of Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, symptomatic treatment of primary dysmenorrhoea, for the relief of acute and/or chronic pain states in which there is an inflammatory component and as an analgesic in acute migraine attack.
Visual Identification: Round yellow tablets debossed NPR LE 250 on one side and a break-bar on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1998-09-24
NAPROSYN ® N A P R O S Y N ® 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? NAPROSYN contains the active ingredient naproxen. NAPROSYN is used to relieve pain and reduces inflammation (swelling, redness and soreness) that may occur with different types of arthritis, muscle and bone injuries, after setting broken or dislocated bones, with period pain, headache, migraines, after surgery, or dental pain. For more information, see Section 1. Why am I using NAPROSYN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NAPROSYN? Do not use if you have ever had an allergic reaction to naproxen, aspirin or any other NSAID medicine, 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? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with NAPROSYN 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? • Your doctor will tell you how many NAPROSYN tablets to take each day. Take the tablets during or immediately after food with a full glass of water or milk. More instructions can be found in Section 4. How do I use NAPROSYN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NAPROSYN? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using NAPROSYN. • Tell your doctor if you get an infection while using NAPROSYN. • 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. THINGS YOU SHOULD NOT DO • Do not give NAPROSYN to anyone else, even if they have the same condition a Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION – NAPROSYN ® AND NAPROSYN ® 500 (NAPROXEN) 1. NAME OF THE MEDICINE Naproxen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NAPROSYN is available as a tablet containing 250 mg of naproxen. NAPROSYN 500 is available as a tablet containing 500 mg of naproxen. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM NAPROSYN is available as round yellow tablets debossed NPR LE 250 on one side and a break-bar on the other. NAPROSYN 500 is available as oblong yellow tablets debossed NPR LE 500 on one side and break-bar on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NAPROSYN is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, for the symptomatic treatment of primary dysmenorrhoea, for the relief of acute and/or chronic pain states in which there is an inflammatory component and as an analgesic in acute migraine attack. 4.2 DOSE AND METHOD OF ADMINISTRATION After assessing the risk/benefit ration in each individual patient, the lowest effective dose for the shortest possible duration should be used. CHRONIC CONDITIONS _OSTEOARTHRITIS / RHEUMATOID ARTHRITIS / ANKYLOSING SPONDYLITIS / CHRONIC PAIN STATES IN WHICH THERE IS _ _AN INFLAMMATORY COMPONENT _ The dosage range of NAPROSYN is 375 mg to 1000 mg daily in two divided doses. The starting dose should not be less than 500 mg daily and may be varied stepwise within the range of 375 mg to 1000 mg daily, maintaining twice daily administration for long term maintenance, depending on the needs of the patient. ACUTE CONDITIONS _ACUTE PAIN STATES IN WHICH THERE IS AN INFLAMMATORY COMPONENT _ The recommended dose of NAPROSYN tablets is 500 mg initially followed by 250 mg every six to eight hours as required. The total daily dose should not exceed 1250 mg. _DYSMENORRHOEA _ In the symptomatic treatment of primary dysmenorrhoea, the recommended dose of NAPROSYN tablets is 500 mg initially, at the first sign of dysmenorrhoea or menstrual bleeding (which Прочитать полный документ