Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
naproxen sodium, Quantity: 550 mg
Atnahs Pharma Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; povidone; purified water; purified talc; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 8000; indigo carmine
Oral
50 tablets
(S4) Prescription Only Medicine
ANAPROX is indicated as an analgesic in acute migraine attacks, for the treatment of gout, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and for the relief of acute and/or chronic pain states in which there is an inflammatory component.
Visual Identification: Oblong dark blue film coated tablets engraved NPS 550 on one face and a break-line on both sides; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1998-11-03
ANAPROX ® A N A P R O X ® 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 ANAPROX? ANAPROX contains the active ingredient naproxen sodium. ANAPROX is used to relieve pain and reduces inflammation (swelling, redness and soreness) that may occur with different types of arthritis, in muscle and bone injuries, after setting broken or dislocated bones, with menstrual cramps (period pain), due to migraine headache, following surgery, or due to dental pain, migraines, after surgery, or dental pain. For more information, see Section 1. Why am I using ANAPROX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ANAPROX? Do not use if you have ever had an allergic reaction to naproxen sodium, 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 ANAPROX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with ANAPROX 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 ANAPROX? • Take ANAPROX exactly as your doctor has prescribed. Your doctor will tell you how many ANAPROX tablets to take each day. More instructions can be found in Section 4. How do I use ANAPROX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ANAPROX? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using ANAPROX. • Tell your doctor if you get an infection while using ANAPROX. • Tell your doctor if you feel the tablets are not helping your condition. • Call your doctor straight away if you become pregnant while taking ANAPROX. THINGS YOU SHOULD NOT DO • Do not give ANAPROX to anyone e Aqra d-dokument sħiħ
1 AUSTRALIAN PRODUCT INFORMATION – ANAPROX ® 550 (NAPROXEN SODIUM) 1. NAME OF THE MEDICINE Naproxen sodium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ANAPROX 550 is available as a film-coated tablet containing 550 mg of naproxen sodium. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. List of excipients with known effect: each film-coated tablet contains 50 mg of sodium. 3. PHARMACEUTICAL FORM Film-coated tablet. ANAPROX 550 is supplied as an oblong, dark blue film-coated tablet engraved "NPS 550" on one side, with a break-line on both faces. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ANAPROX 550 is indicated as an analgesic in acute migraine attacks, for the treatment of gout, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and 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 ration in each individual patient, the lowest effective dose for the shortest possible duration should be used. ACUTE MIGRAINE HEADACHE The recommended dose is 825 mg at the first symptom of an impending headache. An additional 275 mg to 550 mg dose can be given at least an hour after the initial dose, if necessary. The total daily dose should not exceed 1375 mg. ACUTE PAIN STATES WITH AN INFLAMMATORY COMPONENT The recommended dose is 550 mg initially followed by 275 mg every six to eight hours as required. The total daily dose should not exceed 1375 mg. RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, ANKYLOSING SPONDYLITIS AND CHRONIC PAIN STATES WITH AN INFLAMMATORY COMPONENT The dosage range of naproxen sodium is 550 mg to 1100 mg daily in two divided doses. The starting dose should not be less than 550 mg daily. The dose may be increased gradually up to 1100 mg daily, depending on the needs of the patient. 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 Aqra d-dokument sħiħ