Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Ketoprofen 200mg
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Ketoprofen 200 mg
200 mg
Modified release capsule
Active: Ketoprofen 200mg Excipient: Colloidal silicon dioxide Erythrosine Ethylcellulose Gelatin Non pariel beads, maize starch + sucrose Opacode Purified talc Shellac Sodium laurilsulfate Titanium dioxide
Blister pack, PVC/PVdC/Al, 7, 28, 30, 100 capsules (not marketed),
Prescription
Prescription
Sanofi-Aventis Deutschland GmbH
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al, 7, 30, 100 capsules - - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC/Al - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE Securitaianer - 28 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE Securitaianer - 30 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE Securitaianer - 100 capsules - 36 months from date of manufacture stored at or below 25°C - Calendar pack, - 28 capsules - 36 months from date of manufacture stored at or below 25°C
1984-02-16
Oruvail® SR 1 ORUVAIL SR ® 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 ORUVAIL SR? Oruvail SR contains the active ingredient ketoprofen. Oruvail SR is used to treat the symptoms of rheumatoid arthritis and osteoarthritis. Oruvail SR belongs to a family of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by relieving pain and inflammation. For more information, see Section 1. Why am I using Oruvail SR? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ORUVAIL SR? Do not use if you have ever had an allergic reaction to ketoprofen, aspirin or any other anti-inflammatory drugs, or any of the ingredients listed at the end of the CMI. Do not use if you have a peptic ulcer; problems with your heart; severe kidney or liver problems. Do not use if you are in your third trimester of pregnancy. The use of Oruvail SR during the first and second trimester of pregnancy should be avoided, as the safety of Oruvail SR in pregnant women has not been evaluated. 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 Oruvail SR? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Oruvail 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 ORUVAIL SR? • The usual dose for this medicine is 200mg taken once a day, with food and plenty of fluids. • Follow the instructions provided and use Oruvail SR until your doctor tells you to stop. More instructions can be found in Section 4. How do I use Oruvail SR? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ORUVAIL SR? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Read the complete document
oruvail-sr-ccdsv14-dsv17-13nov23 Page 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Oruvail SR 200 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ketoprofen (200mg). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release capsule. _ _ Oruvail SR 200 mg capsules are presented pink/white capsules printed ORUVAIL SR 200. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oruvail is recommended in the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and periarticular disorders (bursitis, capsulitis, synovitis, tendonitis), fibrositis, cervical spondylitis, low back pain, (strain, lumbago, sciatica), gout and dysmenorrhoea. Oruvail reduces joint pain and inflammation and facilitates increase in mobility and functional independence. It is also indicated in the treatment of post-operative pain. As with other non-steroidal anti-inflammatory agents, ketoprofen does not cure the underlying disease. 4.2 DOSE AND METHOD OF ADMINISTRATION 4.2.1 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 Special warnings and precautions for oruvail-sr-ccdsv14-dsv17-13nov23 Page 2 use). Patients on long term treatment should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. 100 to 200 mg once daily depending on the patient’s weight and on the severity of symptoms. Oruvail SR should be taken with food. USE IN PREGNANCY: see Section 4.3 Contraindications and Section 4.6 Fertility, pregnancy and lactation. 4.2.2 ELDERLY It is generally advisable in the elderly to begin ketoprofen therapy at the lower end of the dosage range and to maintain such patients on the lowest effective dosage. Elderly patients are more prone to adverse effects. Caution must be taken with dosage in this group and also in patients with renal impairment. 4.3 CONTRAINDICATIONS Active or history of gastrointestinal inflammatory disorder Read the complete document