Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ketoprofen
Sanofi
M01AE03
Ketoprofen
200mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5000283652502
PACKAGE LEAFLET: INFORMATION FOR THE USER ORUVAIL® 100MG OR 200MG PROLONGED-RELEASE CAPSULES, HARD Ketoprofen IS THIS LEAFLET HARD TO SEE OR READ? PHONE 08453 727101 FOR HELP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Oruvail Capsules are and what they are used for 2. Before you take Oruvail Capsules 3. How to take Oruvail Capsules 4. Possible side effects 5. How to store Oruvail Capsules 6. Further information 1. WHAT ORUVAIL CAPSULES ARE AND WHAT THEY ARE USED FOR WHAT ORUVAIL CAPSULES ARE AND HOW THEY WORK The name of your medicine is Oruvail 100mg or 200mg Prolonged-Release Capsules, Hard (called Oruvail Capsules in this leaflet). Oruvail Capsules contain a medicine called ketoprofen. This belongs to a group of medicines called ‘Non-Steroidal Anti-Inflammatory Drugs’ (NSAID’s). It works by blocking chemicals in your body that normally cause inflammation. WHAT ORUVAIL CAPSULES ARE USED FOR Oruvail Capsules are used to treat the swelling, pain, heat, redness and stiffness in your joints and muscles in the following: • Rheumatoid arthritis (inflammation of your joints) • Osteoarthritis (where the cushioning (cartilage) between your bone joints is damaged) • Pain due to problems with your spine (such as ankylosing spondilitis) • Lower back pain • Sprains and strains • Painful periods • Pain and inflammation after an operation • Other painful inflammatory joint, tendon, nerve or muscle problems • Gout (painful, red, swollen joints) 2. BEFORE YOU TAKE ORUVAIL CAPSULES DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: You are alle Read the complete document
OBJECT 1 ORUVAIL 200MG CAPSULES Summary of Product Characteristics Updated 09-Aug-2017 | SANOFI 1. Name of the medicinal product Oruvail 200 mg Prolonged-Release Capsules, Hard 2. Qualitative and quantitative composition Ketoprofen 200 mg 3. Pharmaceutical form Controlled release capsules 4. Clinical particulars 4.1 Therapeutic indications Oruvail is recommended in the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and peri-articular disorders, (bursitis, capsulitis, synovitis, tendinitis), cervical spondylitis, low back pain (strain, lumbago, sciatica, fibrositis), painful musculo-skeletal conditions, acute gout, dysmenorrhoea and control of pain and inflammation following orthopaedic surgery. Oruvail reduces joint pain and inflammation and facilitates increase in mobility and functional independence. As with other non-steroidal anti-inflammatory agents, it does not cure the underlying disease. 4.2 Posology and method of administration _Adults:_ 100 – 200 mg once daily, depending on patient weight and on severity of symptoms. The maximum daily dose is 200 mg. The balance of risks and benefits should be carefully considered before commencing treatment with 200 mg daily, and higher doses are not recommended (see also section 4.4). _Elderly:_ The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. Paediatric dosage not established. Oruvail capsules are for oral administration. To be taken preferably with or after food. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). 4.3 Contraindications Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as bronchospasm, asthmatic attacks, rhinitis, angioedema, urticaria o Read the complete document