Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ketoprofen
A A H Pharmaceuticals Ltd
M01AE03
Ketoprofen
100mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 060118/1 Ennogen Ketoprofen Leaflet UK English 170 x 450 mm Arial, 9 pt 1 of 1 3 03-05-18 Coreldraw 12 Packaging Development Quality Assurance (QA) Quality Control (QC) Production e-mail : artworkcd@yahoo.com Ph : +91-09845609386 Colours Used Black Keyline Ketoprofen Capsules 50mg and 100mg (Ketoprofen) PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT KETOPROFEN CAPSULES ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KETOPROFEN CAPSULES 3. HOW TO TAKE KETOPROFEN CAPSULES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE KETOPROFEN CAPSULES 6. CONTENTS OF THE PACK AND OTHER INFORMATION Ketoprofen Capsules contain a medicine called Ketoprofen. This belongs to a group of medicines called 'non-steroidal anti-inflammatory drugs' (NSAIDs). Ketoprofen Capsules are used to relieve symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, fibrositis, cervical spondylitis, low back pain, painful musculoskeletal conditions and period pain. Ketoprofen reduces joint pain and inflammation, and facilitates an increase in mobility and functional independence. DO NOT TAKE KETOPROFEN CAPSULES IF YOU: Are ALLERGIC to Ketoprofen or any of the other ingredients in this medicine (see Section 6) If you are allergic to other non−steroidal anti−inflammatory drugs (NSAIDs), including aspirin. Signs of an allergic reaction are breathin Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ketoprofen Capsules BP 100mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains ketoprofen BP 50mg. Excipient(s) with known effect Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ketoprofen capsules are recommended for the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and periarticular disorders, fibrositis, cervical spondylitis, low back pain, painful musculoskeletal conditions and dysmenorrhoea. Ketoprofen 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 Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Ketoprofen capsules should always be taken with food to reduce the occurrence of gastrointestinal disturbance. _Adults:_ 50-100mg twice daily. The dosage can be altered depending on the patient weight and on the severity of symptoms. _Dysmenorrhoea:_ 50mg up to 3 times a day. Three to 4 days treatment is normally required from the onset of menstruation or symptoms of dysmenorrhoea. _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 for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. _Children:_ Dosage has not been established. 4.3 CONTRAINDICATIONS Ketoprofen is contraindicated in the following cases: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Known allergy to aspirin and to other substances with similar effect (non- steroidal anti-inflammatory agents): who have a history of hypersens Διαβάστε το πλήρες έγγραφο