Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aceclofenac
Actavis UK Ltd
M01AB16
Aceclofenac
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5012617018403
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER PRESERVEX™ 100MG TABLETS (aceclofenac) Your medicine is available using the name Preservex 100mg Tablets but will be referred to as Preservex throughout this leaflet. 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 any further questions, 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 also section 4. WHAT IS IN THIS LEAFLET: 1. What Preservex is and what it is used for 2. What you need to know before you take Preservex 3. How to take Preservex 4. Possible side effects 5. How to store Preservex 6. Contents of the pack and other information 1. WHAT PRESERVEX IS AND WHAT IT IS USED FOR Preservex belongs to a group of medicines called non- steroidal anti-inflammatory drugs (NSAIDs). These drugs have anti-inflammatory and painkiller properties. The active ingredient of Preservex is aceclofenac. Preservex works by blocking the production of hormone-like substances called prostaglandins. Prostaglandins are released at the sites of injury, tissue damage and immune reactions. Prostaglandins play an important role in both the inflammatory response of the body and stimulating the re- absorption of bone in diseases. Preservex is used to relieve pain and inflammation in patients suffering from: arthritis of the joints (osteoarthritis). This commonly occurs in patients over the age of 50 and causes the loss of the cartilage and bone tissue next to the joint. autoimmune disease that causes chronic inflammation of the joints (rheumatoid arthritis). arthritis of the spine which can lead to the fusion of the vertebrae (ankylosing spondyl Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aceclofenac 100mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100mg of aceclofenac For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex film-coated tablets, 8mm diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aceclofenac 100mg Film-coated Tablets is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use). _Adults _ The recommended dose is 200mg daily, taken as two separate 100mg doses, one tablet in the morning and one in the evening. _Paediatric population _ There are no clinical data on the use of Aceclofenac 100mg Tablets in children and therefore it is not recommended for use in children. _Elderly _ The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, 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. The pharmacokinetics of Aceclofenac 100mg Tablets are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency. _Patients with renal impairment _ There is no evidence that the dosage of Aceclofenac 100mg Tablets needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see section4.4). _Patients with liver impairment _ There is some evidence that the dose of Aceclofenac 100mg Tablets should be reduced in p Przeczytaj cały dokument