Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aceclofenac
Phoenix Healthcare Distribution Ltd
M01AB16
Aceclofenac
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
1 ACTAVIS LOGO PACKAGE LEAFLET: INFORMATION FOR THE USER ACECLOFENAC 100MG FILM-COATED TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. 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, pharmacist or nurse. - The full name of this medicine is Aceclofenac 100mg Film-coated Tablets but within the leaflet it will be referred to as Aceclofenac Tablets. IN THIS LEAFLET 1. What Aceclofenac Tablets are and what they are used for 2. Before you take Aceclofenac Tablets 3. How to take Aceclofenac Tablets 4. Possible side effects 5. How to store Aceclofenac Tablets 6. Further information 1. WHAT ACECLOFENAC TABLETS ARE AND WHAT THEY ARE USED FOR Aceclofenac Tablets contain a medicine called aceclofenac. This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Aceclofenac Tablets are used to relieve pain and inflammation in adult 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 spondylitis). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACECLOFENAC TABLETS DO NOT TAKE ACECLOFENAC TABLETS: • if you are allergic (hypersensitive) to aceclofenac or any of the other ingredients of Aceclofenac Tablets • if you are allergic (hypersensitive) to aspirin or any other NSAIDs (such as ibuprofen, naproxen or diclofenac) • if you have taken aspirin or any other NSAIDs and experienced one of the following: - asthma Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aceclofenac 100 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg aceclofenac. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Round white or off-white in colour bi-convex film-coated tablets marked “G” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: The maximum recommended dose is 200 mg daily, taken as two separate doses of 100 mg, one tablet in the morning and one tablet in the evening. Children: There are no clinical data supporting the use of aceclofenac in children therefore its use is not recommended. Elderly: Caution should be exercised in the treatment of elderly patients, who are generally more prone to adverse reactions, and who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The elderly should be monitored for GI bleeding regularly during NSAID therapy. The pharmacokinetics of aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency. Renal insufficiency: There is no evidence to suggest that the dosage needs to be altered for patients with mild renal impairment, however caution should be exercised (see section 4.4). Hepatic insufficiency: There is some evidence that the dose of aceclofenac should be reduced in patients with hepatic impairment. It is suggested that an initial daily dose of 100 mg is used. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Method of administration: For Läs hela dokumentet