Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aceclofenac
Viatris UK Healthcare Ltd
M01AB16
Aceclofenac
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5016695001913
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACECLOFENAC 100 MG FILM-COATED TABLETS aceclofenac 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 or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Aceclofenac is and what it is used for 2. What you need to know before you take Aceclofenac 3. How to take Aceclofenac 4. Possible side effects 5. How to store Aceclofenac 6. Contents of the pack and other information 1. WHAT ACECLOFENAC IS AND WHAT IT IS USED FOR Aceclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs, or NSAIDs. Aceclofenac is used to relieve pain and inflammation that occur with: - osteoarthritis - rheumatoid arthritis - ankylosing spondylitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACECLOFENAC DO NOT TAKE ACECLOFENAC: if you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6) if you are allergic to aspirin (acetylsalicylic acid) or any other non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen or diclofenac if you have taken aspirin (acetylsalicylic acid) or any other NSAIDs and experienced one of the following: o asthma attack (wheezing, chest tightness, breathlessness) o runny nose, itching and/or sneezing (irritation of the nose) o swelling of the face, lips, tongue or throat (angioedema) leading to difficulty breathing o raised red circular patchy rash on the skin which may have been itchy, stung or had a burning sensation, known as hives if you have a history of, suffer from, or suspect that Прочетете целия документ
OBJECT 1 ACECLOFENAC 100 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 28-Jun-2017 | Generics UK T/A Mylan 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 shor Прочетете целия документ