Страна: Вірменія
мова: англійська
Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
aceclofenac
Accord Healthcare Limited
M01AB16
aceclofenac
100mg
tablets fim-coated
(60/6x10/), in blister
Prescription
Registered
2015-09-15
PACKAGE LEAFLET: INFORMATION FOR THE USER ACECLOFENAC 100 MG FILM-COATED TABLETS ACECLOFENAC 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 further questions, please 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 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 belongs to a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs. Aceclofenac Tablets 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 spondylitis). 2. BEFORE YOU TAKE ACECLOFENAC TABLETS DO NOT TAKE ACECLOFENAC TABLETS IF; • If you are allergic to aceclofenac or any of the other ingredients of Aceclofenac Tablets • If you are pregnant (unless considered essential by your doctor). • If aspirin or other NSAIDs have caused asthma, rhinitis (running nose) or urticaria (skin rash) or other allergic reaction. • If you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation. • If you have severe kidney disease • If you have severe heart di Прочитайте повний документ
ACECLOFENAC PSUR – 20 MARCH 2011 TO 19 MARCH 2014 The data and conclusions included in this report are confidential and proprietary information of Accord Healthcare Ltd. 52 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aceclofenac 100 mg film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg Aceclofenac. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White to off-white, round shaped, biconvex, film-coated tablet debossed with “100” on one side and plain on the other 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 Aceclofenac film-coated tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid. To be taken preferably with or after food. When Aceclofenac was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). ACECLOFENAC PSUR – 20 MARCH 2011 TO 19 MARCH 2014 The data and conclusions included in this report are confidential and proprietary information of Accord Healthcare Ltd. 53 _Adults _ The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening. _ _ _Paediatric population _ There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children under 18 years of age._ _ _ _ _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 serious consequences of adverse reactions. If an NSAID is considered necessary, the lowe Прочитайте повний документ