Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Ibuprofen
Clonmel Healthcare Ltd
M01AE; M01AE01
Ibuprofen
200 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Propionic acid derivatives; ibuprofen
Marketed
1986-07-02
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER EASOFEN 200 MG FILM-COATED TABLETS IBUPROFEN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET 1. What Easofen 200 mg film-coated tablets are and what they are used for 2. What you need to know before you take Easofen 200 mg film-coated tablets 3. How to take Easofen 200 mg film-coated tablets 4. Possible side effects 5. How to store Easofen 200 mg film-coated tablets 6. Contents of the pack and other information 1. WHAT EASOFEN 200 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR Easofen 200 mg contains the active substance ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines reduce pain and inflammation, and bring down a high temperature. Easofen is used for the relief of headaches, dental pain, period pain, muscle strain and cold and flu symptoms. You must talk to a doctor if you do not feel better or if you feel worse. _ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EASOFEN 200 MG FILM-COATED TABLETS DO NOT TAKE EASOFEN • if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6) • if you previously suffered an allergic reaction (e.g. skin rash, runny nose or wheezing/breathlessness, swelling of the lips, face, tongue or throat) after taking aspirin or any other NSAIDs • if you have or have ever had a stomach or duodenal ulcer, perforation or bleeding, or other stomach or bowel prob Прочитать полный документ
Health Products Regulatory Authority 17 November 2022 CRN00D8GC Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Easofen 200mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg ibuprofen. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Round, white, biconvex film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short term management of mild to moderate pain such as is associated with headache, dental pain, period pain, muscle strain and for the management of head cold and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). Adults and adolescents (over the age of 12 years) The usual initial dose is 400 mg and subsequently if necessary 200 to 400 mg every four hours with a maximum of 1200 mg in a twenty-four hour period. If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Not recommended in children under the age of twelve years. Elderly NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. _See also Section 4.4._ Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Method of administration Oral. Health Products Regulatory Authority 17 November 2022 CRN00D8GC Page 2 of 9 4.3 CONTRAINDICATIONS (i) History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). (ii) Hypersensitiv Прочитать полный документ