מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Diclofenac sodium; Lactose monohydrate; Misoprostol
Pfizer Healthcare Ireland
M01AB; M01AB55
Diclofenac sodium; Lactose monohydrate; Misoprostol
75/0.2 milligram(s)
Modified-release tablet
Product subject to prescription which may not be renewed (A)
Acetic acid derivatives and related substances; diclofenac, combinations
Marketed
1997-02-07
Page 1 of 7 2022-0075380 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ARTHROTEC ® 75 MODIFIED-RELEASE TABLETS diclofenac sodium, misoprostol 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 Arthrotec is and what it is used for 2. What you need to know before you take Arthrotec 3. How to take Arthrotec 4. Possible side effects 5. How to store Arthrotec 6. Contents of the pack and other information 1. WHAT ARTHROTEC IS AND WHAT IT IS USED FOR Arthrotec contains diclofenac and misoprostol. Diclofenac belongs to a group of medicinal products called Non-Steroidal Anti-Inflammatory drugs (NSAIDs). Arthrotec helps to relieve the pain and swelling of RHEUMATOID ARTHRITIS and OSTEOARTHRITIS , and may help to protect patients at risk of irritation or ulceration of the stomach or intestines. Although NSAIDs relieve the pain, they can reduce the amount of natural protective substances called prostaglandins in the stomach lining. This means that NSAIDs can lead to stomach upsets or stomach ulcers. Arthrotec also contains misoprostol which is very similar to these prostaglandins and may help protect your stomach. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARTHROTEC DO NOT TAKE ARTHROTEC IF YOU: • currently have an ulcer or perforation (hole) in your stomach or intestines • currently suffer from bleeding in your stomach, intestines or brain • are pregnant, or trying to become pregnant, because it may cause a miscarriage. Women who have not reached the menopause should use reliable contraception whi קרא את המסמך השלם
Health Products Regulatory Authority 26 June 2023 CRN00D6H8 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arthrotec 75 modified-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet consists of a gastro-resistant core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 micrograms misoprostol. Excipient(s) with known effect Each tablet contains 19.5 mg lactose monohydrate. Each tablet contains 1.3 mg hydrogenated castor oil. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablet. White, round, biconvex tablets marked 'SEARLE' over ‘1421’ on one side, and four times ‘A’ around the circumference with ‘75’ in the centre on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arthrotec 75 is indicated for adult patients who require the non-steroidal anti-inflammatory drug diclofenac together with misoprostol. The diclofenac component of Arthrotec 75 is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. The misoprostol component of Arthrotec 75 is indicated for patients with a special need for the prophylaxis of NSAID-induced gastric and duodenal ulceration. 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). _Adults_ One tablet to be taken with food, two times daily. _Elderly/renal, cardiac and hepatic impairment_ No adjustment of dosage is necessary in the elderly or in patients with hepatic impairment or mild to moderate renal impairment as pharmacokinetics are not altered to any clinically relevant extent. Nevertheless, elderly patients and patients with renal, cardiac or hepatic impairment should be closely monitored (see sections 4.4 and 4.8). _Paediatric population_ The safety and efficacy of Arthrotec 75 in children under 18 years has not been established. Method of administration Health Pr קרא את המסמך השלם