Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Diclofenac sodium; Misoprostol
PCO Manufacturing Ltd.
M01AB; M01AB55
Diclofenac sodium; 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
Authorised
2004-03-31
_ _ _ _ _ _ _ _ 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 while they ar Perskaitykite visą dokumentą
Health Products Regulatory Authority 19 December 2022 CRN00D8LS Page 1 of 2 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 lactose For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Modified-release tablets _Product imported from Italy (Misofenac & Arthrotec):_ White, round, biconvex tablets, plain on both sides or white, round, biconvex tablets marked 'SEARLE' and '1421' on one side with four 'A's and '75' on the other side_._ 4 CLINICAL PARTICULARS As per PA0822/112/002 5 PHARMACOLOGICAL PROPERTIES As per PA0822/112/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose Microcrystalline cellulose Maize starch Povidone K-30 Methacrylic Acid Copolymer Type C Sodium Hydroxide Triethyl Citrate Hypromellose Crospovidone Magnesium stearate Hydrogenated castor oil Colloidal anhydrous silica. Talc 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 19 December 2022 CRN00D8LS Page 2 of 2 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Blister pack containing 30 or 60 tablets. Not all pack sizes may be marketed 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/114/002 9 DATE OF FIRST AUTHORISA Perskaitykite visą dokumentą