País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Misoprostol; DICLOFENAC SODIUM
Imbat Limited
M01AB; M01AB55
Misoprostol; DICLOFENAC SODIUM
75/0.2 milligram(s)
Modified-release tablet
Oral use
60 tablets
Product subject to prescription which may not be renewed (A)
Piramal Healthcare UK Limited
Non-steroidal anti-inflammatory
Acetic acid derivatives and related substances; diclofenac, combinations
It helps to relieve the pain and swelling of rheumatoid arthritis and osteoarthritis
Authorised
2015-05-29
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ARTHROTEC ® 75 MODIFIED-RELEASE TABLETS (diclofenac sodium/ misoprostol) This medicine is available using the name Arthrotec 75 modified-release tablets but will be referred to as Arthrotec throughout this leaflet. 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 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. Arthrotec contains diclofenac and misoprostol. Diclofenac belongs to a group of medicinal products called Non-Steroidal Anti-Inflammatory drugs (NSAIDs). 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: have had an allergic reaction such as a skin rash, swelling or itchiness of the skin, severe nasal congestion, asthma or wheezing after taking diclofenac or other NSAIDs such as as Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arthrotec 75 modified-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 75 mg diclofenac sodium and 200 micrograms misoprostol. Excipient(s) with known effect Lactose monohydrate and hydrogenated castor oil. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablet _Product imported from France_ White, round, biconvex tablets, marked with 4 ‘A’s around ‘75’ on one side, and ‘SEARLE’ on ‘1421’ on the other side. 4 CLINICAL PARTICULARS As per PA0822/112/002 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contains hydrogenated castor oil. May cause stomach upset and diarrhoea. 5 PHARMACOLOGICAL PROPERTIES As per PA0822/112/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate microcrystalline cellulose maize starch povidone K30 magnesium stearate copolymer of methacrylic acid and ethyl acrylate (1:1) (EUDRAGIT L 100-55) sodium hydroxide talc triethyl citrate hypromellose crospovidone colloidal anhydrous silica hydrogenated castor oil H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _8_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _6_ _3_ _4_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the blister strip and outer carton of the product as marked in the country of origin. Leer el documento completo