Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Misoprostol; DICLOFENAC SODIUM
PCO Manufacturing Ltd.
M01AB; M01AB55
Misoprostol; DICLOFENAC SODIUM
50 mg/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 ® 50 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 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: think you may be allergic to diclofenac sodium, aspirin (acetylsalicylic acid), ibuprofen or any other NSAIDs, misoprostol or another prostaglandin medicine, or any of the other ingredients of Arthrotec (see section 6). Signs of a hypersensitivity reaction include a skin rash, swelling or itchiness of the skin, swelling of the Belgenin tamamını okuyun
Health Products Regulatory Authority 08 June 2022 CRN00CZ1L Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arthrotec 50 modified-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet consists of a gastro-resistant core containing 50 milligrams diclofenac sodium surrounded by an outer mantlecontaining 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 tablet _ _ _Product imported from Spain , Netherlands and France:_ White, round, biconvex tablets marked 'Searle' and '1411' on one side and four 'A's on the other side. 4 CLINICAL PARTICULARS As per PA0822/112/001 5 PHARMACOLOGICAL PROPERTIES As per PA0822/112/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose Microcrystalline cellulose Maize starch Povidone Cellulose acetate phthalate Diethyl phthalate Hypromellose Crospovidone Magnesium stearate Hydrogenated castor oil Colloidal anhydrous silica The product imported from France contains the following excipients: Lactose Microcrystalline cellulose Maize starch Povidone Magnesium stearate Methacrylic acid copolymer type C Sodium Hydroxide Talc Triethyl citrate Crospovidone Colloidal anhydrous silica Health Products Regulatory Authority 08 June 2022 CRN00CZ1L Page 2 of 3 Hydrogenated castor oil The product imported from Netherlands contains the following excipients: Lactose monohydrate Microcrystalline cellulose Maize starch Povidone K-30 Hypromellose Crospovidone Magnesium Stearate Methylacrylic acid copolymer type-C Sodium hydroxide Talc Triethyl citrate Hydrogenated castor oil Colloidal silicon dioxide 6.2 INCOMPATIBILITIES Not applicable. 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. Belgenin tamamını okuyun