Quốc gia: Thụy Điển
Ngôn ngữ: Tiếng Thụy Điển
Nguồn: Läkemedelsverket (Medical Products Agency)
diklofenaknatrium; misoprostol
Cipla Europe NV
M01BX
diclofenac sodium; misoprostol
75 mg/0,2 mg
Tablett med modifierad frisättning
diklofenaknatrium 75 mg Aktiv substans; misoprostol 0,2 mg Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagt
Förpacknings: Blister, 20 tabletter; Blister, 30 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 120 tabletter; Blister, 140 tabletter
Avregistrerad
2016-01-28
PACKAGE LEAFLET: INFORMATION FOR THE USER DICLOFENAC/MISOPROSTOL CIPLA 75 MG/200 MICROGRAMS MODIFIED RELEASE TABLETS (Diclofenac sodium/misoprostol) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Diclofenac/Misoprostol Cipla is and what it is used for 2. What you need to know before you use Diclofenac/Misoprostol Cipla 3. How to take Diclofenac/Misoprostol Cipla 4. Possible side effects 5. How to store Diclofenac/Misoprostol Cipla 6. Contents of the pack and other information 1 WHAT DICLOFENAC/MISOPROSTOL CIPLA IS AND WHAT IT IS USED FOR Diclofenac/Misoprostol Cipla 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. This medicinal product contains diclofenac sodium and misoprostol. Diclofenac sodium 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. This medicinal product also contains misoprostol which is very similar to these prostaglandins and may help protect your stomach. This medicinal product is used in adults. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE DICLOFENAC/MISOPROSTOL CIPLA DO NOT TAKE DICLOFENAC/MISOPROSTOL CIPLA IF YOU: • have had an allergic reaction such as a skin rash, swelling Đọc toàn bộ tài liệu
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diclofenac/Misoprostol Cipla 75 mg/200 micrograms modified release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release tablet consists of a gastro-resistant core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 micrograms misoprostol. Excipients with known effects Each modified release tablet contains 30 mg lactose monohydrate. Each modified release tablet contains 3 mg hydrogenated castor oil. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release tablet. White, circular, biconvex uncoated tablet plain on one side and debossed with “DM1” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diclofenac/Misoprostol Cipla 75 mg/200 micrograms modified release tablets are indicated for patients who require the non-steroidal anti-inflammatory drug diclofenac together with misoprostol. The diclofenac sodium component of this medicinal product is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. The misoprostol component of this medicinal product 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_ 2 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 section 4.4 and section 4.8). _Paediatric population_ The safety and efficacy of Diclofenac/Misoprostol Cipla 75 mg/200 micrograms modified re Đọc toàn bộ tài liệu