Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Omeprazole; DICLOFENAC SODIUM
Temmler Pharma GmbH
M01AB; M01AB55
Omeprazole; DICLOFENAC SODIUM
75/20 milligram(s)
Capsules Modified Release
Product subject to prescription which may be renewed (B)
Acetic acid derivatives and related substances; diclofenac, combinations
Not marketed
2018-07-20
___________________________________________________________________________ palde-ceclova-75-mg--20-mg-aug2019-cleaned-26.08.2019 3 Dok-Nr.: TA020198261531580005 PACKAGE LEAFLET: INFORMATION FOR THE USER CECLOVA 75 MG / 20 MG MODIFIED-RELEASE HARD CAPSULES DICLOFENAC SODIUM/OMEPRAZOLE 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, please 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 Ceclova is and what it is used for 2. What you need to know before you take Ceclova 3. How to take Ceclova 4. Possible side effects 5. How to store Ceclova 6. Contents of the pack and other information 1. WHAT CECLOVA 75 MG / 20 MG IS AND WHAT IT IS USED FOR Ceclova has been prescribed for you to relieve the pain and swelling caused by rheumatoid arthritis, osteoarthritis or ankylosing spondylitis and it may help to protect against the risk of irritation or ulceration of the stomach or intestines. Ceclova is indicated in adults who have already been treated with the combination of diclofenac and omeprazole as separate tablets with the same strength as Ceclova. Ceclova contains two active substances in a single capsule, diclofenac sodium (75 mg) and omeprazole (20 mg): Diclofenac belongs to a group of medicinal products called Non-Steroidal Anti-Inflammatory drugs (NSAIDs) which are used to reduce pain and inflammation of joint disorders. Although diclofenac relieves the pain and inflammation, it can also reduce the amount of natural protective substances called prostaglandins in the stomach or duodenum (peptic ulcers). Omeprazole belongs to a gr Leggi il documento completo
Health Products Regulatory Authority 26 November 2019 CRN0099T9 Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceclova 75 mg / 20 mg modified-release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified-release hard capsules contains 75 mg diclofenac sodium (25 mg as gastro-resistant pellets and 50 mg as prolonged release pellets) and 20 mg of omeprazole (gastro-resistant pellets). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified-release capsule, hard. Elongated 21.5 mm x 6.9 mm hard gelatine capsules with pink opaque cap and yellow opaque body, filled with white to light yellow pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceclova is indicated for symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers, who are adequately controlled with diclofenac and omeprazole. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults The dose is one capsule daily (diclofenac 75 mg/ omeprazole 20 mg). In patients switching to Ceclova the symptoms should be adequately controlled with separately administered monocomponent preparations of the same doses as contained in this combination. If symptoms are not controlled by a once daily dosing, the therapy regime must be changed by switching to one or more alternative products. Patients should not take more than one capsule of Ceclova 75 mg / 20 mg per day, as this would lead to over-exposure to omeprazole. Undesirable effects may be minimised by using the shortest duration necessary to control symptoms (see section 4.4). Treatment should be continued to achieve individual treatment goals, reviewed at regular intervals and discontinued if no benefit seen. Special populations _Patients with renal impairment _ In patients with mild to moderate renal impairment Ceclova should be used cautiously and renal function should be monitored closely (see section 5.2). Ceclova is c Leggi il documento completo