Public Assessment Report - GOV.UK

1 Public Assessment Report Decentralised Procedure esomeprazole 20 MG gastro - resistant TABLETS esomeprazole 40 MG gastro - resistant TABLETS Procedure No: UK/H/5028/001-2/DC UK Licence No: PL 15773/0927-8 ratiopharm GmbH esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 2 Lay summary On 12 September 2012, the Medicines and Healthcare products Regulatory Agency (MHRA) granted Marketing Authorisations to ratiopharm GmbH for the medicinal products esomeprazole 20 mg and 40 mg gastro - resistant tablets (PL 15773/0927-8; UK/H/5028/001-2/DC). These medicines are only available on prescription from your doctor and are used to treat the following: In adults and young people aged 12 years and above: gastro -Oesophageal Reflux Disease (GORD).

2 This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria called Helicobacter pylori . If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal. In adults: stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). esomeprazole Tablets can also be used to stop stomach ulcers from forming if you are taking NSAIDs.

3 Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome). prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole . The active ingredient, esomeprazole , belongs to a group of medicines called proton pump inhibitors , which work by reducing the amount of acid that the stomach produces. No new or unexpected safety concerns arose from these applications and it was, therefore, judged that the benefits of taking esomeprazole 20 mg and 40 mg gastro - resistant tablets outweigh the risks and Marketing Authorisations were granted.

4 esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 3 TABLE OF CONTENTS Module 1: Information about initial procedure Page 4 Module 2: Summary of Product Characteristics Page 5 Module 3: Patient Information Leaflet Page 6 Module 4: Labelling Page 7 Module 5: Scientific discussion Page 13 I Introduction II About the product III Scientific overview and discussion III 1 Quality aspects III 2 Non-clinical aspects III 3 Clinical aspects IV Overall conclusion and benefit/risk Assessment Module 6.

5 Steps taken after initial procedure esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 4 Module 1 Information about the initial procedure Product Names UK/H/5028/001/DC: esomeprazole 20 mg gastro - resistant tablets UK/H/5028/002/DC: esomeprazole 40 mg gastro - resistant tablets Type of Applications Generic, Article 10(1) Active Substance esomeprazole magnesium Form gastro - resistant tablets Strengths 20 mg and 40 mg MA Holder ratiopharm GmbH Graf-Arco-Stra e 3, 89079 Ulm, Germany Reference Member State (RMS) UK Concerned Member States (CMS) Greece and Slovenia Procedure Numbers UK/H/5028/001-2/DC Timetable Day 210 12 September 2012 esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 5 Module 2 Summary of Product Characteristics In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website.

6 esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 6 Module 3 Patient Information Leaflet In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 7 Module 4 The labelling text below is that agreed at the end of the Decentralised Procedure. The Marketing Authorisation Holder has committed to submit the UK labelling for review to the competent authority before marketing any pack size.

7 esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 8 esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 9 esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 10 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING {Carton Box/Bottle Label} 1. NAME OF THE MEDICINAL PRODUCT esomeprazole 40 mg gastro - resistant tablets 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each gastro - resistant tablet contains 40 mg esomeprazole (as esomeprazole magnesium). 3. LIST OF EXCIPIENTS Contains lactose and sucrose.

8 See leaflet for further information 4. PHARMACEUTICAL FORM AND CONTENTS gastro - resistant tablet 7 gastro - resistant tablets 14 gastro - resistant tablets 15 gastro - resistant tablets 28 gastro - resistant tablets 30 gastro - resistant tablets 50 gastro - resistant tablets 56 gastro - resistant tablets 60 gastro - resistant tablets 90 gastro - resistant tablets 98 gastro - resistant tablets 100 gastro - resistant tablets 100x1 gastro - resistant tablets 150 gastro - resistant tablets 5. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use Read the package leaflet before use. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children.

9 7. OTHER SPECIAL WARNING(S), IF NECESSARY esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 11 8. EXPIRY DATE EXP 9. SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light and moisture. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ratiopharm GmbH Graf-Arco-Stra e 3, 89079 Ulm, Germany 12. MARKETING AUTHORISATION NUMBER(S) PL 15773/0928 13.

10 BATCH NUMBER Batch 14. GENERAL CLASSIFICATION FOR SUPPLY POM 15. INSTRUCTIONS ON USE Use as directed by the doctor 16. INFORMATION IN BRAILLE esomeprazole 40 mg gastro - resistant tablets esomeprazole 20 mg and 40 mg gastro - resistant tablets UK/H/5028/001-2/DC 12 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {BLISTER} 1. NAME OF THE MEDICINAL PRODUCT esomeprazole 40 mg gastro - resistant tablets 2. NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm GmbH Graf-Arco-Stra e 3, 89079 Ulm, Germany 3. EXPIRY DATE EXP 4.