Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pantoprazole sodium sesquihydrate
Arrow Generics Ltd
A02BC02
Pantoprazole sodium sesquihydrate
20mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500; GTIN: 5060034834069
approved for print/date PROOF ROUND Technical Approval DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: NON PRINTING COLOURS COLOURS 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com G. Worth 07/02/2020 23/03/2020 G. Worth 190x600 10pt Teva Bulgaria Dupnitsa 10/02/2020 10/02/2020 PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLET PIL - UK Black BBBA7530 5 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. GTIN 13 (Belgium & Slovenia): Version 6 12.12.2019 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) 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. • The full name of this medicine is Pantoprazole 20mg Gastro-resistant Tablets but within the leaflet it will be referred to as Pantoprazole tablets. WHAT IS IN THIS LEAFLET: 1 WHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLE TABLETS 3 HOW TO TAKE PANTOPRAZOLE TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE PANTOPRAZOLE TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR Pantoprazole is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine. Pa Read the complete document
OBJECT 1 PANTOPRAZOLE 20MG GASTRO-RESISTANT TABLETS Summary of Product Characteristics Updated 26-Mar-2020 | Accord-UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Pantoprazole 20 mg gastro-resistant tablets 2. Qualitative and quantitative composition Each gastro-resistant tablet contains 20 mg pantoprazole (as pantoprazole sodium sesquihydrate 22.58 mg) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant tablet Elliptical, biconvex, light yellow gastro-resistant tablet 4. Clinical particulars 4.1 Therapeutic indications Pantoprazole is indicated for use in adults and adolescents 12 years of age and above for: • Symptomatic gastro-oesophageal reflux disease. • Long-term management and prevention of relapse in reflux oesophagitis. Pantoprazole is indicated for use in adults for: • Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for Read the complete document