Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
PANTOPRAZOLE SODIUM SESQUIHYDRATE
PCO Manufacturing
A02BC03
PANTOPRAZOLE SODIUM SESQUIHYDRATE
40 Milligram
Tablets Gastro-Resistant
Product subject to prescription which may be renewed (B)
Proton pump inhibitors
Authorised
2001-07-27
PACKAGE LEAFLET: INFORMATION FOR THE USER PROTIUM ® 40MG GASTRO-RESISTANT TABLETS Pantoprazole 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, 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 Protium is and what it is used for 2. What you need to know before you take Protium 3. How to take Protium 4. Possible side effects 5. How to store Protium 6. Contents of the pack and other information 1. WHAT PROTIUM IS AND WHAT IT IS USED FOR Protium contains the active substance pantoprazole. Protium 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. Protium is used to treat adults and adolescents 12 years of age and above for: Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid. Protium is used to treat adults for: An infection with a bacterium called _Helicobacter pylori _in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning. Stomach and duodenal ulcers. Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROTIUM DO NOT TAKE PROTIUM If you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6). read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Protium 40 mg Gastro-Resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 40mg pantoprazole (as sodium sesquihydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. _Product imported from Spain, United Kingdom, Italy, Germany and Hungary_ Yellow, oval, biconvex film-coated tablet imprinted with “P 40” in brown ink on one side. 4 CLINICAL PARTICULARS As per PA1547/009/003 5 PHARMACOLOGICAL PROPERTIES As per PA1547/009/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Core:_ Sodium carbonate, anhydrous Mannitol (E421) Crospovidone Povidone K90 Calcium stearate _Coating:_ Hypromellose Povidone K25 Titanium dioxide (E171) Yellow iron oxide (E172) Propylene glycol Methacrylic acid-ethyl acrylate copolymer (1:1) Polysorbate 80 Sodium laurilsulfate Triethyl citrate _Printing Ink:_ _Shellac_ Red iron oxide (E172) Black iron oxide (E172) H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _6_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _7_ _6_ _0_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ Yellow iron oxide (E172) Titanium dioxide (E171) Antifoam DC 1510 (dimeticone emulsion) 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 SPECIA read_full_document