Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Esomeprazole magnesium dihydrate
Mawdsley-Brooks & Company Ltd
A02BC05
Esomeprazole magnesium dihydrate
20mg
Gastro-resistant capsule
Oral; Gastroenteral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500
ESOMEPRAZOLE 20MG AND 40MG GASTRO-RESISTANT CAPSULES 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 Esomeprazole 20mg and 40mg Gastro-resistant Capsules but within the leaflet it will be referred to as Esomeprazole capsules. WHAT IS IN THIS LEAFLET: 1. WHAT ESOMEPRAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ESOMEPRAZOLE CAPSULES 3. HOW TO TAKE ESOMEPRAZOLE CAPSULES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ESOMEPRAZOLE CAPSULES 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ESOMEPRAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR Esomeprazole capsules contain a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors ’ . They work by reducing the amount of acid that your stomach produces. Esomeprazole capsules are used to treat the following conditions: ADULTS AND ADOLESCENTS AGED 12 YEARS AND ABOVE ‘GASTRO-OESOPHAGEAL REFLUX DISEASE’ (GORD ). 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 ADULTS STOMACH ULCERS CAUSED BY MEDICINES CALLED NSAIDS (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole capsules can also be used to stop sto Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esomeprazole 20mg Gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of esomeprazole (as magnesium dihydrate). Excipient with known effect: each capsule contains 8.04 mg of sucrose, 1.85 micrograms methyl-p-hydroxybenzoate (E218) and 0.56 microgram of propyl-p- hydroxybenzoate (E216) (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard Capsule with an opaque yellow cap and an opaque white body imprinted in black with “20 mg” both on the cap and on the body. The capsule contains off-white to greyish spherical microgranules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults _ Esomeprazole capsules are indicated in adults for: Gastroesophageal Reflux Disease (GORD) - treatment of erosive reflux esophagitis - long-term management of patients with healed esophagitis to prevent relapse - symptomatic treatment of gastroesophageal reflux disease (GORD) In combination with appropriate antibacterial therapeutic regimens for the eradication of _Helicobacter pylori _and - healing of _Helicobacter pylori _associated duodenal ulcer and - prevention of relapse of peptic ulcers in patients with _Helicobacter pylori _ associated ulcers Patients requiring continued NSAID therapy Healing of gastric ulcers associated with NSAID therapy. Prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk. Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers Treatment of Zollinger Ellison Syndrome _ _ _Adolescents from the age of 12 years_ Gastro-oesophageal Reflux Disease (GORD) - treatment of erosive reflux oesophagitis - long-term management of patients with healed oesophagitis to prevent relapse - symptomatic treatment of gastro-oesophageal reflux disease (GORD) In combination with antibiotics in treatment of duodenal ulcer caused by _Helicobacter pylori_ 4.2 POSOLOGY AND METHOD OF Preberite celoten dokument