Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Esomeprazole
Crescent Pharma Ltd
A02BC05
Esomeprazole
20mg
Gastro-resistant tablet
Oral; Gastroenteral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500; GTIN: 5017123180132
WHAT IS IN THIS LEAFLET 1. What Esomeprazole gastro-resistant tablets are and what they are used for 2. What you need to know before you take Esomeprazole gastro-resistant tablets 3. How to take Esomeprazole gastro-resistant tablets 4. Possible side effects 5. How to store Esomeprazole gastro-resistant tablets 6. Contents of the pack and other information 1. WHAT ESOMEPRAZOLE GASTRO-RESISTANT TABLETS ARE AND WHAT THEY ARE USED FOR Esomeprazole gastro-resistant tablets 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 gastro-resistant tablets are used to treat the following conditions: Adults Ÿ ‘Gastroesophageal reflux disease’ (GERD). 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. Ÿ 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. Ÿ Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole gastro-resistant tablets can also be used to stop stomach ulcers from forming if you are taking NSAIDs. Ÿ Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome). Ÿ Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole. Adolescents aged 12 years and above Ÿ ‘Gastroesophageal reflux disease’ (GERD). 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. Ÿ 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 t Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esomeprazole 20mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One gastro-resistant tablet contains 20mg of esomeprazole (corresponding to 21.75mg esomeprazole magnesium dihydrate). Excipient with known effect: Each tablet contains no more than 5.65 mg of sucrose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet. 20mg: A light pink, elliptically shaped, biconvex film-coated tablet, 6.55 x 13.6 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults _ Esomeprazole 20mg tablets are indicated in adults for: 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 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. Treatment of Zollinger Ellison Syndrome Esomeprazole 20mg tablets are indicated in adolescents from the age of 12 years for: 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 ADMINISTRATION Posology _Adults _ Gastro-oesophageal Reflux Disease (GORD) - treatment of erosive reflux oesophagitis 40mg esomeprazole once daily for 4 weeks. An additional 4 weeks treatment is recommend Read the complete document