Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Omeprazole
Neon Healthcare Ltd
A02BC01
Omeprazole
40mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030500; GTIN: 5014162007352
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOSEC 10 MG HARD GASTRO-RESISTANT CAPSULES LOSEC 20 MG HARD GASTRO-RESISTANT CAPSULES LOSEC 40 MG HARD GASTRO-RESISTANT CAPSULES omeprazole 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. WHAT IS IN THIS LEAFLET : 1. What Losec is and what it is used for 2. What you need to know before you take Losec 3. How to take Losec 4. Possible side effects 5. How to store Losec 6. Contents of the pack and other information 1. WHAT LOSEC IS AND WHAT IT IS USED FOR Losec contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. Losec is used to treat the following conditions: In adults: ‘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 upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). Ulcers which 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. Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Losec can also be used to stop ulcers from forming if you are taking NSAIDs. Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome). In children: _Children over 1 year o Διαβάστε το πλήρες έγγραφο
OBJECT 1 LOSEC CAPSULES 40MG Summary of Product Characteristics Updated 09-Jun-2017 | AstraZeneca UK Limited 1. Name of the medicinal product Losec 40 mg hard gastro-resistant capsules 2. Qualitative and quantitative composition Each capsule contains 40 mg omeprazole. Excipient(s) with known effect Each capsule contains 9 mg lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant capsule, hard (gastro-resistant capsule). Hard gelatine capsules with an opaque reddish-brown body, marked 40 and an opaque reddish-brown cap marked A/OL, containing enteric coated pellets. 4. Clinical particulars 4.1 Therapeutic indications Losec capsules are indicated in: Adults • Treatment of duodenal ulcers • Prevention of relapse of duodenal ulcers • Treatment of gastric ulcers • Prevention of relapse of gastric ulcers • In combination with appropriate antibiotics, _Helicobacter pylori (H. pylori)_ eradication in peptic ulcer disease • Treatment of NSAID-associated gastric and duodenal ulcers • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk • Treatment of reflux oesophagitis • Long-term management of patients with healed reflux oesophagitis • Treatment of symptomatic gastro-oesophageal reflux disease • Treatment of Zollinger-Ellison syndrome Paediatric use _Children over 1 year of age and ≥ 10 kg _ • Treatment of reflux oesophagitis • Symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease _Children and adolescents over 4 years of age _ • In combination with antibiotics in treatment of duodenal ulcer caused by _H. pylori_ 4.2 Posology and method of administration Posology _Adults _ _Treatment of duodenal ulcers_ The recommended dose in patients with an active duodenal ulcer is Losec 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two weeks treatment period. In Διαβάστε το πλήρες έγγραφο