Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OMEPRAZOLE
McDermott Laboratories Ltd t/a Gerard Laboratories
A02BC01
OMEPRAZOLE
10 Milligram
Capsules Gastro-Resistant
Product subject to prescription which may be renewed (B)
omeprazole
Marketed
2011-05-06
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size 9 pt 9 pt Min Text Size used Times New Roman 1 Page Count 1/2 No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Glams Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs 1120783 PA0577/150/001-003 Zenara Pharma Pvt., Hyderabad, IN TBC TBC N/A 2 Ireland N/A 470959 N/A 12:06 26 May 17 180 x 500 mm Affiliate Item Code v1/May 2015 Omeprazole 40 mg,10 mg,20 mg 14,28 Leaflet 1120783 1010810 Black Technical Info N/A 1. WHAT OMEPRAZOLE MYLAN IS AND WHAT IT IS USED FOR Omeprazole belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. Omeprazole is used to treat the following conditions: In adults: • ‘Gastro-esophageal 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. • Ulcers in the upper part of the intestines (duodenal ulcer) or stomach (gastric ulcer). • To stop ulcers in the upper part of the intestines (duodenal ulcer) and stomach (gastric ulcer) from coming back. • Ulcers which are also infected with a 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). Omeprazole 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 of age and 10 kg_ • ‘Gastro-esophageal 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, Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Omeprazole Mylan 10 mg Gastro-resistant capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg Gastro-resistant capsule, hard contains 10 mg omeprazole Excipients with known effect Each 10 mg Gastro-resistant capsule, hard contains 16.9 mg sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsules, hard Capsule with light pink opaque cap and white opaque body, hard shell gelatine capsule filled with white to off-white pellets. The capsule is axially printed with ‘MYLAN’ over ‘OM10’ in black ink on cap and body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Omeprazole is indicated in adults and children over 1 year of age and 10kg. Omeprazole gastro-resistant capsules are indicated in: Adults Treatment of duodenal ulcers Prevention of relapse of duodenal ulcer Treatment of gastric ulcers Prevention of relapse of gastric ulcer 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 esophagitis Long term management of patients with healed reflux esophagitis Treatment of symptomatic gastro-esophageal reflux disease, Treatment of Zollinger-Ellison syndrome Paedriatric population _Children over 1 year of age and_ _10 kg_ Treatment of reflux esophagitis Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease _CHILDREN AND ADOLESCENTS OVER 4 YEARS OF AGE_ In combination with antibiotics in the treatment of duodenal ulcer caused by_ H. pylori_ 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Read the complete document