Omeprazole Mylan 20mg gastro-resistant capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

omeprazole 20 mg

Available from:

Mylan S.A.S.

ATC code:

A02BC01

INN (International Name):

omeprazole

Pharmaceutical form:

gastro-resistant hard capsule

Authorization status:

Authorised

Authorization date:

2012-07-06

Patient Information leaflet

 
1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

Omeprazole Mylan  20 mg gastro-resistant capsules, hard 

_ _
{Omeprazole} 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 
-

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. Do not pass it on to others. It may harm them, even if their 
symptoms are the same as yours. 
-

If  any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1. 
What Omeprazole is and what it is used for 
2. 
Before you take Omeprazole 
3. 
How to take use Omeprazole 
4. 
Possible side effects 
5.

How to store Omeprazole 
6. 
Further information 

1.

WHAT OMEPRAZOLE 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). 
•

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-steriodal anti inflammatory drugs). Omeprazole 
can also be use

Summary of Product characteristics

Page 1 of 14 
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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Omeprazole Mylan  20 mg gastro-resistant capsules, hard 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each gastro-resistant capsule, hard contains 20 mg omeprazole 

Each 20mg gastro-resistant capsule, hard contains 33.8 mg sucrose 

Each 20mg gastro-resistant capsule, hard contains 0.0029mg Tartrazine
(E102) and 0.0104mg Allura red 
(E129). 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Gastro-resistant capsules, hard 
20 mg capsule: capsule with dark pink opaque cap and white opaque
body and marked ‘MYLAN’ over 
‘OM20’ axially on both cap and body 
4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Omeprazole gastro-resistant capsules are indicated for: 

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 esophagitis 
- Long term management of of patients with healed reflux
esophagitis 
- Treatment of symptomatic gastro-esophageal reflux disease, 
- Treatment of Zollinger-Ellison syndrome 

- Paedriatric Use 
_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 
Page 2 of 14 
_Children and adolescents over 4 years of age _
- In combination with antibiotics in the treatment of duodenal ulcer
caused by _H. pylori_ 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology in adults 
_Treatment of duodenal ulcers _
The recommended