Omeprazole Aurobindo 10mg gastro-resistant capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OMEPRAZOLE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

A02BC01

INN (International Name):

OMEPRAZOLE 10 mg

Pharmaceutical form:

GASTRO-RESISTANT HARD CAPSULE

Composition:

OMEPRAZOLE 10 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2011-05-31

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOLE AUROBINDO 10 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE AUROBINDO 20 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE AUROBINDO 40 MG GASTRO-RESISTANT CAPSULES, HARD
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 Omeprazole Aurobindo is and what it is used for
2.
What you need to know before you take Omeprazole Aurobindo
3.
How to take Omeprazole Aurobindo
4.
Possible side effects
5.
How to store Omeprazole Aurobindo
6.
Contents of the pack and other information
1.
WHAT OMEPRAZOLE AUROBINDO IS AND WHAT IT IS USED FOR
Omeprazole Aurobindo 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.
Omeprazole Aurobindo 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 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).
Omeprazole Aurobindo can also be used to stop ulcers from formin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Omeprazole Aurobindo 10 mg gastro-resistant capsules, hard
Omeprazole Aurobindo 20 mg gastro-resistant capsules, hard
Omeprazole Aurobindo 40 mg gastro-resistant capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Omeprazole Aurobindo 10 mg: one capsule contains 10 mg of omeprazole.
Omeprazole Aurobindo 20 mg: one capsule contains 20 mg of omeprazole.
Omeprazole Aurobindo 40 mg: one capsule contains 40 mg of omeprazole.
Excipient with known effect
: Lactose monohydrate.
Each 10 mg capsule contains 1 mg of lactose monohydrate
Each 20 mg capsule contains 2 mg of lactose monohydrate
Each 40 mg capsule contains 4 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Omeprazole Aurobindo 10 mg:
Pink / Pink, size ‘3’ hard gelatin capsules (lock length is
15.40-16.20) imprinted with ‘E’ on pink cap
and ‘65’ on pink body with black ink filled with white to
off-white granules covered with a gastro-
resistant coating.
Omeprazole Aurobindo 20 mg:
Reddish brown / Pink, size ‘1’ hard gelatin capsules (lock length
is 18.90-19.70) imprinted with ‘E’ on
Reddish brown cap and ‘67’ on pink body with black ink filled with
white to off-white granules
covered with a gastro-resistant coating.
Omeprazole Aurobindo 40 mg:
Reddish brown / Reddish brown, size ‘0’ hard gelatin capsules
(lock length is 21.00-21.80) imprinted
with ‘E’ on Reddish brown cap and ‘69’ on Reddish brown body
with black ink filled with white to
off-white granules covered with a gastro-resistant coating.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Omeprazole 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