Omeprazole Aristo 20mg Gastro-Resistant Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

OMEPRAZOLE

Available from:

Aristo Pharma GmbH Wallenroder Straße 8–10, 13435, Berlin, Germany

ATC code:

A02BC01

INN (International Name):

OMEPRAZOLE 20 mg

Pharmaceutical form:

GASTRO-RESISTANT CAPSULE

Composition:

OMEPRAZOLE 20 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Withdrawn

Authorization date:

2011-06-03

Patient Information leaflet

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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Omeprazole Aristo 10 mg gastro-resistant capsules, hard
Omeprazole Aristo 20 mg gastro-resistant capsules, hard
Omeprazole Aristo 40 mg gastro-resistant capsules, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Omeprazole Aristo 10 mg: one capsule contains 10 mg of omeprazole.
Omeprazole Aristo 20 mg: one capsule contains 20 mg of omeprazole.
Omeprazole Aristo 40 mg: one capsule contains 40 mg of omeprazole.
Excipient: 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 a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
Omeprazole Aristo 10 mg:
Pink / Pink, size ‘3’ hard gelatin capsules 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 Aristo 20 mg:
Reddish brown / Pink, size ‘1’ hard gelatin capsules 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 Aristo 40 mg:
Reddish brown / Reddish brown, size ‘0’ hard gelatin capsules
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 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 ulc