Omeprazole Amneal Capsules Gastro-Resistant 10mg

Land: Malta

Sprache: Englisch

Quelle: Malta Medicines Authority

Wirkstoff:

OMEPRAZOLE

Verfügbar ab:

Amneal Pharma Europe Limited

ATC-Code:

A02BC01

INN (Internationale Bezeichnung):

OMEPRAZOLE

Darreichungsform:

GASTRO-RESISTANT CAPSULE

Zusammensetzung:

OMEPRAZOLE 10 mg

Verschreibungstyp:

POM

Therapiebereich:

DRUGS FOR ACID RELATED DISORDERS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2011-06-03

Gebrauchsinformation

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOLE AMNEAL 10 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE AMNEAL 20 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE AMNEAL 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 Amneal is and what it is used for
2.
What you need to know before you take Omeprazole Amneal
3.
How to take Omeprazole Amneal
4.
Possible side effects
5.
How to store Omeprazole Amneal
6.
Contents of the pack and other information
1.
WHAT OMEPRAZOLE AMNEAL IS AND WHAT IT IS USED FOR
Omeprazole Amneal 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 Amneal 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
Amneal can also be used to stop ulcers from forming if you are taking
NSAIDs.

T

Fachinformation

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Omeprazole Amneal 10 mg gastro-resistant capsules, hard
Omeprazole Amneal 20 mg gastro-resistant capsules, hard
Omeprazole Amneal 40 mg gastro-resistant capsules, hard
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Omeprazole Amneal 10 mg: one capsule contains 10 mg of omeprazole.
Omeprazole Amneal 20 mg: one capsule contains 20 mg of omeprazole.
Omeprazole Amneal 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 Amneal 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 Amneal 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 Amneal 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 ulcers in p