Omeprazole 10 mg gastro-resistant capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

Actavis Group PTC ehf

ATC code:

A02BC; A02BC01

INN (International Name):

Omeprazole

Dosage:

10 milligram(s)

Pharmaceutical form:

Gastro-resistant capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors; omeprazole

Authorization status:

Marketed

Authorization date:

2010-03-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOLE ACTAVIS 10 MG GASTRO-RESISTANT HARD CAPSULES
OMEPRAZOLE ACTAVIS 20 MG GASTRO-RESISTANT HARD CAPSULES
OMEPRAZOLE ACTAVIS 40 MG GASTRO-RESISTANT HARD CAPSULES
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Omeprazole Actavis
is and what it is used for
2.
What you need to know before you take Omeprazole Actavis
3.
How to take Omeprazole Actavis
4.
Possible side effects
5.
How to store Omeprazole Actavis
6.
Contents of the pack and other information
1.
WHAT OMEPRAZOLE ACTAVIS IS AND WHAT IT IS USED FOR
Omeprazole Actavis 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 Actavis 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 Actavis can also be used to stop ulcers from forming if you

Summary of Product characteristics

Health Products Regulatory Authority
27 September 2019
CRN008YM2
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole 10 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg omeprazole.
Excipient with known effect: Sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard
opaque yellow capsule
The capsules contain off-white (ivory) to cream-white spherical
microgranules.
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 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
Paediatric 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
_Children and adolescents over 4 years of age_

In combination with antibiotics in treatment of duodenal ulcer caused
by _H. pylori_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults_
_ _
_Treatment of duodenal ulcers_
Health Products Regulatory Authority
27 September 2019
CRN008YM2
Page 2 of 12
The recommended dose in patients with an active duodenal ulcer is
Omeprazole Actavis 20 mg once daily. In most patients
healing occurs within two weeks. For those patients who may not be
fully healed after the initial course, healing usually occurs
during a further two weeks treatment period. In patien