OMEPRAZOLE PENSA 40 Milligram Capsules Gastro-Resistant

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OMEPRAZOLE

Available from:

Pensa Pharma AB

ATC code:

A02BC01

INN (International Name):

OMEPRAZOLE

Dosage:

40 Milligram

Pharmaceutical form:

Capsules Gastro-Resistant

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Proton pump inhibitors

Authorization status:

Authorised

Authorization date:

2011-09-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOLE PENSA 10 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE PENSA 20 MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE PENSA 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 Pensa is and what it is used for
2. What you need to know before you take Omeprazole Pensa
3. How to take Omeprazole Pensa
4. Possible side effects
5. How to store Omeprazole Pensa
6. Contents of the pack and other information
1.
WHAT OMEPRAZOLE PENSA IS AND WHAT IT IS USED FOR
Omeprazole Pensa 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 Pensa is used to treat the following conditions:
In adults:
-
‘Gastro-oesophageal reflux disease’ (GORD). 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 Pensa can also be used to stop ulcers from forming if you
are taking NSAIDs.
-
Too much acid in the s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole Pensa 40 mg Gastro-resistant Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant capsule contains 40 mg omeprazole.
Excipient: each gastro-resistant capsule contains 75.2-86.0 mg
sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Omeprazole Pensa 40 mg gastro-resistant capsules: Opaque white
capsules marked with “OM 40”. Contains white to
light beige rounded granules.
Size number 1 capsules (length 19.5 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole Pensa gastro-resistant capsules, hard 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-oesophageal reflux disease
Treatment of Zollinger-Ellison syndrome
Paediatric population
_Children over 1 year of age and_
_10 kg_
Treatment of reflux esophagitis
Symptomatic treatment of heartburn and acid regurgitation in
gastro-oesophageal reflux disease
_Children and adolescents over 4 years of age_
In combination with antibiotics in treatment of duodenal ulcer caused
by_ H. pylori_
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