Omeprazole Rowa 20 mg Gastro-resistant Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Omeprazole

Available from:

Rowa Pharmaceuticals Limited

ATC code:

A02BC; A02BC01

INN (International Name):

Omeprazole

Dosage:

20 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:

2005-02-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OMEPRAZOLE ROWA 20MG GASTRO-RESISTANT CAPSULES, HARD
OMEPRAZOLE ROWA 40MG 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 Rowa is and what it is used for
2.
What you need to know before you take Omeprazole Rowa
3.
How to take Omeprazole Rowa
4.
Possible side effects
5.
How to store Omeprazole Rowa
6.
Contents of the pack and other information
1.
WHAT OMEPRAZOLE ROWA IS AND WHAT IT IS USED FOR
Omeprazole Rowa 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 Rowa 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 Rowa can also be used to stop ulcers from forming if you
are taking NSAIDs.
•
Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-E

Summary of Product characteristics

Health Products Regulatory Authority
23 May 2023
CRN00DHHW
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole Rowa 20 mg Gastro-resistant Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Omeprazole Rowa 20 mg capsules: one capsule contains 20 mg of
omeprazole
Excipient(s) with known effect:

Each 20mg capsule contains 102 to 116mg of sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Opaque yellow capsule containing off-white to cream-white spherical
microgranules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole Rowa is 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

Reflux oesophagitis. Symptomatic treatment of heartburn and acid
regurgitation in gastroesophageal reflux
disease
_Children and adolescents over 4 years of age_

In combination with antibiotics in treatment of duodenal ulcer caused
by _H. pylori_
Health Products Regulatory Authority
23 May 2023
CRN00DHHW
Page 2 of 12
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_Treatment of duodenal ulcers _
The recommended dose in patients with an active duodenal ulcer is
Omeprazole Rowa 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 usu