Omeprazole Rowa 10 mg Gastro-resistant Capsules, hard

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Omeprazole

Предлага се от:

Rowa Pharmaceuticals Limited

АТС код:

A02BC; A02BC01

INN (Международно Name):

Omeprazole

дозиране:

10 milligram(s)

Лекарствена форма:

Gastro-resistant capsule, hard

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

Proton pump inhibitors; omeprazole

Статус Оторизация:

Marketed

Дата Оторизация:

2005-02-04

Листовка

_MARKETED BY _
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-Ellison
syndrome).
In children:
Children over 1 year of age and ≥ 10 kg
• Gastro-oesophageal 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.
In children, the symptoms of the condition can
include the return of stomach contents into the
mouth (regurgitation), being sick (vomiting) and
poor weight gain.
Children and adolescents over 4 years of age
• Ulcers which are infected with bacteria called
‘Helicobacter pylori’. If your child has this
condition, your doctor may also prescribe
antibiotics to treat the infection and allow the
ulcer to heal.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE OMEPRAZOLE ROWA
DO NOT TAKE OMEPRAZOLE ROWA
• If you are allergic to omeprazole or any of
the other ingredients of this medicine (listed in
section 6).
• If you are allergic to medicines containing
other proton pump inhibitors

Данни за продукта

Health Products Regulatory Authority
20 January 2021
CRN00C0MF
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole Rowa 10 mg Gastro-resistant Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 10 mg of omeprazole.
Excipient(s) with known effect:
Each 10mg capsule contains 51 to 58mg 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 in:
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_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_Treatment of duodenal ulcers _
Health Products Regulatory Authority
20 January 2021
CRN00C0MF
Page 2 of 12
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 usually occurs
during a further