Omeprazole Teva 10 mg gastro-resistant capsules, hard

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Omeprazole

Disponível em:

Teva Pharma B.V.

Código ATC:

A02BC; A02BC01

DCI (Denominação Comum Internacional):

Omeprazole

Dosagem:

10 milligram(s)

Forma farmacêutica:

Gastro-resistant capsule, hard

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Proton pump inhibitors; omeprazole

Status de autorização:

Marketed

Data de autorização:

2013-02-15

Folheto informativo - Bula

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

Características técnicas

Health Products Regulatory Authority
03 January 2024
CRN00DQN4
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omeprazole Teva 10 mg gastro-resistant capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg omeprazole.
Excipient with known effect
Each 10 mg capsule contains 40 mg sucrose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, hard.
Omeprazole Teva 10 mg gastro-resistant capsules, hard:
Each capsule consists of an orange body and a red cap. The capsule is
marked with the letter ‘O’ on the cap and the number
‘10’ on the body using white ink. The capsule contains white to
off-white micropellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Omeprazole Teva capsules are 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

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
Health Products Regulatory Authority
03 January 2024
CRN00DQN4
Page 2 of 13
_Adults_
_Treatment of duodenal ulcers _
The recommended dose in patients with an active duodenal ulcer is 20
mg omeprazole once dail