ESOMEPRAZOLE TEVA PHARMA 20 Milligram Tablets Gastro-Resistant

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

ESOMEPRAZOLE

Disponible depuis:

Teva Pharma B.V.

Code ATC:

A02BC05

DCI (Dénomination commune internationale):

ESOMEPRAZOLE

Dosage:

20 Milligram

forme pharmaceutique:

Tablets Gastro-Resistant

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Proton pump inhibitors

Statut de autorisation:

Authorised

Date de l'autorisation:

2011-11-04

Notice patient

Esomeprazole, DE/H/2864/001-002, 14.02.2017
PACKAGE LEAFLET
Esomeprazole, DE/H/2864/001-002, 14.02.2017
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ESOMEPRAZOLE TEVA PHARMA 20 MG GASTRO-RESISTANT TABLETS
ESOMEPRAZOLE TEVA PHARMA 40 MG GASTRO-RESISTANT TABLETS
Esomeprazole
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 Esomeprazole Teva Pharma is and what it is used for
2.
What you need to know before you take Esomeprazole Teva Pharma
3.
How to take Esomeprazole Teva Pharma
4.
Possible side effects
5.
How to store Esomeprazole Teva Pharma
6.
Contents of the pack and other information
1.
WHAT ESOMEPRAZOLE TEVA PHARMA IS AND WHAT IT IS USED FOR
Esomeprazole Teva Pharma contains a medicine called esomeprazole. This
belongs to a group of
medicines called ‘proton pump inhibitors’. They work by reducing
the amount of acid that your stomach
produces.
Esomeprazole Teva Pharma is used to treat the following conditions:
Adults
-
‘Gastroesophageal 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 stomach or upper part of the gut (intestine) that 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.
-
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Esomeprazole Teva Pharma can also be

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Teva Pharma 20 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg esomeprazole (as esomeprazole magnesium).
Excipients with known effect
20 mg: Each tablet contains 14.6 mg sucrose and 30.3 mg lactose per
tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet
Brick-red coloured,
round shape,
biconvex,
film-coated tablet,
imprinted with “20” on one side and plain on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole Teva Pharma Gastro-resistant Tablets are indicated in
adults for:
Gastroesophageal Reflux Disease (GERD)
-
Treatment of erosive reflux esophagitis
-
Long-term management of patients with healed esophagitis to prevent
relapse
-
Symptomatic treatment of gastroesophageal reflux disease (GERD)
In combination with appropriate antibacterial therapeutic regimens for
the eradication of_ Helicobacter pylori_ and
-
Healing of_ Helicobacter pylori_ associated duodenal ulcer and
-
Prevention of relapse of peptic ulcers in patients with_ Helicobacter
pylori_ associated ulcers
Patients requiring continued NSAID therapy
-
Healing of gastric ulcers associated with NSAID therapy
-
Prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients at risk
Prolonged treatment after i.v. induced prevention of rebleeding of
peptic ulcers
Treatment of Zollinger Ellison Syndrome
Esomeprazole Teva Pharma Gastro-resistant Tablets are indicated in
adolescents from the age of 12 years for:
Gastroesophageal Reflux Disease (GERD)
-
Treatment of erosive reflux esophagitis
-
Long-term management of patients with healed esophagitis to prevent
relapse
-
Symptomatic treatment of gastroesophageal reflux disease (GERD)
In combination with antibiotics in treatment of duodenal ulcer caused
by_ Helicobacter pylori_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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