Esomeprazol Ticerin 40mg Powder for solution for injection/infusion

Krajina: Malta

Jazyk: angličtina

Zdroj: Malta Medicines Authority

Aktívna zložka:

ESOMEPRAZOLE

Dostupné z:

Laboratorios Azevedos - Industria Farmaceutica SA Estrada Nacional 117-2 Alfragide, 2614-503 Amadora, Portugal

ATC kód:

A02BC05

INN (Medzinárodný Name):

ESOMEPRAZOLE 40 mg

Forma lieku:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Zloženie:

ESOMEPRAZOLE 40 mg

Typ predpisu:

POM

Terapeutické oblasti:

DRUGS FOR ACID RELATED DISORDERS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2014-02-21

Príbalový leták

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
ESOMEPRAZOLE TICERIN 40 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
Esomeprazole
READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU
START
USING
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, pharmacist or
nurse.
- 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Esomeprazole Ticerin is and what it is used for
2.
What you need to know before you use Esomeprazole Ticerin
3.
How to use Esomeprazole Ticerin
4.
Possible side effects
5.
How to store Esomeprazole Ticerin
6.
Contents of the pack and other information
1. WHAT ESOMEPRAZOLE TICERIN IS AND WHAT IT IS USED FOR
Esomeprazole Ticerin 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 Ticerin is used for the short term treatment of certain
conditions, when you are unable to
have treatment by mouth. It is used to treat:
- ‘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.
- Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs).
Esomeprazole Ticerin can also be used to stop stomach ulcers from
forming if you are taking
NSAIDs.
- Prevention of rebleeding following therapeutic endoscopy for acute
bleeding gastric or duodenal
ulcers.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ESOMEPRAZOLE TICERIN
YOU MUST NOT BE GIVEN ESOMEPRAZOLE TICERIN IF:
Page 2 of 7
- you are allergic to esomeprazole or any of the o

Súhrn charakteristických

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Esomeprazole Ticerin 40 mg Powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains esomeprazole 40 mg (as sodium salt).
Each vial contains <1 mmol sodium.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to off-white porous and uniform lyophilized powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Esomeprazole Ticerin for injection or infusion is indicated for:
_ _
Adults

gastric antisecretory treatment when the oral route is not possible,
such as:

gastro-oesophageal
reflux
disease
(GORD)
in
patients
with
oesophagitis
and/or
severe
symptoms of reflux

healing of gastric ulcers associated with NSAID therapy

prevention of gastric and duodenal ulcers associated with NSAID
therapy, in patients at risk.

prevention of rebleeding following therapeutic endoscopy for acute
bleeding gastric or duodenal
ulcers
Children and adolescents aged 1-18 years

gastric antisecretory treatment when the oral route is not possible,
such as:

gastro-oesophageal reflux disease (GORD) in patients with erosive
reflux oesophagitis and/or
severe symptoms of reflux.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
Page 2 of 16
GASTRIC ANTISECRETORY TREATMENT WHEN THE ORAL ROUTE IS NOT POSSIBLE
Patients who cannot take oral medication may be treated parenterally
with 20–40 mg once daily.
Patients
with
reflux
oesophagitis
should
be
treated
with
40
mg
once
daily.
Patients
treated
symptomatically for reflux disease should be treated with 20 mg once
daily.
For healing of gastric ulcers associated with NSAID therapy the usual
dose is 20 mg once daily. For
prevention of gastric and duodenal ulcers associated with NSAID
therapy, patients at risk should be
treated with 20 mg once daily.
Usually the intravenous treatment duration is short and transfer to
oral treatment should be made as
soon as possible.
PREVENTION