ZANTAC 150 mg/10ml Syrup

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

RANITIDINE HYDROCHLORIDE

Disponible desde:

LTT Pharma Limited

Código ATC:

A02BA02

Designación común internacional (DCI):

RANITIDINE HYDROCHLORIDE

Dosis:

150 mg/10ml

formulario farmacéutico:

Syrup

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

H2-receptor antagonists

Estado de Autorización:

Authorised

Fecha de autorización:

2014-09-26

Información para el usuario

ZANTAC  150MG/10ML SYRUP
(ranitidine)
PATIENT INFORMATION LEAFLET
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.
IN THIS LEAFLET:
What Zantac is and what it is used for
What you need to know before you take Zantac
How to take Zantac Syrup
Possible side effects
How to store Zantac
Contents of the pack and other information
WHAT ZANTAC IS AND WHAT IT IS USED FOR
Zantac contains a medicine called ranitidine. This belongs to a group
of
medicines called H2-receptor antagonists. It lowers the amount of acid
in
your stomach.
FOR ADULTS (INCLUDING THE ELDERLY) Zantac is used to:
*
treat ulcers in the stomach, or the part of the gut it empties into
(the 
duodenum)
*
prevent stomach ulcers when they are a side effect of some medicines
*
treat problems caused by acid in the food pipe (oesophagus) or too
much   
acid in the stomach. Both of these can cause pain or discomfort
sometimes 
known as ‘indigestion’, ‘dyspepsia’ or ‘heartburn’
*
treat other conditions where reduction of acid in the stomach is
likely to be 
beneficial
*
treat Zollinger-Ellison syndrome – a condition in which there is
increased 
production of the hormone gastrin
FOR CHILDREN (3 TO 18 YEARS) Zantac is used to:
*
treat ulcers in the stomach, or the part of the gut it empties into
(the 
duodenum)
*
treat problems caused by acid in the food pipe (oesophagus) or too
much 
acid in the stomach. Both of these can cause pain or discomfort
sometimes   
known as “indigestion”,”dyspepsia” or “heartburn”
WHAT YOU NEED TO KNOW

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 150 mg/10 ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml of syrup contains ranitidine hydrochloride equivalent to 150 mg of ranitidine
Excipients with known effect: each 10ml of Zantac syrup contains:
Approximately 7.5% (800mg) Ethanol equivalent to 750 mg of pure ethanol
Propyl parahydroxybenzoate (E216)
Butyl parahydroxybenzoate
Sorbitol
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
_Product imported from the Netherlands:_
A clear, colourless to pale yellow liquid with an odour of mint.
4 CLINICAL PARTICULARS
As per PA1077/013/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/013/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Hydroxypropylmethylcellulose (E464)
Ethanol
Propyl parahydroxybenzoate (E216)
Butyl parahydroxybenzoate
Potassium dihydrogen phosphate
Disodium hydrogen phosphate
Sodium chloride
Sodium saccharin
Sorbitol (E420)
Peppermint oil flavouring agent
Purified water
6.2 INCOMPATIBILITIES
Dilution of Zantac syrup with syrup BP or sorbitol solution is not recommended as this may result in precipitation.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 29/09/2014_
_CRN 2151814_
_page number: 1_
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on the container and outer package of the product on
the market in the country of origin.
Once opened: 28 days.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Do not freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber Type III glass bottle fitted with propylene scre