DOMPERIDONE 10 Milligram Orodispersible Tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

DOMPERIDONE

Commercializzato da:

PIERRE FABRE Ltd

INN (Nome Internazionale):

DOMPERIDONE

Dosaggio:

10 Milligram

Forma farmaceutica:

Orodispersible Tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2013-07-01

Foglio illustrativo

IE_DOMPERIDONE PIERRE FABRE 10 mg orodispersible tablets PA 1287/002/001 
Date of last approval by RMS: 03/2013 

MRP: FR/H/335/001/IB/10 [CRN 2126246]

PATIENT INFORMATION LEAFLET 

DOMPERIDONE PIERRE FABRE 10MG  ORODISPERSIBLE TABLETS 

Domperidone 

READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 

_•_ Keep this leaflet. You may need to read it again. 
• If you have further questions, ask your doctor, or your
pharmacist. 
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, 
even if   their symptoms are the same as yours. 
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please 
tell your doctor or pharmacist.

IN THIS LEAFLET:  

1. What DOMPERIDONE PIERRE FABRE 10mg, orodispersible tablets is and
what it is 
used for 
2. Before you take DOMPERIDONE PIERRE FABRE 10mg, orodispersible
tablets 
3. How to take DOMPERIDONE PIERRE FABRE 10mg, orodispersible tablets

4. Possible side effects 
5. How to store DOMPERIDONE PIERRE FABRE 10mg, orodispersible
tablets 
6. Further information

1. WHAT DOMPERIDONE PIERRE FABRE 10 MG, ORODISPERSIBLE TABLETS IS AND
WHAT IT 
IS USED FOR 

DOMPERIDONE PIERRE FABRE is an orodispersible tablet (dissolves in the
mouth).  
Domperidone, is a substance belonging to the dopamine antagonist
class of drugs which acts 
on intestinal motility (movements within your intestines). 

This medicine is used for the relief of: 
•  nausea (feeling sick) and vomiting,  
•  feelings of distension (uncomfortable abdomen),  
•  discomfort or gastric regurgitation (back-flow of the stomach
contents into the 
mouth). 

This medicine can be used by adults and adolescents (aged over 12
years  who are also over 
35kg). 

2. BEFORE YOU TAKE DOMPERIDONE PIERRE FABRE 10 MG, ORODISPERSIBLE
TABLETS 

DO NOT TAKE DOMPERIDONE PIERRE 

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Domperidone Pierre Fabre 10mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One orodispersible tablet contains domperidone 10 mg.
Excipient : sulphur dioxide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
Uniformly white or almost white, biconvex, round orodispersible tablet with a characteristic odor of mint.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_ADULTS_
The relief of the symptoms of nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort and
regurgitation of gastric contents.
_ADOLESCENTS (OVER 12 YEARS AND WEIGHING 35 KG OR MORE)_
The relief of the symptoms of nausea and vomiting.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended to take this medicine before meals. If taken after meals, absorption of the drug is somewhat delayed.
The initial duration of treatment is four weeks. Patients should be re-evaluated after four weeks and the need for
continued treatment re-assessed.
_ADULTS AND ADOLESCENTS (OVER 12 YEARS AND WEIGHING 35 KG OR MORE)_
1 to 2 of the 10 mg tablets three to four times per day with a maximum daily dose of 80 mg. (see section 4.4)
Since the tablet dissolves rapidly in the mouth with the help of the saliva, the orodispersible tablet can be taken with or
without water.
Without water, place the tablet on the tongue and let it dissolve in the mouth before swallowing. If convenient, a glass
of water can be taken afterwards.
The tablet can be also dispersed into a glass of water immediately before swallowing.
PAEDIATRIC POPULATION
Orodispersible tablets are unsuitable for use in children under 12 years of age and weighing less than 35 kg.
For children weighing less than 3