Domperidon Actavis 10mg Tablets

Land: Malta

Taal: Engels

Bron: Malta Medicines Authority

Werkstoffen:

DOMPERIDONE

Beschikbaar vanaf:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC-code:

A03FA03

INN (Algemene Internationale Benaming):

DOMPERIDONE 10 mg

farmaceutische vorm:

TABLET

Samenstelling:

DOMPERIDONE 10 mg

Prescription-type:

POM

Therapeutisch gebied:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-12-14

Bijsluiter

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOMPERIDON ACTAVIS 10 MG, TABLETS
Domperidone
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of
section 4 for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has
told 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 Domperidon Actavis is and what it is used for
2.
What you need to know before you take Domperidon Actavis
3.
How to take Domperidon Actavis
4.
Possible side effects
5.
How to store Domperidon Actavis
6.
Contents of the pack and other information
1.
WHAT DOMPERIDON ACTAVIS IS AND WHAT IT IS USED FOR
The active ingredient, domperidone, belongs to the gastrokinetic drugs
(group of medicines which
are used to treat reduced movements of the stomach and to treat nausea
and vomiting).
Domperidone increases the rate at which food passes through the
stomach. Furthermore
domperidone reduces the symptoms of nausea.
This medicine is used in adults and children to treat nausea (feeling
sick) and vomiting (being
sick).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOMPERIDON ACTAVIS
DO NOT TAKE DOMPERIDON ACTAVIS:
-
If you are allergic to the active substance domperidone maleate or to
any of the other
ingredients of this medicine (see section 6).
-
If you have a moderate or severe liver disease
-
If your ECG (echocardiogram) shows a heart

Productkenmerken

Page 1 of 10 

This medicinal product is subject to additional
monitoring. This will allow quick identification 
of new safety information. Healthcare professionals are
asked to report any suspected adverse 
reactions. See section 4.8 for how to
report adverse reactions. 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Domperidon Actavis 10 mg tablets 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

One tablet contains 12.72 mg of domperidone maleate equivalent to
10 mg of domperidone. 

Excipient with known effect: 
One tablet contains 54.5mg of lactose monohydrate. 
For the full list of excipients, see section_ _6.1. 

3. PHARMACEUTICAL FORM 

Tablet 
White, circular, biconvex tablet with inscription
“DM10” at one side. 

4. CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Domperidon Actavis is indicated
for the relief of the symptoms of nausea and vomiting. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Domperidon Actavis should be used
at the lowest effective dose for the shortest duration
necessary 
to control nausea and vomiting. 

It is recommended to
take oral Domperidon Actavis 10 mg tablets before
meals. If taken after 
meals, absorption of the drug is somewhat delayed. 

Patients should try to take each dose at the
scheduled time. If a scheduled dose is missed, the missed 
dose should be omitted and the usual dosing schedule resumed.
The dose should not be doubled to 
make up for a missed dose.  

Usually, the maximum treatment duration should not exceed
one week. 

Adults and adolescents (12 years of age and older and
weighing 35 kg or more) 
One 10 mg tablet up to three times per day with
a maximum daily dose of 30mg per day. 

Neonates, infants and children (less than 12 years of age) and
adolescents weighing