MOTILIUM 10 Milligram Film Coated Tablet

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

DOMPERIDONE

Disponibbli minn:

McNeil Healthcare (Ireland) Ltd

Kodiċi ATC:

A03FA03

INN (Isem Internazzjonali):

DOMPERIDONE

Dożaġġ:

10 Milligram

Għamla farmaċewtika:

Film Coated Tablet

Tip ta 'preskrizzjoni:

Product not subject to medical prescription

Żona terapewtika:

Propulsives

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2009-12-04

Fuljett ta 'informazzjoni

FACE 1
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PACKAGE LEAFL ET:
INFORMATION FOR THE USER
domperidone
MOTILIUM
®
10 mg Film Coated Tablets
This medicine is subject to additional
monitoring. This will allow quick identifi cation
of new safety information. You can help by
reporting any side eff ects you may get.
See the end of section 4 for how to report
side eff ects.
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as
described in this leafl et or as your doctor
or pharmacist have told you.
■
Keep this leafl et. You may need to read it
again.
■
Ask your pharmacist if you need more
information or advice.
■
If you get any side eff ects, talk to your
doctor or pharmacist. This includes any
possible side eff ects not listed in this
leafl et. See section 4.
■
You must talk to a doctor if you do not
feel better or if you feel worse after
7 days.
WHAT IS IN THIS LEAFL ET
1. What Motilium 10mg Tablets are and
what it is used for
2. What you need to know before you
take Motilium 10mg Tablets
3. How to take Motilium 10mg Tablets
4. Possible side eff ects
5. How to store Motilium 10mg Tablets
6. Contents of the pack and other
information
1. WHAT MOTILIUM 10MG
TABLETS ARE AND WHAT IT
IS USED FOR
This medicine is used to treat nausea
(feeling sick) and vomiting (being sick) in
adults and adolescents, 12 years of age
and older and weighing 35kg or more.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE MOTILIUM
10MG TABLETS
DO NOT TAKE MOTILIUM 10MG TABLETS IF
YOU:
■
are allergic (hypersensitive) to
domperidone or any of the other
ingredients of Motilium 10mg Tablets
■
have stomach bleeding or if you
regularly have severe abdominal pain
or persistent black stools
■
have a blocked or perforated gut
■
have a tumour of the pituitary gland
(prolactinoma)
■
have a moderate or severe liver disease
■
have an ECG (electrocardiogram) that
shows a heart problem called
“prolonged QT interval”
■
have or had a problem where your heart

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
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.
1 NAME OF THE MEDICINAL PRODUCT
Motilium 10mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains domperidone 10mg.
Excipients with known effect: Each film-coated tablet contains 54.2mg
of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to faintly cream-coloured, circular biconvex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Motilium Tablets are indicated for the relief of the symptoms of
nausea and vomiting.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Motilium Tablets should be used at the lowest effective dose for the
shortest duration necessary to control nausea and
vomiting.
It is recommended to take Motilium 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 35kg
or more):
One 10mg tablet up to three times per day with a maximum dose of 30mg
per day.
Use in children under 12 years of age (and adolescents weighing less
than 35kg):
Not recommended
Patients > 60 years of age:
Patients older than 60 years of age should consult a healthcare
professional before taking Motilium.
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