Motilium 10mg Film-Coated Tablets

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Domperidone

Fáanlegur frá:

JNTL Consumer Health I (Ireland) Limited

ATC númer:

A03FA; A03FA03

INN (Alþjóðlegt nafn):

Domperidone

Lyfjaform:

Film-coated tablet

Lækningarsvæði:

Propulsives; domperidone

Leyfisstaða:

Marketed

Leyfisdagur:

2007-10-05

Upplýsingar fylgiseðill

PACKAGE LEAFLET:
INFORMATION FOR THE USER
domperidone
MOTILIUM
®
10 mg Film Coated Tablets
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 have told you.
■
Keep this leaflet. You may need to read it
again.
■
Ask your pharmacist if you need more
information or advice.
■
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.
■
You must talk to a doctor if you do not
feel better or if you feel worse after
7 days.
WHAT IS IN THIS LEAFLET
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 effects
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
cannot pump the blood around your
body as well as it should (condition
called heart failure)
■
have a problem that gives you a low
level of potassium or magnesium, or
a high level of potassium in your blood
■
are taking certain medicines (see
“Taking other me

Vara einkenni

Health Products Regulatory Authority
23 February 2024
CRN00DH5V
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Hepatic Impairment
Motilium Tablets are contraindicated in moderate or severe hepatic
impairment (see section 4.3). Dose modification in mild
hepatic impairment is however not needed (see section 5.2).
Renal Impairment
Since the elimination half-life of domperidone is prolonged in severe
renal impairment, on repeated administration, the dosing
frequency of Motilium Tablets should be reduced to once or twice daily
dependi