MOTILIUM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DOMPERIDONE

Available from:

J-C HEALTH CARE LTD

ATC code:

A03FA03

Pharmaceutical form:

TABLETS

Composition:

DOMPERIDONE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

JANSSEN CILAG S.A., FRANCE

Therapeutic group:

DOMPERIDONE

Therapeutic area:

DOMPERIDONE

Therapeutic indications:

Motilium is indicated for the relief of the symptoms of nausea and vomiting.

Authorization date:

2020-11-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
Name of the preparation, its form and strength
MOTILIUM
® 10 MG TABLETS
EACH TABLET CONTAINS DOMPERIDONE 10 MG
Inactive ingredients and allergens in the preparation -
see section 6 “Further Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for the treatment of
your ailment/for you. Do not pass it on to others. It may
harm them, even if it seems to you that their ailment/
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Motilium is used to treat nausea and vomiting in adults
and adolescents over 12 years of age and weighing
over 35 kg.
THERAPEUTIC GROUP: dopamine receptor antagonist.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• you are sensitive (allergic) to the active ingredient
or to any of the other ingredients contained in the
medicine (see section 6 - “Further Information”)
• you suffer from abdominal bleeding or if you
regularly suffer from severe abdominal pain or
persistent black stools
• you
suffer
from
intestinal
obstruction
or
perforation
• you suffer from a tumor in the pituitary gland
(prolactinoma)
• you suffer from moderate to severe liver disease
• you have an ECG that indicates a heart problem
called “prolongation of the QT interval”
• you have or had a problem where the heart cannot
pump the blood around your body as well as it
should (a condition called heart failure)
• you have a problem that causes a low level of
potassium or magnesium, or a high level of
potassium in the blood
• you are taking certain medicines (see below “DRUG
INTERACTIONS”)
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
BEFORE TREATMENT WITH MOTILIUM, TELL THE DOCTOR IF:
• you suffer from liver problems (l

Summary of Product characteristics

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1. NAME OF THE MEDICINAL PRODUCT
MOTILIUM
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains domperidone 10 mg.
Excipients with known effect
Each film-coated tablet (domperidone) contains 54.2 lactose
monohydrate and less than 1 mmol
sodium (23 mg), that is to say essentially ‘sodium-free’.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White to faintly cream coloured, circular, biconvex tablet.
4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Motilium is indicated for the relief of the symptoms of nausea and
vomiting.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Motilium should be used at the lowest effective dose for the shortest
duration necessary to control
nausea and vomiting.
It is recommended to take oral Motilium 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 dose of 30
mg per day.
Hepatic impairment
Motilium is 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 should be reduced to
once or twice daily depending
on the severity of the impairment, and the dose may need to be
reduced.
Paediatric population
Motilium is not indicated for children less than 12 years of age and
adolescents weighing less than
35 kg.
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4.3 CONTRAINDICATIONS
Motilium is contraindicated in the foll