Motilium 1mg/ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Domperidone

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

A03FA; A03FA03

INN (International Name):

Domperidone

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Propulsives; domperidone

Authorization status:

Not marketed

Authorization date:

1990-12-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOTILIUM
®
1MG/ML ORAL SUSPENSION
domperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
-
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 MOTILIUM
is and what it is used for
2.
What you need to know before you take MOTILIUM
3.
How to take MOTILIUM
4.
Possible side effects
5.
How to store MOTILIUM
6.
Contents of the pack and other information
1.
WHAT MOTILIUM IS 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 35 kg or more..
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOTILIUM
DO NOT TAKE MOTILIUM IF YOU

are allergic (hypersensitive) to domperidone or any of the other
ingredients of MOTILIUM

have stomach bleeding or if you regularly have severe abdominal pain
or persistent black stools
(poo)

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 medicines”).
WARNINGS AND PRECAUTIONS
Before taking this medicine contact your doctor if you:

suffer from liver problems (liver function impairment or failure) (see
“Do not take
MOTILIUM”)

s

Summary of Product characteristics

Health Products Regulatory Authority
30 July 2021
CRN0096PN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Motilium 1mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The oral suspension contains domperidone 1 mg/ml.
Excipients with known effect:
Each ml of the oral suspension contains 455 mg sorbitol liquid
non-crystallizing, 1.8 mg methyl parahydroxybenzoate, 0.2 mg
propyl parahydroxybenzoate 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
Oral suspension
White homogenous suspension.
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 weighting 35 kg
or more)_
10 ml (of 1mg/ml oral suspension) up to three times per day with a
maximum dose of 30 ml 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
The efficacy of MOT