Domperidone 1mg/ml Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Domperidone

Available from:

Wockhardt UK Limited

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:

2014-12-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOMPERIDONE 1MG/ML ORAL SUSPENSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR 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 Domperidone Suspension is and what it is used for
2. What you need to know before you take Domperidone Suspension
3. How to take Domperidone Suspension
4. Possible side effects
5. How to store Domperidone Suspension
6. Contents of the pack and other information
1. WHAT DOMPERIDONE SUSPENSION IS AND WHAT IT IS USED FOR
USED FOR
The name of your medicine is Domperidone 1mg/ml Oral Suspension
(called Domperidone
Suspension in this leaflet). The active ingredient in this medicine is
called domperidone. This
belongs to a group of medicines called ‘dopamine antagonists’.
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 DOMPERIDONE SUSPENSION
DO NOT TAKE DOMPERIDONE SUSPENSION IF YOU:

are allergic (hypersensitive) to domperidone or any of the other
ingredients of
Domperidone Suspension (listed in section 6: Contents of the pack and
other information).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling
of your lips, face, throat or tongue

have a tumour of the pituitary gland (prolactinoma)

have a blockage or tear in your intestines

have black, tarry bowel motions (stools) or notice blood in your bowel
motions. This
could be a sign of bleeding in the stomach or inte

Summary of Product characteristics

Health Products Regulatory Authority
21 February 2020
CRN0095VM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Domperidone 1mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1mg of domperidone.
Excipients with known effect
Contains liquid sorbitol (non-crystallising, 400mg/ml), methyl
parahydroxybenzoate (1.80mg/ml) and propyl
parahydroxybenzoate (0.20mg/ml) (see section 4.4).
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
White to off-white, opaque, homogenous suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Domperidone Suspension is indicated in adults for the relief of the
symptoms of nausea and vomiting.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Domperidone Oral Suspension should be used at the lowest effective
dose for the shortest duration necessary to control
nausea and vomiting.
It is recommended to take Domperidone Oral Suspension 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)._
10 ml (of 1mg/ml oral suspension) up to three times per day with a
maximum dose of 30ml per day.
_Hepatic Impairment_
Domperidone Oral Suspension 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 Domperidone Oral Suspension should be reduced to once or
twice daily depending on the severity of the
impairment, and the dose may need to be reduced.