Domerid 10mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Domperidone

Available from:

Rowex Ltd

ATC code:

A03FA; A03FA03

INN (International Name):

Domperidone

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Propulsives; domperidone

Authorization status:

Marketed

Authorization date:

2003-04-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOMERID 10 MG TABLETS
DOMPERIDONE
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 Domerid is and what it is used for
2.
What you need to know before you take Domerid
3.
How to take Domerid
4.
Possible side effects
5.
How to store Domerid
6.
Contents of the pack and other information
1
WHAT DOMERID 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 DOMERID
DO NOT TAKE DOMERID

if you are
ALLERGIC
TO
DOMPERIDONE
or any of the other ingredients of this medicine (listed in
section 6)

if you have stomach bleeding or if you regularly have severe abdominal
pain or persistent black
stools (poo)

if you have a blocked or perforated gut

if you have a
PROLACTIN-PRODUCING TUMOUR OF THE PITUITARY GLAND
(prolactinoma)

if you have a
MODERATE OR SEVERE LIVER DISEASE

if your ECG (electrocardiogram) shows a
HEART PROBLEM
called “prolonged QT interval”

if you have or had a problem where your heart cannot pump the blood
around your body as well as it
should (condition called heart failure)

if you have a problem that gives you
A LOW LEVEL OF POTASSIUM OR MAGNESIUM
, or a
HIGH LEVEL OF
POTASSIUM
in your blood

if you are taking certain medicines (see “Other medicines and
Domerid”).
WARNINGS AND PRECAUTIONS
Domperidone should not be given to children under 12 y

Summary of Product characteristics

Health Products Regulatory Authority
19 May 2020
CRN009K23
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Domerid 10mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg domperidone (as domperidone maleate).
Excipient(s)with known effect
Each tablet contains 51.49 mg lactose (as lactose monohydrate) and
0.012 mg (0.00052 mmol) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round, biconvex tablet with inscription “Dm10” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Domperidone is indicated for the relief of the symptoms of nausea and
vomiting. Domperidone is used in adults and
adolescents over 12 years and with a body weight of 35 kg or more.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Domperidone should be used at the lowest effective dose for the
shortest duration necessary to control nausea and vomiting.
It is recommended to take oral domperidone before meals. If taken
after meals, absorption of the medicinal product 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.
_Paediatric population_
The efficacy of domperidone has not been established in children under
12 years and adolescents aged 12 years or more
with a body weight under 35 kg (see section 5.1).
_ _
Special populations
_Hepatic impairment_
Domperidone 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 sever