Motilium 10 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Domperidone

Available from:

PCO Manufacturing Ltd.

ATC code:

A03FA; A03FA03

INN (International Name):

Domperidone

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propulsives; domperidone

Authorization status:

Authorised

Authorization date:

2017-10-20

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOTILIUM
®
10 MG FILM COATED TABLETS
domperidone
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 10 mg Tablets are and what it is used for
2. What you need to know before you take Motilium 10 mg Tablets
3. How to take Motilium 10 mg Tablets
4. Possible side effects
5. How to store Motilium 10 mg Tablets
6. Contents of the pack and other information
1.
WHAT MOTILIUM 10 MG 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 10 MG
TABLETS
DO NOT TAKE MOTILIUM 10 MG TABLETS IF YOU:

are allergic (hypersensitive) to domperidone or any of the
other ingredients of Motilium 10 mg 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 othe

Summary of Product characteristics

Health Products Regulatory Authority
30 November 2021
CRN00CNVK
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Motilium 10 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains domperidone 10mg.
Excipients with known effect: Each film-coated tablet contains lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_ _
_Product imported from Greece and Austria:_
White to faintly cream-coloured, circular biconvex tablets.
4 CLINICAL PARTICULARS
As per PA0330/040/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0330/040/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
lactose monohydrate
maize starch
microcrystalline cellulose
pregelatinised potato starch
povidone
magnesium stearate
hydrogenated vegetable oil
sodium laurilsulfate
hypromellose
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30ºC. Do not refrigerate or freeze. Store in the
original package in order to protect from light.
Health Products Regulatory Authority
30 November 2021
CRN00CNVK
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 10 tablets, packed in a cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/272/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 20
th
October 2017
10 DATE OF REVISION OF THE TEXT
November 2021