Ridonex 10 mg orodispersible tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Domperidone

Available from:

Clonmel Healthcare Ltd

ATC code:

A03FA; A03FA03

INN (International Name):

Domperidone

Dosage:

10 milligram(s)

Pharmaceutical form:

Orodispersible tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Propulsives; domperidone

Authorization status:

Marketed

Authorization date:

2016-09-16

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
RIDONEX 10 MG ORODISPERSIBLE 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 Ridonex is and what it is used for
2. What you need to know before you take Ridonex
3. How to take Ridonex
4. Possible side effects
5. How to store Ridonex
6. Contents of the pack and other information
1. WHAT RIDONEX IS AND WHAT IT IS USED FOR
This medicine contains domperidone, which is a dopamine antagonist. It
acts as a gastric motility agent.
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 RIDONEX
DO NOT TAKE
RIDONEX IF YOU:
•
are allergic to domperidone or any of the other ingredients of this
medicine (listed in section 6)
•
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 round
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 “Other medicines and Ridonex”)
WARNING

Summary of Product characteristics

Health Products Regulatory Authority
20 January 2023
CRN009ZY4
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ridonex 10 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 10 mg domperidone.
Excipient with known effect:
Each orodispersible tablet contains < 10 ppm sulphur dioxide (E220)
and maltodextrin (source of glucose).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablets. White tablet round with 5 mm of diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ridonex is indicated for the relief of the symptoms of nausea and
vomiting.Ridonex is indicated in adults and adolescents aged
12 years and older and weighing 35 kg or more.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Domperidone tablets 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 tablets 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.
Posology
_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 in children less than 12 years of age has
not been established (see section 5.1).
The efficacy of domperidone in adolescents 12 years of age and older
and weighing less than 35 kg has not been established.
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