Domperidone Crescent 10mg tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

DOMPERIDONE MALEATE

Dostupno od:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC koda:

A03FA03

INN (International ime):

DOMPERIDONE MALEATE 10 mg

Farmaceutski oblik:

TABLET

Sastav:

DOMPERIDONE MALEATE 10 mg

Tip recepta:

POM

Područje terapije:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Proizvod sažetak:

Licence number in the source country: NOT APPLICAPABLE

Status autorizacije:

Authorised

Datum autorizacije:

2020-12-16

Uputa o lijeku

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOMPERIDONE CRESCENT 10MG 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 Domperidone Tablets are and what they are used for
2.
What you need to know before you take Domperidone Tablets
3.
How to take Domperidone Tablets
4.
Possible side effects
5.
How to store Domperidone Tablets
6.
Contents of the pack and other information
1.
WHAT DOMPERIDONE TABLETS ARE AND WHAT THEY ARE USED FOR
The full name of your medicine is Domperidone Crescent 10mg Tablets
but within the leaflet it will be
referred to as Domperidone Tablets.
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 DOMPERIDONE TABLETS
DO NOT TAKE DOMPERIDONE TABLETS IF YOU:
•
are allergic to domperidone or to any of the other ingredients of this
medicine (listed in section 6).
•
have a moderate or severe liver disease.
•
have an ECG (echocardiogram) that shows a heart problem called
“prolonged QT corrected
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 “Other medicines and Domperidone
Tablets”).
•
have a tumour of the pituitary gland (prolactin

Svojstava lijeka

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Domperidone Crescent 10mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of domperidone (as maleate).
Excipient with known effect:
Each tablet contains 54.2 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablet embossed DM10 on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Domperidone is indicated for the relief of the symptoms of nausea and
vomiting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 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)
One 10mg tablet up to three times per day with a maximum daily dose of
30 mg.
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).
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Renal Impairment
Since the elimination half-life of domperidone is prolonged in severe
renal
impairment, on repeated administration, the dosing frequency of
Domperidone 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 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 esta