Domperidone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Domperidone maleate

Available from:

Teva UK Ltd

ATC code:

A03FA03

INN (International Name):

Domperidone maleate

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5017007022152 5017007022114

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone 10mg Tablets
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 IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOMPERIDONE
3. HOW TO TAKE DOMPERIDONE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DOMPERIDONE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DOMPERIDONE IS AND WHAT IT IS USED FOR
Domperidone 10mg tablets (hereinafter referred to as
Domperidone) contains a medicine called domperidone which
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
DO NOT TAKE DOMPERIDONE IF YOU:
are allergic (hypersensitive) to Domperidone or any of the
other ingredients of Domperidone Tablets (see section 6 for
other ingredients)
have a moderate or severe liver disease
if your ECG (electrocardiogram) shows a heart problem
called “prolonged QT corrected interval”
if you have or had a problem where your heart cannot pump
the blood round 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 “Taking other
medicines”)
have prolactinoma (a disease of the pituitary gland)
have an underlying illness affecting the digestive system, for
instan

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Domperidone 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).
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 established.
4.3
CONTRAINDICATIONS
Domp