Domperidone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Domperidone maleate

Available from:

Bristol Laboratories 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: 5060013940835 5060013942600

Patient Information leaflet

Domperidone Tablets
Front
30 mm
IXXXXXX
PACKAGE LEAFLET: INFORMATION FOR 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 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
Domperidone Tablets contain active ingredient called Domperidone and
belongs to a class of medicine called anti-emetics.
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 (hypersensitive) to domperidone or any of the
other ingredients of this medicine (listed under section 6). Signs of
an allergic reaction include: a rash, swallowing or breathing
problems,
swelling of your lips, face, throat or tongue.
• you have a moderate or severe liver disease
• your ECG (electrocardiogram) shows a heart problem called
“prolonged QT corrected interval”
• 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).
• you have a problem that gives you a low level of potassium or
magnesium, or a high level of potassium in your blood.
• you are ta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1
NAME OF THE MEDICINAL PRODUCT
Domperidone 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 12.72mg of Domperidone maleate equivalent to 10
mg
domperidone.
Also contains Lactose monohydrate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablets embossed on one side with “Dm 10”
4.1
THERAPEUTIC INDICATIONS
Domperidone is indicated for the relief of the symptoms nausea and
vomiting
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.
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.
See section 4.4. for further information.
ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER WEIGHING 35 KG OR
MORE):
One 10 mg tablet up to three times per day with a maximum dose of 30
mg per day.
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. Such
patients on prolonged therapy should be reviewed regularly (see
sections 4.4 and 5.2)
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.
Method of Administration
For oral use