Domperidone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Domperidone maleate

Available from:

DE Pharmaceuticals

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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone 10mg Tablets
(domperidone maleate)
This medicine is subject to additional monitoring. This will allow
quick identifi-
cation of new safety information. You can help by reporting any side
effects you
may get. See the end of section 4 for how to report side effects.
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 domperidone as the active ingredient,
which
belongs to a group of medicines called 'dopamine antagonists'.
Domperidone works by helping to move food faster through your food
pipe (oesopha-
gus), stomach
and gut. This is so that it does not stay in the same place for too
long. It also helps stop food flowing the wrong way back up your food
pipe.
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 in
the tablets
.
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your
lips,

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 an amount of domperidone maleate equivalent to
10mg
Domperidone.
Excipient with known effect
Lactose (each tablets contains 54 mg)
For excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White coloured, round, biconvex tablets.
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
POSOLOGY
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 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).
METHOD OF ADMINISTRATION
Domperidone 10mg Tablets are for oral administration.
4.3
CONTRAINDICATIONS
Domperidone is contraindicated in the following situations:
•
Hypersensitivity to domperidone