Domperidone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Domperidone maleate

Available from:

Milpharm 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: 5060035111275 5060035111282

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
DOMPERIDONE
10MG TABLETS
(domperidone maleate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
-
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. Do not pass it on to others. It may
harm them, even if their symptoms 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 name of your medicine is Domperidone
10mg Tablets (called Domperidone in this
leaflet). Domperidone Tablets contain
domperidone as the active ingredient, 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 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 Domperidone 10mg
tablets (listed in section 6)
•
You have black, tarry bowel motions
(stools) or notice blood in your bowel
motions. This could be a sign of bleeding
in the stomach or intestines
•
You have a blockage or tear in your
intestines
•
You have a tumour of the pituitary gland
(prolactinoma).
•
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

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 Domperidone maleate equivalent to 10mg
domperidone base.
Excipient(s) with known effect
Domperidone 10mg tablets contains an excipient called Lactose. Each
tablet contains
54.480 mg of Lactose.
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
Domperidone 10mg Tablet is presented as a white round biconvex tablet
with
“Dm 10” inscription on one side.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Domepridone is indicated for the relief of the symptoms of nausea and
vomiting.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Domeperidone 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 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 and weighing 35 kg
or more) _
_ _
One 10mg tablet up to three times per day with 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
tablets 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