Domperidone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Domperidone maleate

Available from:

Noumed Life Sciences 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: 05060453465028 05060453460115

Patient Information leaflet

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1
LDOM00/02
280mm
275mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone 10mg Tablets
(domperidone maleate)
This medicine is subject to additional monitoring. This will allow
quick
identification 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
(oesophagus), 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).
You must talk to a doctor if you do not feel better or if you feel
worse.
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
▼
This medicinal product is subject to additional monitoring. This will
allow quick
identification of new safety information. Healthcare professionals are
asked to report
any suspected adverse reactions. See the end of section 4.8 for how to
report side
effects.
1
NAME OF THE MEDICINAL PRODUCT
Domperidone 10mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
Each tablet contains Domperidone maleate equivalent to 10mg
domperidone base.
Excipient(s) with known effect
Each tablet contains 54.20mg of lactose monohydrate
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White round biconvex tablet with “Dm 10” inscription on one side.
4.1 THERAPEUTIC INDICATIONS:
Domperidone is indicated in adults and adolescents 12 years of age and
older with a
body weight of 35kg or more 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
(See
section 4.4).
_Adults and adolescents (over12 years and weighing 35kg 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 r