Motilium 10 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Domperidone maleate

Available from:

McNeil Products 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: 5027097902876

Patient Information leaflet

MOTILIUM 10 mg fILM-cOaTed TabLeTs
domperidone
PaTIeNT INfORMaTION LeafLeT
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 any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
• Your doctor may have given you this medicine before from another
company. It may have looked slightly
different. However, either brand will have the same effect
In this leaflet:
1. What Motilium is and what it is used for
2. What you need to know before you take Motilium
3. How to take Motilium
4. Possible side effects
5. How to store Motilium
6. Contents of the pack and other information
1. WhaT MOTILIUM Is aNd WhaT IT Is Used fOR
The name of your medicine is Motilium 10mg Film-Coated Tablets (called
Motilium in this leaflet). Motilium
contains a medicine called domperidone. This belongs to a group of
medicines called ‘dopamine antagonists’.
This medicine is used in adults and children to treat nausea (feeling
sick) and vomiting (being sick).
2. WhaT YOU Need TO KNOW befORe YOU TaKe MOTILIUM
do not take Motilium tablets if:
• You are allergic (hypersensitive) to domperidone or any of the
other ingredients of Motilium 10mg Film-
Coated Tablets (listed in section 6: Contents of the pack and other
information). Signs of an allergic reaction
include: a rash, swallowing or breathing problems, swelling of your
lips, face, throat or tongue.
• You have a tumour of the pituitary gland (prolactinoma)
• You have a blockage or tear in your intestines
• 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 moderate or severe liver disease.
• Your ECG (el

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Motilium 10 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
contains
domperidone
maleate
12.72
mg
equivalent
to
domperidone 10 mg.
Excipients with known effect:
Each film-coated tablet contains 53.88mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
-
white to faintly cream coloured, circular, biconvex tablets.
4.1
THERAPEUTIC INDICATIONS
Motilium is indicated for the relief of the symptoms of nausea and
vomiting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Motilium should be used at the lowest effective dose for the shortest
duration
necessary to control nausea and vomiting.
It is recommended to take oral Motilium 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. 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 a maximum dose of 30 mg
per
day.
Hepatic Impairment
Motilium 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
Motilium
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)
4.3
CONTRAINDICATIONS
Motilium is contraindicated in the following situations:
•
Known hyper