Domperidone 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Domperidone maleate

Available from:

Viatris UK Healthcare 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: 5016695300337 5016695300320

Patient Information leaflet

PATIENT INFORMATION LEAFLET
DOMPERIDONE 10MG TABLETS
PLEASE ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
o
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
o
IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
PHARMACIST.
o
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.
o
IF ANY OF THE SIDE EFFECTS GET SERIOUS, OR IF YOU NOTICE ANY SIDE
EFFECTS NOT LISTED IN THE
LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET
1.
What Domperidone 10mg Tablets are and what they are used for
2.
What you need to know before you take Domperidone 10mg Tablets
3.
How to take Domperidone 10mg Tablets
4.
Possible side effects
5.
How to store Domperidone 10mg Tablets
6.
Contents of the pack and other information
_ _
1. WHAT DOMPERIDONE 10MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Domperidone 10mg Tablets. Domperidone is
an anti-emetic which
can stop you feeling sick. The active ingredient is domperidone
maleate.
Each tablet contains 10mg domperidone as domperidone maleate.
Domperidone is used to treat nausea (feeling sick) and vomiting (being
sick).
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
DOMPERIDONE
10MG
TABLETS
DO NOT TAKE DOMPERIDONE 10MG TABLETS:
o
if you have ever had an allergic reaction to domperidone or any of the
other ingredients
(listed in section 6)
o
if you have moderate or severe liver disease
o
if your ECG (electrocardiogram) shows a heart problem called
“prolonged QT corrected
interval”
o
if 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)
o
if you have a problem that gives you a low level of potassium or
magnesium, or a high level
of potassium in your blood.
o
if you have or think you may have a serious intestinal problem such as
internal bleeding
(symptom being persistent black bowel motions), or an obstruction or
perforation of the
stomach or intestine (usually this

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 10 mg of domperidone (as maleate).
Excipient with known effect:
Each tablet contains 54.2 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablet embossed DM10 on one side
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
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 10mg tablet up to three times per day with a maximum daily dose of
30 mg.
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.
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.
4.3
CONTRAINDICATIONS
Domp