DOMPERIDONE TABLETS 10MG

Active substance: DOMPERIDONE MALEATE

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Patient Information Leaflet for

DOMPERIDONE STOMACH DISCOMFORT RELIEF TABLETS
(Domperidone 10 mg)
Read all of this Leaflet carefully because it contains important information for
you. This medicine is available without a prescription, for you to treat a mild condition
without a doctor’s help. Nevertheless, you still need to take this medicine carefully to
get the best results from it.
 Keep this Leaflet. You may want to read it again
 Ask your pharmacist if you need more information or advice

Your medicine
Each film-coated tablet contains 10mg of the active ingredient domperidone. Each tablet also
contains lactose monohydrate, microcrystalline cellulose, polyvidone, pregelatinised maize
starch, maize starch, sodium lauryl sulphate and magnesium stearate. The film coating
contains hydroxypropyl methylcellulose (E464), titanium dioxide (E171) and polyethylene
glycol.
Stomach Discomfort Relief Tablets are available in blister packs of 4 and 10* tablets.
(*Only marketed pack sizes will feature in the printed leaflet)
Product Licence Holder:
Manufacturer:

Generics [UK] Ltd, Station Close, Potters Bar, Herts, EN6 1TL.
McDermott Laboratories Ltd t/a Gerard Laboratories, Baldoyle,
Dublin 13, Republic of Ireland

What Domperidone is and what it is used for
Your medicine is in the form of a film-coated tablet. Domperidone belongs to a group of
medicines called anti-emetics or anti-sickness medicine. Domperidone Stomach Relief
Tablets are used to treat nausea (feeling sick), bloatedness, wind, or heartburn, following a
meal.

Before you take your medicine
Do not take this medicine if:
 you have had an allergic or unusual reaction to domperidone or any of the tablet
ingredients in the past
 you have a prolactinoma or pituitary tumour
 you have stomach or gut problems such as a blockage or bleeding
 you have liver or kidney problems.
 you have ever had heart problems including heart failure, a previous heart attack, angina
(chest pains), or heart rhythm disorders including a rapid or slow or irregular heartbeat.
Your medicine contains lactose. Patients with rare hereditary problems of galactose
intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, should not take this
medicine.

Check with your doctor or pharmacist before taking your medicine if:
 you are pregnant or intend to become pregnant
 you are breast feeding
 you are already taking other medicines, including medicines prescribed by your doctor
such as ketoconazole, to treat a fungal infection or erythromycin, an antibiotic.
Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac
arrest. This risk may be more likely in those over 60 years old or taking doses higher than
30mg per day. Domperidone should be used at the lowest effective dose in adults and
children.

How to take Domperidone Stomach Discomfort Relief Tablets
Adults (16 and over) and the elderly:
One 10mg tablet may be taken up to half an hour before a meal and at bedtime. No more
than four tablets may be taken in a day.
Do not take the tablets for longer than 2 weeks. If symptoms persist, please consult your
doctor.
Children (under 16 years of age):
Domperidone Stomach Discomfort Relief Tablets are not recommended for children under 16
years of age.
If you forget to take a dose take it as soon as you remember. If it is almost time for your
next dose though, do not double the dose just carry on as before.
IF YOU TAKE TOO MUCH OF YOUR MEDICINE, contact your doctor or
pharmacist or go to the nearest hospital casualty department immediately. Symptoms of
overdose are mainly seen in babies and children and include agitation, fits, being
drowsy or disorientated, muscle spasms in the face and eyes, muscle rigidity, and loss of
consciousness.

Possible side effects
Rare side effects include stomach upset or cramps, swelling and tenderness of the breasts
(even in men), leaking of milk from the breasts or stopping of periods (menstruation). Very
rarely, patients may suffer from itchy red skin or an allergic reaction, which may be severe,
causing swelling of the face, lips or tongue and difficulties in breathing. Other very rare side
effects include diarrhoea, and abnormal liver function tests. A few patients have suffered
from an unusual heartbeat, spasms in the muscles of the face and eyes, tremor, rigidity of the
muscles and noticed a slowness in muscle movement. In addition, very rare cases of
headaches, and nervousness have been reported, and very rare side effects mainly seen in
children include drowsiness, fits (convulsions) and agitation.
Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac
arrest. This risk may be more likely in those over 60 years old or taking doses higher than
30mg per day. Domperidone should be used at the lowest effective dose in adults and
children.

If you should suffer from any of these unwanted side effects or any undesired effect
please tell your pharmacist or doctor.

Storing your medicine
Keep your medicine out of the reach and sight of children
Store in a dry place below 25°C and protect from light.
Do not take this medicine after the expiry date shown on the carton. On the label you will
find the letters ‘Exp’ followed by some numbers. These numbers are the date when the
medicine is no longer fit for use. Do not use this medicine after this date.
Date of Leaflet preparation: July 2001
Date of Leaflet revision: May 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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