Domperidone

• Used to treat nausea
• Tablet for oral use
• Take with food
• Also suitable for children from the age of 12 years

About Domperidone

Domperidone is an anti-sickness medicine. It helps, among other things, to more effectively coordinate the emptying of food from the stomach into the intestine. This reduces nausea and the urge to vomit.

How to use Domperidone

Domperidone tablets should be taken before meals. It may take longer for the medicine to take effect when taken after meals. The tablets should be swallowed whole with some water. Do not chew the tablets.

Most complaints will disappear within three to four days of starting the treatment. Do not use this medicine for more than seven consecutive days without consulting a doctor.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The general recommended dose for Domperidone 10-mg tablets is:

• Adults and adolescents 12 years of age and older with a body weight of 35 kg or more:

The usual dose is one tablet taken up to three times per day, if possible before meals. Do not take more than three tablets per day.

This medicine is not suitable for children under 12 years of age and older with a body weight of less than 35 kg.

Alcohol/driving

This medicine does not interact with alcohol.

Domperidone may cause drowsiness, confusion or affect your coordination. If this happens, do not drive or use any tools or machines.

If you use more/forget to use Domperidone

If you have used or taken too many Domperidone tablets, contact your doctor, pharmacist, or the nearest hospital casualty department immediately. For more information, see the package leaflet.

If you forget to take a dose of Domperidone, take the tablet as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed. Do not use a double dose to make up for a forgotten one.

When not to use Domperidone

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 30 mg per day. Domperidone should be used at the lowest effective dose.

Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Domperidone contains').
• You have a tumour of the pituitary gland (prolactinoma).
• You have, or think you may have, serious stomach problems such as bleeding in your stomach or intestines, or a blockage or tear in your stomach or intestines.
• You have moderate or severe liver problems.
• 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 should (heart failure).
• You have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood.
• You are taking certain medicines (see section 'Other medicines and Domperidone').

When should this medicine be used with caution?

Talk to your doctor before taking this medicine if:

• You suffer from liver problems (liver function impairment or failure). See section 'When not to use Domperidone'.
• You suffer from kidney problems (kidney function impairment or failure). See the package leaflet for more information.

Domperidone may be associated with an increased risk of heart rhythm disorder and cardiac arrest (see section 'When not to use Domperidone'). The risk increases when Domperidone is given together with some medicines. Tell your doctor or pharmacist if you are taking medicines to treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/HIV (see section “Other medicines and Domperidone').

While taking Domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, loss of consciousness. Treatment with Domperidone should be stopped.

Pregnancy and breastfeeding

Pregnancy It is not known whether Domperidone is harmful to an unborn baby when taken by a pregnant woman. If you are pregnant, think you may be pregnant or are planning to have a baby, talk to your doctor before using this medicine.

Breastfeeding Small amounts of Domperidone have been detected in breast milk. Domperidone may cause unwanted side effects affecting the heart in a breastfed baby. Domperidone should be used during breast feeding only if your doctor considers this clearly necessary. Ask your doctor for advice before taking this medicine.

Other medicines and Domperidone

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

Do not take Domperidone if you are taking medicine to treat:

• Fungal infections.
• Bacterial infections.
• Heart problems or high blood pressure.
• Psychosis.
• Depression.
• Gastrointestinal disorders.
• Allergy.
• Malaria.
• AIDS/HIV.
• Hepatitis C.
• Cancer.

See the package leaflet for a list of these medicines.

Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems or AIDS/HIV.

Before you use Domperidone and apomorphine, your doctor will ensure that you tolerate both medicines when used simultaneously. For more information, see the package leaflet.

Side effects

Like all medicines, this medicine can cause side effects, although some people may not experience any. Stop taking Domperidone and see your doctor or go to a hospital immediately if:

• You notice any uncontrolled movements. These include irregular eye movements, unusual movements of the tongue, and abnormal posture such as a twisted neck, trembling and muscle stiffness. This side effect is rare (may affect up to 1 in 100 out of every 1,000 people).

For more rare side effects with unknown frequency, see the package leaflet.

Other side effects that are known to be associated with Domperidone include:

Common (may affect up to 1 in 10 out of every 100 people):

• Dry mouth.

Uncommon (may affect up to 1 in 100 out of every 1,000 people):

• Anxiety.
• Restlessness.
• Nervousness.
• Lowering of sexual drive (libido).
• Headache.
• Sleepiness.
• Diarrhoea.
• Skin rash.
• Itching.
• Hives (like a nettle rash).
• Breast tenderness or soreness.
• Unusual production of breast milk in men and women.
• A general feeling of weakness.
• Dizziness.

For a complete list of possible side effects, see the package leaflet. If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What Domperidone contains

The active substance is domperidone maleate, 10 mg per tablet.

Package leaflet

Read the package leaflet before use.