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).

Always take Domperidone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if

you are not sure. For oral use only. The tablets must be swallowed with a glass of water. Take the tablets 15 to 30 minutes before meals and, if needed, before you go to bed. Do not crush or chew them. Follow these instructions closely

unless your doctor has advised you otherwise.

Use in children and adolescents: 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.

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

• fungal infections such as azole antifungals, specifically oral ketoconazole, fluconazole or voriconazole

• bacterial infections, specifically erythromycin, clarithromycin,

telithromycin,moxifloxacin, pentamidine (these are antibiotics)

• heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide, dofetilide, sotalol, diltiazem, verapamil)

• psychoses (e.g., haloperidol, pimozide, sertindole)

• depression (e.g., citalopram, escitalopram)

• gastrointestinal disorders (e.g., cisapride, dolasetron, prucalopride)

• allergy (e.g., mequitazine, mizolastine)

• malaria (in particular halofantrine)

• AIDS/HIV (protease inhibitors)

• Hepatitis C (e.g., telaprevir)

• cancer (e.g., toremifene, vandetanib, vincamine)

• certain other medicines (e.g., bepridil, diphemanil, methadone)

Before you use Domperidone tablet and apomorphine, your doctor will ensure that you tolerate both medicines when used

simultaneously.

Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems, or AIDS/HIV. It is important to ask your doctor or pharmacist if Domperidone tablet is safe for you when you are taking any other medicines, including medicines obtained without a prescription.

Like all medicines, Domperidone Tablets can have side effects, although not everybody gets them.Uncommon (may affect up to 1 in 100 people):

• Involuntary movements of the face or arms and legs, excessive trembling, excessive muscle stiffness or muscle spasm

Not known (frequency cannot be estimated from the available data):

• Seizures

• A type of reaction that may occur soon after administration and is recognized by skin rash, itching, shortness of breath, and/or a swollen face

• A severe hypersensitivity reaction that may occur soon after administration that is characterized by hives, itching, flushing, fainting, and difficulty in breathing among other possible symptoms

• Disorders of the cardiovascular system: heart rhythm disorders (rapid or irregular heartbeat) have been reported; if this happens, you should stop the treatment immediately.

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.

Stop treatment with Domperidone and contact your doctor immediately if you experience any of the unwanted events described above.

Other unwanted effects that have been observed with Domperidone are listed below:

Common (may affect up to 1 in 10 people):

• Dry mouth

Uncommon (may affect up to 1 in 100 people):

• Anxiety
• Agitation
• Nervousness
• Loss of interest in sex or diminished interest in sex
• Headache
• Sleepiness
• Diarrhoea
• Rash
• Itchiness
• Hives
• Painful or tender breasts
• Milk discharge from breasts
• A general feeling of weakness
• Feeling dizzy

Not known (frequency cannot be estimated from the available data):

• Upward movement of the eyes
• Stopped menstrual periods in women
• Enlarged breasts in men
• Inability to urinate
• Changes in certain laboratory test results
• Restless legs syndrome (uncomfortable feeling, with an irresistible urge to move your legs, and sometimes arms and other parts of your body).

Some patients who have used Domperidone for conditions and dosages requiring medical oversight have experienced the following unwanted effects: Restlessness; swollen or enlarged breasts, unusual discharge from breasts, irregular menstrual periods in women, difficulty breastfeeding, depression, hypersensitivity

Do Not Take Domperidone Tablets if :

You are allergic (hypersensitive) to domperidone or any of the other ingredients in the tablets.

 • 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 blockage or tear in your intestines

• You have a tumor of the pituitary gland called a prolactinoma.

• have a disorder known as phenylketonuria (a metabolic disorder) orodispersible tablets should not be used as they contain aspartamine

• if you have a moderate or severe liver disease

• if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval”

• if you have or had a problem where your heart cannot pump the blood around your body as well as it should (condition called heart failure). 

• if you have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood.

• if you are taking certain medicines (see “Taking other medicines”)

Warnings and precautions:

Before taking this medicine contact your doctor if you:

• suffer from liver problems (liver function impairment or failure) (see “Do not take this medicinal product”)

• suffer from kidney problems (kidney function impairment or failure). It is advisable to ask your doctor for advice in case of prolonged treatment as you may need to take a lower dose or take this medicine less often, and your doctor may want to examine you regularly.

• 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. The risk also increases when domperidone is given together with some drugs.

Tell your doctor or pharmacist

• if you are taking drugs to treat infection (fungal infections or bacterial infection)
• if you have heart problems or AIDS/HIV (see section Other medicines and Domperidone tablets).

Domperidone should be used at the lowest effective dose. While taking domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, and loss of consciousness. Treatment with domperidone should be stopped.

Pregnancy and breast-feeding: Talk to your doctor or pharmacist before taking Domperidone tablets if you are pregnant, might become pregnant or think you may be pregnant, if you are breast-feeding. This is because a small amount of Domperidone has been detected in breast milk. Domperidone may cause unwanted side effects affecting the heart in a breast-fed baby.

Children and adolescents: Domperidone should not be given to adolescents 12 years of age and older weighing less than 35 kg, or in any children less than 12 years of age, as it is not effective in these age groups.

Domperidone Tablet with food and drink: The tablets should be taken before meals.

Driving and using machines: You may feel sleepy, confused, or have less control over your movements while taking Domperidone tablets. if this happens, do not drive or use any tools or machines