Do not take Motilium tablets if:

• You are allergic to domperidone or any of the other ingredients of Motilium 10mg Film-Coated Tablets (listed in section 6). 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 (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 (condition called 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 “Other medicines and Motilium”)

Do not take Motilium if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Motilium.

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 Motilium tablets if”)
• You 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.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Motilium.

Do this even if they have applied in the past.

Motilium 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. The risk also increases when Motilium is given together with some drugs. Tell your doctor or pharmacist if you are taking drugs to treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/HIV (see “Other medicines and Motilium).

Motilium should be used at the lowest effective dose in adults and adolescents 12 years of age and older and a body weight of 35kg or more.

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

Other medicines and Motilium

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without a prescription, including herbal medicines. This is because Motilium can affect the way some other medicines work. Also, some medicines can affect the way Motilium works.

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

• Fungal infections such as azole anti-fungals, 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)
• Gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride)
• Allergy (e.g., mequitazine, mizolastine)
• Malaria (in particular halofantrine)
• AIDS/HIV (protease inhibitors)
• Cancer (e.g., toremifene, vandetanib, vincamine)

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

Motilium and apomorphine

Before you use Motilium and apomorphine, your doctor will ensure that you tolerate both medicines when used simultaneously. Ask your doctor or specialist for a personalised advice. Please refer to the apomorphine leaflet.

It is important to ask your doctor or pharmacist if Motilium is safe for you when you are taking any other medicines, including medicines obtained without prescription.

Taking Motilium with food and drink

It is recommended to take Motilium before meals, as when taken after meals the absorption of the medicine is slightly delayed.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking Motilium if:

• You are pregnant, might become pregnant or think you may be pregnant
• You are breast-feeding. It is best not to take Motilium if you are breast-feeding.

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

Driving and using machines:

Motilium does not affect your ability to drive or use machines.

Motilium tablets contain lactose.

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.