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PACKAGE LEAFLET: INFORMATION FOR THE USER

Domperidone lOmg Tablets

Domperidone Maleate

^This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Please read this leaflet carefully before you start to take your medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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 lOmg Tablets are and what they are used for

2.    Before you take Domperidone lOmg Tablets

3.    How to take Domperidone lOmg Tablets

4.    Possible side effects

5.    How to store Domperidone lOmg Tablets

6.    Further information

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1.    What Domperidone lOmg Tablets are and what they are used for

The name of your medicine is Domperidone lOmg Tablets. Domperidone is an anti-emetic which can stop you feeling sick. The active ingredient is domperidone maleate. Each tablet contains lOmg domperidone as domperidone maleate.

Domperidone is used in adults and in children to treat nausea (feeling sick) and vomiting (being sick).

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2.    What you need to know before you take Domperidone lOmg Tablets

Do not take Domperidone lOmg Tablets if:

•    you have ever had an allergic reaction to domperidone or any of the other ingredients listed in section 6, Further information;

•    you or the adolescent taking the tablets weighs less than 35kg;

•    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 involves severe stomach cramps);

•    you suffer from a tumour of the pituitary gland called a prolactinoma;

•    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 round 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 you take Domperidone 1 Omg Tablets tell your doctor 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;

•    suffer from liver problems (liver function impairment or failure) (see “Do not take Domperidone lOmg tablets”);

•    have been told by your doctor that you have an intolerance to some sugars;

•    are breast-feeding.

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) and/or if you have heart problems or AIDS/HIV (see “Taking other medicines”).

Domperidone should be used at the lowest effective dose in adults and children.

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.

Other medicines and Domperidone lOmg Tablets

Do not take Domperidone lOmg Tablets 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);

•    Parkinson’s disease (e.g., dopamine blockers such as bromocriptine);

•    bowel movements such as antimuscarinics e.g. atropine and hyoscine;

•    pain such as opioid painkillers e.g., morphine, codeine and tramadol;

•    heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide, dofetilide, soltalol, 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.

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

If taken with other medicines the effect of Domperidone lOmg Tablets or the effects of the other medicine may be altered. Pregnancy and breast-feeding

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

•    If you are pregnant, or thinking of becoming pregnant, ask your doctor or pharmacist for advice before taking Domperidone 1 Omg Tablets.

Driving and using machinery

It is unlikely that these tablets will affect your ability to drive or operate machinery.

Important information about one of the ingredients in your medicine

These tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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3.    How to take Domperidone lOmg Tablets

These tablets have been prescribed for you by a doctor. Follow these instructions closely unless your doctor has advised you otherwise.

You should check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed whole with a sufficient quantity of liquid (e.g., one glass of water). Symptoms usually resolve with 3-4 days of taking this medicine. Do not take Domperidone lOmg Tablets for longer than 7 days without consulting your doctor.

Adults and adolescents (over 12 years of aae and older with a body weight of 35kg 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.

Children and adolescents from birth to a body weight of less than 35kg:

Domperidone tablets are not suitable for children weighing less than 35kg.

If domperidone tablets are for a child ask your doctor for the children’s formulation.

Patients with kidney problems:

If you suffer from kidney problems, your doctor may choose to give you a lower dose of Domperidone lOmg Tablets.

Your doctor may advise you to take your medicine in a different way, so you should always follow your doctor's advice about how and when to take your medicine and always read the label. If you feel that the effect of Domperidone lOmg Tablets is too strong or too weak, talk to your doctor or pharmacist.

If your complaint shows no improvement after 14 days while taking Domperidone 1 Omg Tablets, consult your doctor.

If you take more Domperidone lOmg Tablets than you should

If you have used or taken too much domperidone, contact your doctor, pharmacist or your local accident and emergency department immediately, in particular if a child has taken any. In the event of an overdose, symptomatic treatment could be implemented. An ECG monitoring could be undertaken, because of the possibility of a heart problem called prolonged QT interval.

If you forget to take your tablets

Take your tablets as soon as you remember. If it is almost time for your next dose, wait until that is due and continue as normal. Do not take a double dose to make up for the forgotten dose.

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4.    Possible side effects

Like all medicines, Domperidone lOmg Tablets can have side effects.

Very rarely patients have experienced allergic reactions to Domperidone.

If any of the following allergic reactions occur, stop taking your Domperidone lOmg Tablets and either tell your doctor immediately or go to your nearest hospital:

•    Facial swelling

•    Problems with breathing

•    Rash

•    Itching

Rare Side Effects

•    Secretion of milk from the breasts

•    Temporary stopping of periods

•    Breast growth in men

•    Stomach cramps Very Rare Side Effects

•    Trembling and stiffness of the muscles

•    Agitation

•    Nervousness

•    Convulsions (fits)

•    Fleadache

•    Drowsiness

•    Changes to liver function test results

•    Rashes or itching

•    Uncontrolled and strange movements of the body, especially in children

•    Unusual heart rate (rhythm)

Stop taking Domperidone lOmg Tablets and tell your doctor as soon as possible if you experience any of the above very rare side effects.

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

Disorders of the cardiovascular system: heart rhythm disorders (rapid or irregular heart beat) 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 30mg per day. Domperidone should be used at the lowest effective dose in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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5.    How to store Domperidone lOmg Tablets

Keep out of the reach and sight of children.

Do not use your Domperidone lOmg Tablets after the expiry date printed on the package.

Do not store above 30°C.

Store the tablets in the original package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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6.    Further information

Domperidone lOmg Tablets are white coloured, circular flat bevelled-edge tablets marked 'DmlO'. The active ingredient is domperidone maleate. Each tablet also contains several inactive ingredients. These include lactose monohydrate, maize starch, microcrystalline cellulose, povidone, magnesium stearate, anhydrous colloidal silica and sodium lauryl sulfate. Domperidone lOmg Tablets are supplied in cartons of 28, 30 or 100 tablets.

Marketing Authorisation Holder

Focus Pharmaceuticals Ltd, Capital House, 1st Floor, 85 King William Street, London EC4N 7BL, UK.

Tel:    01283 495 280

Fax:    01283 495 290

Email:    medinf o@focuspharma. co.uk

Manufacturer

MEDREICH PLC, Warwick House, Plane Tree Crescent, Feltham, TW13 7HF, UK.

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

For information in large print, audio CD or Braille please telephone 01283 495 280 or email medinfo@focuspharma.co.uk This leaflet was last revised in 06/2015.

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