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CP.DOM.10T.AB.V4P1 PATIENT INFORMATION LEAFLET    sgl

▼ 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.

The name of your medicine is Domperidone 10mg Tablets. Domperidone is an anti-emetic which can stop you feeling sick. The active ingredient is domperidone maleate.

Each tablet contains 10mg domperidone as domperidone maleate.

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

DO NOT TAKE Domperidone 10mg Tablets:

•    if you have ever had an allergic reaction to domperidone or any of the other ingredients listed in section 6, Contents of the pack and other information

•    if you have 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 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)

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

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

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.

Warnings and precautions

Before you use Domperidone 10mg Tablets tell 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 regularly.

•    are pregnant, or likely to become pregnant

•    are breast-feeding

•    suffer from heart problems as this medicine may affect your heart rate. This risk may be greater if you are over 60 years of age or if you are on doses of more than 30 mg / day.

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 section “Other medicines and Domperidone 10mg Tablets”).

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.

Driving and using machinery

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

Other medicines and Domperidone 10mg Tablets

Do not take Domperidone 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)

•    gastrointestinal 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 is safe for you when you are taking, or have recently taken any other medicines, even those not prescribed by a doctor, including any of the following:

•    opioid analgesics, used to treat pain

•    antimuscarinics, used to treat bladder or gastrointestinal disorders

•    amantadine, used to treat viral infections

•    bromocriptine or cabergoline, used for the treatment of pituitary tumours or Parkinson's disease

If taken with other medicines the effect of Domperidone 10mg Tablets or the effects of the other medicine may be altered.

It is important to ask your doctor or pharmacist if Domperidone 10mg Tablets is safe for you when you are taking any other medicines, including medicines obtained without prescription.

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.

CP.DOM.10T.AB.V4P1

CP.DOM.10T.MK.V5P1    PATIENT INFORMATION LEAFLET

▼ 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.

DOMPERIDONE 10mg TABLETS

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 10mg Tablets are and what they are used for

2.    What you need to know before you take Domperidone 10mg Tablets

3.    How to take Domperidone 10mg Tablets

4.    Possible side effects

5.    Howto store Domperidone 10mg Tablets

6.    Contents of the pack and other information

The name of your medicine is Domperidone 10mg Tablets. Domperidone is an anti-emetic which can stop you feeling sick. The active ingredient is domperidone maleate.

Each tablet contains 10mg domperidone as domperidone maleate.

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

DO NOT TAKE Domperidone 10mg Tablets:

•    if you have ever had an allergic reaction to domperidone or any of the other ingredients listed in section 6, Contents of the pack and other information

•    if you have 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 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)

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

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

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.

Warnings and precautions

Before you use Domperidone 10mg Tablets tell 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 regularly.

•    are pregnant, or likely to become pregnant

•    are breast-feeding

•    suffer from heart problems as this medicine may affect your heart rate. This risk may be greater if you are over 60 years of age or if you are on doses of more than 30 mg / day.

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 section “Other medicines and Domperidone 10mg Tablets”).

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.

Driving and using machinery

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

Other medicines and Domperidone 10mg Tablets

Do not take Domperidone 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)

•    gastrointestinal 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 is safe for you when you are taking, or have recently taken any other medicines, even those not prescribed by a doctor, including any of the following:

•    opioid analgesics, used to treat pain

•    antimuscarinics, used to treat bladder or gastrointestinal disorders

•    amantadine, used to treat viral infections

•    bromocriptine or cabergoline, used for the treatment of pituitary tumours or Parkinson’s disease

If taken with other medicines the effect of Domperidone 10mg Tablets or the effects of the other medicine may be altered.

It is important to ask your doctor or pharmacist if Domperidone 10mg Tablets is safe for you when you are taking any other medicines, including medicines obtained without prescription.

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.

Follow these instructions closely unless your doctor has advised you otherwise. Domperidone should be used at the lowest effective dose in adults and children.

The tablets should be swallowed whole with a sufficient quantity of liquid (e.g. one glass of water).

Domperidone should be used at the lowest effective dose in    Duration of treatment:

adults and children.    Symptoms usually resolve with 3-4 days of taking this medicine.

Do not take Domperidone 10mg Tablets for longer than 7 days

without consulting your doctor.

Adults and adolescents 12 years of aae and older with a body weight of 35 kg or more

The usual dose is one tablet taken up to 3 times a 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 35 kg

Tablets are not suitable for children weighing less than 35 kg. If Domperidone is for a child, ask your Doctor for the children's formulation

People with kidney problems

Your doctor may tell you to take a lower dose or take the medicine less often.

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 10mg Tablets is too strong or too weak, talk to your doctor or pharmacist.

If you take more Domperidone 10mg Tablets than you should

If you have used or taken too much Domperidone, contact your doctor, pharmacist or the poison centre immediately, or go to the nearest hospital, in particular if a child has taken too much. In the event of an overdose, symptomatic treatment could be implemented. You may be given active charcoal, which can prevent the absorption of domperidone, if taken soon after having taken the overdose. An ECG monitoring could be undertaken, because of the possibility of a heart problem called prolonged QT interval.

Symptoms of overdose are drowsiness, disorientation, irregular eye movements and strange movements of the body.

If you forget to take Domperidone 10mg Tablets

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

Like all medicines, Domperidone 10mg Tablets can have side effects.

If any of the following side effects occur, STOP TAKING your Domperidone 10mg Tablets and tell your doctor immediately or go to your nearest hospital as it may be an allergic reaction:

•    swelling of the hands, feet, ankles, face, lips or throat

•    problems with breathing

•    skin rash, itching or hives

If you experience any of the following, STOP TAKING Domperidone 10mg Tablets and talk to your doctor:

•    convulsions (fits)

•    uncontrolled movements, including irregular eye movements, unusual tongue movements, twisting, turning movements of the neck, or trembling and stiffness of the muscles. This reaction may be more likely to occur in children.

•    heart rhythm disorders - symptoms include fast or slow heart beat

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 and children.

If you notice any side effects not mentioned in this leaflet, or if any of the side effects listed become serious or last longer than a few days please inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

Do not use your Domperidone 10mg Tablets after the expiry date printed on the package. If you have any tablets that are out of date, please return them to your pharmacist for disposal.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Store the tablets in the original package.

6 CONTENTS OF THE PACK AND OTHER . INFORMATION

Domperidone 10mg Tablets are white coloured, round, biconvex tablets. The active ingredient is domperidone maleate. Each tablet also contains several inactive ingredients. These include lactose monohydrate, maize starch, microcrystalline cellulose, povidone, magnesium stearate, colloidal anhydrous silica and sodium laurilsulfate.

Domperidone 10mg Tablets are supplied in cartons of 10, 30 or 100 tablets.

The marketing authorisation holder:

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Distributor:

Kent Pharmaceuticals Limited, Repton Road, Measham,

DE12 7DT, U.K.

Company Responsible for release of this medicine

Kent Pharmaceuticals Limited, Repton Road, Measham,

DE12 7DT, U.K.

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.

PL 30464/0093

This leaflet was last revised in June 2014.

Common side effects (may affect up to 1 in 10 people)

•    dry mouth

Uncommon side effects (may affect up to 1 in 100 people)

•    loss of sexual desire

•    anxiety

•    breast pain or tenderness

•    cause milk to leak from the breast

•    headache

•    drowsiness

•    weakness

•    rash or itchiness

•    diarrhoea

Rare side effects (may affect up to 1 in 1,000 people)

In rare cases domperidone may:

•    cause stomach disturbances

•    cause mild stomach cramps

•    disrupt menstrual flow

•    cause breast growth in men

Very rare side effects (may affect up to 1 in 10,000 people)

•    hives

•    heart rhythm disorders

•    nervousness or restlessness

•    raised liver function tests (this is detected in a blood test)

•    blood prolactin increased

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

•    sudden cardiac death

•    difficulty or inability to empty the bladder

•    oculogyric crisis - spasm of eyeballs in which they move into an extreme fixed position (usually upward)