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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 1mg Tablets.

Domperidone is an anti-emetic which can stop you feeling sick.

The active ingredient is domperidone maleate.

Each tablet contains 1mg domperidone as domperidone maleate.

Domperidone is used to treat:

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.

DO NOT TAKE Domperidone 1mg Tablets if you:

Before you use Domperidone 1mg Tablets tell your doctor if you:

Driving and using machinery

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

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicine, even those not prescribed by a doctor, including any of the following:

If taken with other medicines the effect of Domperidone 1mg Tablets or the effects of the other medicine may be altered.

These tablets have been prescribed for you by a doctor. Take them exactly as he or she has told you. Please read the label carefully.

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).

Adults and adolescents (weighing 35kg or more i.e. approximately 5 stone)

The usual dose for the treatment is 1 to 2 tablets taken 3 to 4 times a day before meals. Do not take more than 8 tablets (8mg) in 24 hours.

Infants and Children

Children weighing less than 35kg (5 stone) should not take these tablets. The usual dose for the treatment is .25 .5mg per kg bodyweight taken 3 to 4 times a day before meals. Your pharmacist may be able to help you if you are not sure.

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 1mg Tablets is too strong or too weak, talk to your doctor or pharmacist.

If your complaint shows no improvement after 28 days while taking Domperidone 1mg Tablets, consult your doctor to see if you need to go on taking this medicine.

If you take more Domperidone 1mg Tablets than you should

If you take more tablets than you should, tell your doctor immediately or go to the nearest hospital.

You may be given active charcoal, which can prevent the absorption of domperidone, if taken soon after having taken the overdose. Symptoms of overdose are drowsiness, disorientation, irregular eye movements and strange movements of the body, especially in children.

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.

Like all medicines, Domperidone 1mg Tablets can have side
effects.

If any of the following side effects occur, STOP TAKING your
Domperidone 1mg Tablets and tell your doctor immediately
or go to your nearest hospital as it may be an allergic reaction:

If you experience any of the following, STOP TAKING
Domperidone 1mg Tablets and talk to your doctor:

Rare side effects

In rare cases domperidone may:

Very rare side effects

Frequency unknown

Domperidone may be associated with an increased risk of heart
rhythm disorder and cardiac arrest. This risk may be more likely in
those over 6 years old or taking doses higher than 3mg 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.

Do not use your Domperidone 1mg Tablets after the expiry date printed on the package. If you have any tablets that are out of date, please them to your pharmacist for disposal.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store the tablets in the original package.

Domperidone 1mg 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 1mg Tablets are supplied in cartons of 1, 3 or 1 tablets.

The marketing authorisation holder:

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

Distributor:

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT.

Product Licence Number: PL3464/93

This leaflet was last revised in April 212.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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(domperidone)

Domperidone belongs to the group of medications called dopamine antagonists. It is used to treat slowed movement in the gastrointestinal tract associated with diabetes and gastritis (inflammation of the stomach lining). For these people, domperidone improves symptoms of nausea, vomiting, bloating, and feeling of fullness.

Domperidone is also used to prevent stomach problems such as nausea and vomiting associated with certain medications used to treat Parkinson’s disease. It works to improve symptoms by helping the stomach to empty more quickly and to reduce nausea.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Each white, round, biconvex, film-coated tablet, engraved “DM” on one side and “1” on the other, contains domperidone maleate equivalent to 1 mg of domperidone. Non-medicinal ingredients: fumaric acid, magnesium stearate, colloidal silicon dioxide, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl methylcellulose, and Opadry White (contains polyethylene glycol, titanium dioxide, and hypromellose).

The usual adult dose of domperidone is 1 mg, taken 15 to 3 minutes before meals. The maximum recommended dose is a total of 3 mg daily for the shortest possible duration of treatment. Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Do not take domperidone if you:

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Stop taking the medication and seek immediate medical attention if any of the following occur:

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Health Canada has issued new restrictions concerning the use of domperidone. To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.

Heart rhythm problems and cardiac arrest: Recent studies have shown that the risk of serious abnormal heart rhythms or cardiac arrest (sudden death) may be higher in people who take more than 3 mg of domperidone per day, or in people who are over 6 years of age. If you have a heart condition with abnormal electrical activity of your heart (e.g., QT prolongation), heart failure, or low blood levels of magnesium or potassium, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This is especially important if you are taking other medications that can change the electrical activity of the heart. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, droperidol, pimozide, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, ondansetron, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with domperidone if possible. You are more at risk for this type of abnormal heart rhythm and its complications if you:

Hormone levels: This medication may increase prolactin, a hormone in the body. If you have a history of breast cancer, ask your doctor about the benefits and risks associated with using this medication, since some breast cancers are thought to be prolactin-dependent.

Kidney : Reduced kidney may cause this medication to build up in the body, causing side effects. If you have reduced kidney , discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may suggest a lower dose or that you take this medication only once or twice a day.

Liver : Liver disease or reduced liver may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking domperidone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: People over the age of 6 appear to be more likely to experience heart problems including heart attack with the use of domperidone. Talk to your doctor about the risks and benefits of taking this medication.

There may be an interaction between domperidone and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all preion, over-the-counter (non-preion), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 218. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Mar-Domperidone