Domperidone 10mg Tablets

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Document: leaflet MAH GENERIC_PL 16363-0106 change

Pharmacode position may change as per supplier M/C requirement &additional small pharma code may appear on the front & back panel

PACKAGE LEAFLET: INFORMATION FOR THE USER Domperidone 10mg 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.

Read all of this leaflet carefully before you start taking this medicine.

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

- If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you. Do not pass it on to others. Itmay harm them, even if their symptoms are the same as yours.

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2. Before you take Domperidone Tablets

3. How to take Domperidone Tablets

4. Possible side effects

5. How to store Domperidone Tablets

6. Further information

1. WHAT DOMPERIDONE TABLETS ARE AND WHAT THEY ARE USED FOR

Domperidone Tablets contain domperidone as the active ingredient, which belongs to a group of medicines called 'dopamine antagonists'.

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

2. BEFORE YOU TAKE DOMPERIDONE TABLETS

Do Not take Domperidone Tablets if :

You are allergic (hypersensitive) to domperidone or any of the other ingredients in the tablets. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

• Youhave black, tarry bowel motions (stools) or notice blood in your bowel motions.

This could be a sign of bleeding in the stomach or intestines

• Youhave a blockage or tear in your intestines

• Youhave a tumour of the pituitary gland called a prolactinoma.

• ifyouhave a moderate or severe liver disease

• ifyourECG (electrocardiogram) shows a heart problem called "prolonged QT corrected interval"

• ifyouhave or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure).

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

• ifyouare taking certain medicines (see "Taking other medicines")

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

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Domperidone. Do this even if they have applied in the past.

Warnings and precautions

Before taking this medicine contact your doctor if you:

• sufferfrom liver problems (liver function impairment or failure) (see “Do not take this medicinal product")

• sufferfrom 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) and/or if you have heart problems or AIDS/HIV (see section other medicines and Domperidone 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.

Other medicines and Domperidone tablets

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

• fungalinfections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole

• bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin, pentamidine (these are antibiotics)

• heartproblems 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.

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 prescription.

Taking Domperidone Tablets with food and drink

The tablets should be taken before meals.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking Domperidone tablets if:

• Youarepregnant, might become pregnant or think you may be pregnant

• Youarebreast-feeding. It is best not to take Domperidone tablets if you are breastfeeding. This is because small amount 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.

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.

Important information about some of the ingredients of Domperidone Tablets

The product contains lactose - if you know you have an intolerance to some sugars, tell your doctor before use.

3. HOW TO TAKE DOMPERIDONE TABLETS

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.

Duration of treatment:

Symptoms usually resolve with 3-4 days of taking this medicine. Do not take Domperidone tablets for longer than 7 days without consulting your doctor.

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

Tablets 10 mg

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 35 kg

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

If Domperidone tablet is for a child, ask your doctor for the children's formulation.

If you take more Domperidone Tablets than you should

If you or someone else have used or taken too much Domperidone tablets, contact your doctor, pharmacist, nearest hospital casualty department or the poison centre immediately, in particular if a child has taken too much. Always take any tablet left over with you, this leaflet and also the box, as this will allow easier identification of the tablets. In the events of overdose, symptomatic treatment could be implemented. An ECG monitoring could be undertaken, because of the possibility of heart problem called prolonged QT interval.

The signs of taking more than you should include feeling sleepy, confused, uncontrolled movements (especially in children) which include unusual eye movements, unusual movements of the tongue or abnormal posture (such as a twisted neck).

If you forget to take Domperidone Tablets

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Domperidone Tablets can have side effects, although not everybody gets them.

Stop taking Domperidone tablets and see your doctor or go to a hospital straightaway if:

• Yougetswelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).This may mean you are having an allergic reaction to Domperidone tablets.

• Younotice uncontrolled movements. These include irregular eye movements, unusual movements of the tongue, and abnormal posture such as a twisted neck, trembling and muscle stiffness. This is more likely to happen in children. These symptoms should stop once you stop taking Domperidone tablets.

• Youhave a very fast or unusual heartbeat. This could be a sign of a life-threatening heart problem.

Other side effects include:

Common (less than 1 in 10 people)

• Drymouth.

Uncommon (less than 1 in 100 people)

• Anxiety.

• Lossofinterest in sex or diminished interest in sex.

• Sleepiness or headache.

• Diarrhoea.

• Rashoritchiness

• Painfulortender breasts, or discharge from breasts

• A general feeling of weakness.

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

• Hives.

• Agitation or Nervousness.

• Eyemovement disorder.

• Inabilityto urinate.

• Swollenbreasts (even in men).

• Stopinmenstrual periods.

• Changes in certain laboratory test results. If you have a blood test to check your liver function tell your doctor or nurse that you are taking Domperidone.

Side effects such as feeling drowsy, nervous, agitated or irritable or having a fit are more likely to happen in children.

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 this over 60 years old or taking doses higher than 30 mg per day. Domperidone should be used at the lowest effective dose in adults and children.

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: HYPERLINK "http://www.mhra.gov.uk/yellowcard" www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DOMPERIDONE TABLETS

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not use the tablets after the expiry date is stated on the label.

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.

6. FURTHER INFORMATION

What Domperidone Tablets contain

The active substance is domperidone maleate, 10mg per tablet.

The other ingredients are microcrystalline cellulose, lactose monohydrate, maize starch, povidone K30, sodium lauryl sulphate, silica colloidal anhydrous, magnesium stearate (see Section 2 'Important information about some of the ingredients of Domperidone Tablets').

What Domperidone Tablets looks like and contents of the pack

The tablets are white, round, biconvex and uncoated with “Dm 10" marked on one side. They are available in blister packs of 30 and 100 tablets.

Marketing Authorisation Holder:

Milpharm Limited

Ares, Odyssey Business Park,

West End Road,

South Ruislip, HA4 6QD,

United Kingdom

Manufacturers: