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Domperidone 10mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Domperldone 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 while you are receiving your treatment.

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

- This medicine has been prescribed for you. Do not pass it onto 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 this leaflet, please tell your doctor or pharmacist.

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In this leaflet:

1. What Domperidone 10mg Film-Coated Tablets are and what they are used for

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

3. How to take Domperidone 10mg Film-Coated Tablets

4. Possible side effects

5. How to store Domperidone 10mg Film-Coated Tablets

6. Further information

1. What Domperidone 10mg Film-Coated Tablets are and what are they used for

The name of your medicine is Domperidone 10mg Film-Coated 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.

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

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

Important information about some of the ingredients in your medicine

• If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking Domperidone 10mg Film-Coated Tablets.

• This medicinal product contains 0.97 mmol (0.042 mg) of sodium per tablet. To be taken into consideration by patients on a controlled sodium dose.

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, Further Information

• 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)

• suffer from a tumour of the pituitary gland called prolactinoma

• if you have a moderate or severe liver disease

• if you 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 taking this medicine contact 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 your regularly

• are pregnant, or likely to become pregnant

• are breast-feeding

• suffer from liver problems (liver function impairment or failure) (see “Do not take this medicinal product”)

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 Domeperidone 10mg Film-Coated 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 Domeperidone 10mg Film-Coated Tablets

Do not take Domperidone 10mg Film-Coated 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)

• 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)

• opiods, used to treat pain or as an analgesic

• ritonavir, used to treat virus infections.

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 100mg Film-Coated Tablets are 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.

Product name	Reference number
Domperidone 10mg Film-Coated Tablets	29831/0076

This is a service provided by the Royal National Institute of Blind People.

Driving and using machinery

You may have less control over your movements whilst taking Domperidone Tablets. If this happens do not drive or use any tools or machines.

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.

If you have any doubts about whether you should take this medicine then talk to your doctor.

3. How to take Domperidone 10mg Film-Coated Tablets

These tablets have been prescribed for you by a doctor. Follow these instructions closely unless your doctor has advised you otherwise. The tablets should be swallowed whole with a sufficient quantity of liquid (e.g. one glass of water). Duration of treatment:

Symptoms usually resolve with 3-4 days of taking this medicine. Do not take Domperidone 10mg Film-Coated Tablets for longer than 7 days without consulting your doctor. Adults and adolescents 12 years of age 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 35 kg

Domperidone 10mg Film-Coated Tablets are not suitable for children weighing less than 35kg.

If Domperidone 10mg Film-Coated Tablets is for a child, ask your doctor for the children’s formulation.

If you take more Domperidone 10mg Tablets than you should

If you have used or taken too much Domperidone 10mg Film-Coated Tablets, contact your doctor, pharmacist or the poison centre immediately, in particular if a child has taken too much. Take this leaflet and any tablets you have left to show the doctor or pharmacist. In the event of 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.

4. Possible side effects

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

Very rarely patients have experienced allergic reactions to Domperidone.

If any of the following reactions occur, STOP taking your Domperidone 10mg Film-Coated Tablets and either tell your doctor immediately or go to your nearest hospital:

• Palpitations or dizziness or changes to heart traces (ECG) indicating a heart problem

• Facial or neck swelling, flushing or fainting

• Problems with breathing including shortness of breath and wheezing

• Rash and itching (hives) or nettle rash (urticaria)

• Other allergic reactions such as anaphylactic reaction and shock

• Uncontrolled movements of the limbs and face, including the eyes (twitching)

• In exceptional cases mild stomach cramps can occur, but these should go away quickly.

Other side effects include:

Uncommon (affects less than 1 in 100 people)

• Breast pain

Rare (affects less than 1 in 1,000 people)

• Unusual production of breast milk in men and women

• Disruption of menstrual flow

• Breast growth in men

Very rare (affects less than 1 in 10,000 people)

• Agitation

• Nervousness

• Convulsions (fits)

• Drowsiness

• Headache

• Diarrhoea

• Abnormal liver function test

Not known (cannot be estimated from available data)

• reduced libido

• abnormal movements (muscle spasms causing twisting or repetitive movements)

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 30 mg per day.

Domperidone should be

used at the lowest effective dose in adults and children.

Side effects more likely to occur in children include convulsions (fits) agitation and drowsiness.

Stop taking Domperidone 10mg Tablets and tell your doctor as soon as possible if you experience any of the above very rare side effects.

If you notice any side effects not mentioned in this leaflet, or if you suffer from any of the side effects listed please inform your doctor or pharmacist.

Reporting of side effects

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

5. How to store Domperidone 10mg Film-Coated Tablets

• Keep out of the sight and reach of children.

• 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.

• Do not store above 25°C. Store the tablets in the original package. Do not transfer Domperidone 10mg Film-Coated tablets to another container.

6. Further Information

Domperidone 10mg Film-Coated tablets are white, circular, film coated tablets marked DM on one face, 10 on the reverse. The active ingredient is domperidone maleate. Other ingredients in your tablets are lactose, pregelatinised maize starch, microcrystalline cellulose, sodium starch glycollate, magnesium stearate and Opadry white OY-S-28899 which consists of hypromellose, titanium dioxide (E171) and macrogol.

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

Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Limited,

Ash Road North, Wrexham, LL13 9UF, UK.

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0800 198 5000 (UK Only).

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This leaflet was last revised in October 2014