EZOFLUX

EZOFLUX 10 mg tablets

Domperidone

Package Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What EZOFLUX is and what it is used for
2. What you need to know before you take EZOFLUX
3. How to take EZOFLUX
4. Possible side effects
5. How to store EZOFLUX
6. Contents of the pack and other information

1. What EZOFLUX is and what it is used for

The name of your medicine is EZOFLUX and its active ingredient is domperidone, which belongs to a group of medicines called “dopamine antagonists”. They can increase the rate at which food passes through the gut in conditions where this is taking longer than it should.

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 EZOFLUX

Do not take EZOFLUX:

• If you are allergic to domperidone or any of the ingredients listed in section 6. An allergic reaction can occur with many medicines and may be recognized as a rash, itching, swollen face or lips, or shortness of breath.
• If your doctor has told you that you have a serious gut problem such as internal bleeding, an obstruction or perforation.
• If you suffer from a disease of the pituitary gland called prolactinoma.
• If 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 Other medicines and EZOFLUX)

You should not use EZOFLUX if you have severe stomach cramps or persistent bowel motions. If you experience either of these, see your doctor before starting EZOFLUX treatment.

Warnings and precautions

Before taking this medicine contact your doctor if you:

• suffer from liver problems (liver function impairment or failure) (see Do not take EZOFLUX)
• 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.
• You use domperidone for a children or an elderly (increased risk of extrapyramidal reactions like irregular eye movements, twisted neck, trembling and muscle stiffness)

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 EZOFLUX).

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 EZOFLUX

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take EZOFLUX if you are taking medicines 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)

EZOFLUX and apomorphine

Before you use EZOFLUX and apomorphine, your doctor will ensure that you tolerate both medicines when used simultaneously. Ask your doctor or specialist for a personalised advice. Please refer to the apomorphine leaflet.

Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems or AIDS/HIV or a medicine called levodopa for Parkinson’s disease.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The drug should not be used in pregnancy unless the benefit is considered to outweigh the potential risk for the foetus.

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.

Driving and using machines

Driving and using machines should not be a problem since EZOFLUX is a drug which does not usually cause loss of alertness. However, you should know how you are affected by this medicine before you drive or operate machines.

3. How to take EZOFLUX

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

It is recommended to take oral EZOFLUX before meals. If taken after meals, absorption of the drug is somewhat delayed.

Follow these instructions closely unless your doctor has advised you otherwise.

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

Duration of treatment

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

Important: do not exceed the recommended dose.

If you take more EZOFLUX than you should

If you have used or taken too much EZOFLUX contact your doctor, pharmacist or the poison centre immediately, in particular if a child has taken too much. 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 EZOFLUX

Take your medicine 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Domperidone is well tolerated and most patients do not experience any adverse reactions.

If you experience any of the following, stop using the medicine and seek immediate medical help:

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

• Fits or seizures.
• Involuntary movements of the face or arms and legs, excessive trembling,
• Excessive muscle stiffness or muscle spasm.
• Allergic reactions: signs of allergy include rash (such as hives), itching, shortness of breath, wheezing and or swollen face or neck, flushing or fainting.
• 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.

If you experience any of the following, stop using the medicine and talk to your doctor:

Common (may affect up to 1 in 10 people)

• Dry mouth.

Uncommon (may affect up to 1 in 100 people)

• Loss of interest in sex or diminished interest in sex.
• Sleepiness or headache.
• Painful or tender breasts, or discharge from breasts
• A general feeling of weakness.

Other side effects which can occur

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

• Irresistible urge to move the legs (restless leg syndrome).
• Agitation or Nervousness.
• Eye movement disorder.
• Inability to urinate.
• Swollen breasts (even in men).
• Stop in menstrual periods.
• Changes in certain laboratory test results. If you have a blood test to check your liver functions tell your doctor or nurse that you are taking EZOFLUX.

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 national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EZOFLUX

Store below 25^oC, protected from light, in a dry place.

Keep the tablets in the original packaging.

Keep this medicine out of the sight and reach of children.

Do not use the medicine after the expiry date. This is written on the carton. It is also on each blister of tablets.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What EZOFLUX contains

• The active substance is domperidone. Each tablet of EZOFLUX 10 mg contains 10 mg of domperidone.
• The other ingredients are: pregelatinised starch maize, microcrystalline cellulose, sodium starch glycollate, crosscarmellose sodium, colloidal silicon dioxide, magnesium stearate, erythrosine sodium.

What EZOFLUX looks like and contents of the pack

The tablet of EZOFLUX 10 mg is pink, round, flat, scored tablets marked “MC” with a 7 mm diameter.

Tablets are packed into PVC-Al foils of ten tablets in a carton box with a patient information leaflet.

Boxes of 20 are available.

Marketing Authorisation Holder and Manufacturer

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

This leaflet was last revised in April 2019.