Domperidone EG

Patient Information Leaflet

Domperidone EG 10 mg tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Domperidone EG is and what it is used for

This medicine is used in adults and adolescents (aged 12 years and over and weighing 35 kg or more) for the treatment of nausea and vomiting (feeling of sickness).

2. What you need to know before taking Domperidone EG

Do not take Domperidone EG if:

• you are allergic to domperidone or to any of the other ingredients of this medicine (listed in section 6);
• you have stomach bleeding or regularly experience severe abdominal pain or persistent black stools;
• you have intestinal obstructions or perforations;
• you have tumours of the pituitary gland (prolactinoma);
• you have moderate or severe liver disease;
• your ECG (electrocardiogram) shows a heart condition known as “prolongation of the QT interval”;
• you have or have had a condition in which your heart is unable to pump blood properly (a condition called heart failure);
• you have a condition causing low levels of potassium or magnesium in your blood, or high levels of potassium in your blood;
• you are taking certain medicines (see “Other medicines and Domperidone EG”).

Warnings and precautions
This medicine must not be used in newborns, infants and children under 12 years of age and in adolescents weighing less than 35 kg. If Domperidone EG is intended for a child, consult your doctor for a formulation suitable for children.
Before taking this medicine, contact your doctor if:

• you suffer from liver disorders (hepatic impairment or liver failure) (see “Do not take Domperidone EG”);
• you suffer from kidney disorders (renal impairment or kidney failure). Consult your doctor for advice if long-term treatment is needed, as you may need to take a lower dose or take this medicine less frequently. Your doctor may also wish to monitor you regularly.

Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. The risk may be higher in patients over 60 years of age or in those taking doses exceeding 30 mg per day. The risk is further increased when domperidone is taken together with other medicines. Inform your doctor or pharmacist if you are taking medicines for infections (fungal or bacterial infections) and/or if you have heart problems or AIDS/HIV (see section “Other medicines and Domperidone EG”).
Domperidone EG should be used at the lowest effective dose in adults and adolescents.
While taking Domperidone EG, contact your doctor if you experience heart rhythm disturbances such as palpitations, difficulty breathing, or loss of consciousness. In such cases, treatment with Domperidone EG must be stopped.

Other medicines and Domperidone EG
Do not take Domperidone EG if you are taking medicines for the treatment of:

• fungal infections, for example pentamidine or azole antifungals, particularly itraconazole, oral ketoconazole, fluconazole, posaconazole or voriconazole;
• bacterial infections, particularly erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, spiramycin (these medicines are antibiotics);
• heart problems or high blood pressure (e.g. amiodarone, dronedarone, ibutilide, disopyramide, dofetilide, sotalol, hydroquinidine, quinidine);
• psychosis (e.g. haloperidol, pimozide, sertindole);
• depression (e.g. citalopram, escitalopram);
• gastrointestinal disorders (e.g. cisapride, dolasetron, prucalopride);
• allergies (e.g. mequitazine, mizolastine);
• malaria (particularly halofantrine, lumefantrine);
• AIDS/HIV, e.g. ritonavir or saquinavir (these are protease inhibitors);
• Hepatitis C (e.g. telaprevir);
• tumours (e.g. toremifene, vandetanib, vincamine).

Do not take Domperidone EG if you are taking other medicines (e.g. bepridil, difemanyl, methadone). Inform your doctor or pharmacist if you are taking medicines for infections, heart conditions, AIDS/HIV or Parkinson’s disease.

Domperidone EG and apomorphine
Before using Domperidone EG and apomorphine together, your doctor will ensure that your body can tolerate taking both medicines at the same time. Ask your doctor or a specialist for personalized advice. Refer to the apomorphine package leaflet.
It is important that you ask your doctor or pharmacist whether Domperidone EG is safe for you while taking other medicines, including over-the-counter medicines.

Domperidone EG with food and drink
Take Domperidone EG before meals. If taken after meals, absorption of the medicine is slightly delayed.

Pregnancy
It is not known whether the use of Domperidone EG during pregnancy is harmful.
If you are pregnant or think you may be pregnant, inform your doctor before taking Domperidone EG.

Breast-feeding
Small amounts of domperidone have been detected in breast milk. Domperidone EG may cause unwanted effects on the heart of a breastfed newborn. Domperidone EG should be used during breast-feeding only if your doctor considers it strictly necessary. Consult your doctor before taking this medicine.

Driving and using machines
Some patients have reported dizziness or drowsiness after taking Domperidone EG.
Do not drive or operate machinery while taking Domperidone EG until you know how this medicine affects you.

Domperidone EG contains lactose, sodium and hydrogenated castor oil
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
This medicine contains hydrogenated castor oil: it may cause gastrointestinal disturbances and diarrhoea.

3. How to take Domperidone EG

Strictly follow these instructions, unless your doctor has given you different ones.
Always take Domperidone EG before meals, as taking it after meals slightly delays the absorption of the medicine.

Duration of treatment:
Symptoms usually resolve within 3–4 days of taking this medicine. Do not take Domperidone EG for more than 7 days without consulting your doctor.

Adults and adolescents aged 12 years and older and weighing 35 kg or more
The usual dose is one tablet taken up to three times daily, preferably before meals.
Take the tablets with some water or another liquid. Do not chew them. Do not take more than 3 tablets per day.

Newborns, infants, children under 12 years of age, and adolescents weighing less than 35 kg
The tablets are not suitable for use in children under 12 years of age or in adolescents weighing less than 35 kg. If Domperidone EG is intended for a child, consult your doctor for a formulation appropriate for children.

If you take more Domperidone EG than you should
If you have taken an excessive amount of Domperidone EG, contact your doctor, pharmacist, or the nearest poison control center immediately, especially if the overdose was taken by a child. In case of overdose, symptomatic treatment may be administered. Electrocardiogram monitoring may be performed due to the possibility of a heart problem known as "QT interval prolongation".

Information for the physician: close medical supervision, gastric lavage, activated charcoal, and supportive therapy are recommended. Antiparkinsonian anticholinergic drugs may be helpful in controlling extrapyramidal disorders.

If you forget to take Domperidone EG
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then and continue as normal. Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people)

• Involuntary movements of the face, arms or legs, excessive tremor, excessive muscle rigidity or muscle spasm.

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

• Seizures
• A type of reaction that may occur shortly after administration and is characterised by rash, itching, shortness of breath and/or facial swelling
• A severe hypersensitivity reaction that may occur shortly after administration and is characterised by urticaria, itching, flushing, fainting, and among other possible symptoms, breathing difficulties
• Cardiovascular disorders: disturbances in heart rhythm (fast or irregular heartbeat) have been reported; if such disturbances occur, treatment must be stopped immediately. Domperidone may be associated with an increased risk of cardiac rhythm disturbances and cardiac arrest. This risk may be higher in patients over 60 years of age or in those taking doses exceeding 30 mg per day. Domperidone should be used at the lowest effective dose in adults and children.

Stop treatment with domperidone and contact your doctor immediately if any of the side effects listed above occur.
Other side effects reported with Domperidone EG are listed below.
Common (may affect up to 1 in 10 people)

• Dry mouth

Uncommon (may affect up to 1 in 100 people)

• Anxiety
• Restlessness
• Nervousness
• Loss or reduction of libido
• Headache
• Drowsiness
• Diarrhoea
• Rash
• Itching
• Urticaria
• Breast tenderness or soreness
• Lactation (milk secretion from the breast)
• General feeling of weakness
• Dizziness.

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

• Upward movement of the eyes
• Interruption of menstrual cycle in women
• Breast enlargement in men
• Inability to urinate
• Changes in results of certain laboratory tests
• Restless legs syndrome (uncomfortable sensation with an irresistible urge to move the legs, and sometimes arms and other body parts).

Some patients who have used Domperidone EG for conditions and at dosages requiring medical supervision have experienced the following side effects: restlessness; breast swelling or enlargement, abnormal breast secretions, irregular menstrual cycle in women, difficulty in breastfeeding, depression, hypersensitivity.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Domperidone EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Domperidone EG contains

• The active substance is domperidone. Each tablet contains 10 mg of domperidone.
• The other components are: lactose, maize starch, povidone, sodium lauryl sulfate, microcrystalline cellulose, colloidal hydrated silica, sodium carmellose, hydrogenated castor oil, magnesium stearate.

Description of the appearance of Domperidone EG and contents of the pack
Pack containing 30 tablets.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Francia Farmaceutici S.r.l., Via dei Pestagalli, 7, Milan, Italy