Domperidone ABC

Package leaflet: Information for the patient

Domperidone ABC 10 mg tablets

Domperidone
Generic medicine
Please read this leaflet carefully before using 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Domperidone ABC 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 ABC

Do not take Domperidone ABC if:

• you are allergic (hypersensitive) to domperidone or to any of the other ingredients of Domperidone ABC;
• you have gastrointestinal bleeding or regularly experience severe abdominal pain or persistent black stools;
• you have intestinal obstructions or perforations;
• you have tumours of the pituitary gland that secrete prolactin (prolactinoma);
• you have moderate or severe liver disease;
• your ECG (electrocardiogram) shows a heart condition known as “QT interval prolongation”;
• you have or have previously 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, or high levels of potassium in your blood;
• you are taking certain medicines (see “Taking other medicines”).

Warnings and precautions
Before taking this medicine, contact your doctor if:

• you suffer from liver disorders (hepatic impairment or liver failure) (see “Do not take Domperidone ABC”);
• 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 of this medicine or take it less frequently, and your doctor may 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 ABC”).
Domperidone should be used at the lowest effective dose.
While taking Domperidone ABC, contact your doctor if you experience heart rhythm disturbances such as palpitations, difficulty breathing, or loss of consciousness. In such cases, treatment with Domperidone ABC should be discontinued.

Adolescents weighing less than 35 kg and children
Domperidone ABC must not be given to adolescents aged 12 years or older who weigh less than 35 kg, or to any child under 12 years of age, as it is not effective at these ages.

Other medicines and Domperidone ABC
Do not take Domperidone ABC 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, levofloxacin, clarithromycin, telithromycin, moxifloxacin, spiramycin (these medicines are antibiotics);
• heart problems or high blood pressure (e.g. amiodarone, dronedarone, ibutilide, hydroquinidine, quinidine, disopyramide, dofetilide, sotalol);
• 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, saquinavir (these are protease inhibitors);
• hepatitis C (e.g. telaprevir);
• tumours (e.g. toremifene, vandetanib, vincamine).

Do not take Domperidone ABC if you are taking other medicines (e.g. bepridil, difemamil, methadone).
Inform your doctor or pharmacist if you are taking medicines for infections, heart disorders, AIDS/HIV or Parkinson’s disease.
Domperidone ABC and apomorphine
Before using Domperidone ABC together with apomorphine, your doctor will ensure that your body can tolerate taking both medicines together. Seek personalized advice from your doctor or a specialist. Refer to the apomorphine package leaflet.
It is important to ask your doctor or pharmacist whether Domperidone ABC is safe for you while taking other medicines, including over-the-counter medicines.

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

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

Breast-feeding
Small amounts of domperidone have been detected in breast milk. Domperidone ABC may cause unwanted effects on the heart of a breastfed newborn. Domperidone ABC 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 ABC. Do not drive or operate machinery while taking Domperidone ABC until you know how it affects you.

Important information about some ingredients of Domperidone ABC
Domperidone ABC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Domperidone ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Domperidone ABC

Strictly follow these instructions, unless your doctor has given you different ones.
It is recommended to take Domperidone ABC before meals; if taken after meals, absorption of the medicine is slightly delayed.

Duration of treatment:
Symptoms normally resolve within 3–4 days of taking this medicine.
Do not take Domperidone ABC 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 a day, preferably before meals.
Take the tablets with some water or another liquid. Do not chew them.
Do not take more than three tablets per day.

If you take more Domperidone ABC than you should
If you have taken an excessive amount of Domperidone ABC, contact your doctor, pharmacist, or nearest poison control centre immediately. In case of overdose, symptomatic treatment should 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 of the patient, gastric lavage, administration of activated charcoal, and supportive therapy are recommended. Anticholinergic anti-Parkinson drugs may be helpful in controlling extrapyramidal disorders.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 spasms.

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 skin rash, itching, shortness of breath and/or facial swelling.
• A severe hypersensitivity reaction that may occur immediately after administration and is characterised by urticaria, itching, hot flushes, fainting, and among other possible symptoms, breathing difficulties.
• Cardiovascular system disorders have been reported: disturbances in heart rhythm (fast or irregular heartbeat); if you experience any of these disturbances, you should stop treatment 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.

Stop treatment with domperidone and contact your doctor immediately if you experience any of the side effects listed above.

Other side effects that have occurred with Domperidone ABC 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 in libido
• Headache
• Drowsiness
• Diarrhoea
• Skin rash
• Itching
• Urticaria
• Painful or tender breasts
• Milky discharge from the breasts
• 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 certain laboratory tests
• Restless legs syndrome (a sensation of discomfort with an irresistible urge to move the legs, and sometimes arms or other body parts)

In some patients who have used Domperidone ABC for conditions and at doses requiring medical supervision, the following adverse effects have been observed:
Restlessness; breast swelling or enlargement, abnormal breast discharge, irregular menstrual cycle in women, difficulty breastfeeding, depression, hypersensitivity.

Reporting of suspected adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Domperidone ABC

Keep this medicine out of the sight and reach of children.
Do not take Domperidone ABC after the expiry date stated on the label.
The expiry date "EXP." refers to the last day of that month; the first two digits indicate the month,
the following digits the year.
Do not store the tablets above 25 °C.
Do not dispose of medicines 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 ABC contains
The active substance is domperidone.
The other components are:
lactose, maize starch, povidone, sodium lauryl sulfate, microcrystalline cellulose, colloidal silicon dioxide,
sodium carmellose, hydrogenated vegetable oil, magnesium stearate

Description of the appearance of Domperidone ABC and contents of the pack
Domperidone ABC 10 mg tablets - Pack size: 30 tablets.

Marketing Authorization Holder
ABC Farmaceutici S.p.A. - Corso Vittorio Emanuele II, 72 – 10121 Turin

Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – San Bernardo d’Ivrea (TO)