Package leaflet: Information for the patient

DOMPERIDONE DOC Generics 10 mg tablets

Equivalent medicine
▼Medicinal product subject to additional monitoring. This will allow any new safety information to be identified quickly. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before taking this medicine, as 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 effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DOMPERIDONE DOC Generics is and what it is used for
What you need to know before taking DOMPERIDONE DOC Generics
How to take DOMPERIDONE DOC Generics
Possible side effects
How to store DOMPERIDONE DOC Generics
Contents of the pack and other information

1. What DOMPERIDONE DOC Generici is and what it is used for

DOMPERIDONE DOC Generici contains the active substance domperidone, which belongs to a group of
medicines called "dopamine antagonists".
This medicine is used in adults and children for the treatment of nausea and vomiting (feeling of
sickness).

2. What you need to know before taking DOMPERIDONE DOC Generici

Do not take DOMPERIDONE DOC Generici:

if you are allergic to domperidone or to any of the other ingredients of this medicine (listed in section 6);
if you have a pituitary tumour (prolactinoma);
if you have moderate or severe liver disease;
if your ECG (electrocardiogram) shows a heart condition called "corrected QT interval prolongation";
if you have or have had a condition in which your heart is unable to pump blood properly (a condition known as heart failure);
if you have a condition causing low levels of potassium or magnesium, or high levels of potassium in your blood;
if you are taking certain medicines (see section “Other medicines and DOMPERIDONE DOC Generici”);
if you have stomach or intestinal problems (gastrointestinal bleeding, perforation, mechanical obstruction).

Warnings and precautions
Talk to your doctor or pharmacist before taking DOMPERIDONE DOC Generici.
Before taking this medicine, contact your doctor if:

you have liver problems (hepatic impairment or liver failure) (see “Do not use DOMPERIDONE DOC Generici”);
you have kidney problems (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, 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 DOC Generici”).
Domperidone should be used at the lowest effective dose in adults and children.
While taking domperidone, contact your doctor if you experience heart rhythm disturbances such as palpitations,
shortness of breath, or loss of consciousness. In such cases, treatment with domperidone must be discontinued.
Other medicines and DOMPERIDONE DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
DOMPERIDONE DOC Generici and apomorphine
Before using DOMPERIDONE DOC Generici and apomorphine, your doctor will ensure that your
body can tolerate taking both medicines together.
Ask your doctor or a specialist for personalized advice.
Refer to the apomorphine package leaflet.
Do not take DOMPERIDONE DOC Generici if you are taking medicines for the treatment of:

fungal infections, e.g. azole antifungals, particularly ketoconazole, fluconazole, or voriconazole;
oral;
bacterial infections, particularly erythromycin, clarithromycin, telithromycin, moxifloxacin, pentamidine
(these medicines are antibiotics);
heart problems or high blood pressure (e.g. amiodarone, dronedarone, quinidine, disopyramide,
dofetilide, sotalol, diltiazem, verapamil);
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);
AIDS/HIV (protease inhibitors);
tumours (e.g. toremifene, vandetanib, vincamine);

Inform your doctor or pharmacist if you are taking medicines for infections, heart conditions,
AIDS/HIV, or for the treatment of Parkinson’s disease (levodopa).
It is important that you ask your doctor or pharmacist whether DOMPERIDONE DOC Generici is safe for you while taking
other medicines, including over-the-counter medicines.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
If you are pregnant, take this medicine only if strictly necessary and under direct medical supervision.
Small amounts of domperidone have been detected in breast milk. Domperidone may cause
adverse effects on the heart of a breastfed newborn. Domperidone should be used during breastfeeding
only if your doctor considers it strictly necessary. Consult your doctor before taking this
medicine.
Driving and using machines
This medicine does not affect or has negligible effect on the ability to drive vehicles or operate
machinery.
DOMPERIDONE DOC Generici contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him or her before taking this medicine.

3. How to take DOMPERIDONE DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Always follow these instructions carefully unless your doctor has given you different instructions.

Duration of treatment:
Do not take DOMPERIDONE DOC Generici for more than 7 days.

Adults and adolescents aged 12 years and older and weighing 35 kg or more
Take the medicine at the scheduled time of day.
The usual dose is one tablet taken up to three times a day, preferably before meals.
Do not take more than 3 tablets per day.

Children and adolescents from birth up to a body weight below 35 kg
The tablets are not suitable for children weighing less than 35 kg.

Use in patients with liver problems
If you have liver problems (moderate or severe hepatic impairment), do not take this medicine
(see section “Do not take DOMPERIDONE DOC Generici”). Dosage adjustment is not necessary
if liver problems are mild.

Use in patients with kidney problems
If you have severe kidney problems (severe renal impairment), your doctor may decide to reduce the dose or
the dosing frequency to 1–2 times a day.

If you take more DOMPERIDONE DOC Generici than you should
The following symptoms may occur after taking an excessive dose of this medicine:

agitation;
altered consciousness;
seizures;
disorientation;
drowsiness;
movement disorders (extrapyramidal symptoms).

If you have taken too much DOMPERIDONE DOC Generici, contact your doctor, pharmacist, or the nearest
poison control center immediately, especially if the overdose occurred in a child.
In case of overdose, symptomatic treatment may be administered. ECG monitoring may be performed due to the
risk of a heart problem known as QT interval prolongation.

If you forget to take DOMPERIDONE DOC Generici
Take the medicine as soon as you remember. If it is almost time for the next dose, skip the missed dose and take
the next dose at the regular time. 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.
The following side effects may occur:
Rare (may affect up to 1 in 1,000 patients):

increased levels of prolactin (a hormone) in the blood;
gastrointestinal disorders including transient intestinal cramps;
breast development in men (gynaecomastia);
absence of menstruation (amenorrhoea); milk production in women who are not pregnant (galactorrhoea);
Very rare (may affect up to 1 in 10,000 people):
allergic reactions, including severe reactions (anaphylaxis, anaphylactic shock, anaphylactic reaction); urticaria, rash, and pruritus;
swelling of the face, mouth, tongue, and throat due to fluid accumulation (angioedema);
agitation, nervousness;
difficulty controlling movement and abnormal muscle movements (extrapyramidal disorders);
diarrhoea;
changes in liver function test results (liver function tests).

Not known (frequency cannot be estimated from the available data)
Cardiovascular system disorders have been reported: disturbances in heart rhythm (fast or irregular heartbeat); if you experience such disturbances, you should stop treatment immediately.
Domperidone may be associated with an increased risk of heart 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.
Neurological disorders have also been reported: restless legs syndrome (worsened in patients with Parkinson's disease).
Other reported side effects: seizures, agitation, and somnolence (more frequent in children).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DOMPERIDONE DOC Generici

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 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 DOC Generici 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, anhydrous colloidal silica, sodium carboxymethylcellulose, hydrogenated vegetable oil, magnesium stearate.

Description of the appearance of DOMPERIDONE DOC Generici and pack contents
Pack containing 30 tablets in blister.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan - Italy
Manufacturer
Francia Farmaceutici S.r.l. - Via dei Pestagalli, 7 – Milan – Italy