Domperidone Sandoz

Package leaflet: Information for the patient

Domperidone Sandoz 10 mg tablets

Generic medicine
Read this leaflet carefully before 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, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Domperidone Sandoz contains the active substance domperidone, which belongs to a group of medicines called
prokinetics.
This medicine is used in adults and adolescents (aged 12 years and older and weighing 35 kg or more) for the treatment of nausea and vomiting (feeling of sickness).

2. What you should know before taking Domperidone Sandoz

Do not take Domperidone Sandoz:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have stomach bleeding or regularly experience severe abdominal pain or persistent black stools;
• if you have intestinal blockages or perforations;
• if you have tumours of the pituitary gland causing prolactin release (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 in your blood, or high levels of potassium in your blood;
• if you are taking certain medicines (see "Other medicines and Domperidone Sandoz").

Warnings and precautions
Talk to your doctor or pharmacist before taking Domperidone Sandoz.
Before taking this medicine, contact your doctor if:

• you suffer from liver disorders (hepatic impairment or liver failure) (see "Do not take Domperidone Sandoz");
• you suffer from kidney disorders (renal impairment or kidney failure).
  Consult your doctor for advice if you require long-term treatment, as you may need to take a lower dose or take the 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 the treatment of infections (fungal or bacterial infections) and/or if you have heart problems or AIDS/HIV (see section "Other medicines and Domperidone Sandoz").

Domperidone should be used at the lowest effective dose.
While taking domperidone, contact your doctor if you notice symptoms of heart rhythm disturbances such as palpitations, difficulty breathing, or fainting. In such cases, treatment with domperidone must be stopped.

Adolescents weighing less than 35 kg and children
DOMPERIDONE SANDOZ 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 Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Domperidone Sandoz if you are taking medicines for the treatment of:

• fungal infections, such as pentamidine or azole antifungals, particularly oral itraconazole, ketoconazole, posaconazole, fluconazole, or voriconazole;
• bacterial infections, particularly erythromycin, clarithromycin, telithromycin, moxifloxacin, levofloxacin, or spiramycin (these medicines are antibiotics);
• heart problems or high blood pressure (e.g. amiodarone, dronedarone, ibutilide, disopyramide, dofetilide, sotalol, hydroquinidine, quinidine, 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, lumefantrine);
• AIDS/HIV (protease inhibitors) (e.g. ritonavir or saquinavir);
• hepatitis C (e.g. telaprevir);
• tumours (e.g. toremifene, vandetanib, vincamine).

Do not take Domperidone Sandoz if you are taking other medicines such as bepridil, diphemanil, or methadone.
Inform your doctor or pharmacist if you are taking medicines for the treatment of infections, heart disorders, AIDS/HIV, or Parkinson’s disease.

It is important that you ask your doctor or pharmacist whether Domperidone Sandoz is safe for you while taking other medicines, including those available without a prescription.

Domperidone Sandoz and apomorphine
Before using Domperidone Sandoz and apomorphine together, your doctor will ensure that your body can tolerate taking both medicines simultaneously. Ask your doctor or a specialist for personalised advice. Refer to the apomorphine package leaflet.

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

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.

Pregnancy
It is not known whether the use of Domperidone Sandoz during pregnancy is harmful.
If you are pregnant or think you may be, inform your doctor, who will decide whether you can take Domperidone Sandoz.

Breastfeeding
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
Some patients have reported dizziness or drowsiness after taking domperidone. Do not drive or operate machinery while taking domperidone until you know how it affects you.

Domperidone Sandoz contains lactose and sodium
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".

3. How to take Domperidone Sandoz

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 unless your doctor has given you different advice.
It is recommended to take Domperidone Sandoz before meals; if taken after meals, absorption of the
medicine is somewhat delayed.
Duration of treatment:
Symptoms usually resolve within 3–4 days of taking this medicine. Do not take Domperidone Sandoz for
more than 7 days without consulting your doctor.
Adults and adolescents aged 12 years and over and weighing 35 kg or more
Take the medicine at approximately the same time each day.
The usual dose is one tablet up to three times a day, preferably before meals. Do not take more than three
tablets per day. Swallow the tablets with some water or another liquid. Do not chew them.
If you take more Domperidone Sandoz than you should
If you have taken an excessive amount of Domperidone Sandoz, contact your doctor, pharmacist, or the nearest
poison control centre immediately. In case of overdose, symptomatic treatment is recommended. Electrocardiogram
monitoring should be performed due to the possibility of a heart problem known as "QT interval prolongation".
Information for the physician: close medical supervision and general supportive therapy are recommended.
Antiparkinsonian anticholinergic medicines may be helpful in controlling extrapyramidal disorders.
If you forget to take Domperidone Sandoz
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 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.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people):

• Involuntary movements of the face, arms or legs, excessive trembling, excessive muscle rigidity or spasms

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

• Seizures
• A type of reaction that may occur immediately 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 hives, itching, flushing, fainting, and among other possible symptoms, difficulty breathing

Cardiovascular system disorders have been reported: disturbances in heart rhythm (fast or irregular heartbeat); if such disturbances occur, 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. 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 Sandoz are listed below:
Common (may affect up to 1 in 10 people):

• Dry mouth

Uncommon (may affect up to 1 in 100 people):

• Anxiety
• Agitation
• Nervousness
• Loss or reduction in libido
• Headache
• Drowsiness
• Diarrhoea
• Rash
• Itching
• Hives
• Painful or tender breasts
• Lactation (milk secretion from the breasts)
• General feeling of weakness
• Dizziness

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

• Upward eye movement
• Interruption of menstrual cycle in women
• Breast enlargement in men
• Inability to urinate
• Changes in certain laboratory tests
• Unpleasant sensation in the legs (also known as restless legs syndrome)

Some patients who have used Domperidone Sandoz for conditions and at doses requiring medical supervision have experienced the following side effects: restlessness; breast swelling or enlargement, abnormal breast secretions, irregular menstrual cycle in women, difficulty 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 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton 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 Sandoz contains

• The active substance is domperidone. Each tablet contains 10 mg of domperidone.
• The other ingredients are: monohydrate lactose, maize starch, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Domperidone Sandoz and package contents
White, circular, biconvex tablets, with a score on one side.
PVC/Al blister pack containing 30 tablets.
Marketing Authorization Holder
Sandoz S.p.A., Largo U. Boccioni 1, Origgio (VA) - Italy
Manufacturer
Salutas Pharma GmbH, Otto-von Guericke Allee 1, Barleben - Germany
LEK d.d., Verovškova 57, 1526 Ljubljana (Slovenia)
LEK d.d. BU Production Lendava, Trimlini 2 D, 9220 Lendava (Slovenia)