Motilium 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Motilium 10 mg film-coated tablets

Domperidone

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Motilium is and what it is used for

This medicine is used in adults and adolescents (12 years of age and older, weighing 35 kg or more) to treat nausea and vomiting.

2. What you need to know before taking Motilium

Do not take Motilium

• If you are allergic (hypersensitive) to domperidone or to any of the other components of Motilium.

• If you have stomach bleeding or regular severe abdominal pain or persistent black stools.

• If you have a blocked or perforated intestine.

• If you suffer from a tumor of the pituitary gland (prolactinoma).

• If you have moderate or severe liver disease.

• If your ECG (electrocardiogram) shows a heart problem known as "corrected QT interval prolongation".

• If you have or have had a condition in which your heart cannot pump blood properly throughout the body (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 "Use with other medicines").

• If you have or may have a rare tumor of the adrenal gland (pheochromocytoma), as this could increase your blood pressure.

Warnings and precautions

Before taking this medicine, consult your doctor if you:

• have liver problems (hepatic dysfunction or hepatic insufficiency) (see "Do not take Motilium")
• have kidney problems (renal dysfunction or renal insufficiency). In this case, it is advisable to seek medical advice if prolonged treatment is required, as you may need a lower dose or less frequent dosing, and your doctor may wish to monitor you regularly.

Domperidone may be associated with an increased risk of cardiac rhythm disorders and cardiac arrest. This risk is higher in patients over 60 years of age or in those taking doses exceeding 30 milligrams per day. The risk also increases when domperidone is administered concomitantly with certain medications. Inform your doctor or pharmacist if you are taking medicines to treat infections (fungal or bacterial) and/or if you have heart problems or AIDS/HIV infection (see section "Use of other medicines").

Domperidone should be used at the lowest effective dose.

While taking domperidone, contact your doctor if you experience cardiac rhythm disturbances such as palpitations, difficulty breathing, or loss of consciousness. In such cases, treatment with domperidone should be discontinued.

Adolescents weighing less than 35 kg and children

Motilium should not be administered to adolescents aged 12 years and older who weigh less than 35 kg, or to children under 12 years of age, as it is not effective in these age groups.

Use of other medicines

Do not take Motilium if you are taking medicines to treat:

• fungal infections, e.g., pentamidine or azole antifungals, specifically itraconazole, oral ketoconazole, fluconazole, posaconazole, or voriconazole
• bacterial infections, specifically erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, or spiramycin (these 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 infection such as ritonavir or saquinavir (these are protease inhibitors)
• Hepatitis C, e.g., telaprevir
• cancer, e.g., toremifene, vandetanib, vincamine.

Do not take Motilium if you are taking certain other medicines (e.g., bepridil, difemethilium, methadone).

Inform your doctor or pharmacist if you are taking medicines for infections, heart problems, AIDS/HIV infection, or Parkinson's disease.

Motilium and apomorphine

Before using Motilium and apomorphine together, your doctor will ensure that it is safe for you to take both medicines simultaneously. Consult your doctor or specialist for personalized advice. For further information, refer to the apomorphine package leaflet.

It is important to ask your doctor or pharmacist whether Motilium is safe for you when you are taking any other medicine, including those obtained without a prescription.

Taking Motilium with food and drinks

Take Motilium before meals, as taking it after meals slightly delays its absorption.

Pregnancy

It is unknown whether the use of Motilium is safe in pregnant women. If you are pregnant or think you may be pregnant, inform your doctor, who will decide whether you may take Motilium.

Breast-feeding

Small amounts of domperidone have been detected in breast milk.

Domperidone may cause unwanted side effects affecting the infant's heart. Domperidone should be used during breast-feeding only if your doctor considers it clearly necessary. Consult your doctor for advice before taking this medicine.

Driving and operating machinery

Some patients have reported feeling dizzy or drowsy after taking Motilium. Do not drive or operate machinery while taking Motilium until you know how it affects you.

Important information about some of the components of Motilium:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.

This medicine contains less than 23 milligrams (1 millimole) of sodium per dose, therefore it is considered essentially “sodium-free”.

3. How to take Motilium

Follow these administration instructions exactly unless your doctor has told you otherwise.

Take Motilium before meals, because if taken afterwards, its absorption is slightly delayed.

Duration of treatment

Symptoms usually resolve within 3–4 days after starting this medicine. Do not take Motilium for longer than 7 days without consulting your doctor.

Adults and adolescents aged 12 years and older with a body weight of 35 kilograms 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 the tablets. Do not take more than three tablets per day.

If you take more Motilium than you should

If you have used or taken too much Motilium, contact your doctor, pharmacist, or poison control center immediately. In case of overdose, symptomatic treatment may be administered. ECG monitoring may be performed due to the possibility of a heart problem known as "QT interval prolongation".

In cases of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

Information for the physician: close observation of the patient is recommended, along with general supportive measures. Antiparkinsonian anticholinergic drugs may help counteract extrapyramidal effects.

If you forget to take Motilium

Take your medicine as soon as you remember. If it is almost time for your next dose, wait until then and continue with your regular schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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

Frequency not known (cannot be estimated from available data):

• Seizures
• A type of reaction that may occur immediately after administration and is characterized by skin rash, itching, shortness of breath, and/or facial swelling
• A severe hypersensitivity reaction that may occur immediately after administration, characterized by urticaria, itching, flushing, fainting, and breathing difficulties, among other possible symptoms
• Cardiovascular disorders: disturbances in heart rhythm (fast or irregular heartbeat) have been reported; if this occurs, you must stop treatment immediately. Domperidone may be associated with an increased risk of heart rhythm disturbances and cardiac arrest. This risk is higher in patients over 60 years of age or in those taking doses exceeding 30 milligrams 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 adverse effects described above.

Other adverse effects observed with Motilium 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 decrease in sexual interest
• Headache
• Drowsiness
• Diarrhea
• Skin rash
• Itching
• Urticaria
• Breast pain or tenderness
• Breast milk secretion
• General feeling of weakness
• Dizziness

Frequency not known (cannot be estimated from available data):

• Upward movement of the eyes
• Cessation of menstrual periods in women
• Breast enlargement in men
• Inability to urinate
• Changes in the 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 taken Motilium for conditions and at doses requiring medical supervision have experienced the following adverse effects:

Restlessness; breast swelling or enlargement, unusual breast secretion, irregular menstrual periods in women, difficulty breastfeeding, depression, hypersensitivity.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Motilium

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

• Do not store above 30°C.

• Do not use Motilium after the expiry date stated on the packaging. The expiry date "EXP" refers to the last day of the month indicated, where the first two digits represent the month and the following digits the year.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Motilium

• The active substance is domperidone.
• The other components are: lactose monohydrate, corn starch, microcrystalline cellulose (E-460), pregelatinized potato starch, povidone, magnesium stearate (E-572), sodium lauryl sulfate and hydrogenated castor oil, sodium lauryl sulfate, hypromellose (E-464).

Appearance of the product and contents of the container

Biconvex, coated, bright white tablet, free from defects or roughness. Unmarked on both sides.

The tablets are presented in a blister pack and the container contains 30 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturing Responsible Party:

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

This summary has been approved in September 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/