Motilium 1 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Motilium 1 mg/ml oral suspension

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 could 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 starting to take 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, regular severe abdominal pain, or persistent black stools.

• If you have a blocked or perforated intestine.

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

• If you have moderate or severe liver disease.

• If your ECG (electrocardiogram) shows a heart problem called "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 of other medicines").

• If you have or might have a rare tumour of the adrenal gland (pheochromocytoma), as this could raise your blood pressure.

Warnings and precautions

Before taking this medicine, consult your doctor if you:

• have liver problems (hepatic dysfunction or liver failure) (see "Do not take Motilium")
• have kidney problems (renal dysfunction or kidney failure). In this case, it is advisable to seek medical advice if prolonged treatment is needed, as you may require a lower dose or take this medicine less frequently. Your doctor may wish to examine you regularly.

Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. This risk is higher in patients over 60 years of age or in those taking doses exceeding 30 mg/day. The risk also increases when domperidone is taken together with certain medicines. Inform your doctor or pharmacist if you are taking medicines to treat infections (caused by fungi or bacteria) 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 heart 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 must not be given 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, 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, difemethil, methadone).

Inform your doctor or pharmacist if you are taking medicines to treat 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 if 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 afterwards 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 using machines

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

• Motilium oral suspension contains less than 23 milligrams (1 millimole) of sodium per dose and is therefore considered essentially “sodium-free”.

Motilium oral suspension contains sorbitol (E420). If your doctor has informed you of an intolerance to certain sugars, consult with your doctor before taking this medicine. It may cause a mild laxative effect, as it contains 4.554 grams of sorbitol as an excipient per 10 milliliters. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor (or your child’s doctor) before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Motilium oral suspension may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm, as it contains methyl p-hydroxybenzoate (E218) and propyl p-hydroxybenzoate (E216).

3. How to take Motilium

Follow the instructions for administration 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 taking this medicine. Do not take Motilium for longer than 7 days without consulting your doctor.

Mix the contents of the bottle thoroughly by gently tilting it to avoid foam formation.

The bottle is protected by a child-resistant cap. To open it, press down on the plastic screw cap while turning it counterclockwise, as shown below.

A dosing cup is provided with this medicine. This cup has markings for the following measures:

• small cup: 1, 2, 3 and 4 ml
• large cup: 5, 10, 15 and 20 ml

Make sure the marking on the dosing cup is at the top; this is where you should add the medicine (for example, it will contain 10 ml of oral suspension when filled up to the line indicating 10 ml on the large dosing cup).

Adults and adolescents aged 12 years and older and with a body weight of 35 kg or more

• Measure the required amount using the dosing cup.
• Do not dilute Motilium and do not mix it with other liquids.
• The usual dose is 10 millilitres administered up to three times daily, preferably before meals. Do not take more than 30 millilitres per day.
• Clean the dosing cup after use.

If you take more Motilium than you should

If you have used or taken too much Motilium, contact your doctor, pharmacist, or poison control centre 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 case 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. Anticholinergic anti-Parkinson 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 experiences them.

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

• Involuntary movements of the face or arms and legs, excessive trembling, excessive muscle stiffness, 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 hives, itching, flushing, fainting, and difficulty breathing, 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/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
• Restlessness
• Nervousness
• Loss or decrease in sexual interest
• Headache
• Drowsiness
• Diarrhea
• Skin rash
• Itching
• Hives
• Pain or tenderness in the breasts
• 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 parts of the body)

Some patients who have taken Motilium for conditions and at doses requiring medical supervision have experienced the following adverse effects:

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 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 marked “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 drains or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. 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 sodium saccharin (E954), microcrystalline cellulose (E460), sodium carboxymethylcellulose (E466), non-crystallizable liquid sorbitol (E420), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polysorbate 20 (E432), sodium hydroxide and purified water.

Appearance of the medicine and contents of the pack

Homogeneous white suspension.

Each bottle contains 200 ml of suspension. The pack includes a dosing cup.

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 of product characteristics was approved in September 2025

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