Package Leaflet: Information for the User

Motilium 1 mg/ml Oral Suspension

Domperidone

Read this leaflet carefully before you start taking this medicine

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
  

1. What is Motilium and what it is used for

2. What you need to know before you start taking Motilium

3. How to take Motilium

4. Possible side effects

5. Storage of Motilium

6. Contents of the pack and additional information

This medication is used in adultsand adolescents (12 years of age and older and who weigh 35 kg or more)to treat nausea (feeling like vomiting) and vomiting.

Do not take Motilium

• If you are allergic (hypersensitive) to domperidone or any of the other components of Motilium.
• If you have stomach bleeding or persistent severe abdominal pain or black stools.
• If you have a blocked or perforated intestine.
• If you have a pituitary gland tumor (prolactinoma).
• If you have moderate or severe liver disease.
• If your ECG (electrocardiogram) shows a heart problem called "prolongation of the corrected QT interval".
• If you have a heart condition where your heart cannot pump blood properly (known as heart failure).
• If you have low levels of potassium or magnesium in your blood or high levels of potassium in your blood.
• If you are taking certain medications (see "Use of other medications").

Warnings and precautions

Before taking this medication, consult your doctor if you:

• Have liver problems (dysfunction or liver insufficiency) (see "Do not take Motilium").
• Have kidney problems (dysfunction or kidney insufficiency). In this case, it is recommended to consult your doctor for prolonged treatment, as you may need a lower dose or take this medication less frequently. Your doctor may want to examine you regularly.

Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. This risk is more likely in patients over 60 years old or those taking doses above 30 mg/day. The risk also increases when domperidone is administered with certain medications. Inform your doctor or pharmacist if you are taking medications to treat infections (produced by fungi or bacteria) and/or if you have heart problems or HIV/AIDS/ HIV infection (see the section "Use of other medications").

Domperidone should be used at the most effective low dose.

While taking domperidone, contact your doctor if you experience heart rhythm disorders, such as palpitations, difficulty breathing, or loss of consciousness. In this case, the treatment with domperidone should be suspended.

Adolescents weighing less than 35 kg and children

Motilium should not be administered to adolescents 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 medications

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

• Infections produced by fungi, e.g., pentamidine or azole antifungals, specifically itraconazole, ketoconazole orally, fluconazole, posaconazole, or voriconazole.
• Infections produced by bacteria, 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, or quinidine).
• Psychosis (e.g., haloperidol, pimozide, or sertindol).
• Depression (e.g., citalopram or escitalopram).
• Digestive disorders (e.g., cisapride, dolasetron, or prucalopride).
• Allergies (e.g., mequitazine or mizolastine).
• Malaria (particularly halofantrine or lumefantrine).
• HIV/AIDS or HIV infection, such as ritonavir or saquinavir (these are protease inhibitors).
• Hepatitis C (e.g., telaprevir).
• Cancer (e.g., toremifene, vandetanib, or vincamine).

Do not take Motilium if you are taking certain other medications (e.g., bepridil, difemanil, or methadone).

Inform your doctor or pharmacist if you are using medications to treat infections, heart problems, or HIV/AIDS/HIV infection or Parkinson's disease.

Motilium and apomorphine

Before using Motilium and apomorphine, your doctor will ensure that you can take both medications simultaneously. Consult your doctor or specialist for personalized attention. For more information, see the apomorphine prospectus.

It is essential to ask your doctor or pharmacist if Motilium is safe for you when using any other medication, even those purchased without a prescription.

Taking Motilium with food and drinks

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

Pregnancy

The safety of using Motilium in pregnant women is unknown. If you are pregnant or think you may be pregnant, inform your doctor, who will decide if you can take Motilium.

Breastfeeding

Small amounts of domperidone have been detected in breast milk. Domperidone may cause unwanted side effects that affect the infant's heart. Domperidone should be used during breastfeeding only if your doctor considers it clearly necessary. Consult your doctor for advice before taking this medication.

Driving and operating machinery

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

Important information about some of the components of Motilium

• Motilium suspension contains less than 23 milligrams (1 millimole) of sodium per dose, making it essentially "sodium-free".

Motilium suspension contains sorbitol (E420). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause a mild laxative effect because it contains 4,554 grams of sorbitol as an excipient per 10 milliliters. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult with your doctor before taking this medication.

The sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Motilium suspension may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm because it contains p-hydroxybenzoate of methanol (E218) and p-hydroxybenzoate of propyl (E216).

Follow the administration instructions exactly unless your doctor tells you otherwise.

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

Treatment duration

Symptoms usually resolve 3-4 days after taking this medication. Do not take Motilium for more than 7 days without consulting your doctor.

Mix the contents of the bottle thoroughly, performing a gentle tilting motion 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 supplied with this medication. This cup has markings for the following measurements:

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

Ensure the mark on the dosing cup is at the top; this is the part where you need to add the medication (for example, it will contain 10 ml of oral suspension when filled to the 10 ml line on the large dosing cup).

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

• Measure the required amount in the dosing cup.
• Do not dilute Motilium and do not mix it with other liquids.
• The usual dose is 10 milliliters administered up to three times a day, if possible, before meals. Do not take more than 30 milliliters 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 center immediately. In case of overdose, symptomatic treatment may be administered. A heart problem called "prolongation of the QT interval" may be monitored due to the possibility of a heart problem.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

Information for the doctor: it is recommended to closely monitor the patient and take general supportive measures. Anticholinergic antiparkinsonian medications may help counteract extrapyramidal effects.

If you forgot to take Motilium

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Unintentional 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 urticaria, itching, shortness of breath, dizziness, and difficulty breathing, among other possible symptoms
• Cardiovascular system disorders: arrhythmias (rapid or irregular heartbeat) have been reported; if this occurs, you should stop treatment immediately. Domperidone may be associated with an increased risk of arrhythmias and cardiac arrest. This risk is more likely in patients over 60 years old or those taking doses above 30 milligrams/day. Domperidone should be used at the lowest effective dose.

Stop treatment with domperidone and contact your doctor immediatelyif you experience any of the side effects described above.

Other side effects observed with Motilium are listed below:

Common(may affect up to 1 in 10 people):

• Dry mouth

Rare(may affect up to 1 in 100 people)

• Anxiety
• Agitation
• Nervousness
• Loss or decreased interest in sex
• Headache
• Drowsiness
• Diarrhea
• Skin rash
• Itching
• Urticaria
• Breast tenderness or pain
• Milk secretion from the breasts
• General feeling of weakness
• Sensation of dizziness

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

• Eye rolling
• Cessation of menstruation in women
• Enlargement of breasts in men
• Inability to urinate
• Changes in laboratory test results.
• Restless legs syndrome (uncomfortable sensation, with an irresistible desire to move your legs, and sometimes arms and other parts of your body).

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not useMotiliumafter the expiration date that appears on the packaging. The expiration date “CAD” is the last day of the month indicated, wherethe first two digits indicate the month and the following, the year.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Motilium Composition

• The active ingredient 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 product and contents of the packaging

White homogeneous suspension.

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

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 10908038 Barcelona

Spain

Responsible for Manufacturing

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí,75-9708107 Martorelles (Barcelona)

Spain

This leaflet was approved in May 2019

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/