Package Leaflet: Information for the User

Motilium 10 mg Film-Coated Tablets

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.
  

1. What Motilium is 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 adults and adolescents (12 years of age and older and weighing 35 kg or more)to treat nausea (feeling like vomiting) and vomiting.

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 intense abdominal pain regularly or persistent 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 throughout your body as it should (known as heart failure).
• If you have a condition where 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 renal insufficiency). In this case, it is recommended to seek advice from your doctor if you are taking this medication for a long time, as you may need a lower dose or take this medication less frequently, and 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 milligrams per 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 lowest 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, 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).
• Digestive disorders (e.g., cisapride, dolasetron, prucalopride).
• Allergies (e.g., mequitazine, mizolastine).
• Malaria (particularly halofantrine, lumefantrine).
• HIV/AIDS infection as ritonavir or saquinavir (these are protease inhibitors).
• Hepatitis C (e.g., telaprevir).
• Cancer (e.g., toremifene, vandetanib, vincamine).

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

Inform your doctor or pharmacist if you are taking 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 beverages

Take Motilium before meals, as taking it afterwards 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 effects that affect the heart of the infant. 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:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

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

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

TakeMotiliumbefore meals, as absorption may be slightly delayed if taken afterwards.

Treatment duration

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

Adults and adolescents 12 years of age or older and with a body weight of35 kilogramsor more

The usual dose is a tablet taken up to three times a day, preferably before meals. Take the tablets with some water or other liquid. Do not chew the tablets. Do not take more than three tablets a day.

If you take moreMotiliumthan you should

If you have used or taken too muchMotilium, 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 called “prolongation of the QT interval”.

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 observe the patient and take general supportive measures. Anticholinergic antiparkinsonian medications may help counteract extrapyramidal effects.

If you forgot to takeMotilium

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

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 can occur immediately after administration and is characterized by skin rash, itching, shortness of breath, and/or facial swelling
• A severe hypersensitivity reaction that can 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 per 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 decrease of sexual interest
• 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 the 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 in 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 that does not appear in this prospectus. You can also report them directly through theSpanish System for the 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 this medication out of the sight and reach of children.
• Do not store at a temperature above30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines 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 you no longer need. In this way, you will help protect the environment.

Composition ofMotilium

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

Appearance of the product and contents of the packaging

Biconvex coated tablet, bright white, without defects or roughness. Anonymous on both sides.

The tablets are presented inside a blister pack and the packaging contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing:

TOWA Pharmaceutical Europe, S.L.

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

Spain

This prospectus was approved in May 2019

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