MOTILIUM 1 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Motilium 1 mg/ml Oral Suspension

Domperidone

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Motilium and what is it used for

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

2. What you need to know before you take Motilium

Do not take Motilium

• If you are allergic (hypersensitive) to domperidone or any of the other ingredients of Motilium.
• If you have stomach bleeding or severe abdominal pain or persistent black stools.
• If you have a blockage or perforation of the intestine.
• If you have a tumor of the pituitary gland (prolactinoma).
• If you have moderate or severe liver disease.
• If your ECG (electrocardiogram) shows a heart problem called "prolonged QT corrected interval".
• If you have or have had a problem where your heart does not pump blood to the whole body as it should (this is called heart failure).
• If you have a problem where you have low levels of potassium or magnesium in the blood or high levels of potassium in the blood.
• If you are taking certain medicines (see "Using other medicines").

Warnings and Precautions

Before taking this medicine, talk to your doctor if you:

• have liver problems (liver dysfunction or liver failure) (see "Do not take Motilium")
• have kidney problems (kidney dysfunction or kidney failure). In this case, it is recommended to ask your doctor for advice in case of prolonged treatment, as you may need a lower dose or take this medicine 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 of age or in those taking doses higher than 30 mg/day. The risk also increases when domperidone is given with certain other medicines. Tell 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 HIV/AIDS (see the section "Using other medicines").

Domperidone should be used at the lowest effective 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, treatment with domperidone should be discontinued.

Adolescents who weigh less than 35 kg and children

Motilium should not be given to adolescents 12 years of age 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.

Using other medicines

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

• fungal infections, e.g. pentamidine or azole antifungals, specifically itraconazole, ketoconazole by mouth, 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 (in particular halofantrine, lumefantrine)
• HIV/AIDS (e.g. 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, difemanil, methadone).

Tell your doctor or pharmacist if you are using medicines to treat infections, heart problems, or HIV/AIDS.

Motilium and Apomorphine

Before using Motilium and apomorphine, your doctor will make sure that you can take both medicines at the same time. Consult your doctor or specialist for personalized advice. For more information, see the apomorphine package leaflet.

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

Taking Motilium with food and drinks

Take Motilium before meals, as its absorption may be slightly delayed if taken after meals.

Pregnancy

It is not known if Motilium is safe in pregnant women. If you are pregnant or think you may be pregnant, tell your doctor, who will decide if you can take Motilium.

Breast-feeding

Small amounts of domperidone have been detected in breast milk. Domperidone may cause unwanted effects that affect the heart of the breastfed baby. Domperidone should be used during breastfeeding 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 use machinery while taking Motilium until you know how it affects you.

Important information about some of the ingredients of Motilium

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

Motilium suspension contains sorbitol (E420). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. It may have 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 some 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 medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

Motilium suspension may cause allergic reactions (possibly delayed) and exceptionally, bronchospasm because 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 tells you otherwise.

Take Motilium before meals, as its absorption may be slightly delayed if taken after meals.

Duration of treatment

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

Mix the contents of the bottle completely, making a gentle tilting motion to avoid foaming.

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 measuring cup is provided with this medicine. This cup has marks for the following measures:

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

Make sure the mark on the measuring 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 to the line that indicates 10 ml of the large measuring cup).

Adults and adolescents 12 years of age and older and weighing 35 kg or more

• Measure the required amount in the measuring 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 measuring 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 can be administered. ECG monitoring may be carried out due to the possibility of a heart problem called "prolonged QT interval".

In case of overdose or accidental ingestion, consult the Toxicology 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 medicines 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 the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Involuntary movements of the face or arms and legs, excessive tremor, excessive muscle stiffness, or muscle spasms

Frequency not known(cannot be estimated from the 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 swelling of the face
• A severe allergic reaction that can occur immediately after administration, characterized by hives, itching, flushing, fainting, and difficulty breathing, among other possible symptoms
• Cardiovascular disorders: heart rhythm disorders (fast or irregular heartbeat) have been reported; if this occurs, you should discontinue treatment immediately. 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 of age or in those taking doses higher than 30 mg/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

Uncommon(may affect up to 1 in 100 people)

• Anxiety
• Agitation
• Nervousness
• Loss or decreased sexual interest
• Headache
• Drowsiness
• Diarrhea
• Skin rash
• Itching
• Hives
• Pain or tenderness in the breasts
• Discharge of milk from the breasts
• General feeling of weakness
• Feeling of dizziness

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

• Rolling of the eyes
• Stop of menstrual periods in women
• Enlargement of the breasts in men
• Difficulty urinating
• Changes in the results of certain laboratory tests
• Restless legs syndrome (uncomfortable feeling, with an irresistible urge to move your legs, and sometimes arms and other parts of your body).

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 "CAD" is the last day of the month indicated, where the first two digits indicate the month and the next ones, the year.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Motilium

• The active substance is domperidone.
• The other ingredients are sodium saccharin (E954), microcrystalline cellulose (E460), sodium carboxymethylcellulose (E466), non-crystallizing liquid sorbitol (E420), methyl p-hydroxybenzoate (E218), propyl p-hydroxybenzoate (E216), polysorbate 20 (E432), sodium hydroxide, and purified water.

Appearance and packaging of the product

Homogeneous white suspension.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109 08038 Barcelona

Spain

Manufacturer

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97 08107 Martorelles (Barcelona)

Spain

This leaflet was approved in May 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/