Motilium

Package leaflet: Information for the patient

Motilium 1 mg/ml oral suspension

(1 mg of domperidone per 1 ml of suspension)
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. 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 give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 to treat nausea and vomiting (feeling of discomfort)
in adults and adolescents (aged 12 years and older, and weighing 35 kg or more).

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 ingredients of MOTILIUM
• you have stomach bleeding or regularly experience severe abdominal pain or persistent black stools
• you have intestinal blockages or perforations
• you have tumours of the pituitary gland associated with prolactin release (prolactinomas)
• you have moderate or severe liver disease
• your ECG (electrocardiogram) shows a heart condition known as "prolonged QT interval"
• you have or have had a condition in which your heart is unable to pump blood properly (a condition called heart failure)
• you have a condition causing low levels of potassium or magnesium, or high levels of potassium in your blood
• you are taking certain medicines (see "Other medicines and MOTILIUM").

Warnings and precautions
Before taking this medicine, contact your doctor if:

• you have liver problems (hepatic impairment or liver failure) (see "Do not use MOTILIUM")
• you have kidney problems (renal impairment or kidney failure). Consult your doctor for advice if prolonged treatment is needed, as you may need to take a lower dose or take the medicine less frequently. Your doctor may wish to monitor you regularly.

Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. The risk may be higher in patients over 60 years of age or those taking doses exceeding 30 mg per day. The risk is further increased when domperidone is taken together with other medicines. Inform your doctor or pharmacist if you are taking medicines for infections (fungal or bacterial infections) and/or if you have heart problems or AIDS/HIV (see "Other medicines and MOTILIUM").
MOTILIUM should be used at the lowest effective dose.
While taking MOTILIUM, contact your doctor if you experience symptoms of heart rhythm disturbances such as palpitations, difficulty breathing, or fainting. In such cases, treatment with MOTILIUM must be discontinued.
Adolescents weighing less than 35 kg and children
MOTILIUM must not be administered to adolescents aged 12 years or older weighing less than 35 kg or to any child under 12 years of age, as it is not effective at these ages.
Other medicines and MOTILIUM
Do not take MOTILIUM if you are taking medicines for the treatment of:

• fungal infections, such as pentamidine or azole antifungals, particularly itraconazole, oral ketoconazole, fluconazole, posaconazole, or voriconazole
• bacterial infections, particularly erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, or spiramycin (these medicines 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, e.g. ritonavir or saquinavir (these are protease inhibitors)
• hepatitis C (e.g. telaprevir)
• tumours (e.g. toremifene, vandetanib, vincamine) Do not take MOTILIUM if you are taking other medicines (e.g. bepridil, dofetilide, methadone).

Inform your doctor or pharmacist if you are taking medicines for infections, heart conditions, AIDS/HIV, or Parkinson’s disease.
Before using MOTILIUM and apomorphine, your doctor will ensure that your body can tolerate the concomitant use of both medicines when taken simultaneously. Seek personalized advice from your doctor or a specialist. Refer to the apomorphine package leaflet.
It is important to ask your doctor or pharmacist whether MOTILIUM is safe for you while taking other medicines, including over-the-counter medicines.
MOTILIUM with food and drink
Take MOTILIUM before meals. If taken after meals, absorption of the medicine is slightly delayed.
Pregnancy
It is not known whether the use of MOTILIUM during pregnancy is harmful.
If you are pregnant or think you may be pregnant, inform your doctor, who will decide whether you can take MOTILIUM.
Breast-feeding
Small amounts of domperidone have been detected in breast milk. MOTILIUM may cause adverse effects on the heart of a breastfed newborn. MOTILIUM should be used during breast-feeding only if your doctor considers it strictly necessary. Consult your doctor before taking this medicine.
Driving and using machines
Some patients have reported dizziness or drowsiness after taking MOTILIUM. Do not drive or operate machinery while taking MOTILIUM until you know how it affects you.
Important information about some ingredients of MOTILIUM

• MOTILIUM oral suspension contains less than 1 mmol of sodium (23 mg) per ml, i.e. essentially "sodium-free".
• MOTILIUM suspension contains 455 mg of sorbitol (E420) per ml, which may cause gastrointestinal disturbances and has a mild laxative effect. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.
• MOTILIUM oral suspension also contains methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216). These substances may cause allergic reactions (including delayed reactions) and, in rare cases, bronchospasm.

3. How to take MOTILIUM

Follow these instructions carefully, unless your doctor has given you different advice.
Take MOTILIUM before meals, as absorption of the medicine is slightly delayed if taken after meals.

Duration of treatment:
Symptoms usually resolve within 3–4 days of taking this medicine. Do not take MOTILIUM for more than 7 days without consulting your doctor.

The bottle is protected by a child-resistant cap. To open the bottle, press down on the plastic screw cap and simultaneously turn it counterclockwise, as illustrated below.

Thoroughly mix the contents of the bottle by gently tilting it to avoid foam formation.

Adults and adolescents aged 12 years and older, and weighing 35 kg or more

• A measuring cap is provided with this medicine. This measuring cap has three markings: 2.5 ml, 5 ml, and 10 ml (for example, filling to the top line gives 10 ml of oral suspension).
• Use the measuring cap in the orientation as it appears on the bottle. Ensure that the side with the graduations (the side holding less liquid) is facing upwards; this is the side to be filled. When the arrow on the side points upward, the cap is correctly positioned.

• Measure the required amount using the provided measuring cap.
• Do not dilute MOTILIUM and do not mix it with other liquids.
• The usual dose is 10 ml up to three times daily. Do not exceed 30 ml per day (equivalent to 3 measuring caps filled to the top line).
• Clean the measuring cap after use.

If you take more MOTILIUM than you should
If you have taken an excessive amount of MOTILIUM, contact your doctor, pharmacist, or nearest poison control center immediately. In case of overdose, symptomatic treatment is recommended. Electrocardiogram monitoring should be performed due to the possibility of a heart problem known as "QT interval prolongation".
Information for the physician: close medical supervision and general supportive therapy are recommended. Anti-parkinsonian anticholinergic drugs may be helpful in controlling extrapyramidal disorders.

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

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, arms or legs, excessive tremor, excessive muscle stiffness or muscle spasms

Not known (frequency cannot be estimated from the available data)

• Seizures.
• A type of reaction that may occur shortly after administration and is characterized by skin rash, itching, shortness of breath and/or swelling of the face
• A severe hypersensitivity reaction that may occur shortly after administration and is characterized by urticaria, itching, flushing, fainting, and among other possible symptoms, breathing difficulties.
• Cardiovascular disorders: heart rhythm disturbances (fast or irregular heartbeat); if you experience any of these disturbances, you should stop treatment immediately. Domperidone may be associated with an increased risk of heart rhythm disturbances and cardiac arrest. This risk may be higher in patients over 60 years of age or in those taking doses exceeding 30 mg per day. Domperidone should be used at the lowest effective dose.

Stop treatment with MOTILIUM and contact your doctor immediately if 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 reduction in libido
• Headache
• Drowsiness
• Diarrhea
• Skin rash
• Itching
• Urticaria
• Breast tenderness or pain
• Milk secretion from the breast
• General feeling of weakness
• Dizziness

Not known (frequency cannot be estimated from the available data)

• Upward movement of the eyes
• Interruption of the menstrual cycle in women
• Breast enlargement in men
• Inability to urinate
• Changes in the results of certain laboratory tests
• Restless legs syndrome (feeling of discomfort with an irresistible urge to move the legs, and sometimes arms or other body parts).

In some patients who have used MOTILIUM for conditions and at doses requiring medical supervision, the following side effects have been reported:
Restlessness; breast swelling or enlargement, abnormal breast secretions, irregular menstrual cycle in women, breastfeeding difficulties, depression, hypersensitivity.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MOTILIUM

• Keep the medicine out of the sight and reach of children.
• Do not use MOTILIUM after the expiry date stated on the label. The expiry date "EXP." refers to the last day of that month; the first two digits indicate the month, the following ones the year.
• MOTILIUM oral suspension must not be used more than 3 months after first opening the bottle.
• This medicine does not require any special storage conditions.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MOTILIUM contains
The active substance is domperidone.
The other components are:
non-crystallizable liquid sorbitol (E420), microcrystalline cellulose and
sodium carboxymethylcellulose, methyl 4-hydroxybenzoate (E218), propyl
4-hydroxybenzoate (E216), sodium saccharin, polysorbate 20, sodium hydroxide and purified water.
Description of the appearance of MOTILIUM and contents of the pack
MOTILIUM 1 mg/ml oral suspension – 200 ml bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Johnson & Johnson S.p.A., Via Ardeatina, km 23,500 - 00071 Santa Palomba – Pomezia - Rome
Manufacturer
Janssen Pharmaceutica N.V., Turnhoutseweg, 30, B-2340 Beerse (Belgium)
or
Johnson & Johnson Consumer NV/SA, Antwerpseweg 15-17, 2340 Beerse, Belgium

Patient Information Leaflet

Motilium 10 mg film-coated tablets

Domperidone
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 (aged 12 years and older, and weighing 35 kg or more) for the treatment of nausea and vomiting (feeling of sickness).

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 ingredients of MOTILIUM
• you have gastrointestinal bleeding or regularly experience severe abdominal pain or persistent black stools
• you have intestinal obstruction or perforation
• you have tumours of the pituitary gland associated with prolactin release (prolactinoma)
• you have moderate or severe liver disease
• your ECG (electrocardiogram) shows a heart condition known as “prolonged QT interval”
• you have or have had a condition in which your heart is unable to pump blood properly (a condition known as heart failure)
• you have a condition causing low levels of potassium or magnesium, or high levels of potassium in your blood
• you are taking certain medicines (see “Other medicines and MOTILIUM”)

Warnings and precautions
Before taking this medicine, contact your doctor if:

• you suffer from liver disorders (hepatic impairment or liver failure) (see “Do not take MOTILIUM”)
• you suffer from kidney disorders (renal impairment or kidney failure). Consult your doctor for advice if long-term treatment is needed, as you may need to take a lower dose or take this medicine less frequently, and your doctor may wish to monitor you regularly. Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. The risk may be higher in patients over 60 years of age or in those taking doses exceeding 30 mg per day. The risk is further increased when domperidone is taken together with other medicines. Inform your doctor or pharmacist if you are taking medicines for infections (fungal or bacterial infections) and/or if you have heart problems or AIDS/HIV (see “Other medicines and MOTILIUM”). MOTILIUM should be used at the lowest effective dose. While taking MOTILIUM, contact your doctor if you notice symptoms of heart rhythm disturbances such as palpitations, difficulty breathing, or fainting. In such cases, treatment with MOTILIUM must be stopped.

Adolescents weighing less than 35 kg and children
MOTILIUM must not be given to adolescents aged 12 years or older who weigh less than 35 kg, or to any child under 12 years of age, as it is not effective at this age.

Other medicines and MOTILIUM
Do not take MOTILIUM if you are taking medicines for the treatment of:

• fungal infections, such as pentamidine or azole antifungals, particularly itraconazole, oral ketoconazole, fluconazole, posaconazole or voriconazole
• bacterial infections, particularly erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, spiramycin (these medicines 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, e.g. ritonavir or saquinavir (these are protease inhibitors)
• hepatitis C (e.g. telaprevir)
• tumours (e.g. toremifene, vandetanib, vincaamine)

Do not take MOTILIUM if you are taking other medicines (e.g. bepridil, dofetilide, methadone).
Inform your doctor or pharmacist if you are taking medicines for infections, heart disorders, AIDS/HIV or Parkinson’s disease.
Before using MOTILIUM and apomorphine, your doctor will ensure that your body can tolerate the concomitant use of both medicines when taken simultaneously. Ask for personalized advice from your doctor or a specialist. Refer to the apomorphine package leaflet.
It is important that you ask your doctor or pharmacist whether MOTILIUM is safe for you while taking other medicines, including over-the-counter medicines.

MOTILIUM with food and drinks
Take MOTILIUM before meals. If taken after meals, absorption of the medicine is slightly delayed.

Pregnancy
It is not known whether the use of MOTILIUM during pregnancy is harmful.
If you are pregnant or think you may be pregnant, inform your doctor, who will decide whether you can take MOTILIUM.

Breast-feeding
Small amounts of domperidone have been detected in breast milk. MOTILIUM may cause unwanted effects on the heart of a breast-fed newborn. MOTILIUM should be used during breast-feeding only if your doctor considers it strictly necessary. Ask your doctor for advice before taking this medicine.

Driving and using machines
Some patients have reported dizziness or drowsiness 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 ingredients of MOTILIUM

• The film-coated tablets contain lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
• Each domperidone film-coated tablet contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”

3. How to take MOTILIUM

Follow these instructions carefully, unless your doctor has given you different advice.
It is recommended to take MOTILIUM before meals; if taken after meals, absorption of the medicine is slightly delayed.

Duration of treatment:
Symptoms usually resolve within 3–4 days of taking this medicine. Do not take MOTILIUM for more than 7 days without consulting your doctor.

Adults and adolescents aged 12 years and over and weighing 35 kg 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 them. Do not take more than three tablets per day.

If you take more MOTILIUM than you should
If you have taken an excessive amount of MOTILIUM, contact your doctor, pharmacist, or nearest poison control centre immediately. In case of overdose, symptomatic treatment should be administered. Electrocardiogram monitoring may be performed due to the possibility of a heart problem known as "QT interval prolongation".

Information for the physician: close medical supervision and general supportive therapy are recommended. Antiparkinsonian anticholinergic drugs may be helpful in controlling extrapyramidal disorders.

If you forget to take MOTILIUM
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then and continue your treatment as normal. Do not take a double dose to make up for the missed 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, arms or legs, excessive tremor, excessive muscle rigidity or muscle spasms

Not known (frequency cannot be estimated from the available data)

• Seizures
• A type of reaction that may occur immediately after administration and is characterised by skin rash, itching, shortness of breath and/or facial swelling
• A severe hypersensitivity reaction that may occur immediately after administration and is characterised by hives, itching, flushing, fainting, and among other possible symptoms, breathing difficulties
• Cardiovascular system disorders have been reported: heart rhythm disorders (fast or irregular heartbeat); if you experience such disorders, you should stop treatment immediately. Domperidone may be associated with an increased risk of heart rhythm disturbances and cardiac arrest. This risk may be higher in patients over 60 years of age or those taking doses exceeding 30 mg 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 side effects listed above.
Other side effects that have occurred 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 reduction in libido
• Headache
• Drowsiness
• Diarrhoea
• Skin rash
• Itching
• Hives
• Painful or tender breasts
• Lactation (milk secretion from the breasts)
• General feeling of weakness
• Dizziness

Not known (frequency cannot be estimated from the available data)

• Upward movement of the eyes
• Interruption of the menstrual cycle in women
• Breast enlargement in men
• Inability to urinate
• Changes in the results of certain laboratory tests
• Restless legs syndrome (a sensation of discomfort with an irresistible urge to move the legs, and sometimes arms or other body parts).

Some patients who have used MOTILIUM for conditions and at dosages requiring medical supervision have experienced the following side effects: restlessness; swelling or enlargement of the breasts, abnormal breast secretions, irregular menstrual cycle in women, breastfeeding difficulties, depression, hypersensitivity.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MOTILIUM

• Keep this medicine out of the sight and reach of children.
• Do not use MOTILIUM after the expiry date stated on the label. The expiry date "EXP." refers to the last day of that month; the first two numbers indicate the month, the following ones the year.
• This medicine does not require any special storage conditions.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MOTILIUM contains
The active substance is domperidone.
The other components are:
film-coated tablets (domperidone): monohydrate lactose, corn starch, microcrystalline cellulose,
pregelatinized potato starch, povidone K90, magnesium stearate, hydrogenated cottonseed oil,
sodium lauryl sulfate, hypromellose.
Description of the appearance of MOTILIUM and contents of the pack
The film-coated tablets (domperidone) are available in blister packs containing
30 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina, km 23,500 - 00071 Santa Palomba – Pomezia - Roma
Manufacturer and final controller
Film-coated tablets (domperidone)
JNTL Consumer Health (France) SAS, Domaine de Maigremont – 27100 Val de Reuil, France
or
Lusomedicamenta Sociedade Técnica Farmacêutica SA, Estrada Consiglieri Pedroso, 69 – B,
Queluz de Baixo, 2730-055 Barcarena, Portugal
or
Johnson & Johnson Consumer NV/SA, Antwerpeweg 15-17, 2340 Beerse, Belgium