MOTILIUM 1 mg /Ml Oral Suspension

Зміст інструкції

1. Motilium 1 mg/ml oral suspension
   1. What is MOTILIUM and what it is used for
   2. What you need to know before you use MOTILIUM
   3. How to take MOTILIUM
   4. Possible side effects
   5. How to store MOTILIUM
   6. Contents of the pack and other information
2. Motilium 10 mg film-coated tablets
   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. How to store MOTILIUM
   6. Contents of the pack and other information

Motilium 1 mg/ml oral suspension

(1 mg of domperidone per 1 ml of suspension)

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, 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 you take 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 is MOTILIUM and what it is used for

This medicine is used for the treatment of nausea and vomiting (feeling unwell)
in adults and adolescents (aged 12 years and over and weighing 35
kg or more).

2. What you need to know before you use MOTILIUM

Do not take MOTILIUM if:

• you are allergic (hypersensitive) to domperidone or any of the other ingredients of MOTILIUM
• you have bleeding in the stomach or usually experience severe abdominal pain or persistent black stools
• you have obstructions or perforations of the intestines
• you have tumors of the pituitary gland with prolactin release (prolactinomas).
• you suffer from moderate or severe liver disorder
• the ECG (electrocardiogram) shows a heart disorder called “prolongation of the QT interval”
• you suffer from or have suffered from a disorder in which your heart is unable to pump blood around the body as it should (a condition called heart failure).
• you suffer from a disorder that causes you to have low levels of potassium or magnesium or high levels of potassium in the blood
• you are taking certain medications (see “Other medicines and MOTILIUM”).

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

• you suffer from liver disorders (liver impairment or failure) (see “Do not use MOTILIUM”)
• you suffer from kidney disorders (kidney impairment or failure). Consult your doctor for advice if prolonged treatment is required as you may need to take a lower dose of this medicine or take this medicine less often and your doctor may want to check you regularly.

Domperidone may be associated with an increased risk of heart rhythm disorders and
cardiac arrest. The risk may be more likely in subjects over 60 years of age or who
are taking doses greater than 30 mg per day. The risk also increases when domperidone is
administered together with other medicines. Tell your doctor or pharmacist if you are taking
medicines for the treatment of 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 heart rhythm disorders such as
palpitations, difficulty breathing, fainting. In this case, treatment with MOTILIUM
must be stopped.

Adolescents weighing less than 35 kg and children
MOTILIUM should not be given to adolescents aged 12 years and over and weighing
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, for example pentamidine or azole antifungals, in particular itraconazole, oral ketoconazole, fluconazole, posaconazole or voriconazole
• bacterial infections, in particular erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, spiramycin (these medicines are antibiotics)
• heart problems or high blood pressure (for example amiodarone, dronedarone, ibutilide, disopyramide, dofetilide, sotalol, hydroquinidine, quinidine)
• psychosis (for example haloperidol, pimozide, sertindole)
• depression (for example citalopram, escitalopram)
• gastro-intestinal disorders (for example cisapride, dolasetron, prucalopride)
• allergy (for example mequitazine, mizolastine)
• malaria (in particular halofantrine, lumefantrine)
• AIDS/HIV for example ritonavir or saquinavir (these are protease inhibitors)
• hepatitis C (for example telaprevir)
• tumors (for example toremifene, vandetanib, vincamine) Do not take MOTILIUM if you are taking other medicines (for example bepridil, difemanil, methadone).

Tell your doctor or pharmacist if you are taking medicines for the treatment of infections, heart
problems, AIDS/HIV or Parkinson's disease.
Before using MOTILIUM and apomorphine, your doctor will make sure that your body
can tolerate taking both medicines at the same time when used
simultaneously. Ask for personalized advice from your doctor or a specialist. Read
the leaflet of apomorphine.
It is important that you ask your doctor or pharmacist if 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, the absorption of the
medicine is slightly slowed down.

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

Breastfeeding
Small amounts of domperidone have been detected in breast milk. MOTILIUM may cause
undesirable effects on the heart of the breastfed infant. MOTILIUM should be used
during breastfeeding 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 feeling dizzy or sleepy after taking MOTILIUM.
Do not drive or use machines while taking MOTILIUM until you know how
MOTILIUM affects you.

Important information about some of the 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 can cause gastrointestinal problems and have a mild laxative effect. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars or if you have a diagnosis of hereditary fructose intolerance (HFI), a rare genetic disease in which patients cannot break down fructose, talk to your doctor before taking this medicine.
• MOTILIUM oral suspension also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These substances can cause allergic reactions (including delayed reactions) and, in rare cases, bronchospasm.

3. How to take MOTILIUM

Follow these instructions strictly, unless your doctor has given you different instructions.
Take MOTILIUM before meals because if taken after meals, the 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.
The bottle is protected by a child-resistant cap. To open the bottle, press down on the
plastic screw cap and rotate it counterclockwise at the same time, as
illustrated below.
Thoroughly mix the contents of the bottle with a slight tilting motion
to avoid foam formation.

Adults and adolescents aged 12 years or over and weighing 35 kg or more

• A measuring cap is supplied with this medicine. This measuring cap has three lines: 2.5 ml, 5 ml and 10 ml (for example, you will have 10 ml of oral suspension when the measuring cap is filled to the upper line).
• Use the measuring cap in the direction it appears on the bottle. Make sure the side with the graduations (the side that holds less liquid) is facing up; this is the part to be filled. When the arrow on the side points upwards, the position is correct.

• Measure the required amount with the special measuring cap.
• Do not dilute MOTILIUM or mix it with other liquids.
• The usual dose is 10 ml up to three times a day. Do not take more than 30 ml per day (this is equivalent to 3 measuring caps filled to the upper 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, your
pharmacist or your nearest poison control center immediately. In case of overdose, symptomatic
treatment should be administered.
Electrocardiographic monitoring should be performed due to the possibility of a heart problem called “QT interval prolongation”.

Information for the doctor:close medical supervision of the subject and general supportive therapy are recommended. Anti-cholinergic anti-Parkinsonian drugs may be useful in controlling
extrapyramidal disorders.

If you forget to take MOTILIUM
Take the medicine as soon as you remember. If it is almost time for your next dose,
wait for the time of that dose and then continue 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 or arms or legs, excessive tremor, excessive rigidity or muscle spasm

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

• Convulsions.
• A type of reaction that can occur immediately after administration and is characterised by skin rash, itching, shortness of breath and/or facial swelling
• A severe hypersensitivity reaction that can occur immediately after administration and is characterised by urticaria, itching, flushing, fainting, and among other possible symptoms, difficulty breathing.
• Cardiovascular system disorders: heart rhythm disturbances (fast or irregular heartbeat); if you experience such 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 more likely in patients over 60 years of age or who are taking doses greater than 30 mg per day. Domperidone should be used at the lowest effective dose.

Stop treatment with MOTILIUM and contact your doctor immediatelyif any of the
side effects described above occur.
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 of libido
• Headache
• Drowsiness
• Diarrhoea
• Skin rash
• Itching
• Urticaria
• Painful or tender breasts
• Breast milk secretion
• 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
• Enlarged breasts in men
• Inability to urinate
• Changes in the results of some laboratory tests
• Restless legs syndrome (feeling of discomfort, with an irresistible need to move the legs, and sometimes arms and other parts of the body).

Some patients who have used MOTILIUM for conditions and dosages that require medical
supervision have experienced the following side effects:
Restlessness; swelling or enlargement of the breasts, abnormal breast discharge, in women
irregular menstrual cycle, difficulty breastfeeding, depression, hypersensitivity.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through 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, and the following ones the year.
• MOTILIUM oral suspension must not be used for more than 3 months after the first opening of the bottle.
• This medicine does not require special storage conditions.

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

6. Contents of the pack and other information

What MOTILIUM contains
The active ingredient is domperidone.
The other ingredients are:
non-crystallizable liquid sorbitol (E420), microcrystalline cellulose and
sodium carboxymethylcellulose, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (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 –Bottle of 200 ml.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Johnson & Johnson S.p.A., Via Ardeatina, km 23,500 - 00071 Santa Palomba – Pomezia - Roma

Manufacturer
Janssen Pharmaceutica N.V., Turnhoutseweg, 30, B-2340 Beerse (Belgium)
or
Johnson & Johnson Consumer NV/SA, Antwerpseweg 15-17, 2340 Beerse, Belgium

Motilium 10 mg film-coated tablets

Domperidone

Read this leaflet carefully before using this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is MOTILIUM and what is it used for

This medicine is used in adults and adolescents (aged 12 years and over and weighing
35 kg or more) for the treatment of nausea and vomiting (feeling unwell).

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
• you have bleeding in the stomach or regularly experience severe abdominal pain or persistent black stools
• you have obstructions or perforations of the intestines
• you have tumors of the pituitary gland with prolactin release (prolactinoma).
• you suffer from moderate or severe liver disorder
• the ECG (electrocardiogram) detects a heart disorder called “prolongation of the QT interval”
• you suffer from or have suffered from a disorder in which your heart is unable to pump blood around the body as it should (a condition called heart failure).
• you suffer from a disorder that causes you to have low levels of potassium or magnesium or high levels of potassium in the 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 failure) (see “Do not take MOTILIUM”)
• you suffer from kidney disorders (renal impairment or failure). Consult your doctor for advice if prolonged treatment is required as you may need to take a lower dose of this medicine or take this medicine less often and your doctor may want to check you regularly. Domperidone may be associated with an increased risk of heart rhythm disorders and cardiac arrest. The risk may be more likely in people over 60 years of age or who are taking doses greater than 30 mg per day. The risk also increases when domperidone is given with other medicines. Tell your doctor or pharmacist if you are taking medicines for the treatment of infections (fungal infections or bacterial infection) 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 heart rhythm disturbances such as palpitations, difficulty breathing, fainting. In this case, treatment with MOTILIUM must be stopped.

Adolescents weighing less than 35 kg and children
MOTILIUM should not be given to adolescents aged 12 years and over and weighing
less than 35 kg or 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, for example pentamidine or azole antifungals, in particular itraconazole, oral ketoconazole, fluconazole, posaconazole or voriconazole
• bacterial infections, in particular erythromycin, clarithromycin, telithromycin, levofloxacin, moxifloxacin, spiramycin (these medicines are antibiotics)
• heart problems or high blood pressure (for example amiodarone, dronedarone, ibutilide, disopyramide, dofetilide, sotalol, hydroquinidine, quinidine)
• psychosis (for example haloperidol, pimozide, sertindole)
• depression (for example citalopram, escitalopram)
• gastro-intestinal disorders (for example cisapride, dolasetron, prucalopride)
• allergy (for example mequitazine, mizolastine)
• malaria (in particular halofantrine, lumefantrine)
• AIDS/HIV for example ritonavir or saquinavir (these are protease inhibitors)
• hepatitis C (for example telaprevir)
• tumors (for example toremifene, vandetanib, vincamine)

Do not take MOTILIUM if you are taking other medicines (for example bepridil, difemanil,
methadone).
Tell your doctor or pharmacist if you are taking medicines for the treatment of infections, heart
disorders, AIDS/HIV or Parkinson’s disease.
Before using MOTILIUM and apomorphine, your doctor will make sure that your body
can tolerate taking both medicines at the same time when used
simultaneously. Ask for personalized advice from your doctor or a specialist. Consult
the leaflet of apomorphine.
It is important that you ask your doctor or pharmacist if 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, the absorption of the
medicine is slightly slowed down.

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

Breastfeeding
Small amounts of domperidone have been detected in breast milk. MOTILIUM may cause
undesirable effects on the heart of the breastfed newborn. MOTILIUM should be used
during breastfeeding 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 feeling dizzy or sleepy after taking MOTILIUM.
Do not drive or use machines while taking MOTILIUM until you know how
MOTILIUM affects you.

Important information about some 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 before taking this medicine.
• Each domperidone coated tablet contains less than 1 mmol of sodium (23 mg) per dose, that is to say it is essentially “sodium-free”

3. How to take MOTILIUM

Follow these instructions strictly, unless your doctor has provided you with different instructions.
It is recommended to use MOTILIUM before meals; if taken after meals, the 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 or older 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 other liquid. Do not chew them. Do not take more than three tablets a day.

If you take more MOTILIUM than you should
If you have taken an excessive amount of MOTILIUM, contact your doctor, pharmacist or the nearest poison control center immediately. In case of overdose, symptomatic treatment is appropriate. An electrocardiogram may be performed, given the possibility of a heart problem called “QT interval prolongation”.

Information for the doctor:close medical supervision of the subject and general supportive therapy are recommended. Anti-parkinsonian anticholinergic medications may be useful in controlling extrapiramidal disorders.

If you forget to take MOTILIUM
Take the medicine as soon as you remember. If it is almost time to take the next dose, wait until the time of that dose and then continue normally. 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 or arms or legs, excessive tremor, excessive muscle rigidity or spasm

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

• Convulsions
• A type of reaction that can occur immediately after administration and is characterised by skin rash, itching, shortness of breath and/or swelling of the face
• A severe hypersensitivity reaction that can occur immediately after administration and is characterised by urticaria, itching, flushing, fainting, and among other possible symptoms, difficulty breathing
• 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 disorders and cardiac arrest. This risk may be more likely in patients over 60 years of age or who are taking doses greater than 30 mg per day. Domperidone should be used at the minimum effective dosage.

Stop treatment with domperidone and contact your doctor immediatelyif you
experience any of the side effects described 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 decrease in libido
• Headache
• Drowsiness
• Diarrhoea
• Skin rash
• Itching
• Urticaria
• Painful or tender breasts
• Breast milk secretion
• General feeling of weakness
• Feeling dizzy.

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

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

Some patients who have used MOTILIUM for conditions and dosages that require
medical supervision have experienced the following side effects: restlessness; swelling or
enlargement of the breasts, abnormal secretions from the breasts, in women irregular
menstrual cycle, difficulty breastfeeding, depression, hypersensitivity.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through
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 special storage conditions

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

6. Contents of the pack and other information

What MOTILIUM contains
The active ingredient is domperidone.
The other ingredients are:
film-coated tablets (domperidone): lactose monohydrate, 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
Film-coated tablets (domperidone) are available in blister packs containing
30 tablets

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Johnson & Johnson S.p.A., Via Ardeatina, km 23,500 - 00071 Santa Palomba – Pomezia - Roma

Manufacturer and batch control
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