Motilex

Package leaflet: Information for the patient

MOTILEX 0.5 mg tablets, 0.5 mg/5 ml syrup, 1 mg/2 ml injectable solution

Clebopride
Please read this leaflet carefully before taking 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, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Motilex is and what it is used for

Motilex contains the active substance clebopride, which belongs to a class of medicines called "prokinetics" that work by stimulating the motility of the stomach and intestine.
Motilex is indicated for:

• the treatment of nausea and vomiting occurring due to problems affecting the stomach or intestine (organic or functional origin) or caused by medicines used in cancer treatment;
• the treatment of symptoms of a disease causing stomach disturbances (functional dyspepsia);
• the radiological examination of the stomach and intestine.

2. What you need to know before taking Motilex

Do not take Motilex

• If you are allergic to clebopride, to other medicines similar to Motilex (benzamides), or to any of the other ingredients of this medicine (listed in section 6).
• In cases where stimulation of intestinal emptying may be dangerous, for example in the presence of severe bleeding (haemorrhage), perforation, or mechanical obstruction of the stomach and intestine.
• If you suffer from epilepsy.
• If you have movement disorders (tardive dyskinesia) after treatment with medicines called "neuroleptics", used for mental disorders.
• If you have been diagnosed with Parkinson's disease or other diseases of a part of the nervous system called the "extrapyramidal system" that controls movement.
• If you are pregnant or during breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Motilex.
Do not take doses of Motilex higher than those recommended by your doctor, as higher doses
may increase the likelihood of developing reactions affecting the system that controls
movement (extrapyramidal reactions, see section 3 “If you take more Motilex than you should”).
Your doctor will prescribe Motilex with particular care if you have breast cancer or a benign tumor
in a gland in the brain (pituitary adenoma) causing the release of a hormone called "prolactin",
because Motilex may further increase levels of this hormone.
Your doctor will prescribe Motilex with particular caution if you have severe kidney (renal failure) and/or liver (hepatic failure) impairment, as blood levels of clebopride may be higher or last longer.

Children and adolescents
In children and adolescents, taking doses of Motilex higher than those recommended by the
doctor may further increase the likelihood of developing reactions affecting the system that controls movement (extrapyramidal reactions).

Other medicines and Motilex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of Motilex may be influenced by, or may influence, the following medicines:

• Medicines called "anti Monoamine Oxidase" (MAO inhibitors) used for depression, because this may increase the risk of adverse effects.
• Medicines called "neuroleptics", used to treat mental disorders (phenothiazines, butyrophenones, thioxanthenes, etc.), because these medicines may increase the activity of Motilex on the Nervous System and the risk of adverse effects.
• Digoxin (a medicine acting on heart contraction) and cimetidine (a medicine used for stomach lesions, "ulcers"), because Motilex may reduce the effectiveness of these medicines.

The following combinations with Motilex should be avoided:

• Medicines used for pain called "narcotic analgesics" and medicines used to block the action of a substance in the body called "acetylcholine" (anticholinergics), because these medicines counteract the effects of Motilex on stomach and intestinal motility.
• Other medicines that affect the release of a substance called "dopamine".

Motilex with food, drinks and alcohol
Do not take Motilex with alcoholic beverages, because this medicine may enhance the effects
of alcohol, such as drowsiness and reduced alertness.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Due to insufficient safety data currently available, Motilex is contraindicated during pregnancy.

Breastfeeding
Due to insufficient safety data currently available, Motilex is contraindicated during breastfeeding.

Fertility
No data on fertility in humans are available.

Driving and using machines
Motilex may impair your ability to drive or operate machinery, as it may cause drowsiness.
Take this into account before driving a vehicle and/or performing tasks requiring full alertness.

Motilex tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Motilex syrup and Motilex injectable solution contain sorbitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Sorbitol may cause a mild laxative effect.
The caloric value of sorbitol is 2.6 Kcal/g.

3. How to take Motilex

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Use in adults
The recommended dose is:

• Motilex tablets: 1 tablet three times a day before meals
• Motilex syrup: 1 measuring spoonful of 5 ml three times a day before meals
• Motilex injectable solution: half or 1 vial for injection into a muscle (intramuscular route) or into a vein (intravenous route), during the acute phase. If necessary, the dose may be repeated.

Use in children and adolescents

• Motilex tablets: Adolescents (12 to 20 years of age): half a tablet three times a day (before meals)
• Motilex syrup: Adolescents (12 to 20 years of age): half a measuring spoon (2.5 ml) three times a day before meals
  Children: as a general rule, 15 mcg per kg of body weight per day, divided into 3 doses.

As a guide (1 ml = 100 mcg):
Children from 1 to 4 years: 0.5 ml three times a day
Children from 4 to 8 years: 1 ml three times a day
Children from 8 to 10 years: 1.5 ml three times a day
Children from 10 to 12 years: 2 ml three times a day

If you take more Motilex than you should
If you take too much Motilex, inform your doctor immediately or go to the nearest hospital.
Taking an excessive dose of Motilex may cause drowsiness, disorientation, and movement disorders, which usually resolve upon discontinuation of therapy. If symptoms persist, your doctor or healthcare professionals will decide on the appropriate treatment.
In case of movement-related side effects (extrapyramidal symptoms), your doctor or healthcare providers will administer medicines that counteract these effects (anti-Parkinson drugs, anticholinergic drugs, or antiallergic medicines with the ability to block a substance in the body called "acetylcholine").

If you forget to take Motilex
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1,000 people):

• movement disorders (dystonia), usually affecting the neck, tongue or face,
• motor disturbances (dyskinesia and tardive dyskinesia, especially in elderly patients and after long-term treatment), tremor,
• drowsiness,
• sedation.

Very rare (may affect up to 1 in 10,000 people):

• excessive production of the hormone prolactin (hyperprolactinaemia),
• abnormal production of milk from the breast (galactorrhoea),
• absence of menstrual periods (amenorrhoea),
• breast enlargement in men (gynaecomastia),
• problems with erection (erectile dysfunction).

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Motilex

Motilex tablets: store in a dry place.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month and to the product in its original, undamaged packaging, stored correctly.
Do not dispose of any medicine 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 the medicine contains
Motilex 0.5 mg tablets:

• The active substance is: clebopride malate acid. One tablet contains 0.68 mg of clebopride malate acid equivalent to 0.50 mg of clebopride base.
• The other components are: lactose, microcrystalline cellulose, silicon dioxide, povidone, sodium carboxymethylamido, magnesium stearate.

Motilex 0.5 mg/5 ml syrup:

• The active substance is: clebopride malate acid. 1 ml of syrup contains 0.136 mg of clebopride malate acid (equivalent to 0.10 mg of clebopride base).
• The other components are: sorbitol solution, propylene glycol, benzoic acid, raspberry flavor, purified water.

Motilex 1 mg/2 ml injectable solution:

• The active substance is: clebopride malate acid. A 2 ml vial contains 1.36 mg of clebopride malate acid (equivalent to 1.0 mg of clebopride base).
• The other components are: sorbitol, water for injections.

Description of the appearance of Motilex and contents of the pack
Motilex is available as tablets, syrup, and injectable solution in the following pack sizes:
Motilex tablets: carton containing 30 tablets
Motilex Syrup: bottle containing 120 ml
Motilex Injectable Solution: carton containing 6 vials of 2 ml each

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Almirall S.A
Ronda General Mitre, 151
08022 Barcelona
Spain

Manufacturer
Motilex Tablets
Industrias Farmaceuticas Almirall S.A. – Ctra Nacional II, km. 593 – 08740 Sant Andreu de la Barca,
Barcelona (Spain)
Motilex Syrup
Berlin Chemie AG - Glienicker Weg 125, 12489 - Berlin – Germany
Almirall Hermal GmbH Scholtzstraße 3, D-21465 – Reinbek, Germany
Motilex Injectable Solution
Prasfarma Oncologicos S.L., / San Joan 9-13, 08560 Manlleu (Barcelona), Spain