Инструкция по применению MOTILEX
Содержание инструкции
MOTILEX 0.5 mg tablets, 0.5 mg/5ml syrup, 1 mg/2 ml injectable solution
Clebopride
Read this leaflet carefully before taking 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 Motilex is and what it is used for
- 2. What you need to know before you take 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 ingredient clebopride which belongs to a class of medicines called
“prokinetics” that work by stimulating the motility of the stomach and intestines.
Motilex is indicated for:
- the treatment of nausea and vomiting that occur due to problems at the level of the stomach or intestines (organic or functional origin) or caused by medicines used for the treatment of tumors;
- the treatment of symptoms of a disease that leads to disorders at the level of the stomach (functional dyspepsia);
- the exploration of the stomach and intestines through a radiological examination.
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 components of this medicine (listed in section 6).
- In cases where stimulating the emptying of the intestine may be dangerous, for example in the presence of severe bleeding (hemorrhage), perforation, mechanical obstruction of the stomach and intestines.
- If you suffer from epilepsy.
- If you suffer from movement disorders (tardive dyskinesia) after being treated 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 “extrapyramidal” that regulates movement.
- If you are pregnant and during breastfeeding (see “Pregnancy and breastfeeding”).
Warnings and precautions
Consult your doctor or pharmacist before taking Motilex.
Do not take doses of Motilex higher than those recommended by your doctor, because high doses
may increase the possibility of developing reactions at the level of the system that regulates
movement (extrapyramidal reactions, see section 3 “If you take more Motilex than you should”).
The doctor will prescribe Motilex with particular attention if you suffer from breast cancer or a
benign tumor at the level of a gland in the brain (pituitary adenoma) that leads to the release
of a hormone called “prolactin”, because Motilex may lead to a further increase in the
levels of this hormone.
The doctor will prescribe Motilex with particular caution if you suffer from severe kidney
impairment (renal insufficiency) and/or liver (hepatic insufficiency), because the levels in the blood 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 possibility of developing reactions at the level of the system
that regulates movement (extrapyramidal reactions).
Other medicines and Motilex
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The effects of Motilex may be influenced by or influence the following medicines.
- Medicines called “Monoamine Oxidase Inhibitors” (MAOIs) used against depression, because it increases the risk of developing side effects.
- Medicines called “neuroleptics”, used to treat mental disorders (phenothiazines, butyrophenones, thioxanthenes etc.), because these medicines can increase the activity of Motilex at the level of the Nervous System and the risk of side effects.
- Digoxin (a medicine that acts on the contraction of the heart) and cimetidine (a medicine used against lesions, "ulcers", in the stomach), because Motilex may decrease the effect of these medicines.
The association between Motilex and the following medicines should be avoided:
- Medicines used against pain called “narcotic analgesics” and medicines used to block the action of a substance present in the body called “acetylcholine” (anticholinergics), because these medicines counteract the effects of Motilex on the motility of the stomach and intestines.
- Other medicines that act on the release of a substance called “dopamine”.
Motilex with food, drinks and alcohol
Do not take Motilex with alcoholic beverages ,because this medicine may increase the effects
due to alcohol, such as drowsiness and decreased attention.
Pregnancy, Breastfeeding and Fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
As there is currently insufficient data on safety of use, Motilex is contraindicated in
pregnancy.
Breastfeeding
As there is currently insufficient data on safety of use, Motilex is contraindicated
during breastfeeding.
Fertility
No data are available on fertility in men.
Driving and operating machinery
Motilex impairs your ability to drive vehicles or operate machinery, because it
can cause drowsiness.
Keep this in mind before getting behind the wheel of a vehicle and/or performing operations that
require you to be alert.
Motilex tablets contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.
Motilex syrup and Motilex injectable solution contain sorbitol
If your doctor has diagnosed you with intolerance to certain sugars, contact him 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 following exactly the instructions of 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 3 times a day before meals
- Motilex syrup: 1 measuring spoon of 5 ml 3 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 can be repeated.
Use in children and adolescents
- Motilex tablets Adolescents(12 to 20 years): half a tablet 3 times a day (before meals)
- Motilex syrup: Adolescents(12 to 20 years): half a measuring spoon (2.5 ml) 3 times a day before meals Children: as a general rule 15 mcg per kg of body weight per day, divided into 3 administrations.
Indicatively (1 ml = 100 mcg):
Children from 1 to 4 years: 0.5 ml 3 times a day
Children from 4 to 8 years: 1 ml 3 times a day
Children from 8 to 10 years: 1.5 ml 3 times a day
Children from 10 to 12 years: 2 ml 3 times a day
If you take more Motilex than you should
In case of taking an excessive dose of Motilex, immediately inform your doctor or go to the
nearest hospital.
Taking an excessive dose of Motilex can cause drowsiness, disorientation and
movement disorders, which usually disappear with discontinuation of therapy. If symptoms
persist, your doctor or healthcare professionals will decide on the treatments to be administered.
In case of appearance of phenomena that affect movement (extrapyramidal effects), the
doctor or healthcare professionals will administer you medicines that will block these effects
(medicines for Parkinson's disease, medicines that block acetylcholine or medicines for allergies
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 a missed 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 at the level of the neck, tongue or face,
- motor alterations (dyskinesia and tardive dyskinesia especially in the elderly and after prolonged treatment periods), tremor,
- drowsiness,
- sedation.
Very rare (may affect up to 1 in 10,000 people):
- excessive production of the hormone prolactin (hyperprolactinemia),
- abnormal production of milk from the breast (galactorrhea),
- disappearance of the menstrual cycle (amenorrhea),
- growth of the breasts in men (gynecomastia),
- problems with erection (erectile dysfunction).
undesirable.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
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 intact packaging,
correctly stored.
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. Package Contents and Other Information
Contents
Motilex 0.5 mg tablets:
- The active ingredient is: clebopride maleate acid. One tablet contains 0.68 mg of clebopride maleate acid equivalent to 0.50 mg of clebopride base.
- The other ingredients are: lactose, microgranular cellulose, silicon dioxide, povidone, sodium carboxymethylamide, magnesium stearate.
Motilex 0.5 mg/5 ml syrup:
- The active ingredient is: clebopride maleate acid. 1 ml of syrup contains 0.136 mg of clebopride maleate acid (equivalent to 0.10 mg of clebopride base).
- The other ingredients are: sorbitolsolution, propylene glycol, benzoic acid, raspberry flavour, purified water.
Motilex 1 mg/2ml injectable solution
- The active ingredient is: clebopride maleate acid. One 2 ml vial contains: 1.36 mg of clebopride maleate acid (equivalent to 1.0 mg of clebopride base).
- The other ingredients are: sorbitol, water for injections.
Description of the appearance of Motilex and contents of the pack
Motilex is available in tablet, syrup and injectable solution form in the packs listed below:
Motilex tablets: pack of 30 tablets
Motilex Syrup: 120 ml bottle
Motilex Injectable solution: pack of 6 vials of 2 ml
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almirall S.A
Ronda General Mitre, 151
08022 Barcelona
Spain
Manufacturer
Motilex Tablets
Industrias Farmaceuticas Almirall S.A. – CtraNacional II, km. 593 – 08740 SantAndreu 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

- Страна регистрации
- Форма выпускаTablet, 0.5 MG
- Код АТХA03FA06
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги MOTILEXФорма выпуска: Tablet, 10 MGДействующее вещество: домперидонаПроизводитель: ABC FARMACEUTICI S.P.A.Отпускается по рецептуФорма выпуска: Coated tablet, 10 MGДействующее вещество: домперидонаПроизводитель: DOC GENERICI SRLОтпускается по рецептуФорма выпуска: Coated tablet, 10 MGДействующее вещество: домперидонаПроизводитель: EG S.P.A.Отпускается по рецепту
Аналоги MOTILEX в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог MOTILEX в Испания
Аналог MOTILEX в Польша
Аналог MOTILEX в Украина
Врачи онлайн по MOTILEX
Обсудите применение MOTILEX и возможные следующие шаги — по оценке врача.
Получите рецепт на MOTILEX онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
MOTILEX требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество MOTILEX — clebopride. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
MOTILEX производится компанией ALMIRALL S.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения MOTILEX с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить MOTILEX в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (clebopride) включают DOMPERIDONE ABK, DOMPERIDONE DOK JENERIKI, DOMPERIDONE EG. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















