Інструкція із застосування METOKLOPRAMIDE AKKORD
Зміст інструкції
- Metoclopramide Accord 10 mg tablets
- Metoclopramide Accord is not recommended during breastfeeding, because metoclopramide
Metoclopramide Accord 10 mg tablets
Generic medicine
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 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 Metoclopramide Accord is and what it is used for
- 2. What you need to know before you take Metoclopramide Accord
- 3. How to take Metoclopramide Accord
- 4. Possible side effects
- 5. How to store Metoclopramide Accord
- 6. Contents of the pack and other information
1. What is Metoclopramide Accord and what is it used for
Metoclopramide Accord is an antiemetic medicine. It contains a medicine called
“metoclopramide”. It acts on a part of the brain that prevents the feeling of unwellness
(nausea) or the state of unwellness (vomiting).
Adults:
Metoclopramide is used in adults:
- to prevent nausea and vomiting that may occur after chemotherapy
- to prevent nausea and vomiting caused by radiotherapy
- to treat nausea and vomiting including nausea and vomiting that may occur with migraine. In case of migraine Metoclopramide Accord can be taken together with oral painkillers in order to help them to be more effective.
Paediatric population
Metoclopramide Accord is used in children (aged between 1 and 18 years) only if
other treatments are not effective or cannot be used for the prevention of
nausea and vomiting that may occur after chemotherapy.
2. What you need to know before you take Metoclopramide Accord
Do not use Metoclopramide Accord:
- if you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6);
- if you have bleeding, obstruction or a tear in the stomach or intestine;
- if you have or may have a rare tumour of the adrenal gland, located next to the kidneys (pheochromocytoma).
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- if you have already had a particular movement disorder (tardive dyskinesia) when you were treated with the medicine;
- if you suffer from epilepsy.
- if you suffer from Parkinson's disease.
- if you are taking levodopa (a medicine for Parkinson's disease) or dopaminergic agonists (see below “Other medicines and Metoclopramide Accord”).
- if you have ever had abnormal levels of blood pigment (methaemoglobinemia) or NADH cytochrome-b5 deficiency.
Do not use Metoclopramide Accordin children under 1 year of age (see below
“Children and adolescents”).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Metoclopramide
Accordif:
- you have a history of abnormal heartbeat (prolongation of the QT interval) or any other heart problem.
- you have problems with salt levels in your blood, such as potassium, sodium and magnesium.
- you are using other medicines known to affect the heartbeat.
- you have neurological (brain) problems.
- you have liver or kidney problems. The dose may be reduced (see section 3).
The doctor may perform blood tests to check the levels of pigment in the
blood. If levels are abnormal (methaemoglobinemia), treatment must be
immediately and permanently stopped.
At least 6 hours must pass between one administration of metoclopramide and the
next, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Children and adolescents
Uncontrollable movements (extrapyramidal disorders) can be observed in children and young
adults. The medicine should not be used in children under 1 year of age, due to the
increased risk of uncontrollable movements (see above “Do not use Metoclopramide Accord
if”).
Other medicines and Metoclopramide Accord
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicines. This is important because some medicines can
affect the way Metoclopramide Accord works or Metoclopramide Accord can affect the way other medicines work. These medicines include:
- levodopa or other medicines used to treat Parkinson's disease (see above “Do not take Metoclopramide Accord if”)
- anticholinergics (medicines used to relieve cramps or spasms in the stomach)
- morphine derivatives (medicines used to treat severe pain)
- sedatives
- any medicine used to treat mental problems
- digoxin (a medicine used to treat heart failure)
- cyclosporine (a medicine used to treat some problems of the immune system)
- mivacurium and suxamethonium (medicines used to relax muscles)
- fluoxetine and paroxetine (medicines used to treat depression)
Metoclopramide Accord with alcohol
Do not drink alcohol during treatment with metoclopramide, because it increases the sedative
effect of Metoclopramide Accord.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before taking this medicine. If necessary,
Metoclopramide Accord can be taken during pregnancy. The doctor will decide whether you
should take the medicine or not.
Metoclopramide Accord is not recommended during breastfeeding, because metoclopramide
passes into breast milk and may have effects on the baby.
Driving and operating machinery
You may feel sleepy, dizzy, or experience uncontrolled spasms, contractions, or convulsive movements and unusual muscle tone causing body distortion after taking
Metoclopramide Accord. These symptoms may affect your vision and also
interfere with your ability to drive and operate machinery.
Metoclopramide Accord contains Lactose
This medicine contains lactose monohydrate. Patients with rare hereditary problems
of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption,
should not take this medicine. Tell your doctor if you are intolerant to sugars.
3. How to take Metoclopramide Accord
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
Adults:
The recommended single dose is 10 mg, repeated up to 3 times a day.
The recommended maximum daily dose is 30 mg or 0.5 mg/kg of body weight.
The recommended maximum treatment duration is 5 days.
For the prevention of nausea and vomiting that may occur after chemotherapy
(children from 1 to 18 years) the recommended maximum dose is between 0.1 and 0.15 mg/kg of body
weight, repeated up to 3 times a day, taken orally.
The maximum dose in 24 hours is 0.5 mg/kg of body weight.
Dosage table
Advice/instruction for use
Do not take the medicine for more than 5 days to prevent delayed nausea and vomiting that
may occur after chemotherapy.
Metoclopramide Accord is not suitable for use in children weighing less than 30 kg.
Other pharmaceutical forms/concentrations may be more appropriate for
administration.
Method of administration
| Age | Body weight | Dose | Frequency |
| 1-3 years | i 10-14 kg | 1 mg | Up to 3 times a day |
| 3-5 years | z 15-19 kg | 2 mg | Up to 3 times a day |
| 5-9 years | 20-29 kg |
| Up to 3 times a day |
| n 9-18 years | 30-60 kg | 5 mg | Up to 3 times a day |
| 15-18 years | Over 60kg | 10 mg | Up to 3 times a day |
The tablets must be swallowed with a glass of water. It is necessary to wait
at least 6 hours between one administration of metoclopramide and the next, even in case of
vomiting and rejection of the dose, in order to avoid overdose.
Elderly
The dose may need to be reduced based on kidney problems, liver problems and general health.
problems.
Adults with kidney problems
Talk to your doctor if you have kidney problems. The dose must be reduced in case of moderate or severe
kidney problems.
Adults with liver problems
Discuss with your doctor if you have liver problems. The dose must be reduced in case of severe
liver problems.
Children and adolescents
Metoclopramide should not be used in children under 1 year of age (see
paragraph 2).
If you take more Metoclopramide Accord than you should
Seek immediate medical advice or contact your pharmacist. You may experience
uncontrollable movements (extrapyramidal disorders), feel sleepy, have some disturbances of
consciousness, be confused, have hallucinations and heart problems.
The doctor may prescribe treatment for these symptoms, if necessary.
If you forget to take Metoclopramide Accord
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, nurse or
pharmacist.
4. Possible side effects
Like all medicines, Metoclopramide Accord can cause side effects, although
not everyone gets them.
Stop treatment and speak to your doctor, pharmacist or
nurse immediately if you experience any of the following
symptoms during therapy with this medicine:
- uncontrollable movements (often affecting the head or neck). These can occur in children or young adults, particularly if high doses are used. These symptoms usually appear at the beginning of treatment and can also occur after a single dose. The movements disappear if treated appropriately.
- high fever, high blood pressure, convulsions, sweating, increased saliva production. These may be signs of a condition called neuroleptic malignant syndrome.
- itching or skin rash, swelling of the face, lips or throat, difficulty breathing. These may be signs of an allergic reaction, which may be severe.
Very common(may affect more than 1 in 10 people)
- feeling sleepy.
Common(may affect up to 1 in 10 people)
- depression
- uncontrollable movements such as tics, tremors, twisting movements or muscle contractions (rigidity)
- symptoms similar to Parkinson's disease (rigidity, tremors)
- feeling restless
- low blood pressure (particularly with intravenous administration)
- diarrhoea
- feeling weak
Uncommon(may affect up to 1 in 100 people)
- increased levels in the blood of a hormone called prolactin, which can cause: production of milk in men and women who are not breastfeeding
- irregular menstrual cycle
- hallucinations
- reduced level of consciousness
- slow heartbeat (particularly with intravenous administration)
- allergy.
Rare(may affect up to 1 in 1,000 people)
- confusional state
- convulsions (especially in patients with epilepsy).
Not known(frequency cannot be estimated from available data)
- abnormal levels of blood pigment, which can change the color of the skin
- abnormal development of breast tissue (gynaecomastia)
- involuntary muscle spasms after prolonged use, particularly in elderly patients
- high fever, high blood pressure, convulsions, sweating, increased saliva production. These may be symptoms of a condition called neuroleptic malignant syndrome
- changes in heartbeat, which can be detected by an electrocardiogram
- cardiac arrest (particularly with injection)
- shock (severe drop in blood pressure) (particularly with injection)
- fainting (particularly with intravenous administration)
- allergic reaction that may be severe (particularly with intravenous administration)
- Very high blood pressure.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system at the website:
http://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 Metoclopramide Accord
Keep this medicine out of the sight and reach of children.
- Store at a temperature below 30 C.
- Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘Exp.’. The expiry date refers to the last day of that month.
- Do not dispose of any medicine in waste water 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 Metoclopramide Accord contains
The name of your medicine is Metoclopramide Accord, and the active ingredient is metoclopramide
hydrochloride.
Metoclopramide Accord contains 10 mg of metoclopramide hydrochloride.
The tablets contain the following excipients:
Lactose monohydrate, pregelatinized starch, corn starch, anhydrous colloidal silica,
magnesium stearate.
Description of the appearance of Metoclopramide Accord and contents of the pack
Tablets of colour from white to off-white, round, biconvex, with “BD” imprinted on one side
and with a score line on the other.
The tablet can be divided into two equal halves.
The tablets are packaged in PVC/PVdC/Aluminum blisters.
The carton contains 8, 20, 24, 28, 30, 60 and 500 tablets.
Marketing Authorisation Holder and Manufacturer
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations.
CountryName of the medicinal product
Cyprus Metoclopramide Accord 10 mg tablets
Spain Metoclopramide Accord 10 mg comprimidos
Italy Metoclopramide Accord
Netherlands Metoclopramidemonohydrochloride Accord 10 mg Tablets
Malta Metoclopramide10 mg tablets
United Kingdom Metoclopramide Hydrochloride 10 mg tablets
Austria Metoclopramid hydrochloride Accord 10 mg Tabletten
Denmark Metoclopramide hydrochloride Accord
Estonia Metoclopramide Accord
Finland Metoclopramide hydrochloride Accord 10 mg tabletti
Ireland Metoclopramide hydrochloride 10 mg tablets
Norway Metoclopramide Accord
Poland Metoclopramide Accord
Sweden Metoclopramide hydrochloride Accord 10 mg tabletter

- Країна реєстрації
- Лікарська формаCoated tablet, 10 MG
- Код АТХA03FA01
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до METOKLOPRAMIDE AKKORDЛікарська форма: Effervescent tablet, 5 MGДіюча речовина: metoclopramideВиробник: OPELLA HEALTHCARE ITALY S.R.L.Рецепт не потрібенЛікарська форма: Injectable solution, 5 MG/MLДіюча речовина: metoclopramideВиробник: NORIDEM ENTERPRISES LTDПотрібен рецептЛікарська форма: Injectable solution, 10 MG/2 MLДіюча речовина: metoclopramideВиробник: S.A.L.F. SPA LABORATORIO FARMACOLOGICOПотрібен рецепт
Аналоги METOKLOPRAMIDE AKKORD в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог METOKLOPRAMIDE AKKORD у Іспанія
Аналог METOKLOPRAMIDE AKKORD у Польща
Аналог METOKLOPRAMIDE AKKORD у Україна
Лікарі онлайн щодо METOKLOPRAMIDE AKKORD
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на METOKLOPRAMIDE AKKORD онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
METOKLOPRAMIDE AKKORD потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у METOKLOPRAMIDE AKKORD — metoclopramide. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
METOKLOPRAMIDE AKKORD виробляється компанією ACCORD HEALTHCARE, S.L.U.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування METOKLOPRAMIDE AKKORD з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати METOKLOPRAMIDE AKKORD у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (metoclopramide) включають MAALOX NAUSEA, METOKLOPRAMIDE KLORIDRATO NORIDEM, METOKLOPRAMIDE SALF. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















