Leaflet: information for the user

Metoclopramide Accord 10 mg tablets EFG

Metoclopramide hydrochloride

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isMetoclopramide Accordand what it is used for

2. What you need to know before starting to takeMetoclopramide Accord

3. How to takeMetoclopramide Accord

4. Possible side effects

5. Storage ofMetoclopramide Accord

6. Contents of the pack and additional information

Metoclopramida Accord is an antiemetic. It contains a medicine called “metoclopramida”. It acts on an area of the brain that prevents nausea or vomiting.

Adult population:

Metoclopramida is indicated in adults:

- to prevent delayed nausea and vomiting that may appear after chemotherapy

- to prevent nausea and vomiting caused by radiation therapy

- to treat nausea and vomiting, including nausea and vomiting that may appear with a migraine.

Metoclopramida can be taken in combination with oral analgesics in the case of migraine so that the analgesics are more effective.

Pediatric population

Metoclopramida is indicated in children (from 1 to 18 years of age) if other treatments do not work or cannot be used to prevent nausea and vomiting that may appear after chemotherapy.

Do not take Metoclopramida Accord:

Do not administer Metoclopramida Accord to children under 1 year of age (see below "Children and adolescents").

Do not take Metoclopramida Accord if any of the above cases apply to you. If you are unsure, consult your doctor, pharmacist, or nurse before taking Metoclopramida Accord.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Metoclopramida Accord if:

• You have a history of abnormal heartbeats (prolongation of the QT interval) or any other heart problem,
• You have problems with blood salt levels, such as potassium, sodium, and magnesium,
• You are taking other medications that are known to affect the way your heart beats
• You have any neurological problems (brain problems)
• You have problems with your liver or kidneys. Your dose may need to be reduced (see section 3).

Your doctor may perform blood tests to monitor your blood pigment levels. In cases of abnormal levels (methemoglobinemia), treatment should be stopped immediately and permanently.

You should wait at least 6 hours between each dose of metoclopramide, even in cases of vomiting and dose rejection, to avoid overdose.

Do not exceed 3 months of treatment due to the risk of involuntary muscle spasms.

Children and adolescents

Uncontrolled movements (extrapyramidal disorders) may occur in children and young adults.

This medication should not be used in children under 1 year of age due to the high risk of uncontrolled movements (see above "Do not take Metoclopramida Accord if").

Use of Metoclopramida Accord with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. This is because some medications may affect the way Metoclopramida Accord works or Metoclopramida Accord may affect the way other medications work. These medications include:

• levodopa or other medications used to treat Parkinson's disease (see above “Do not take Metoclopramida Accord”)
• anticholinergics (medications used to relieve stomach spasms or cramps)
• opioid derivatives (medications used to treat severe pain)
• sedatives
• any medication used to treat mental health problems
• digoxin (medication used to treat heart failure)
• ciclosporin (medication used to treat some immune system problems)
• mivacurium and suxamethonium (medications used to relax muscles)
• fluoxetine and paroxetine (medications used to treat depression).
• rifampicin (medication used to treat tuberculosis or other infections), which may reduce the amount of metoclopramide in the blood if taken at the same time.

Use of Metoclopramida Accord with alcohol

Do not consume alcohol during treatment with metoclopramide as it increases the sedative effect of Metoclopramida Accord.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Metoclopramida Accord may be taken during pregnancy if necessary. Your doctor will decide whether you can take this medication or not.

Metoclopramida Accord is not recommended during breastfeeding as metoclopramide passes into breast milk and may affect your baby.

Driving and operating machinery

After taking Metoclopramida Accord, you may feel drowsy, dizzy, or have uncontrolled movements of tics, jerks, or muscle tone that cause body distortion. This may affect your vision and also interfere with your ability to drive and operate machinery.

Metoclopramida Accord contains lactose.

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are unsure.

Adult population:

A single dose of 10 mg is recommended, which can be repeated up to three times a day.

The maximum recommended daily dose is 30 mg or 0.5 mg/kg of body weight.

The maximum duration of treatment is 5 days.

To prevent delayed nausea and vomiting that may appear after chemotherapy (children aged 1 – 18 years)

The recommended dose is 0.1 to 0.15 mg/kg of body weight, which can be repeated up to a maximum of 3 times a day orally.

The maximum dose in 24 hours is 0.5 mg/kg of body weight.

Dosage table:

Instructions for use

Do not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may appear after chemotherapy.

Metoclopramida Accord is not suitable for use in children weighing less than 30 kg. It may be more suitable to use other pharmaceutical forms/concentrations for this population.

Administration form

Swallow the tablet with a glass of water.

You should wait at least 6 hours between each dose of metoclopramide, even in case of vomiting and dose rejection, to avoid overdose.

Geriatric population

It may be necessary to reduce the dose depending on kidney problems, liver problems, and general health problems.

Adults with renal problems

Inform your doctor if you have kidney problems. The dose should be reduced if you have moderate or severe kidney problems.

Adults with liver problems

Inform your doctor if you have liver problems. The dose should be reduced if you have severe liver problems.

Children and adolescents

Metoclopramide should not be used in children under 1 year (see section 2).

If you take more Metoclopramida Accord than you should

Contact your doctor or pharmacist immediately. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have some consciousness problems, be confused, have hallucinations, and heart problems. Your doctor may prescribe treatment for these effects if necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forgot to take Metoclopramida Accord

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medicine, ask your doctor, nurse, or pharmacist.

Like all medicines, Metoclopramide Accord can cause side effects, although not everyone will experience them.

Stop treatment and immediately inform your doctor or pharmacist if you experience any of the following side effects while using this medicine:

• uncontrolled movements (which often affect the head and neck). These may appear in children and young adults and particularly when high doses are used. These reactions usually occur at the beginning of treatment and may even occur after a single administration. These movements will cease when properly treated.
• high fever, high blood pressure, seizures/convulsions, sweating, salivation. These may be signs of a condition called malignant neuroleptic syndrome.
• itching and skin rash, facial inflammation, lip, tongue, or throat inflammation, difficulty breathing, shortness of breath, cold and moist skin, rapid heartbeats, dizziness, weakness, or fainting. These may be signs of an allergic reaction, which can be severe (such as anaphylaxis, angioedema, and urticaria).

Very common(may affect more than 1 in 10 people)

• feeling drowsy.

Common(may affect up to 1 in 10 people)

• melancholy (depression)
• uncontrolled movements such as tics, jerks, twisting movements, or muscle contractions (rigidity, stiffness)
• symptoms similar to Parkinson's disease (rigidity, tremor)
• feeling restless
• decreased blood pressure (particularly with intravenous administration)
• diarrhea
• feeling weak.

Uncommon(may affect up to 1 in 100 people)

• elevated blood levels of a hormone called prolactin, which may cause: milk production in men and in women who are not breastfeeding
• irregular periods
• hallucinations
• decreased level of consciousness
• slow heart rate (particularly with intravenous administration)
• allergy
• visual disturbances (vision problems) and involuntary deviation of the eyeball.

Rare(may affect up to 1 in 1,000 people)

• confusion
• seizures (especially in patients with epilepsy).

Frequency not known(frequency that cannot be estimated from available data)

• abnormal levels of blood pigments: which may change the color of your skin
• abnormal development of the breasts (gynecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• high fever, high blood pressure, seizures/convulsions, sweating, salivation. These may be signs of a disease called malignant neuroleptic syndrome
• changes in heartbeats, which may be seen on an ECG (electrocardiogram)
• cardiac arrest (particularly with intravenous administration)
• shock (severe drop in blood pressure) (particularly with intravenous administration)
• fainting (particularly with intravenous administration)
• severe allergic reaction (particularly with intravenous administration)
• very high blood pressure in patients with or without phaeochromocytoma.
• suicidal thoughts

Reporting of side effects:If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine

..

Keep this medication out of the sight and reach of children

• Store below 30?°C.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.Unused medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Metoclopramide Accord

The name of your medicine is Metoclopramide Accord, and the active ingredient is metoclopramide hydrochloride. Each tablet contains 10 mg of metoclopramide hydrochloride.

The tablets contain the following inactive components:

Lactose monohydrate, maize starch pregelatinised, maize starch, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the pack

White or off-white, round, biconvex tablets with the inscription "BD" on one face and a notch on the other.

The tablets can be divided into two equal halves.

The tablets are packaged in PVC/PVdC/aluminium blisters.

The pack contains 20, 28, 30, 40, 50, 60, 84, 100, and 500 tablets.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est 6th floor

08039 Barcelona

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200

Pabianice,

Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, 32009,

Greece

This medicine is authorised in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet:July 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/