Metoclopramide Accord 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metoclopramide Accord 10 mg tablets EFG

Metoclopramide hydrochloride

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

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Metoclopramide Accord is and what it is used for
2. What you need to know before taking 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 Metoclopramide Accord is and what it is used for

Metoclopramide Accord is an antiemetic. It contains a medicine called "metoclopramide". It acts on an area of the brain that controls nausea and vomiting.

Adult population:

Metoclopramide is indicated in adults:

• to prevent delayed 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 associated with migraine.

Metoclopramide may be taken in combination with oral analgesics during migraine to make the analgesics more effective.

Paediatric population

Metoclopramide is indicated in children (1 to 18 years of age) when other treatments do not work or cannot be used, to prevent nausea and vomiting that may occur after chemotherapy.

2. What you need to know before starting to take Metoclopramide Accord

Do not take Metoclopramide Accord:

• If you are allergic to metoclopramide or to any of the other ingredients of this medicine (listed in section 6),
• If you have bleeding, obstruction, or perforation in your stomach or intestine,
• If you have or may have a rare tumour of the adrenal gland (phaeochromocytoma),
• If you have ever experienced involuntary muscle spasms (tardive dyskinesia) while being treated with a medicine,
• If you have epilepsy,
• If you have Parkinson's disease,
• If you are taking levodopa (a medicine for Parkinson's disease) or dopaminergic agonists (see below "Use of Metoclopramide Accord with other medicines"),
• If you have ever had abnormal levels of blood pigments (methaemoglobinaemia) or deficiency of NADH-cytochrome b5 reductase.

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

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

Warnings and precautions

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

• You have a history of abnormal heartbeats (QT interval prolongation) or any other heart problems,
• You have problems with electrolyte levels in your blood, such as potassium, sodium, or magnesium,
• You are taking other medicines known to affect your heart rhythm,
• You have a neurological disorder (brain-related problems),
• You have liver or kidney problems. Your dose may need to be reduced (see section 3).

Your doctor may perform blood tests to monitor your blood pigment levels. If abnormal levels (methaemoglobinaemia) occur, treatment must be stopped immediately and permanently.

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

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

Children and adolescents

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

This medicine must not be used in children under 1 year of age due to the high risk of uncontrollable movements (see above "Do not take Metoclopramide Accord if").

Use of Metoclopramide Accord with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicine. This is because some medicines may affect how Metoclopramide Accord works, or Metoclopramide Accord may affect how other medicines work. These medicines include the following:

• levodopa or other medicines used to treat Parkinson's disease (see above “Do not take Metoclopramide Accord”)
• anticholinergics (medicines used to relieve stomach spasms or cramps)
• morphine derivatives (medicines used to treat severe pain)
• sedative medicines
• any medicine used to treat mental health conditions
• digoxin (a medicine used to treat heart failure)
• cyclosporine (a medicine used to treat certain immune system problems)
• mivacurium and suxamethonium (medicines used to relax muscles)
• fluoxetine and paroxetine (medicines used to treat depression)
• rifampicin (a medicine used to treat tuberculosis or other infections), which may reduce the amount of metoclopramide in the blood if administered at the same time.

Use of Metoclopramide Accord with alcohol

Alcohol must not be consumed during treatment with metoclopramide, as it increases the sedative effect of Metoclopramide Accord.

Pregnancy, breastfeeding, and fertility

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

Metoclopramide Accord may be used during pregnancy if considered necessary. Your doctor will decide whether or not this medicine should be given to you.

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

Driving and use of machines

After taking Metoclopramide Accord, you may feel drowsy, dizzy, or experience uncontrollable movements such as tics, jerks, or muscle twisting and unusual muscle tone causing body distortion. These effects may affect your vision and may also impair your ability to drive or operate machinery.

Metoclopramide Accord contains lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Metoclopramide Accord

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

Adult population:

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

The recommended maximum daily dose is 30 mg or 0,5 mg/kg body weight.

The maximum duration of treatment is 5 days.

For the prevention of delayed nausea and vomiting that may occur after chemotherapy (children aged 1 – 18 years)

The recommended dose is 0,1 to 0,15 mg/kg body weight, which may be repeated up to a maximum of 3 times a day orally.

The maximum dose in 24 hours is 0,5 mg/kg body weight.

Dosing table:

Instructions for use

Do not take this 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 in this population.

Method of administration

Swallow the tablet with a glass of water.

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

Elderly population

Dosage reduction may be necessary depending on kidney problems, liver problems, and general health status.

Adults with renal problems

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

Adults with hepatic problems

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

Children and adolescents

Metoclopramide must not be used in children under 1 year of age (see section 2).

If you take more Metoclopramide Accord than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Metoclopramide Accord

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask 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 contact your doctor or pharmacist immediately if you experience any of the following side effects while taking this medicine:

• uncontrollable movements (often affecting the head and neck). These may occur in children and young adults, particularly when high doses are used. These reactions usually occur at the beginning of treatment and may even appear after a single dose. These movements will cease when appropriately treated.
• high fever, high blood pressure, seizures/convulsions, sweating, excessive salivation. These may be signs of a condition called neuroleptic malignant syndrome.
• itching and skin rash, swelling of the face, lips, tongue or throat, difficulty breathing, shortness of breath, cold and clammy skin, rapid heartbeat, dizziness, weakness or fainting. These may be signs of an allergic reaction, which can be serious (such as anaphylaxis, angioedema and urticaria).

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

• feeling sleepy.

Common (may affect up to 1 in 10 people)

• low mood (depression)
• uncontrollable movements such as tics, jerking movements, twisting movements or muscle spasms (stiffness, rigidity)
• Parkinsonism-like symptoms (stiffness, tremor)
• feeling restless
• low blood pressure (particularly with intravenous administration)
• diarrhoea
• feeling weak.

Uncommon (may affect up to 1 in 100 people)

• increased 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)
• allergic reaction
• 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 cannot be estimated from the available data)

• abnormal levels of blood pigments: which may change the colour of your skin
• abnormal breast development (gynaecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• high fever, high blood pressure, seizures, sweating, excessive salivation. These may be signs of a condition called neuroleptic malignant syndrome
• changes in heart rhythm, 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)
• allergic reaction which may be serious (particularly with intravenous administration)
• very high blood pressure in patients with or without phaeochromocytoma
• suicidal thoughts

Reporting of side effects: If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Metoclopramide Accord

Keep this medicine out of sight and reach of children.

• Store below 30 °C.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
  Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located at your usual pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metoclopramide Accord

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

The tablets contain the following inactive ingredients:

Monohydrate lactose, pregelatinized corn starch, corn starch, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the pack

Round, biconvex tablets, white or almost white, with the imprint "BD" on one side and a score line on the other.

The tablets may be divided into two equal parts.

The tablets are packaged in PVC/PVdC/aluminum blister strips.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of last review of this leaflet: July 2024

The detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/