METOCLOPRAMIDE ACCORD 10 mg TABLETS

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

Do not take 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 perforation in your stomach or intestine
• if you have or may have a rare tumour of the adrenal gland (pheochromocytoma)
• if you have ever had involuntary muscle spasms (tardive dyskinesia) when you have been 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 dopamine agonists (see below "Using Metoclopramide Accord with other medicines")
• if you have ever had abnormal levels of blood pigments (methaemoglobinemia) or deficiency of NADH cytochrome b5 reductase

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting Metoclopramide Accord if:

• you have a history of abnormal heartbeats (prolonged QT interval) or any other heart problems

• you have problems with salt levels in your blood, such as potassium, sodium and magnesium
• you are using other medicines that are known to affect the way your heart beats
• you have any neurological problems (brain problems)
• you have liver or kidney problems. The dose may need to be reduced (see section 3)

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

You should wait at least 6 hours between each dose of metoclopramide, even in case of vomiting and rejection of the dose, 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 should 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").

Using Metoclopramide Accord with other medicines

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines may affect the way Metoclopramide Accord works or Metoclopramide Accord may 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")
• anticholinergics (medicines used to relieve stomach spasms or cramps)
• opioid derivatives (medicines used to treat severe pain)
• sedative medicines
• any medicine used to treat mental health problems
• digoxin (a medicine used to treat heart failure)
• ciclosporin (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)
• rifampicin (a medicine used to treat tuberculosis or other infections), may reduce the amount of metoclopramide in the blood if given at the same time

Using Metoclopramide Accord with alcohol

Do not drink alcohol while being treated with metoclopramide because it increases the sedative effect of Metoclopramide Accord.

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Metoclopramide Accord may be taken during pregnancy if necessary. Your doctor will decide whether you can be given this medicine or not.

Metoclopramide Accord is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby.

Driving and using machines

After taking Metoclopramide Accord, you may feel drowsy, dizzy or have uncontrollable movements of tics, twitches or torsion and muscle tone that causes distortion of your body. This may affect your vision and also interfere with your ability to drive and use machines.

Metoclopramide Accord contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Metoclopramide Accord

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 body weight.

The maximum duration of treatment is 5 days.

To prevent delayed nausea and vomiting that may occur after chemotherapy (children from 1 to 18 years of age)

The recommended dose is 0.1 to 0.15 mg/kg 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 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 who weigh less than 30 kg. It may be more suitable for the administration of other pharmaceutical forms/concentrations for this population.

Method of administration

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 rejection of the dose, to avoid overdose.

Elderly population

The dose may need to be reduced depending on kidney problems, liver problems and general health problems.

Adults with kidney problems

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

Adults with liver problems

Tell 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 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 problems with consciousness, be confused, have hallucinations and heart problems. Your doctor may prescribe a treatment for these effects if necessary.

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

If you forget to take Metoclopramide Accord

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

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, Metoclopramide Accord can cause side effects, although not everybody gets them.

Stop the treatment and inform your doctor, pharmacist immediately if you experience one of the following side effects while taking this medicine:

• uncontrollable movements (which often affect the head and neck). These can occur in children and young adults and particularly when high doses are used. These reactions usually occur at the start of treatment and can even occur after a single administration. These movements will stop when treated properly
• high fever, high blood pressure, fits/seizures, sweating, saliva production. These can be signs of a condition called neuroleptic malignant syndrome
• itching and skin rash, inflammation of the face, lips, tongue or throat, difficulty breathing, shortness of breath, cool and moist skin, rapid heartbeat, dizziness, weakness or fainting. These can 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)
• uncontrollable movements such as tics, twitches, torsion or muscle contractions (stiffness, rigidity)
• symptoms similar to Parkinson's disease (stiffness, tremor)
• feeling restless
• decrease in blood pressure (particularly with intravenous administration)
• diarrhoea
• feeling weak

Uncommon(may affect up to 1 in 100 people)

• high levels in the blood of a hormone called prolactin which can produce: milk production in men and in women who are not breast-feeding
• irregular periods
• hallucinations
• reduced 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
• fits (especially in patients with epilepsy)

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

• abnormal levels of blood pigments: which can change the colour of your skin
• abnormal development of the breasts (gynaecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• high fever, high blood pressure, fits/seizures, sweating, saliva production. These can be signs of a condition called neuroleptic malignant syndrome
• changes in heartbeats, which can be seen on an ECG (electrocardiogram)
• heart arrest (particularly with intravenous administration)
• shock (severe drop in blood pressure) (particularly with intravenous administration)
• fainting (particularly with intravenous administration)
• allergic reaction which can be severe (particularly with intravenous administration)
• very high blood pressure in patients with or without pheochromocytoma
• suicidal thoughts

Reporting of side effects:If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of Metoclopramide Accord

Keep this medicine out of the sight and reach of children

• Store below 30°C
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 non-active ingredients:

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

Appearance of the product and pack contents

White or almost white, round, biconvex tablets with "BD" engraved on one face and a score line on the other face.

The tablets can be divided into two equal halves.

The tablets are packaged in blister packs of PVC/PVdC/aluminium.

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

Not all 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 6ª planta

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) under the following names:

Date of last revision of this leaflet:July 2024

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