METOCLOPRAMIDE ACCORD

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metoclopramide Accord 10 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform 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 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 medicine. It contains an active substance called
"metoclopramide". It acts on a part of the brain to prevent the feeling of sickness
(nausea) or the act of 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 associated with migraine. In the case of migraine, Metoclopramide Accord may be taken together with oral painkillers to help make them 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, to prevent nausea and vomiting
that may occur after chemotherapy.

2. What you need to know before taking Metoclopramide Accord

Do not use 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 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 (phaeochromocytoma);
• if you have previously experienced a specific movement disorder (tardive dyskinesia) while being treated with this 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 (methaemoglobinaemia) or NADH-cytochrome-b5 deficiency.

Do not use Metoclopramide Accord in children under 1 year of age (see below “Children and adolescents”).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Metoclopramide Accord if:

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

Your doctor may carry out blood tests to monitor your blood pigment levels. If abnormal levels (methaemoglobinaemia) occur, treatment must be immediately and permanently discontinued.
You must wait at least 6 hours between each dose of metoclopramide, even if you vomit and expel the dose, to avoid overdose.
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 higher risk of uncontrollable movements (see above “Do not use Metoclopramide Accord if”).
Other medicines and Metoclopramide Accord
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is important because some medicines may affect how Metoclopramide Accord works, or Metoclopramide Accord may affect how 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 stomach cramps or spasms);
• morphine derivatives (medicines used to treat severe pain);
• sedatives;
• any medicine used to treat mental health conditions;
• digoxin (a medicine used to treat heart failure);
• ciclosporin (a medicine used to treat certain immune system disorders);
• mivacurium and suxamethonium (medicines used to relax muscles);
• fluoxetine and paroxetine (medicines used to treat depression).

Metoclopramide Accord and alcohol
Do not drink alcohol 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, ask your doctor or pharmacist for advice before taking this medicine. If necessary, Metoclopramide Accord may be taken during pregnancy. Your doctor will decide whether you should take the medicine.
Metoclopramide Accord is not recommended during breastfeeding, because metoclopramide passes into breast milk and may affect the baby.
Driving and using machines
You may feel drowsy, dizzy, or experience uncontrolled spasms, convulsive contractions, or unusual muscle movements causing body distortions after taking Metoclopramide Accord. These symptoms may affect your vision and may also impair your ability to drive or 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. Inform your doctor if you are intolerant to sugars.

3. How to take Metoclopramide Accord

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any 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 body weight.
The recommended maximum duration of treatment is 5 days.
For the prevention of nausea and vomiting that may occur after chemotherapy (children aged 1 to 18 years), the recommended maximum dose is between 0.1 and 0.15 mg/kg body weight, repeated up to 3 times a day, taken orally.
The maximum dose in 24 hours is 0.5 mg/kg body weight.
Dosing table

Advice/Instruction 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.
Method of administration
The tablets should be swallowed with a glass of water. You must wait at least 6 hours between one dose 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 renal impairment, hepatic impairment, and general health status.
Adults with renal impairment
Talk to your doctor if you have renal problems. The dose should be reduced in cases of moderate or severe renal impairment.
Adults with hepatic impairment
Discuss with your doctor if you have hepatic problems. The dose should be reduced in cases of 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 symptoms), feel drowsy, have disturbances of consciousness, confusion, hallucinations, or cardiac problems.
Your 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 the 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 experiences them.
Stop treatment and contact your doctor, pharmacist or
nurse immediately if you experience any of the following
symptoms while taking this medicine:

• uncontrollable movements (often affecting the head or neck). These may occur in children or young adults, particularly when high doses are used. These symptoms usually appear at the beginning of treatment and may even occur after a single dose. The movements disappear if appropriately treated.
• high fever, high blood pressure, seizures, sweating, saliva production. These may be signs of a disorder 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 could 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 (stiffness)
• symptoms similar to Parkinson’s disease (stiffness, tremors)
• 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 women who are not breastfeeding
• irregular menstrual cycle
• hallucinations
• reduced level of consciousness
• slow heart rate (particularly with intravenous administration)
• allergy.

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

• confusion
• seizures (especially in epileptic patients).

Not known (frequency cannot be estimated from available data)

• abnormal levels of blood pigment, which may change skin colour
• abnormal breast development (gynaecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• high fever, high blood pressure, seizures, sweating, saliva production. These may be symptoms of a disorder called neuroleptic malignant syndrome
• changes in heart rhythm, which may 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 which may be severe (particularly with intravenous administration)
• very high blood pressure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please inform your doctor, pharmacist or nurse. You can also report side effects
directly via 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 below 30 °C.
• Do not use this medicine after the expiry date stated on the blister and the carton after 'Exp.'. The expiry date refers to the last day of that month.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Metoclopramide Accord contains
The name of your medicine is Metoclopramide Accord, and the active substance is metoclopramide hydrochloride.
Metoclopramide Accord contains 10 mg of metoclopramide hydrochloride.
The tablets contain the following excipients:
Monohydrate lactose, pregelatinized starch, maize starch, anhydrous colloidal silica,
magnesium stearate.

What Metoclopramide Accord looks like and contents of the pack
White to almost white, round, biconvex tablets, engraved with "BD" on one side and a score line on the other.
The tablet can be divided into two equal parts.
The tablets are packed in PVC/PVdC/Aluminium blisters.
The carton contains 8, 20, 24, 28, 30, 60 or 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 European Economic Area countries under the following names:

| Country | Name of the medicinal product | |---------|-------------------------------| | Cyprus | Metoclopramide Accord 10 mg tablety | | Spain | Metoclopramide Accord 10 mg comprimidos | | Italy | Metoclopramide Accord | | Netherlands | Metoclopramidemonohydrochloride Accord 10 mg Tabletten | | Malta | Metoclopramide 10 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 |

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