METOCLOPRAMIDE BASE 5 mg/mL Injectable Solution and Infusion Solution

Introduction

Package Leaflet: Information for the User

Metoclopramide Basi 5 mg/ml Solution for Injection and Infusion EFG

metoclopramide hydrochloride anhydrous

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Metoclopramide Basi and what is it used for
2. What you need to know before you use Metoclopramida Basi
3. How to use Metoclopramida Basi
4. Possible side effects
5. Storage of Metoclopramida Basi
6. Contents of the pack and other information

1. What is Metoclopramide Basi and what is it used for

Metoclopramide Basi is an antiemetic. It contains a medicine called “metoclopramide”. It works in an area of the brain that prevents nausea or vomiting.

Adult population

Metoclopramide is used in adults:

• to prevent nausea and vomiting that may occur after an operation
• to treat nausea and vomiting, including nausea and vomiting that may occur with migraine
• to prevent nausea and vomiting caused by radiotherapy

Pediatric population

Metoclopramide is used in children (1-18 years of age) only if other treatments do not work or cannot be used:

• to prevent delayed nausea and vomiting that may occur after chemotherapy
• to treat nausea and vomiting that may occur after an operation

2. What you need to know before you use Metoclopramide Basi

Do not use Metoclopramide Basi

• 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 the stomach or intestine.
• if you have or could have a rare tumor of the adrenal gland, which is near the kidney (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 dopaminergic agonists (see below “Other medicines and Metoclopramide Basi”).
• if you have ever had abnormal levels of blood pigments (methemoglobinemia) or deficiency of NADH cytochrome b5 reductase.

Do not give metoclopramide to children under 1 year of age (see below “Children and adolescents”).

Do not use metoclopramide if you are breastfeeding (see below “Pregnancy and breastfeeding”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Metoclopramide Basi if:

• you have a history of abnormal heartbeats (prolongation of the QT interval) or any other heart problem
• you have problems with the levels of salts in your blood, such as potassium, sodium, and magnesium
• you are using other medicines known to affect the way your heart beats
• you have any neurological problem (brain)
• 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 levels of blood pigments. In cases of abnormal levels (methemoglobinemia), treatment should be stopped immediately and permanently.

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 use Metoclopramide Basi”).

Other medicines and Metoclopramide Basi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because some medicines may affect the way Metoclopramide Basi works or Metoclopramide Basi may affect the way other medicines work. These medicines include:

• levodopa or other medicines used to treat Parkinson's disease (see above “Do not use Metoclopramide Basi”)
• anticholinergics (medicines used to relieve stomach spasms or cramps)
• opioid derivatives (medicines used to treat severe pain)
• sedatives
• any medicine used to treat mental health problems
• digoxin (a medicine used to treat heart failure)
• cyclosporin (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).

Using Metoclopramide Basi with alcohol

Do not drink alcohol during treatment with metoclopramide because it increases the sedative effect of metoclopramide.

Pregnancy and breastfeeding

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

Metoclopramide Basi may be used during pregnancy if necessary. Your doctor will decide whether or not to administer this medicine.

Metoclopramide Basi is not recommended if you are breastfeeding because metoclopramide passes into breast milk and may affect your baby.

Driving and using machines

After using Metoclopramide Basi, you may feel drowsy, dizzy, or have uncontrollable movements of tics, twitches, or torsion and muscle tone that is not usual, causing distortion of your body. This may affect your vision and also interfere with your ability to drive and use machines.

Metoclopramide Basi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ampoule; it is essentially “sodium-free”.

3. How to use Metoclopramide Basi

This medicine will normally be administered by a doctor or nurse. It will be administered as a slow injection into a vein (at least over 3 minutes) or by injection into a muscle.

In adult patients

For the treatment of nausea and vomiting, including nausea and vomiting that may occur with migraine, and for the prevention of nausea and vomiting caused by radiotherapy: a single dose of 10 mg is recommended, which can be repeated up to 3 times a day.

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

For the prevention of nausea and vomiting that may occur after an operation: a single dose of 10 mg is recommended.

Use in children and adolescents

All indications (pediatric patients 1-18 years of age)

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

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

Dose table

Treatment should not exceed 48 hours for the treatment of nausea and vomiting that occurs after an operation.

Treatment should not exceed 5 days for the prevention of nausea and vomiting that may occur after chemotherapy.

Method of administration

You should wait at least 6 hours between each dose of metoclopramide, even in case of vomiting and rejection of the dose, to avoid an 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 to 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 use more Metoclopramide Basi 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, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Metoclopramide Basi

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop treatment and inform your doctor, pharmacist, or nurse immediately if you experience one of the following signs while using 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 signs usually appear at the beginning of treatment and can even occur after a single administration. These movements will stop when treated properly.
• High fever, high blood pressure, convulsions, sweating, saliva production. These can be signs of a condition called malignant neuroleptic syndrome.
• Itching and skin rash, swelling of the face, lips, or throat, difficulty breathing. These can be signs of an allergic reaction, which can be severe.

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

• Feeling drowsy.

Common(may affect up to 1 in 10 people)

• depression
• uncontrollable movements like tics, twitches, or muscle contractions (stiffness, rigidity)
• symptoms similar to Parkinson's disease (stiffness, tremor)
• feeling restless
• decrease in blood pressure (particularly with intravenous administration)
• diarrhea
• feeling weak.

Uncommon(may affect up to 1 in 100 people)

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

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

• confusional state
• convulsions (especially in patients with epilepsy).

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

• abnormal levels of blood pigments: which can 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, convulsions, sweating, saliva production. These can be signs of a disease called malignant neuroleptic syndrome
• changes in heartbeats, which can be seen on an ECG (electrocardiogram)
• cardiac arrest (particularly with intravenous administration)
• shock (sharp drop in blood pressure) (particularly with intravenous administration)
• fainting (particularly with intravenous administration)
• allergic reaction that can be severe (particularly with intravenous administration)
• very high blood pressure.

Reporting of side effects

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

5. Storage of Metoclopramide Basi

Store below 30°C.

Store in the original packaging to protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date is the last day of the month stated.

After the first opening of the ampoule and/or dilution, the product must be used immediately.

For single use only. Any unused solution should be discarded.

Do not use this medicine if you notice it is altered. Before administration, the product must be visually inspected. Do not use a solution that is not transparent or in which crystallization is visible.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metoclopramide Basi

• The active substance is metoclopramide, hydrochloride monohydrate. Each ml of solution contains metoclopramide hydrochloride monohydrate equivalent to 5 mg of metoclopramide hydrochloride anhydrous.
• The other ingredients are sodium chloride, hydrochloric acid, and water for injectable preparations.

Appearance and packaging of the product

Transparent, colorless solution, free of visible particles, with a pH of 4.0-6.5.

Packaging of 50 glass ampoules of 2 ml.

Marketing authorization holder and manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua, Portugal

Tel.: +351 231 920 250

Fax: +351 231 921 055

E-mail: [email protected]

Local representative

Laphysan, S.A.U.

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D,

28108 Alcobendas (Madrid) Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal: Metoclopramida Basi

Spain: Metoclopramida Basi 5 mg/ml solution for injection and infusion

Germany: Metoclopramidhydrochlorid Basi 5 mg/ml Injektions-/Infusionslösung

Estonia: Metoclopramide Basi

Lithuania: Metoklopramido hidrochloridas monohidratas Basi 5 mg/ml injekcinis ar infuzinis tirpalas

Latvia: Metoclopramid Basi 5 mg/mL šķīdums injekcijām/infūzijām

Netherlands: Metoclopramide Basi 5 mg/mL oplossing voor injectie / infusie

Date of last revision of this leaflet:February 2023

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