Metoclopramide Basi 5 mg/ml solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metoclopramide Basi 5 mg/ml injection and infusion solution EFG

anhydrous metoclopramide hydrochloride

Read the entire 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 questions, ask your doctor, pharmacist or nurse.

• 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 could harm them.

• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Metoclopramide Basi is an antiemetic. It contains a medicine called "metoclopramide". It acts on an area of the brain to prevent nausea or vomiting.

Adult population

Metoclopramide is used in adults:

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

Paediatric 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 surgery

2. What you need to know before using Metoclopramide Basi

Do not use Metoclopramide Basi

• 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 the stomach or intestine.
• if you have or may have a rare tumor of the adrenal gland near the kidney (pheochromocytoma).
• if you have ever experienced involuntary muscle spasms (tardive dyskinesia) while being treated with a medication.
• 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 administer 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

Talk to your doctor, pharmacist, or nurse before starting to use Metoclopramide Basi 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 any neurological (brain) disorders
• you have liver or kidney problems. The dose may need to be reduced (see section 3).

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

Children and adolescents

Uncontrolled 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 uncontrolled 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 need to take any other medicines. This is because some medicines may affect how Metoclopramide Basi works, or Metoclopramide Basi may affect how 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)
• 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 disorders)
• mivacurium and suxamethonium (medicines used to relax muscles)
• fluoxetine and paroxetine (medicines used to treat depression).

Use of Metoclopramide Basi with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Metoclopramide Basi is not recommended during 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 experience uncontrolled movements such as tics, jerks, or twisting muscle contractions and unusual muscle tone causing body distortion. These effects may impair your vision and may also interfere with your ability to drive or operate machinery.

Metoclopramide Basi contains sodium

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

3. How to use Metoclopramide Basi

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

In adult patients

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

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

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

Use in children and adolescents

All indications (pediatric patients aged 1–18 years)

The recommended dose is 0.1 to 0.15 mg/kg body weight, which may be repeated up to three times daily, administered slowly into a vein.

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

Dose table

The treatment should not exceed 48 hours for the treatment of nausea and vomiting occurring after surgery.

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

Method of administration

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

Elderly population

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

Adults with renal impairment

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

Adults with hepatic impairment

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 use more Metoclopramide Basi 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, telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Metoclopramide Basi

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop treatment and inform your doctor, pharmacist or nurse immediately if you experience any of the following signs 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 signs usually appear at the beginning of treatment and may even occur after a single dose. These movements will cease when appropriately treated.
• High fever, high blood pressure, seizures, sweating, salivation. These may be signs of a condition called neuroleptic malignant syndrome.
• Itching and skin rash, swelling of the face, lips or throat, difficulty breathing. These may 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 such as tics, jerks, twisting movements or muscle contractures (stiffness, rigidity)
• Parkinsonism-like symptoms (stiffness, 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 women who are not breastfeeding
• Irregular periods
• Hallucinations
• Reduced level of consciousness
• Slow heart rate (particularly with intravenous administration)
• Allergic reaction
• Visual disturbances and involuntary deviation of the eyeball.

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

• Confusional state
• Seizures (especially in patients with epilepsy).

Frequency not known (cannot be estimated from available data)

• Abnormal levels of blood pigments: which may change the color of your skin
• Abnormal breast development (gynaecomastia)
• Involuntary muscle spasms after prolonged use, particularly in elderly patients
• High fever, high blood pressure, seizures, sweating, 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 severe (particularly with intravenous administration)
• Very high blood pressure.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse 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 adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metoclopramide Basi

Store below 30 °C.

Keep 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 stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

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

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

Do not use this medicine if you notice any change in its appearance. The product should be inspected visually before administration. Do not use a solution that is not clear or in which crystallization is visible.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your 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 Basi

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

Appearance of the product and contents of the container

Clear, colourless solution, free from visible particles, with a pH of 4.0–6.5.

Packs 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Portugal: Metoclopramide Basi

Spain: Metoclopramide Basi 5 mg/ml injectable and infusion solution

Germany: Metoclopramide Hydrochloride Basi 5 mg/ml Injection/Infusion Solution

Estonia: Metoclopramide Basi

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

Latvia: Metoclopramid Basi 5 mg/mL škidums injekcijam/ infuzijam

Netherlands: Metoclopramide Basi 5 mg/mL solution for injection / infusion

Date of the most recent revision of this leaflet: February 2023

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