Metoclopramide Pensa 1 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metoclopramide Pensa 1 mg/ml oral solution EFG

Read the entire 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 must not give it to others, even if they have the same symptoms as you, because it could 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.

Leaflet contents:

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

1. What Metoclopramida Pensa is and what it is used for

Metoclopramida Pensa is an antiemetic. It contains a medicine called "metoclopramide". It acts on an area of the brain that prevents nausea or vomiting.

Adult population

Metoclopramida Pensa is used 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 in the case of migraine to make the analgesics more effective.

Paediatric population

Metoclopramida Pensa is indicated in children (1–18 years) when other treatments are ineffective or cannot be used, to prevent delayed nausea and vomiting that may occur after chemotherapy.

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

Do not take Metoclopramide Pensa

• 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 this 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 "Taking Metoclopramide Pensa with other medicines").
• if you have ever had abnormal levels of blood pigments (methemoglobinemia) or deficiency of NADH cytochrome b5 reductase.

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

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Metoclopramide Pensa 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. Your dose may need to be reduced (see section 3).

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

You must wait at least 6 hours between each dose of metoclopramide, even if you vomit or fail to take a dose, to avoid overdose.

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

Consult your doctor or pharmacist if such symptoms occur.

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 Pensa”).

Use of Metoclopramide Pensa with other medicines

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because some medicines may affect how Metoclopramide Pensa works, or Metoclopramide Pensa 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 Pensa”)
• 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 Pensa with alcohol

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

Pregnancy and breastfeeding

Pregnancy

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

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

Breastfeeding

Metoclopramide Pensa is not recommended if you are breastfeeding, as metoclopramide passes into breast milk and may affect your baby.

Driving and using machines

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

Important information about some of the components of this medicine

May cause allergic reactions (possibly delayed) as it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).

3. How to take Metoclopramide Pensa

Follow exactly the administration instructions for Metoclopramide Pensa provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dosage

• All indications (adult patients): a single dose of 10 mg (10 ml) is recommended, which may be repeated up to three times daily.

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

The maximum duration of treatment is 5 days.

• To prevent 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 of body weight, which may be repeated up to three times daily, taken by mouth (orally).

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

Dosing table

Use the dosing cap provided in the oral solution pack to administer the correct dose of metoclopramide.

The dosing cap is graduated in ml. The correspondence with body weight is detailed in the dosing table.

Do not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.

Method of administration

Metoclopramide Pensa is administered orally.

Wait at least 6 hours between each dose of metoclopramide, even in the case of vomiting or rejection of the dose, to avoid overdose.

Elderly population

Dose 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 to 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 Pensa than you should

Contact your doctor or pharmacist immediately. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have disturbances in consciousness, confusion, hallucinations, or 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Metoclopramide Pensa

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

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

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 symptoms 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, excessive 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 sleepy

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 in women who are not breastfeeding
• Irregular periods
• Hallucinations
• Decreased 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):

• Confusion
• Seizures (especially in patients with epilepsy)

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

• Abnormal levels of pigments in the blood: which may change the color of your skin
• Abnormal breast development (gynecomastia)
• 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 severe (particularly with intravenous administration)
• Very high blood pressure

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metoclopramide Pensa

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

No special storage conditions are required.

Do not use Metoclopramide Pensa after the expiry date stated on the packaging and on the bottle 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 pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metoclopramide Pensa 1 mg/ml oral solution

• The active substance is metoclopramide. Each ml of solution contains 1 mg of metoclopramide hydrochloride.
• The other components are: hydroxyethylcellulose, sodium saccharin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), citric acid monohydrate, lemon flavor, lime aroma, purified water.

Appearance of the product and contents of the container

Metoclopramide Pensa 1 mg/ml oral solution is a solution packaged in a topaz-colored plastic bottle containing 250 ml of solution, with a 10 ml dosing cap for oral administration.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II. c/Venus, 72

08228 Terrassa (Barcelona)

Spain

This summary of product characteristics was approved in September 2019

Detailed and up-to-date 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/