METOCLOPRAMIDE PENSA 1 mg/ml ORAL SOLUTION

Introduction

PROSPECTUS: INFORMATION FOR THE USER

Metoclopramide Pensa 1 mg/ml oral solution EFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus. See section 4.

Contents of the prospectus:

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. Storage of Metoclopramide Pensa
6. Package contents and additional information

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

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

Adult population

Metoclopramide Pensa is used in adults:

• to prevent delayed nausea and vomiting that may appear after chemotherapy
• to prevent nausea and vomiting caused by radiotherapy
• to treat nausea and vomiting, including nausea and vomiting that may appear with migraine.

Metoclopramide can be taken in combination with oral analgesics in the case of migraine so that the analgesics are more effective.

Pediatric population

Metoclopramide Pensa is indicated in children (1-18 years) if other treatments do not work or cannot be used to prevent delayed nausea and vomiting that may appear after chemotherapy.

2. What you need to know before taking Metoclopramide Pensa

Do not take Metoclopramide Pensa

• if you are allergic to metoclopramide or any of the other components of this medication (listed in section 6).
• if you have bleeding, obstruction, or perforation in the stomach or intestine.
• if you have or may have a rare adrenal gland tumor, which is near the kidney (pheochromocytoma).
• if you have ever had involuntary muscle spasms (tardive dyskinesia) when treated with this medication.
• if you have epilepsy
• if you have Parkinson's disease
• if you are taking levodopa (medication for Parkinson's disease) or dopaminergic agonists (see below "Use of Metoclopramide Pensa with other medications").
• if you have ever had abnormal blood pigment levels (methemoglobinemia) or NADH cytochrome b5 reductase deficiency.

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 cases 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 (prolonged QT interval) or any other heart problem.
• you have problems with salt levels in your blood, such as potassium, sodium, and magnesium.
• you are using other medications 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 monitor your blood pigment levels. In cases of abnormal levels (methemoglobinemia), treatment should be discontinued immediately and permanently.

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

Children and adolescents

Uncontrollable movements (extrapyramidal disorders) may appear in children and young adults. This medication 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 medications

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or may need to take any other medication. This is because some medications can affect the way Metoclopramide Pensa works or Metoclopramide Pensa may affect the way other medications work. These medications include:

• levodopa or other medications used to treat Parkinson's disease (see above "Do not take Metoclopramide Pensa")
• anticholinergics (medications used to relieve stomach spasms or cramps)
• opioid derivatives (medications used to treat intense pain)
• sedatives
• any medication used to treat mental health problems
• digoxin (medication used to treat heart failure)
• cyclosporine (medication used to treat some immune system problems)
• mivacurium and suxamethonium (medications used to relax muscles)
• fluoxetine and paroxetine (medications for treating depression)

Use of Metoclopramide Pensa with alcohol

Do not consume alcohol during treatment with metoclopramide because it increases the sedative effect of Metoclopramide Pensa.

Pregnancy and breastfeeding

Pregnancy

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

If necessary, Metoclopramide Pensa can be taken during pregnancy. Your doctor will decide whether or not to administer this medication.

Breastfeeding

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

Driving and using machines

After taking Metoclopramide Pensa, you may feel drowsy, dizzy, or have uncontrollable movements, tics, or muscle spasms that can affect your vision and interfere with your ability to drive and use machines.

Important information about some of the components of this medication

It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).

3. How to take Metoclopramide Pensa

Follow the administration instructions of Metoclopramide Pensa indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Dosage

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

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

The maximum treatment duration is 5 days.

• To prevent delayed nausea and vomiting that may appear after chemotherapy (children 1-18 years old)

The recommended dose is 0.1 to 0.15 mg/kg of body weight, which can be repeated up to three times a day, taken orally.

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

Dosing table

Use the dosing cap included in the package of the oral solution 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 medication for more than 5 days to prevent delayed nausea and vomiting that may appear after chemotherapy.

Method of administration

Metoclopramide Pensa is administered orally.

You should 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

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

Adults with kidney problems

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

Adults with liver problems

Inform 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 Pensa 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, tel. 91 562 04 20, indicating the medication 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 medication, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

Stop treatment and inform your doctor, pharmacist, or nurse immediately if you experience one of the following signs while taking this medication:

• uncontrollable movements (which often affect the head and neck). These can appear in children and young adults, 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, facial swelling, 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 such as tics, twitches, torsion movements, or muscle contractions (stiffness, rigidity)
• symptoms similar to Parkinson's disease (stiffness, tremors)
• feeling restless
• decreased blood pressure (particularly with intravenous administration)
• diarrhea
• feeling weak

Uncommon (may affect up to 1 in 100 people)

• high levels of a hormone called prolactin in the blood, which 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):

• confusion
• convulsions (especially in patients with epilepsy).

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

• abnormal blood pigment levels: 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 condition 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 side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Metoclopramide Pensa

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use Metoclopramide Pensa after the expiration date that appears on the packaging and on the bottle after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Metoclopramide Pensa 1 mg/ml oral solution

• The active ingredient 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 essence, lime flavor, purified water.

Appearance of the product and package contents

Metoclopramide Pensa 1 mg/ml oral solution is a solution packaged in a topaz-colored plastic bottle with 250 ml of solution and 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 prospectus was approved in September 2019

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