PACKAGE INSERT: INFORMATION FOR THE USER

Metoclopramide Pensa 1 mg/ml Oral Solution

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Metoclopramida Pensa is an antiemetic. It contains a medication called “metoclopramida”. 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 appear after chemotherapy
• to prevent nausea and vomiting caused by radiation therapy
• to treat nausea and vomiting, including nausea and vomiting that may appear with a migraine.

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

Pediatric population

Metoclopramida 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.

Do not take Metoclopramida Pensa

• 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 may 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 treated with this medicine.
• if you have epilepsy
• if you have Parkinson's disease
• if you are taking levodopa (medicine for Parkinson's disease) or dopamine agonists (see below “Use of Metoclopramida 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 Metoclopramida Pensa to children under 1 year (see below “Children and adolescents”).

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking Metoclopramida Pensa 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 taking other medicines known to affect the way your heart beats
• you have any neurological problem (brain)
• you have problems in the liver or kidneys. Your dose may be reduced (see section 3).

Your doctor may perform blood tests to monitor your levels of blood pigments. In cases of abnormal levels (methemoglobinemia), treatment should be stopped 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

Uncontrolled movements (extrapyramidal disorders) may appear in children and young adults. This medicine should not be used in children under 1 year due to the high risk of uncontrolled movements (see above “Do not take Metoclopramida Pensa”).

Use of Metoclopramida Pensa with other medicines

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may need to take any other medicine. This is because some medicines may affect the way Metoclopramida Pensa works or Metoclopramida Pensa may affect the way other medicines work. These medicines include the following:

• levodopa or other medicines used to treat Parkinson's disease (see above “Do not take Metoclopramida Pensa”)
• anticholinergics (medicines used to relieve stomach spasms or cramps)
• morphine derivatives (medicines used to treat intense pain)
• sedatives
• any medicine used to treat mental health problems
• digoxin (medicine used to treat heart failure)
• ciclosporin (medicine used to treat some immune system problems)
• mivacurium and suxamethonium (medicines used to relax muscles)
• fluoxetine and paroxetine (medicines for depression)

Use of Metoclopramida Pensa with alcohol

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

Pregnancy and breastfeeding

Pregnancy

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

If necessary, Metoclopramida Pensa may be taken during pregnancy. Your doctor will decide whether or not to administer this medicine.

Breastfeeding

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

Driving and operating machines

After taking Metoclopramida Pensa, you may feel drowsy, dizzy or have uncontrolled movements of tics, jerks or torsion and unusual muscle tone that causes distortion of your body. This may affect your vision and also interfere with your ability to drive and operate machines.

Important information about some of the components of this medicine

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

Follow exactly the administration instructions for Metoclopramide Pensa as indicated 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 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 aged 1-18 years)

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.

Dosage Table

Use the dosing device provided in the oral solution container to administer the appropriate dose of metoclopramide.

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

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

Administration Form

Metoclopramide Pensa is administered orally.

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

Geriatric Population

It may be necessary to reduce the dose depending on kidney problems, liver problems, and general health issues.

Adults with Renal Problems

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

Adults with Hepatic 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 (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 consciousness problems, be confused, have hallucinations, and heart problems. Your doctor may prescribe 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 at tel. 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Metoclopramide Pensa

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• uncontrollable movements (which often affect the head and neck). These may appear in children and young adults and particularly when high doses are used. These signs usually appear at the beginning of treatment and may even occur after a single administration. These movements will cease when properly treated.
• high fever, high blood pressure, convulsions, sweating, salivation. These may be signs of a condition called malignant neuroleptic syndrome.
• itching and skin rash, inflammation 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, tremors, twisting movements, or muscle contractions (stiffness, rigidity)
• symptoms similar to Parkinson's disease (rigidity, tremor)
• feeling restless
• low blood pressure (particularly with intravenous administration)
• diarrhea
• feeling weak

Uncommon(may affect up to 1 in 100 people)

• elevated levels of a hormone called prolactin in the blood, which may 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 that cannot be estimated from available data)

• abnormal levels of pigments in the blood: which may 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, salivation. These may be signs of a disease called malignant neuroleptic syndrome
• changes in heartbeats, which may be seen on an ECG (electrocardiogram)
• cardiac arrest (particularly with intravenous administration)
• shock (intense drop in blood pressure) (particularly with intravenous administration)
• syncope (fainting) (particularly with intravenous administration)
• severe allergic reaction (particularly with intravenous administration)
• very high blood pressure

Reporting of adverse effects:

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

Keep this medication out of the 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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 aroma, purified water.

Appearance of the product and contents of the packaging

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.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Kern Pharma, S.L.

Polígono Ind. Colón II. c/Venus, 72

08228 Terrassa (Barcelona)

Spain

This leaflet was approved in September 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/