METOCLOPRAMIDUM 5 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Metoclopramidum 0.5% Polpharma, 5 mg/ml, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Metoclopramidum 0.5% Polpharma and what is it used for
4. Important information before using Metoclopramidum 0.5% Polpharma
   1. When not to use Metoclopramidum 0.5% Polpharma:
   2. Warnings and precautions
   3. Children and adolescents
   4. Metoclopramidum 0.5% Polpharma and other medicines
   5. Metoclopramidum 0.5% Polpharma with alcohol
   6. Pregnancy and breastfeeding
   7. Driving and operating machines
   8. Metoclopramidum 0.5% Polpharma contains sodium metabisulfite (E 223) and sodium
5. How to use Metoclopramidum 0.5% Polpharma
   1. Adults
   2. All indications (children and adolescents aged 1-18 years)
   3. Elderly patients
   4. Adults with renal impairment
   5. Adults with hepatic impairment
   6. Children and adolescents
   7. Using a higher dose of Metoclopramidum 0.5% Polpharma than recommended
   8. Missing a dose of Metoclopramidum 0.5% Polpharma
6. Possible side effects
   1. Reporting side effects
7. How to store Metoclopramidum 0.5% Polpharma
8. Package contents and other information
   1. What Metoclopramidum 0.5% Polpharma contains
   2. What Metoclopramidum 0.5% Polpharma looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Metoclopramidum 0.5% Polpharma, 5 mg/ml, solution for injection

Metoclopramide hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Metoclopramidum 0.5% Polpharma and what is it used for
• 2. Important information before using Metoclopramidum 0.5% Polpharma
• 3. How to use Metoclopramidum 0.5% Polpharma
• 4. Possible side effects
• 5. How to store Metoclopramidum 0.5% Polpharma
• 6. Package contents and other information

1. What is Metoclopramidum 0.5% Polpharma and what is it used for

Metoclopramidum 0.5% Polpharma is an antiemetic medicine. It contains the active substance called "metoclopramide". The medicine works on the part of the brain that prevents nausea and vomiting.

Adults

Metoclopramidum 0.5% Polpharma is used in adults for the following conditions:

• prevention of nausea and vomiting that may occur after surgical procedures;
• treatment of nausea and vomiting, including nausea and vomiting associated with migraine;
• prevention of nausea and vomiting associated with radiotherapy.

Children and adolescents

Metoclopramidum 0.5% Polpharma is indicated for use in children and adolescents (aged 1-18 years) only if other treatment methods have been ineffective or cannot be used:

• prevention of delayed nausea and vomiting that may occur after chemotherapy;
• treatment of nausea and vomiting that occur after surgical procedures.

2. Important information before using Metoclopramidum 0.5% Polpharma

When not to use Metoclopramidum 0.5% Polpharma:

• if the patient is allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6);
• in case of bleeding, obstruction, or perforation of the stomach or intestines;
• if the patient has a rare adrenal gland tumor located near the kidney (pheochromocytoma);
• if the patient has or has had involuntary muscle contractions (tardive dyskinesia) during treatment with medicines;
• if the patient has epilepsy;
• if the patient has Parkinson's disease;
• if the patient is taking levodopa (a medicine for Parkinson's disease) or dopamine agonists (see "Metoclopramidum 0.5% Polpharma and other medicines" below);
• if the patient has ever had abnormal blood pigment levels (methemoglobinemia) or a deficiency of NADH cytochrome b5 reductase.

Metoclopramidum 0.5% Polpharma should not be used in children under 1 year of age (see "Children and adolescents" below). If the patient experiences any of the above symptoms, they should not use Metoclopramidum 0.5% Polpharma. In case of doubts, consult a doctor, pharmacist, or nurse before using Metoclopramidum 0.5% Polpharma.

Warnings and precautions

Before starting treatment with Metoclopramidum 0.5% Polpharma, discuss it with your doctor, pharmacist, or nurse if:

• the patient has had an irregular heartbeat (QT interval prolongation) or other heart problems;
• the patient has problems with salt levels in the blood, such as potassium, sodium, or magnesium;
• the patient is taking other medicines that affect heart function;
• the patient has neurological problems (brain);
• the patient has kidney or liver problems. It may be necessary to reduce the dose (see section 3);
• the patient has had depression, especially moderate or severe, with suicidal tendencies, as metoclopramide treatment may cause a relapse of the disease;
• the patient has been diagnosed with breast cancer.

Metoclopramide causes a transient increase in aldosterone levels in the blood, which may cause fluid retention. The doctor may order a blood test to check the blood pigment level. In case of abnormal levels (methemoglobinemia), the medicine should be discontinued immediately. It is recommended to maintain a minimum 6-hour interval between doses, even in case of vomiting and rejection of the dose, to avoid overdose. Do not exceed the treatment period of 3 months due to the risk of involuntary muscle contractions.

Children and adolescents

Uncontrolled movements (extrapyramidal symptoms) may occur in children and adolescents. This medicine should not be used in children under 1 year of age due to the increased risk of uncontrolled movements (see "When not to use Metoclopramidum 0.5% Polpharma").

Metoclopramidum 0.5% Polpharma and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is important because some medicines may affect the action of Metoclopramidum 0.5% Polpharma or Metoclopramidum 0.5% Polpharma may affect the action of other medicines. In particular, inform your doctor about the use of the following medicines:

• levodopa or other medicines used to treat Parkinson's disease (see "When not to use Metoclopramidum 0.5% Polpharma");
• anticholinergic medicines (medicines used to relieve stomach cramps);
• opioid derivatives (medicines used to treat severe pain);
• sedatives;
• medicines used to treat mental problems;
• 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);
• monoamine oxidase inhibitors (MAOIs), such as phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine.

Metoclopramidum 0.5% Polpharma with alcohol

Do not consume alcohol while taking metoclopramide, as it enhances the sedative effect of Metoclopramidum 0.5% Polpharma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. If necessary, Metoclopramidum 0.5% Polpharma may be used during pregnancy. The doctor will decide on the need to use the medicine. Metoclopramidum 0.5% Polpharma is not recommended during breastfeeding, as metoclopramide passes into breast milk and may affect the baby.

Driving and operating machines

The patient may feel drowsy, dizzy, or experience uncontrolled tremors, making sudden or sharp movements, and unusual muscle tension causing body distortion after taking Metoclopramidum 0.5% Polpharma. This may cause vision disturbances and impaired ability to drive vehicles and operate machines.

Metoclopramidum 0.5% Polpharma contains sodium metabisulfite (E 223) and sodium

The medicine may rarely cause severe allergic reactions and bronchospasm. The medicine contains less than 1 mmol (23 mg) of sodium per ml, which means the medicine is considered "sodium-free".

3. How to use Metoclopramidum 0.5% Polpharma

The medicine is usually administered by a doctor or nurse - in a slow injection into a vein (over at least 3 minutes) or intramuscularly.

Adults

Treatment of nausea and vomiting, including nausea and vomiting that may occur in case of migraine, and prevention of nausea and vomiting associated with radiotherapy: the recommended single dose is 10 mg. The dose can be repeated up to three times a day. The maximum recommended daily dose is 30 mg or 0.5 mg/kg body weight. Prevention of nausea and vomiting after surgical procedures: the recommended single dose is 10 mg.

All indications (children and adolescents aged 1-18 years)

The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times a day, administered as a slow injection into a vein. The maximum daily dose is 0.5 mg/kg body weight.

Dosing table

Treatment should not last longer than 48 hours in case of treatment of nausea and vomiting after surgical procedures. Treatment should not last longer than 5 days in case of prevention of delayed nausea and vomiting after chemotherapy. Administration method. Maintain a minimum 6-hour interval between doses, even in case of vomiting and rejection of the dose.

Elderly patients

A dose reduction may be necessary depending on kidney and liver function and overall health.

Adults with renal impairment

Tell your doctor about kidney problems. In patients with moderate or severe renal impairment, the dose should be reduced.

Adults with hepatic impairment

Tell your doctor about liver problems. In patients with severe hepatic impairment, the dose should be reduced.

Children and adolescents

Metoclopramide should not be used in children under 1 year of age (see section 2).

Using a higher dose of Metoclopramidum 0.5% Polpharma than recommended

Immediately consult a doctor or pharmacist. The patient may experience uncontrolled movements (extrapyramidal symptoms), drowsiness, consciousness problems, disorientation, hallucinations, and heart problems. If necessary, the doctor will order appropriate symptomatic treatment.

Missing a dose of Metoclopramidum 0.5% Polpharma

Do not take a double dose to make up for a missed dose. If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop using this medicine and immediately inform your doctor, pharmacist, or nurse:

• uncontrolled movements (often in the head and neck area). These may occur in children and adolescents, especially with high doses. These symptoms usually occur at the beginning of treatment and may occur even after a single dose. Proper treatment will stop these movements.
• high fever, high blood pressure, seizures, sweating, salivation. These may be symptoms of a disorder called malignant neuroleptic syndrome.
• itching or skin rash, facial swelling, lip or throat swelling, difficulty breathing. These may be symptoms of a potentially severe allergic reaction.

Very common(occurring in more than 1 in 10 patients)

• drowsiness.

Common(occurring in less than 1 in 10 patients)

• depression (see section "Warnings and precautions")
• uncontrolled movements, such as tics, tremors, body twisting or muscle contractions (stiffness, rigidity)
• symptoms similar to Parkinson's disease (stiffness, tremors)
• restlessness
• anxiety, fatigue, and exhaustion
• low blood pressure (especially after intravenous administration)
• diarrhea
• weakness.

Uncommon(occurring in less than 1 in 100 patients)

• allergy
• increased levels of a hormone called prolactin in the blood, which may cause: milk production in men and non-breastfeeding women, irregular menstrual periods
• hallucinations
• acute dystonia (involuntary movements causing twisting and bending of different body parts)
• dyskinesia (uncoordinated and involuntary movements of limbs or the whole body)
• vision disturbances and involuntary eye deviation upwards
• reduced level of consciousness
• slow heart rate (especially after intravenous administration).

Rare(occurring in less than 1 in 1,000 patients)

• insomnia, disorientation
• vision disturbances
• tongue or throat swelling
• confusion
• seizures (especially in patients with epilepsy)
• headaches and dizziness
• harmful effects on the liver.

Very rare(occurring in less than 1 in 10,000 patients)

• rash, urticaria, or bronchospasm, especially in patients with a history of asthma
• decreased white blood cell count.

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

• nausea
• urinary incontinence or frequent urination
• porphyria (symptoms may include severe abdominal pain, nausea, vomiting, constipation, weakness, muscle pain, rapid heartbeat, high blood pressure, numbness, weakness of limbs, consciousness disturbances)
• abnormal blood pigment levels, which may cause skin color changes
• abnormal breast growth (gynecomastia), impotence
• involuntary muscle contractions after long-term treatment, especially in elderly patients
• high fever, high blood pressure, seizures, sweating, salivation. These may be symptoms of a disorder called malignant neuroleptic syndrome.
• rapid heartbeat or other changes in heart function, which may be visible on an ECG
• cardiac arrest (especially after intravenous administration)
• shock (severe decrease in blood pressure) (especially after intravenous administration)
• loss of consciousness (especially after intravenous administration)
• allergic reaction, which may be severe (especially after intravenous administration)
• very high blood pressure.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metoclopramidum 0.5% Polpharma

Store the medicine out of sight and reach of children. Do not store above 25°C. Store in the original packaging to protect from light. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month. The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Metoclopramidum 0.5% Polpharma contains

• The active substance of the medicine is metoclopramide hydrochloride. Each ml of solution contains 5 mg of metoclopramide hydrochloride.
• The other ingredients are: sodium metabisulfite (E 223), sodium chloride, water for injections.

What Metoclopramidum 0.5% Polpharma looks like and what the package contains

Metoclopramidum 0.5% Polpharma is a colorless and clear solution. The package contains 5 ampoules of 2 ml each.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Date of last revision of the leaflet: