Metoclopramide 0,5% polpharma

Package leaflet: Information for the patient

Metoclopramidum 0.5% Polpharma, 5 mg/ml, solution for injection
Metoclopramidi hydrochloridum
Please read all of this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of the leaflet

1. What Metoclopramidum 0.5% Polpharma is and what it is 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. Contents of the pack and other information

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

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

Adults
Metoclopramidum 0.5% Polpharma is used in adults in the following cases:

• 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 when other treatment methods have proven ineffective or cannot be used:

• prevention of delayed nausea and vomiting that may occur after chemotherapy;
• treatment of nausea and vomiting occurring 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 tumour located near the kidney (pheochromocytoma);
• if the patient currently has or has previously had involuntary muscle spasms (tardive dyskinesia) while taking 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 experienced abnormal levels of blood pigment (methemoglobinemia) or deficiency of NADH-cytochrome b5 reductase.

Metoclopramidum 0,5% Polpharma must not be used in children under 1 year of age (see "Children and adolescents" below).
If any of the above symptoms occur in the patient, Metoclopramidum 0,5% Polpharma must not be used.
In case of doubt, consult a doctor, pharmacist or nurse before using Metoclopramidum 0,5% Polpharma.

Warnings and precautions

Before starting treatment with Metoclopramidum 0,5% Polpharma, discuss with your doctor, pharmacist or nurse if:

• the patient has previously had irregular heartbeat (prolonged QT interval) or other heart problems;
• the patient has electrolyte imbalances in the blood, such as potassium, sodium or magnesium;
• the patient is taking other medicines that affect heart function;
• the patient has neurological (brain) disorders;
• the patient has kidney or liver problems. A dose reduction may be necessary (see section 3);
• the patient has a history of depression, especially moderate to severe depression with suicidal tendencies, as treatment with metoclopramide may lead to recurrence of the illness;
• the patient has been diagnosed with breast cancer.

Metoclopramide causes a transient increase in plasma aldosterone concentration, which may lead to fluid retention.
The doctor may order a blood test to check blood pigment levels. If abnormal levels are detected (methemoglobinemia), the medicine must be discontinued immediately.
At least a six-hour interval must be maintained between doses, even if vomiting occurs and the dose is expelled, to avoid overdose.
Do not exceed a treatment duration of 3 months due to the risk of developing involuntary muscle spasms.

Children and adolescents

Uncontrolled movements (extrapyramidal symptoms) may occur in children and adolescents. This medicine must not be used in children under 1 year of age due to 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 currently 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 if you are taking 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);
• morphine derivatives (medicines used to treat severe pain);
• sedatives;
• medicines used to treat psychiatric disorders;
• 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), e.g. phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine.

Metoclopramidum 0,5% Polpharma and alcohol

Do not consume alcohol while taking metoclopramide, as alcohol enhances the sedative effect of Metoclopramidum 0,5% Polpharma.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine. If necessary, Metoclopramidum 0,5% Polpharma may be used during pregnancy. The doctor will decide whether treatment is required.

Metoclopramidum 0,5% Polpharma is not recommended during breastfeeding because metoclopramide passes into breast milk and may affect the infant.

Driving and operating machinery

The patient may experience drowsiness, dizziness, uncontrolled tremors, sudden or twisting movements, and unusual muscle tension causing body distortion after taking Metoclopramidum 0,5% Polpharma. This may impair vision and the ability to drive or operate machinery.

Metoclopramidum 0,5% Polpharma contains sodium metabisulfite (E 223) and sodium

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

3. How to use Metoclopramidum 0,5% Polpharma

The medicine is usually administered by a doctor or nurse—as a slow intravenous injection (over at least 3 minutes) or intramuscularly.
Adults
Treatment of nausea and vomiting, including nausea and vomiting associated with migraine, and prevention of nausea and vomiting related to radiotherapy: the recommended single dose is 10 mg. The dose may 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 intravenous injection.
The maximum daily dose is 0.5 mg/kg body weight.
Dosing table

Treatment should not last longer than 48 hours for the treatment of nausea and vomiting following surgical procedures.
Treatment should not last longer than 5 days for the prevention of delayed nausea and vomiting after chemotherapy.
Method of administration
At least a six-hour interval should be maintained between doses, even if vomiting occurs and the dose is expelled.
Elderly patients
Dose reduction may be necessary depending on renal and hepatic function and general health status.
Adults with renal impairment
Inform your doctor about any kidney problems. The dose should be reduced in patients with moderate or severe renal impairment.
Adults with hepatic impairment
Inform your doctor about any liver problems. The dose should be reduced in patients with severe hepatic impairment.
Children and adolescents
Metoclopramide must not be used in children under 1 year of age (see section 2).
Use of a higher than recommended dose of Metoclopramidum 0,5% Polpharma
Contact your doctor or pharmacist immediately. The patient may experience uncontrolled movements (extrapyramidal symptoms), drowsiness, consciousness disturbances, disorientation, hallucinations, and cardiac problems. If necessary, the doctor will prescribe appropriate symptomatic treatment.
Missed dose of Metoclopramidum 0,5% Polpharma
Do not use a double dose to make up for a missed dose.
If you have any further questions concerning the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If any of the following adverse symptoms occur, stop using this medicine immediately and inform your doctor, pharmacist or nurse without delay:

• Uncontrolled movements (often around the head and neck). These may occur in children and adolescents, especially when high doses are used. These symptoms usually occur at the beginning of treatment and may appear even after a single dose. Appropriate treatment will stop these movements.
• High fever, high blood pressure, seizures, sweating, salivation. These may be symptoms of a disorder called neuroleptic malignant syndrome.
• Itching or skin rash, swelling of the face, lips or throat, difficulty breathing. These may be potentially severe symptoms of an allergic reaction.

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

• Drowsiness.

Common (occurs in less than 1 in 10 patients)

• Depression (see section “Warnings and precautions”)
• Uncontrolled movements such as tics, tremors, twisting of the body or muscle spasms (stiffness, rigidity)
• Parkinsonism-like symptoms (stiffness, tremor)
• Motor restlessness
• Anxiety, fatigue and weakness
• Low blood pressure (especially after intravenous administration)
• Diarrhea
• Weakness.

Uncommon (occurs in less than 1 in 100 patients)

• Hypersensitivity
• Increased blood levels of a hormone called prolactin, which may cause: milk production in men and in women who are not breastfeeding
• Irregular menstruation
• Hallucinations
• Acute dystonia (involuntary movements causing twisting and posturing of various body parts)
• Dyskinesia (incoordinated and involuntary movements of limbs or entire body)
• Visual disturbances and involuntary upward deviation of the eyeball
• Reduced level of consciousness
• Slow heart rate (especially after intravenous administration).

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

• Insomnia, disorientation
• Visual disturbances
• Swelling of the tongue or larynx
• Confusion
• Seizures (especially in patients with epilepsy)
• Headaches and dizziness
• Harmful effects on the liver.

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

• Rash, urticaria or bronchospasm, especially in patients with a history of bronchial 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, limb weakness, disturbances of consciousness)
• Abnormal blood pigment levels, which may cause skin discoloration
• Abnormal breast enlargement (gynaecomastia), impotence
• Involuntary muscle contractions after long-term treatment, particularly in elderly patients
• High fever, high blood pressure, seizures, sweating, salivation. These may be symptoms of a disorder called neuroleptic malignant syndrome.
• Rapid heartbeat or other heart rhythm changes, which may be visible on ECG
• Circulatory arrest (especially after intravenous administration)
• Shock (severe drop 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 of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Metoclopramidum 0,5% Polpharma

Keep this 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 stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Metoclopramidum 0,5% Polpharma contains

• The active substance is metoclopramide hydrochloride. Each ml of solution contains 5 mg of metoclopramide hydrochloride.
• Other components are: sodium metabisulphite (E 223), sodium chloride, water for injections.

What Metoclopramidum 0,5% Polpharma looks like and contents of the pack
Metoclopramidum 0,5% Polpharma is a colourless and clear solution.
The pack contains 5 ampoules with 2 ml each.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01