Metoclopramidum Polpharma

Package Leaflet: Information for the Patient

Metoclopramidum Polpharma, 10 mg, Tablets

Metoclopramidi hydrochloridum

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Metoclopramidum Polpharma and what is it used for
• 2. Important information before taking Metoclopramidum Polpharma
• 3. How to take Metoclopramidum Polpharma
• 4. Possible side effects
• 5. How to store Metoclopramidum Polpharma
• 6. Contents of the pack and other information

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

Metoclopramidum 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 Polpharma is used in adults for the following conditions:

• prevention of delayed nausea and vomiting that may occur after chemotherapy;
• prevention of nausea and vomiting associated with radiotherapy;
• treatment of nausea and vomiting, including nausea and vomiting associated with migraine. Metoclopramide may be used in combination with oral painkillers for migraine, to increase the pain-relieving effect.

Adolescents
Metoclopramidum Polpharma is indicated for use in adolescents (aged 15 to 18 years),
only if other treatment methods have been ineffective or cannot be used to prevent nausea and vomiting that may occur after chemotherapy.

2. Important information before taking Metoclopramidum Polpharma

When not to take Metoclopramidum Polpharma:

• if you are 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 you have a rare tumor of the adrenal gland located near the kidney (pheochromocytoma);
• if you have had involuntary muscle contractions (late dyskinesia) in the past, while taking medications;
• if you have epilepsy;
• if you have Parkinson's disease;
• if you are taking levodopa (a medicine for Parkinson's disease) or dopamine agonists (see “Metoclopramidum Polpharma and other medicines” below);
• if you have ever had abnormal blood pigment levels (methemoglobinemia) or a deficiency of NADH cytochrome b5 reductase.

Metoclopramidum Polpharma should not be used in children under 1 year of age (see “Children and adolescents” below).
If you experience any of the above symptoms, do not take Metoclopramidum Polpharma. If in doubt, consult your doctor, pharmacist or nurse before taking Metoclopramidum Polpharma.

Warnings and precautions

Before starting treatment with Metoclopramidum Polpharma, discuss with your doctor or pharmacist if:

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

Metoclopramide causes a transient increase in aldosterone levels in the blood, which may cause fluid retention.
Your doctor may order a blood test to check your blood pigment levels. If the levels are abnormal (methemoglobinemia), the medicine should be stopped immediately.
A minimum interval of 6 hours should be observed 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 take Metoclopramidum Polpharma”).

Metoclopramidum 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 Polpharma or Metoclopramidum 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 take Metoclopramidum 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 Polpharma with alcohol

Do not drink alcohol while taking metoclopramide, as it increases the sedative effect of Metoclopramidum Polpharma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, Metoclopramidum Polpharma may be used during pregnancy. The doctor will decide whether to use the medicine.
Metoclopramidum Polpharma is not recommended during breastfeeding, as metoclopramide passes into breast milk and may affect the baby.

Driving and using machines

You may feel drowsy, dizzy or have uncontrolled tremors, perform sudden or twisting movements and unusual muscle tension causing body distortion after taking Metoclopramidum Polpharma. This may cause impaired vision and ability to drive and use machines.

Metoclopramidum Polpharma contains lactose monohydrate

Each tablet contains 50 mg of lactose monohydrate.
If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Metoclopramidum Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

All indications (adult patients)

The recommended single dose is 10 mg, repeated up to three times a day.
The maximum recommended daily dose is 30 mg or 0.5 mg/kg body weight.
The maximum recommended treatment duration is 5 days.

Prevention of delayed nausea and vomiting after chemotherapy (adolescents aged 15 to 18 years)

The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times a day (orally).
The maximum daily dose is 0.5 mg/kg body weight.
In adolescents aged 15 to 18 years with a body weight over 60 kg, 1 tablet of 10 mg is given orally up to three times a day.
The medicine should be used for a maximum of 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.
Metoclopramidum Polpharma tablets are not a suitable formulation for use in children with a body weight below 61 kg. For this patient group, other pharmaceutical forms/strengths of the product should be used.
Administration method
A minimum interval of 6 hours should be observed 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.
Other pharmaceutical forms and strengths may be more suitable for this patient group.

Adult patients with renal impairment

Tell your doctor if you have kidney problems. In patients with moderate or severe renal impairment, the dose should be reduced.
Other pharmaceutical forms and strengths may be more suitable for this patient group.

Adult patients with hepatic impairment

Tell your doctor if you have liver problems. In patients with severe hepatic impairment, the dose should be reduced.
Other pharmaceutical forms and strengths may be more suitable for this patient group.

Children and adolescents

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

Overdose of Metoclopramidum Polpharma

Contact your doctor or pharmacist immediately. The patient may experience uncontrolled movements (extrapyramidal symptoms), drowsiness, consciousness disorders, disorientation, hallucinations and heart problems. If necessary, the doctor will prescribe appropriate symptomatic treatment.

Missed dose of Metoclopramidum Polpharma

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask 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 taking this medicine and tell your doctor, pharmacist or nurse immediately:

• uncontrolled movements (often in the head and neck area). They may occur in children and adolescents, especially when using 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(may affect more than 1 in 10 people)

• drowsiness.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• allergic reaction
• increased levels of a hormone called prolactin in the blood, which may cause: milk production in men and in 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 disorders and involuntary eye deviation upwards
• reduced level of consciousness
• slow heart rate (especially after intravenous administration).

Rare(may affect up to 1 in 1,000 people)

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

Very rare(may affect less than 1 in 10,000 people)

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

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

• nausea
• urinary incontinence or frequent urination
• porphyria (its symptoms may include severe abdominal pain, nausea, vomiting, constipation, weakness, muscle pain, rapid heart rate, high blood pressure, numbness, weakness of limbs, consciousness disorders)
• 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 heart rate 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 not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Polpharma

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package to protect from light and moisture.
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 month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means 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. Contents of the pack and other information

What Metoclopramidum Polpharma contains

• The active substance of the medicine is metoclopramide hydrochloride. Each tablet contains 10 mg of metoclopramide hydrochloride.
• The other ingredients are: lactose monohydrate, potato starch, povidone K-25, magnesium stearate.

What Metoclopramidum Polpharma looks like and contents of the pack

White, round, biconvex tablets with the inscription “M” on one side, with a diameter of 6 mm.
The tablets are packaged in blisters in a pack.
The pack contains 10, 15, 50 tablets.

Marketing authorization holder and manufacturer

Pharmaceutical Works POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the package leaflet: