Metoclopramide hameln

Leaflet attached to the packaging: patient information

Metoclopramide hameln, 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, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Metoclopramide hameln and what is it used for
• 2. Important information before using Metoclopramide hameln
• 3. How to use Metoclopramide hameln
• 4. Possible side effects
• 5. How to store Metoclopramide hameln
• 6. Contents of the packaging and other information

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

Metoclopramide hameln 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
Metoclopramide hameln is used in adults for:

• preventing nausea and vomiting that may occur after surgical procedures;
• treating nausea and vomiting, including nausea and vomiting associated with migraine;
• preventing nausea and vomiting associated with radiotherapy.

Children and adolescents
Metoclopramide hameln is indicated for use in children (aged 1-18 years) only if other
treatment methods have proven ineffective or cannot be used for:

• preventing delayed nausea and vomiting that may occur after chemotherapy;
• treating nausea and vomiting that occur after surgical procedures.

2. Important information before using Metoclopramide hameln

When not to use Metoclopramide hameln

• 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 (late dyskinesia) while taking medications.
• 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 "Metoclopramide hameln and other medicines" below).
• if the patient has ever had abnormal blood pigment (methemoglobinemia) or a deficiency of NADH cytochrome b5 reductase.

Metoclopramide hameln must not be used in children under 1 year of age (see "Children and adolescents" below).

Warnings and precautions

Before starting treatment with Metoclopramide hameln, the patient should discuss with their doctor,
pharmacist, or nurse:

• if the patient has a history of irregular heart rhythm (prolonged QT interval) or other heart problems.
• if the patient has electrolyte imbalances, such as potassium, sodium, or magnesium.
• if the patient is taking other medicines that affect heart function.
• if the patient has neurological disorders (brain).
• if the patient has kidney or liver disorders. The dose may need to be reduced (see section 3).

The doctor may order a blood test to check the level of blood pigment. If the levels are abnormal (methemoglobinemia), treatment with this medicine should be stopped immediately.
Treatment should not be continued for more than 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 must not be used in children under 1 year of age due to the increased risk of
uncontrolled movements (see above: "When not to use Metoclopramide hameln")

Metoclopramide hameln and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or
have recently taken, as well as any medicines they plan to take. This is important because some
medicines may affect the action of Metoclopramide hameln or Metoclopramide hameln may affect the
action of other medicines.
In particular, the patient should inform their doctor if they are taking any of the following medicines:

• levodopa or other medicines used to treat Parkinson's disease (see: "When not to use Metoclopramide hameln")
• anticholinergic medicines (used to relieve cramps or spasms of the stomach)
• opioid derivatives (used to treat severe pain)
• sedatives
• medicines used to treat mental disorders
• digoxin (used to treat heart failure)
• cyclosporine (used to treat certain immune system disorders)
• mivacurium and suxamethonium (used to relax muscles)
• fluoxetine and paroxetine (used to treat depression)
• rifampicin, a medicine used to treat tuberculosis or other infections, may reduce the level of metoclopramide in the blood if taken at the same time.

Metoclopramide hameln with alcohol

During treatment with metoclopramide, the patient should not drink alcohol, as it enhances the
sedative effect of Metoclopramide hameln.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child,
they should consult their doctor or pharmacist before using this medicine.
If necessary, Metoclopramide hameln may be used during pregnancy. The doctor will decide on the
necessity of using the medicine.
Breastfeeding
It is not recommended to use Metoclopramide hameln during breastfeeding, as metoclopramide passes
into breast milk and may affect the baby.

Driving and using machines

The patient may feel drowsy, dizzy, or experience uncontrolled movements or may make sudden or
jerky movements and may have unusual muscle tension causing distortion of body position after
taking Metoclopramide hameln. This may cause impaired vision and ability to drive vehicles and
operate machines.

Metoclopramide hameln contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule (2 ml), i.e., the medicine is
considered "sodium-free".

3. How to use Metoclopramide hameln

The medicine is usually administered by a doctor or nurse. It should be administered as a slow
intravenous injection (over at least 3 minutes) or intramuscular injection.

Use in adults

Treatment of nausea and vomiting, including nausea and vomiting associated with migraine, and
prevention of nausea and vomiting associated with radiotherapy:
the recommended single dose is 10 mg. The dose can be repeated up to 3 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.
Use in children and adolescents (aged 1 to 18 years)(in all indications)
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 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 be longer than 48 hours in the case of nausea and vomiting after surgical
procedures.
Treatment should not be longer than 5 days in the case of prevention of delayed nausea and vomiting
that may occur after chemotherapy.

Children and adolescents

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

Elderly

The dose may need to be reduced depending on kidney and liver function and overall health.

Adults with kidney disorders

The patient should inform their doctor about kidney problems. In patients with moderate or severe
kidney disorders, the dose should be reduced.

Adults with liver disorders

The patient should inform their doctor about liver problems. In patients with severe liver disorders,
the dose should be reduced.

Using a higher dose of Metoclopramide hameln than recommended

The patient should immediately contact their doctor or pharmacist. The patient may experience
uncontrolled movements (extrapyramidal symptoms), drowsiness, decreased level of consciousness,
disorientation, hallucinations, and cardiovascular and respiratory disorders (cardiac arrest and
respiratory arrest).
If necessary, the doctor will order appropriate symptomatic treatment.

Missing a dose of Metoclopramide hameln

The patient should not take a double dose to make up for a missed dose.
In case of any doubts about using this medicine, the patient should contact their doctor, pharmacist, or
nurse.

4. Possible side effects

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

• Uncontrolled movements (often in the head and neck area). These can occur in children and adolescents and young adults, especially when using high doses. These symptoms usually occur at the beginning of treatment and can occur even after a single dose. Proper treatment will stop these movements.
• High fever, high blood pressure, seizures, excessive sweating, excessive salivation. These may be symptoms of a condition called malignant neuroleptic 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 side effects(occurring in more than 1 in 10 patients) include:

• drowsiness

Common side effects(occurring in less than 1 in 10 patients) include:

• depression
• uncontrolled movements, such as tics, tremors, twisting of the body, or muscle contractions (stiffness, rigidity)
• symptoms similar to those of Parkinson's disease (stiffness, tremors)
• restlessness
• decreased blood pressure (especially after intravenous administration)
• diarrhea
• weakness

Uncommon side effects(occurring in less than 1 in 100 patients) include:

• increased level of a hormone called prolactin in the blood, which can cause milk production in men and non-breastfeeding women
• irregular menstrual periods
• vision disturbances and involuntary deviation of the eyeball upwards
• hallucinations
• decreased level of consciousness
• slow heart rate (especially after intravenous administration)
• allergic reactions

Rare side effects(occurring in less than 1 in 1000 patients)

• confusion
• seizures (especially in patients with epilepsy)

Side effects with unknown frequency(frequency cannot be estimated from available data):

• presence of abnormal blood pigment, which can cause skin discoloration
• abnormal breast growth (gynecomastia)
• involuntary muscle contractions after long-term treatment, especially in elderly patients
• high fever, high blood pressure, seizures, excessive sweating, excessive salivation
• changes in heart function, which can be seen 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 can be severe (especially after intravenous administration)
• sudden increase in blood pressure in patients with an adrenal gland tumor located near the kidney (pheochromocytoma)
• very high blood pressure
• suicidal thoughts

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they
should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the
Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of
Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: 22 49 21 301,
Fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Metoclopramide hameln

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label or carton after EXP. The expiry
date refers to the last day of the month.

There are no special instructions for the storage temperature of the medicinal product.

Store the ampoules in the outer packaging to protect them from light.

Medicines should not be disposed of via wastewater or household waste. The patient should ask
their pharmacist how to dispose of medicines that are no longer needed. This will help protect the
environment.

6. Contents of the packaging and other information

What Metoclopramide hameln contains

• The active substance is metoclopramide hydrochloride. Each 1 ml of solution contains metoclopramide hydrochloride monohydrate equivalent to 5 mg of metoclopramide hydrochloride.
• The other ingredients are: sodium chloride, citric acid monohydrate, sodium citrate, hydrochloric acid or sodium hydroxide (to adjust pH) and water for injections.

What Metoclopramide hameln looks like and contents of the pack

Metoclopramide hameln is a clear, colorless solution, free from visible particles, supplied in 2 ml
ampoules made of neutral glass type I.
Each pack contains 10 ampoules.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

hameln pharma gmbh, Inselstraße 1, 31787 Hameln, Germany

Manufacturer/Importer:

Siegfried Hameln GmbH, Langes Feld 13, 31789 Hameln, Germany
hameln rds s.r.o., Horná 36, 900 01 Modra, Slovakia
Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Poland

This medicinal product is authorized in the Member States of the European Economic Area under
the following names:

Date of last revision of the leaflet:2024-08-25
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Information intended for healthcare professionals only:

PREPARATION INSTRUCTIONS

Metoclopramide hameln, 5 mg/ml, solution for injection To obtain full information about the medicine, please refer to the Summary of Product Characteristics.

Administration

The solution should be administered intravenously or intramuscularly.
Intravenous administration should be as a slow bolus (lasting at least 3 minutes).

Storage

There are no special instructions for the storage temperature of the medicinal product.

Store the ampoules in the outer packaging to protect them from light.