Metoclopramide hydrochloride Noridem

PACKAGE LEAFLET

Package leaflet: Information for the user

Metoclopramide Hydrochloride Noridem 5 mg/ml Solution for Injection

metoclopramide hydrochloride monohydrate
Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Metoclopramide Hydrochloride Noridem is and what it is used for
2. What you need to know before taking Metoclopramide Hydrochloride Noridem
3. How Metoclopramide Hydrochloride Noridem is administered
4. Possible side effects
5. How to store Metoclopramide Hydrochloride Noridem
6. Package contents and other information

1. What Metoclopramide Hydrochloride Noridem is and what it is used for

Metoclopramide Hydrochloride Noridem is an antiemetic. It contains the active substance metoclopramide.
It works on a part of the brain that prevents you from feeling sick (nausea) or being sick (vomiting).
Metoclopramide Hydrochloride Noridem is used in adults for:
preventing nausea and vomiting that may occur after surgery
treatment of nausea and vomiting, including nausea and vomiting occurring
during a migraine
prevention of nausea and vomiting caused by radiotherapy

Metoclopramide Hydrochloride Noridem is used in children and adolescents (aged 1–18 years) only if other
treatments do not work or cannot be used:
prevention of delayed nausea and vomiting that may occur after chemotherapy
treatment of nausea and vomiting that have occurred after surgery

2. What you need to know before taking Metoclopramide hydrochloride Noridem

Do not take Metoclopramide hydrochloride Noridem if
you are allergic to metoclopramide hydrochloride monohydrate or to any of the other ingredients of
this medicine (listed in section 6);
you have bleeding, an obstruction, or a perforation in your stomach or intestine;
you have a confirmed or suspected tumour of the adrenal glands located next to the kidneys
(phaeochromocytoma);
you have previously experienced involuntary muscle spasms (tardive dyskinesia) after taking
medicines;
you suffer from epilepsy;
you have Parkinson's disease;
you are taking levodopa (a medicine used to treat Parkinson's disease) or dopaminergic agonists
(see below "Other medicines and Metoclopramide hydrochloride Noridem");
you have previously had abnormal levels of pigment in your blood (methaemoglobinaemia) or NADH
cytochrome-b5 deficiency.
Do not administer Metoclopramide hydrochloride Noridem to children under 1 year of age (see below
"Children and adolescents").

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Metoclopramide hydrochloride Noridem if:
you have a history of abnormal heartbeats (prolonged QT interval) or any other heart condition;
you have problems with salt levels in your blood, such as potassium, sodium, or magnesium;
you are taking other medicines known to affect the way your heart beats;
you have any neurological (brain-related) problems;
you have liver or kidney problems. Your dose may need to be reduced (see section 3).

Your doctor may perform blood tests to monitor levels of pigment in your blood. If abnormal levels are detected (methaemoglobinaemia), treatment must be stopped immediately and permanently.

Children and adolescents
In children and adolescents, uncontrolled movements (extrapyramidal disorders) may occur. This medicine must not be used in children under 1 year of age due to an increased risk of uncontrolled movements (see above "Metoclopramide hydrochloride Noridem must not be administered if").

Other medicines and Metoclopramide hydrochloride Noridem
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because some medicines may affect the action of Metoclopramide hydrochloride Noridem, or Metoclopramide hydrochloride Noridem may affect the action of other medicines. These include:
levodopa or other medicines used to treat Parkinson's disease (see above "Metoclopramide hydrochloride Noridem must not be administered if");
anticholinergics (medicines used to relieve stomach cramps or spasms);
morphine derivatives (medicines used to treat severe pain);
sedative medicines;
any medicine used to treat mental health conditions;
digoxin (a medicine used to treat heart failure);
cyclosporine (a medicine used to treat certain immune system disorders);
mivacurium and suxamethonium (medicines used in anaesthesia to relax muscles);
fluoxetine and paroxetine (medicines used to treat depression).

Metoclopramide hydrochloride Noridem and alcohol
You must not consume alcohol during treatment with metoclopramide, as it increases the sedative effect of Metoclopramide hydrochloride Noridem.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Metoclopramide hydrochloride Noridem may be used during pregnancy if necessary. Your doctor will decide whether this medicine should be administered.
Metoclopramide hydrochloride Noridem is not recommended if you are breastfeeding, as metoclopramide passes into breast milk and may affect the infant.

Driving and using machines
After receiving Metoclopramide hydrochloride Noridem, you may feel drowsy, dizzy, or experience contractions, spasms, uncontrolled movements, or abnormal muscle tone leading to body distortions. These effects may impair your vision and could interfere with your ability to drive or operate machinery.

Metoclopramide hydrochloride Noridem contains sodium
Each ml contains 3.35 mg (0.1455 mmol) of sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially "sodium-free".

3. How Metoclopramide Hydrochloride Noridem is administered

The medicine will normally be administered to you by a doctor or nurse. It will be given by slow intravenous injection (over at least 3 minutes) or by intramuscular injection.

Use in adults
For the treatment of nausea and vomiting, including nausea and vomiting that may occur during migraine, and for the prevention of nausea and vomiting caused by radiotherapy: the recommended single dose is 10 mg, repeated up to 3 times a day.
The maximum recommended daily dose is 30 mg or 0.5 mg/kg body weight.
For the prevention of postoperative nausea and vomiting: a single dose of 10 mg is recommended.

Use in children and adolescents aged between 1 and 18 years (all indications)
The recommended dose is between 0.1 and 0.15 mg/kg body weight, repeated up to 3 times a day, administered by slow intravenous injection.
The maximum dose in 24 hours is 0.5 mg/kg body weight.

Dosage table
Age Body weight Dose Frequency
1-3 years 10-14 kg 1 mg Up to 3 times a day
3-5 years 15-19 kg 2 mg Up to 3 times a day
5-9 years 20-29 kg 2.5 mg Up to 3 times a day
9-15 years 30-60 kg 5 mg Up to 3 times a day
15-18 years Over 60 kg 10 mg Up to 3 times a day

Treatment should not exceed 48 hours for the treatment of postoperative nausea and vomiting.
Treatment should not exceed 5 days for the prevention of delayed nausea and vomiting that may occur after chemotherapy.

Use in elderly patients
Dose reduction may be necessary depending on renal, hepatic and general health status.
Other pharmaceutical forms might be more appropriate for administration.

Use in adults with renal problems
Consult your doctor if you have kidney problems. The dose should be reduced if you have moderate or severe renal impairment.
Other pharmaceutical forms might be more appropriate for administration.

Use in adults with liver problems
Consult your doctor if you have liver problems. The dose should be reduced if you have moderate or severe hepatic impairment.
Other pharmaceutical forms might be more appropriate for administration.

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

If you are given more Metoclopramide Hydrochloride Noridem than you should
Contact your doctor or pharmacist immediately. You may experience uncontrollable movements (extrapyramidal symptoms), drowsiness, disturbances in consciousness, confusion, hallucinations and heart problems. If necessary, your doctor may prescribe treatment for these symptoms.

If you forget to take Metoclopramide Hydrochloride Noridem
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment and contact your doctor, pharmacist, or nurse immediately
if you experience any of the following symptoms while taking this medicine:
uncontrolled movements (often affecting the head or neck). These may occur in children or young adults, particularly when high doses are used. These symptoms usually occur at the beginning of treatment and may even appear after a single dose. These movements will stop if treated appropriately.
high fever, high blood pressure, seizures (fits), sweating, excessive saliva production. These may be symptoms of a condition called neuroleptic malignant syndrome.
itching or skin rashes, swelling 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)
drowsiness

Common (may affect up to 1 in 10 people)
depression
uncontrolled movements such as tics, tremors, twisting movements or muscle contractions (soreness, stiffness)
Parkinsonism-like symptoms (stiffness, tremor)
feeling restless
decrease in blood pressure (particularly with intravenous administration)
diarrhoea
feeling weak

Uncommon (may affect up to 1 in 100 people)
increased levels of a hormone called prolactin in the blood, which may cause: milk production in men and women who are not breastfeeding
irregular menstrual periods
hallucinations
decreased level of consciousness
slow heart rate (particularly with intravenous administration)
allergic reaction
vision disorders and involuntary deviation of the eyeball

Rare (may affect up to 1 in 1,000 people)
confusional state
seizures (especially in patients with epilepsy)

Not known (frequency cannot be estimated from the available data)
abnormal levels of pigment in the blood: may change skin colour
abnormal breast development (gynaecomastia)
involuntary muscle spasms after prolonged use, particularly in elderly patients
high fever, high blood pressure, seizures, sweating, excessive saliva production. These may be signs of a condition called neuroleptic malignant syndrome
changes in heart rhythm, which may be shown on an ECG test
cardiac arrest (particularly with injection route)
shock (severe drop in blood pressure) (particularly with injection route)
fainting (particularly with intravenous administration)
allergic reaction that may be severe (particularly with intravenous administration)
very high blood pressure
suicidal ideation

If you experience any side effect, contact your doctor, pharmacist, or nurse. This includes any side effect not listed in this leaflet.

Reporting of side effects
If you experience any side effect, contact your doctor, pharmacist, or nurse. This includes any possible side effect not listed in this leaflet. You can also report side effects directly via
Website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metoclopramide hydrochloride Noridem

Keep this medicine out of the sight and reach of children.
Store the vials in their pouch and outer carton to protect them from light.
This medicine does not require any special storage temperature.
After first opening:
Use within 2 months if the vials are stored without the pouch.
After reconstitution/dilution: Chemical and physical stability of mixtures with 0.9% sodium chloride, 5% glucose, Ringer's lactate, and 4% glucose in 0.18% sodium chloride is maintained for 48 hours at 15–25°C under artificial light and for 48 hours at 5 (± 3)°C, at a concentration of Metoclopramide hydrochloride Noridem 0.1 mg/ml.
From a microbiological standpoint, unless the opening method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the duration and conditions of storage during use are the responsibility of the user.
Do not use this medicine after the expiry date stated on the pouch and carton after “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Metoclopramide Hydrochloride Noridem contains

• The active substance is metoclopramide hydrochloride monohydrate. Each ml of solution contains 5.27 mg of metoclopramide hydrochloride monohydrate, equivalent to 5 mg of anhydrous metoclopramide hydrochloride.
• The other ingredients are sodium chloride, sodium hydroxide and/or hydrochloric acid, and water for injections.

Description of the appearance of Metoclopramide Hydrochloride Noridem and contents of the pack
Metoclopramide Hydrochloride 5 mg/ml solution for injection is a clear, colourless injectable solution.
Polypropylene vials containing 2 ml of solution, packed in boxes of 5, 10 (2 x 5), 20 (4 x 5),
50 (10 x 5) or 60 (12 x 5) vials.
Each set of 5 vials is wrapped in a protective pouch.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Noridem Enterprises Limited
Evagorou & Makariou, Mitsi Building 3, Office 115,
1065 Nicosia, Cyprus

Manufacturer:
DEMO S.A., Pharmaceutical Industry
21st km National Road Athens – Lamia, 14568 Krioneri Attiki, Greece
Τ: +30 210 8161802, F: +30 210 8161587.

This medicinal product is authorised in the European Economic Area countries with the following names:

This patient information leaflet was last updated on
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The following information is intended exclusively for healthcare professionals:
Preparation and handling

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products,
except the following solutions:

• 0.9% sodium chloride solution,
• 5% dextrose,
• Ringer's lactate solution,
• 4% dextrose in 0.18% sodium chloride at a final concentration of Metoclopramide hydrochloride Noridem 0.1 mg/ml.

Dosage and administration
All indications (adult patients)
For dosage, refer to section 3 of the package leaflet.
The duration of injectable treatment should be as short as possible, and transition to oral or rectal treatment
should be carried out as soon as possible.
Frequency of administration:
A minimum interval of 6 hours must be maintained between two administrations, even in case of vomiting
or rejection of the dose.

Special populations
Elderly:
In elderly patients, dose reduction should be considered based on renal and hepatic function and overall frailty.

Renal impairment:
In patients with end-stage renal disease (creatinine clearance < 15 ml/min), the daily dose should be reduced by 75%.
In patients with moderate to severe renal impairment (creatinine clearance 15–60 ml/min), the dose should be reduced by 50%.

Hepatic impairment:
In patients with severe hepatic impairment, the dose should be reduced by 50%.
Alternative dosage forms may be more appropriate for treating these populations.

Paediatric population:
Metoclopramide is contraindicated in children under 1 year of age.

Disposal
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

Overdose
Symptoms
Extrapyramidal disorders, drowsiness, reduced level of consciousness, confusion, hallucinations, and cardio-respiratory arrest may occur.

Management
In case of extrapyramidal symptoms, whether or not related to overdose, treatment is symptomatic only
(benzodiazepines in children and/or antiparkinsonian anticholinergic drugs in adults).
Depending on the clinical status, symptomatic treatment and continuous monitoring of cardiovascular and respiratory functions should be performed.