METOCLOPRAMIDE 5 mg /Ml Инъекционный Раствор

Содержание инструкции

1. Metoclopramide hydrochloride Noridem 5 mg / ml Solution for injection
   1. What Metoclopramide hydrochloride Noridem is and what it is used for
   2. What you need to know before you take 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

PACKAGE LEAFLET

Metoclopramide hydrochloride Noridem 5 mg / ml Solution for injection

metoclopramide hydrochloride monohydrate

Generic medicine

Read this leaflet carefully before you are given this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you are given Metoclopramide hydrochloride Noridem
• 3. How Metoclopramide hydrochloride Noridem is administered
• 4. Possible side effects
• 5. How to store Metoclopramide hydrochloride Noridem
• 6. Contents of the pack 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 ingredient metoclopramide.
It works on a part of the brain that prevents feeling sick (nausea) or being sick (vomiting).
Metoclopramide hydrochloride Noridem is used in adults:
to prevent nausea and vomiting that may occur after surgery
for the treatment of nausea and vomiting, including nausea and vomiting that may occur
during a migraine
to prevent nausea and vomiting caused by radiotherapy
Metoclopramide hydrochloride Noridem is used in children and adolescents(age 1 – 18 years) only if other
treatments do not work or cannot be used:
to prevent delayed nausea and vomiting that may occur after chemotherapy
to treat nausea and vomiting that have occurred after surgery

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

You must not be given Metoclopramide hydrochloride Noridem if
you are allergic to metoclopramide hydrochloride monohydrate or any of the other ingredients of
this medicine (listed in section 6);
you have a bleeding, blockage or perforation in your stomach or intestine;
you have a confirmed or suspected tumor of the adrenal glands, located next to the kidneys
(pheochromocytoma);
you have had involuntary spasms of the muscles (tardive dyskinesia) in the past after taking
medicines;
you suffer from epilepsy;
you suffer from Parkinson's disease;
you are taking levodopa (a medicine for the treatment of Parkinson's disease) or dopaminergic
agonists (see below “Other medicines and Metoclopramide hydrochloride Noridem")
you have had abnormal levels of pigment in the blood (methemoglobinemia) or deficiency of NADH
cytochrome-b5.
Do not give 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 (prolongation of the QT interval) or any other
heart problem;
you have problems with salt levels in your blood, such as potassium, sodium and magnesium;
you are taking other medicines known to affect the way your heart beats
you have any neurological (brain) problems;
you have problems with your liver or kidneys. The dose may be reduced (see section 3).
Your doctor may perform blood tests to check the levels of pigment in your blood. If
abnormal levels (methemoglobinemia) are found, treatment must be stopped immediately and
definitively.

Children and adolescents
Uncontrollable movements (extrapyramidal disorders) 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
uncontrollable movements (see above "Metoclopramide hydrochloride Noridem must not be given 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 can affect the action of
Metoclopramide hydrochloride Noridem or Metoclopramide hydrochloride Noridem can affect the action
of other medicines. These medicines include the following:
levodopa or other medicines used to treat Parkinson's disease (see above "Metoclopramide
hydrochloride Noridem must not be given if")
anticholinergics (medicines used to relieve cramps or spasms in the stomach)
morphine derivatives (medicines used to treat severe pain)
sedative medicines
any medicine used to treat mental health problems
digoxin (a medicine used to treat heart failure)
cyclosporine (a medicine used to treat some problems of the immune system)
mivacurium and suxamethonium (medicines used in anesthesia to relax muscles)

• fluoxetine and paroxetine (medicines used to treat depression)

Metoclopramide hydrochloride Noridem with alcohol
You should not consume alcohol during treatment with metoclopramide because it increases the sedative
effect of Metoclopramide hydrochloride Noridem.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before you are given this
medicine. If necessary, Metoclopramide hydrochloride Noridem can be used during
pregnancy. The doctor will decide whether or not to give you this medicine.
Metoclopramide hydrochloride Noridem is not recommended if you are breastfeeding because
metoclopramide passes into breast milk and can have effects on the baby.

Driving and using machines
After you have been given Metoclopramide hydrochloride Noridem you may feel sleepy,
dizzy or have jerks, spasms or uncontrollable movements and unusual muscle tone
causing distortions of the body. This could affect your vision and also interfere with your ability
to drive and use machines.

Metoclopramide hydrochloride Noridemcontains 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, meaning
essentially "sodium-free".

3. How Metoclopramide hydrochloride Noridem is administered

The medicine will normally be administered to you by a doctor or a nurse. It will be
administered via slow injection into a vein (over at least 3 minutes) or by injection into
a muscle.

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 of body weight.
For the prevention of nausea and vomiting that may occur after surgery: 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 of body weight, repeated up to 3 times a
day, administered by slow injection into a vein.
The maximum dose in 24 hours is 0.5 mg/kg of 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 nausea and vomiting that may
occur after surgery.
Treatment should not exceed 5 days for the prevention of delayed nausea and vomiting that
may occur after chemotherapy.

Use in the elderly
It may be necessary to reduce the dose depending on kidney problems, liver problems and general
health.
Other pharmaceutical forms may be more appropriate for administration.

Use in adults with kidney problems
Contact your doctor if you have kidney problems. The dose must be reduced if you have moderate
or severe kidney problems.
Other pharmaceutical forms may be more appropriate for administration.

Use in adults with liver problems
Contact your doctor if you have liver problems. The dose must be reduced if you have moderate
or severe liver problems.
Other pharmaceutical forms may be more appropriate for administration.

Use in children under 1 year of age
Metoclopramide should 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. Uncontrollable movements (extrapyramidal
disorders) may occur, you may feel sleepy, have some disturbance of consciousness, be confused,
have hallucinations and heart problems. If necessary, your doctor may prescribe treatment for
these symptoms.

If you forget to takeMetoclopramide hydrochloride Noridem
Do not take a double dose to make up for a missed dose.
If you have any questions about the use of this medicine, ask 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:
uncontrollable movements (often involving the head or neck). These can occur
in children or young adults and particularly when high doses are used. These
symptoms usually start early in treatment and can also occur after a
single dose. These movements will stop if treated appropriately.
high fever, high blood pressure, seizures (fits), sweating, increased saliva production. These
may be symptoms of a condition called neuroleptic malignant syndrome.
itching or skin rash, 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)
feeling sleepy

Common(may affect up to 1 in 10 people)
depression
uncontrollable movements such as tics, tremors, twisting or muscle contractions
(stiffness, rigidity)
symptoms similar to Parkinson's disease (rigidity, tremor)
feeling restless
decreased blood pressure (particularly with intravenous route)
diarrhoea
feeling weak

Uncommon(may affect up to 1 in 100 people)
increased levels of a hormone called prolactin in the blood which can cause: production of milk
in men and women who are not breastfeeding
irregular periods
hallucinations
decreased level of consciousness
slow heartbeat (particularly with intravenous route)
allergy
vision disturbances and involuntary eye movement

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 available data)
abnormal levels of pigment in the blood: which can change the colour of the skin
abnormal development of the breast (gynaecomastia)
involuntary muscle spasms after prolonged use, especially 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 heartbeat, 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 route)
allergic reaction which can be severe (particularly with intravenous route)
very high blood pressure
suicidal thoughts
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
report side effects directly through
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 the bag and in the outer carton to protect them from light.
This medicine does not require any particular storage temperature.
After first opening:
Use within 2 months if the vials are stored without the bag.
After mixing/dilution: Chemical and physical stability during use of mixtures with 0.9% sodium chloride, 5% dextrose, Ringer's lactate and 4% dextrose in 0.18% sodium chloride
are stable 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 point of view, unless the opening method excludes the risk of
microbial contamination, the product must be used immediately. If not used
immediately, the storage times and conditions during use are the responsibility of the user.
Do not use this medicine after the expiry date which is stated on the bag and the carton after
“EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Metoclopramide hydrochloride Noridem contains

• The active ingredient is metoclopramide hydrochloride monohydrate. Each ml of solution contains 5.27 mg of metoclopramide hydrochloride monohydrate equivalent to 5 mg of metoclopramide hydrochloride anhydrous.
• 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, colorless injection solution.
Polypropylene vials containing 2 ml of solution, packaged in cartons of 5, 10 (2 x 5), 20 (4 x 5),
50 (10 x 5) or 60 (12 x 5) vials.
Each 5 vials are 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 Member States of the European Economic Area with the
following denominations:

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

Preparation and handling

Incompatibilities
In the absence of compatibility studies, this medicine should not be mixed with other medicines,
except for 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 Noridem0.1 mg/ml.

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

Elderly:
A dose reduction should be considered in elderly patients, based on
renal and hepatic function and general 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%.
Other pharmaceutical forms may be more appropriate for the treatment of these populations.

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

Disposal
Any unused medicine or waste material should be disposed of in accordance with
local regulations.

Overdose
Symptoms
Extrapyramidal disturbances, drowsiness, reduced level of consciousness, confusion,
hallucinations and cardio-respiratory arrest may occur.
Management
In case of extrapyramidal symptoms related or not to overdose, treatment is symptomatic only
(benzodiazepines in children and/or antiparkinsonian anticholinergic drugs in adults).
Depending on the clinical condition, symptomatic treatment and continuous monitoring
of cardiovascular and respiratory functions should be performed.