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METOCLOPRAMIDE 5 MG/ML INJECTION

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE

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Patient Information Leaflet

hameln

Metoclopramide 5 mg/ml Injection
metoclopramide hydrochloride

Important information about your medicine
• Your doctor or nurse will give you the injection.
• If this injection causes you any problems talk to your doctor, nurse or pharmacist.
• Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine.
• Please tell your doctor or pharmacist, if you are taking any other medicines.
• Read all of this leaflet carefully before you start using this medicine because it contains
important information for you. In some circumstances this may not be possible and this leaflet will
be kept in a safe place should you wish to read it.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get side effects, talk to your doctor, nurse or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Metoclopramide 5 mg/ml Injection is and what it is used for
2. What you need to know before you use Metoclopramide 5 mg/ml Injection
3. How to use Metoclopramide 5 mg/ml Injection
4. Possible side effects
5. How to store Metoclopramide 5 mg/ml Injection
6. Contents of the pack and other information

1. What Metoclopramide 5 mg/ml Injection
is and what it is used for
Metoclopramide 5 mg/ml Injection is an antiemetic.
It contains a medicine called “metoclopramide”.
It works on a part of your brain that prevents
you from feeling sick (nausea) or being sick
(vomiting)

Adult population

Metoclopramide 5 mg/ml Injection is used in
adults:
• to prevent nausea and vomiting that may
occur after surgery
• to treat nausea and vomiting including nausea
and vomiting which may occur with a migraine
• to prevent nausea and vomiting caused by

radiotherapy

Paediatric population

Metoclopramide 5 mg/ml Injection is used in
children (aged 1-18 years) if other treatment does
not work or cannot be used:
• to prevent delayed nausea and vomiting that
may occur after chemotherapy
• to treat nausea and vomiting that has occurred
after surgery

2. What you need to know before you use
Metoclopramide 5 mg/ml Injection
Do NOT use Metoclopramide 5 mg/ml
Injection if:
• you are allergic to metoclopramide or any of
the other ingredients of this medicine (listed in
section 6).
• you have bleeding, obstruction or a tear in your
stomach or gut.
• you have or may have a rare tumour of the
adrenal gland, which sits near the kidney
(phaeochromocytoma).
• you have ever had involuntary muscle spasms
(tardive dyskinesia), when you have been
treated with a medicine.
• you have epilepsy
• you have Parkinson’s disease
• you are taking levodopa (a medicine
for Parkinson’s disease) or dopaminergic
agonists (see below “Other medicines and
Metoclopramide 5 mg/ml Injection).
• you have ever had an abnormal blood pigment
level (methaemoglobinaemia) or NADH
cytochrome-b5 deficiency.
Do not give Metoclopramide 5 mg/ml injection
to a child less than one year of age (see below
“Children and adolescents”).
You should not use Metoclopramide 5 mg/ml
injection if any of the above apply to you. If you
are not sure, talk to your doctor, pharmacist or
nurse before you use Metoclopramide 5 mg/ml
injection.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before
using Metoclopramide 5 mg/ml Injection if:
• you have a history of abnormal heart beats
(QT interval prolongation) or any other heart
problems
• you have problems with the levels of salts in
your blood, such as potassium, sodium and
magnesium.
• you are using other medicines known to affect
the way your heart beats
• you have any neurological (brain) problems
• you have liver or kidney problems. The dose
may be reduced (see section 3).
Your doctor may perform blood tests to check your
blood pigment levels. In cases of abnormal levels
(methaemoglobinaemia),
the
treatment
should be immediately and permanently stopped.

Children and adolescents

Uncontrollable
movements
(extrapyramidal
disorders) may occur in children and young
adults. This medicine must not be used in children
below 1 year of age because of the increased risk
of the uncontrollable movements (see above “Do
not use Metoclopramide 5 mg/ml Injection if”).

Other medicines and Metoclopramide
5 mg/ml Injection:

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 way Metoclopramide
5 mg/ml Injection works or Metoclopramide 5 mg/
ml Injection can affect how other medicines work.
These medicines include the following:
• levodopa or other medicines used to treat
Parkinson’s disease (see above “Do not use
Metoclopramide 5 mg/ml Injection if”)
• anticholinergics (medicines used to relieve
stomach cramps or spasms)
• morphine derivatives (medicines used to treat
severe pain)
• sedative medicines
• any medicines used to treat mental health
problems
• digoxin (medicine used to treat heart failure)
• cyclosporine (medicine used to treat certain
problems with the immune system)
• mivacurium
and
suxamethonium
(medicines used to relax muscles)
• fluoxetine and paroxetine (medicine used
to treat depression)

Metoclopramide 5 mg/ml Injection with
alcohol
Alcohol should not be consumed during
treatment with metoclopramide because it
increases the sedative effect of Metoclopramide
5 mg/ml Injection.

Pregnancy and breast feeding:
If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your doctor

or pharmacist for advice before being given this
medicine. If necessary, Metoclopramide 5 mg/ml
Injection may be given during pregnancy. Your
doctor will decide whether or not you should be
given this medicine.
5 mg/ml Injection is not
recommended if you are breast-feeding
Metoclopramide

because metoclopramide passes into breast milk
and may affect your baby.

Driving and using machines:
You may feel drowsy, dizzy or have
uncontrollable twitching, jerking or writhing
movements and unusual muscle tone causing

distortion of the body after using Metoclopramide
5 mg/ml Injection. This may affect your vision
and also interfere with your ability to drive and
use machines

3. How to use Metoclopramide 5 mg/ml
Injection
The medicine will normally be given to you by
a doctor or a nurse. It will be given as a slow
injection into a vein (over at least 3 minutes) or by
injection into a muscle.

In adults patients

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

For the prevention of nausea and vomiting that
may occur after surgery: a single dose of 10 mg
is recommended.

• slow heartbeat (particularly with intravenous
route)
• allergy

All indications (paediatric patients aged
1-18 years)

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

The recommended dose is 0.1 to 0.15 mg/kg body
weight, repeated up to 3 times daily, given by slow
injection into a vein.
The maximum dose in 24 hours is 0.5 mg/kg body
weight.
Dosing table
Age
1-3 years

Body Weight Dose
10-14 kg
1 mg

3-5 years

15-19 kg

5-9 years

20-29 kg

9-18 years

30-60 kg

15-18 years Over 60 kg

Frequency
Up to 3
times daily
2 mg
Up to 3
times daily
2.5 mg Up to 3
times daily
5 mg
Up to 3
times daily
10 mg Up to 3
times daily

The treatment should not exceed 48 hours
for treatment of nausea and vomiting that has
occurred after surgery.
The treatment should not exceed 5 days for
prevention of delayed nausea and vomiting that
may occur after chemotherapy.

Older people

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

Adults with kidney problems
Talk to your doctor if you have kidney problems.
The dose should be reduced if you have moderate
or severe kidney problems.

Adults with liver problems

Talk to your doctor if you have liver problems.
The dose should be reduced if you have severe
liver problems.

Children and adolescents
Metoclopramide must not be used in children
aged less than 1 year (see section 2).
If you receive more Metoclopramide
5 mg/ml Injection than you should
Contact your doctor or pharmacist straight
away. You may experience uncontrollable
movements (extrapyramidal disorders), feel
drowsy, have a reduced level of consciousness,
be confused, have hallucinations and cardiorespiratory arrest (your heart and breathing stop).
Your doctor may prescribe you a treatment for
these if necessary.

If you forget to use Metoclopramide
5 mg/ml Injection:
Do not have 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, nurse or pharmacist.

4. Possible side effects

• confusional state
• convulsion (especially in patients with epilepsy).

Not known (frequency cannot be estimated

from the available data)
• abnormal blood pigment levels: which may
change the colour of your skin
• abnormal
development
of
breasts
(gynaecomastia)
• involuntary muscle spasms after prolonged use,
particularly in elderly patients
• high fever, high blood pressure, convulsions,
sweating, production of saliva. These may be
signs of a condition called neuroleptic malignant
syndrome
• changes in heart beat, which may be shown on
an ECG test
• cardiac arrest (particularly with the injectable
route)
• shock (severe decrease of heart pressure)
(particularly with the injectable route)
• fainting (particularly with the intravenous route)
• allergic reaction which may be severe
(particularly with the intravenous route)
• very high blood pressure.
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any 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 includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme - website: www.mhra.gov.
uk/yellowcard. Alternatively you can call
Freephone 0808 100 3352 (available from 10
a.m. to 2 p.m. Mondays to Fridays) or fill in a
paper form available from your local pharmacy.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Metoclopramide 5 mg/ml
Injection
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label/ carton after “EXP:”
The expiry date refers to the last day of that
month.
Your injection will be stored at less than 25°C and
protected from light.

6. Contents of
information

the

pack

and

other

What Metoclopramide 5 mg/ml Injection
contains:
This injection contains the active ingredient
metoclopramide hydrochloride. Each 1 ml of
solution contains metoclopramide hydrochloride
equivalent to 5 mg of anhydrous metoclopramide
hydrochloride in a sterile solution for injection.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop the treatment and talk straight away to
your doctor, pharmacist or nurse if you
experience one of the following signs while having
this medicine:
• uncontrollable movements (often involving
head or neck). These may occur in children
or young adults and particularly when high
doses are used. These signs usually occur
at the beginning of treatment and may even
occur after one single administration. These
movements will stop when treated appropriately.
• high fever, high blood pressure, convulsions,
sweating, production of saliva. These may
be signs of a condition called neuroleptic

This injection contains the following inactive
ingredients: sodium chloride, citric acid
monohydrate, sodium citrate, hydrochloric acid,
sodium hydroxide, nitrogen and sterile water for
injections.

• Itching or skin rashes, swelling of the face, lips
or throat, difficulty in breathing. These may be
signs of an allergic reaction, which may be
severe.

Manufacturers:

malignant syndrome.

Very common (may affect more than 1 in 10
people)
• feeling drowsy.

Common (may affect up to 1 in 10 people)

• depression
• uncontrollable movements such as tics, shaking,
twisting movements or muscle contracture
(stiffness, rigidity)
• symptoms similar to Parkinson’s disease
(rigidity, tremor)
• feeling restless
• blood pressure decrease (particularly with
intravenous route)
• diarrhoea
• feeling weak.

What Metoclopramide 5 mg/ml Injection
looks like and contents of the pack:
The injection is supplied in 2 ml, 10 ml and 20
ml clear glass ampoules. 10 ampoules supplied in
each carton. Not all pack sizes may be marketed.
The marketing authorisation number of this
medicine is: PL 01502/0044

Marketing Authorisation Holder:
hameln pharmaceuticals ltd
Gloucester
United Kingdom

hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
hameln rds a.s. Horná 36
900 01 Modra
Slovak Republic
For any information about this medicine,
please contact the Marketing Authorisation
Holder
This leaflet was last approved September 2014

Uncommon (may affect up to 1 in 100 people)

• raised levels of a hormone called prolactin in the
blood which may cause milk production in men
and in women who are not breast-feeding
• irregular periods
• hallucination
• decreased level of consciousness

43887/40/14

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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