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METOCLOPRAMIDE 10 MG TABLETS

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE

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TEVA UK Ref:

Version:

70423-W LEA METOCLOPRAMIDE 10mg TAB TUK

5

15 September 2015

Original Artwork Scale = 1:1 (100%)
50mm

PAGE 1: FRONT FACE (INSIDE OF REEL)

Do not exceed 3-month treatment because of the risk of
involuntary muscle spasms.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this 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 signs of illness
are the same as yours.
• If any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:

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 take
Metoclopramide if”).
Other medicines and Metoclopramide
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
works or Metoclopramide can affect how other medicines
work. These medicines include the following:

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

Pharma code 160

• levodopa or other medicines used to treat Parkinson’s
disease (see above “Do not take Metoclopramide 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
1 WHAT METOCLOPRAMIDE IS AND WHAT IT IS USED • digoxin (medicine used to treat heart failure)
FOR
• cyclosporine (medicine used to treat certain problems with
the immune system)
Metoclopramide is an antiemetic. It contains a medicine called
“metoclopramide” It works on a part of your brain that prevents • mivacurium and suxamethonium (medicines used to relax
.
muscles)
you from feeling sick (nausea) or being sick (vomiting).
• fluoxetine and paroxetine (medicine used to treat
Adult population
depression)
Metoclopramide is used in adults:
Metoclopramide with alcohol
• to prevent delayed nausea and vomiting that may occur after
chemotherapy
• to prevent nausea and vomiting caused by radiotherapy
• to treat nausea and vomiting including nausea and vomiting
which may occur with a migraine.
• Metoclopramide can be taken with oral painkillers in case of
migraine to help painkillers work more effectively.
Paediatric population
Metoclopramide is indicated 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

2

WHAT YOU NEED TO KNOW BEFORE YOU TAKE
METOCLOPRAMIDE

Do not take Metoclopramide 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 (pheochromocytoma).
• 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”)
• you have ever had an abnormal blood pigment levels
(methaemoglobinemia) or NADH cytochrome-b5 deficiency
Do not give Metoclopramide to a child less than 1 year of age
(see below “Children and adolescents”).
Do not take Metoclopramide if any of the above apply to you. If
you are not sure, talk to your doctor, pharmacist or nurse
before you take Metoclopramide.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Metoclopramide if:

Alcohol should not be consumed during treatment with
metoclopramide because it increases the sedative effect of
Metoclopramide.
Pregnancy, 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 may be taken during pregnancy. Your doctor
will decide whether or not you should be given this medicine.
Metoclopramide is not recommended if you are
breast-feeding 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 taking Metoclopramide.
This may affect your vision and also interfere with your ability
to drive and use machines.
Metoclopramide contains Lactose
Metoclopramide 10mg tablets contains Lactose monohydrate.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product

3

HOW TO TAKE METOCLOPRAMIDE

Adult patients (All indications)
The recommended single dose is 10 mg, repeated up to three
times daily.
The maximum recommended dose per day is 30 mg or
0.5 mg/kg body weight.
The maximum recommended treatment duration is 5 days.
To prevent delayed nausea and vomiting that may occur after
chemotherapy (children aged 1-18 years)
The recommended dose is 0.1 to 0.15 mg/kg body weight,
repeated up to 3 times daily, taken by mouth (oral route).
The maximum dose in 24 hours is 0.5 mg/kg body weight.
Dosing table

• 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).

Age

Body
Weight

Dose

Frequency

1-3 years

10-14 kg

1 mg

Up to 3
times daily

3-5 years

15-19 kg

2 mg

5-9 years

20-29 kg

2.5 mg

Your doctor may perform blood tests to check your blood
pigment levels. In cases of abnormal levels
(methaemoglobinemia), the treatment should be immediately
and permanently stopped.

9-18 years

30-60 kg

5 mg

15-18 years

Over 60kg

10 mg

Up to 3
times daily
Up to 3
times daily
Up to 3
times daily
Up to 3
times daily

You must wait at least 6 hours between each metoclopramide
dose, even in case of vomiting and rejection of the dose, in
order to avoid overdose.

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METOCLOPRAMIDE 10 mg TABLETS
Package leaflet: information for the user

TEVA UK Ref:

Version:

70423-W LEA METOCLOPRAMIDE 10mg TAB TUK

5

15 September 2015

Original Artwork Scale = 1:1 (100%)
50mm

PAGE 2: REAR FACE (OUTSIDE OF REEL)

You should not take this medicine for more than 5 days to
prevent delayed nausea and vomiting that may occur after
chemotherapy.
Metoclopramide Tablets is not suitable for use in children
weighing less than 61 kg.
Other pharmaceutical forms/strengths may be more
appropriate for administration.
Method of administration
You must wait at least 6 hours between each metoclopramide
dose, even in case of vomiting and rejection of the dose, in
order to avoid overdose.
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 take more Metoclopramide than you should
Contact your doctor or pharmacist straight away. You may
experience uncontrollable movements (extrapyramidal
disorders), feel drowsy, have some troubles of consciousness,
be confused, have hallucination and heart problems. Your
doctor may prescribe you a treatment for these signs if
necessary.
If you forget to take Metoclopramide
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, nurse or pharmacist.
If you stop taking Metoclopramide
DO NOT stop taking your medicine without talking to your
doctor first, even if you feel better.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

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 malignant syndrome.
• 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.

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 injection route)
• shock (severe decrease of heart pressure) (particularly with
injection route)
• fainting (particularly with intravenous route)
• allergic reaction which may be severe (particularly with
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 at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5

HOW TO STORE METOCLOPRAMIDE

Keep this medicine out of the sight and reach of children.
These tablets should be stored in a dry place at or below 25º C
and protected from light in the package or container supplied.
Do not transfer them to another container.
Do not use Metoclopramide after the expiry date that is stated
on the outer packaging. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

6

CONTENTS OF THE PACK AND OTHER INFORMATION

What Metoclopramide tablets contain:
• The active ingredient is metoclopramide hydrochloride.
• The other ingredients are lactose monohydrate,
microcrystalline cellulose (E460), maize starch, colloidal
anhydrous silica and magnesium stearate.
What Metoclopramide tablets look like and contents of the
pack:
• The Metoclopramide 10 mg tablets are white, shallow,
biconvex tablets. They are marked ‘1P5’ on one side with a
breakline on the other side.
• The product is available in pack sizes of 7, 10, 14, 21, 28, 30,
56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, 500, 12 x 500
and 10 x 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, England.
This leaflet was last revised: August 2015
PL 00289/0192

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 disease (rigidity, tremor)
• feel restless
• blood pressure decrease (particularly with intravenous route)
• diarrhoea
• feeling weak.
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 women who are not
breast-feeding
• irregular periods
• hallucination
• decreased level of consciousness
• slow heartbeat (particularly with intravenous route)
• allergy
Rare (may affect up to 1 in 1,000 people)

70423-W

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

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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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