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METOCLOPRAMIDE TABLETS BP 10MG

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE

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METOCLOPRAMIDE PIL:00070216/03

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2/6/16

5:14 PM

Page 1

Patient Information Leaflet

METOCLOPRAMIDE 10 MG TABLETS

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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section-4.

In this leaflet:

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 Tablets
4. Possible side effects
5. How to store Metoclopramide Tablets
6. Contents of the pack and other information

1. What Metoclopramide is and what it is used for

Metoclopramide 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 is used in adults:
• 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 tablets if you:
• are allergic to metoclopramide, or any of the other ingredients of this
medicine (see section 6)
• have bleeding, obstruction or a tear in your stomach or gut
• have or may have a tumour of the adrenal gland, which sits near the
kidney (phaeochromocytoma)
• have ever had involuntary muscle spasms (tardive dyskinesia), when
you have treated with a medicine
• have epilepsy
• have Parkinson’s disease
• are taking levodopa (a medicine for Parkinson’s disease) or
dopaminergic agonists (see below “Other medicines and
Metoclopramide”)
• 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”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Metoclopramide
tablets if you:
• have a history of abnormal heart beats (QT interval prolongation) or
any other heart problems
• have problems with the levels of salts in your blood, such as
potassium, sodium and magnesium
• are using other medicines known to affect the way your heart beats
• have any neurological (brain) problems
• 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
(methaemoglobinemia), the treatment should be immediately and
permanently stopped.
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.
Do not exceed 3-month treatment because of the risk of involuntary
muscle spasms.

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 MetoclopramideTell your doctor, pharmacist or
nurse if you are taking, have recently taken or might take any other
medicines. This is because some medicine can affect the way
Metoclopramide works or Metoclopramide 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 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
• 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 with alcohol
Alcohol should not be consumed during treatment with metoclopramide
because it increases the sedative effect of Metoclopramide.

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 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 tablet contains lactose
If you have been told you have intolerance to some sugars, contact your
doctor before taking this medicine, as it contains a type of sugar called
lactose.

Surgery and tests
If you need to have an operation including having your teeth removed or
blood and urine tests, tell your doctor or dentist that you are taking this
medicine.

3. How to take Metoclopramide

Always take Metoclopramide tablets exactly as your doctor has told you.
The pharmacist’s label should tell you how much to take and how often.
Check with your doctor or pharmacist if you are not sure.
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
Age
Body Weight
1-3 years
10-14 kg
3-5 years
15-19 kg
5-9 years
20-29 kg
9-18 years 30-60 kg
15-18 years Over 60kg

Dose
1 mg
2 mg
2.5 mg
5 mg
10 mg

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

METOCLOPRAMIDE PIL:00070216/03

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5:14 PM

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 forget
to take a dose take it as soon as you remember it and then take the next
dose at the right time.
If you stop taking the tablets
Talk to your doctor before you stop taking the tablets and follow their
advice.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. Possible side effects

Like all medicines, Metoclopramide tablets 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 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
Tell your doctor if you notice any of the following side effects or
notice any other effects not listed
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 breastfeeding
• irregular periods






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hallucination
decreased level of consciousness
slow heartbeat (particularly with intravenous route)
allergy

Rare (may affect up to 1 in 1,000 people)
• 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 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 all the medicines out of the sight and reach of children
• Do not use the Tablets after the expiry date stated on the label after
‘EXP’. The expiry date refers to the last day of that month
• Store in dry cool condition protected from bright sun light
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 substance is 10mg of anhydrous Metoclopramide
hydrochloride BP
• The other ingredients are lactose, maize starch, magnesium stearate,
colloidal silicon dioxide and sodium starch glycollate
See end of section 2 for further information on lactose
What Metoclopramide tablets looks like and contents of the pack
• White, circular, biconvex uncoated tablets. Embossed M/10 on one
face and ‘PV’ on the other
• Metoclopramide tablets are available in 28, 50, 56, 100, 200, 500 and
1000’s pack sizes. Pharmvit Metoclopramide tablets are only
available from pharmacies. Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433
To request a copy of this leaflet in large print or audio format or
additional copies, please contact the licence holder at the address (or
telephone, fax) above.
PL 04556 / 0007

Reference: 00070216/03

POM

Date leaflet last revised: February 2016

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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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