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METOCLOPRAMIDE HYDROCHLORIDE 10 MG TABLETS

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Metoclopramide
Hydrochloride
10 mg tablets

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

1. What Metoclopramide
Hydrochloride tablets is and
what it is used for
Metoclopramide Hydrochlride 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 Hydrochloride 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 Hydrochloride 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
Hydrochloride tablets
Do not take Metoclopramide Hydrochloride
tablets if:
• you are allergic (hypersensitive) 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 Hydrochloride tablets”)
• you have ever had an abnormal blood pigment
levels (methaemoglobinemia) or NADH
cytochrome-b5 deficiency
Do not give Metoclopramide Hydrochloride
tablets 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 Hydrochloride tablets 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 (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.
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 Hydrochloride tablets if”).
Other medicines and Metoclopramide
Hydrochloride tablets
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
Hydrochloride tablets works or Metoclopramide
Hydrochloride tablets 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 Hydrochloride tablets 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 Hydrochloride tablets with
alcohol
Alcohol should not be consumed during
treatment with metoclopramide because it
increases the sedative effect of Metoclopramide
Hydrochloride tablets.
Pregnancy, breast-feeding and fertility
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
Hydrochloride tablets may be taken during
pregnancy. Your doctor will decide whether or not
you should be given this medicine.
Trade Metoclopramide Hydrochloride tablets
name 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
Hydrochloride tablets. This may affect your
vision and also interfere with your ability to drive
and use machines.
Metoclopramide Hydrochloride tablets
contains Lactose
This drug contains lactose monohydrate. Patients
with rare hereditary abnormalities of galactose
tolerance, those with Lapp lactase deficiency or
glucose-galactose malabsorption should not use
this medication. Tell your doctor if you know you
have a sugar intolerance.

3. How to take Metoclopramide
Hydrochloride tablets
Adult population:
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.
The maximum dose in 24 hours is 0.5 mg/kg
body weight.
Dosing table
Age
Body Weight Dose
1-3 years
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 60kg

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

Device / instruction for use
You should not take this medicine for more than 5
days to prevent delayed nausea and vomiting
that may occur after chemotherapy.
Metoclopramide Hydrochloride tablets is not
suitable for use in children weighing less than 30 kg.
Other pharmaceutical forms/strengths may be
more appropriate for administration
Method of administration
Swallow the tablet with glass of water.
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
Hydrochloride tablets 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. You
doctor may prescribe you a treatment for these
signs if necessary.
If you forget to take Metoclopramide
Hydrochloride tablets
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.

4. Possible side effects
Like all medicines, Metoclopramide
Hydrochloride 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 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.
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)
• 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 the national
reporting system. By reporting side effects you
can help provide more information on the safety
of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie

5. How to store Metoclopramide
Hydrochloride tablets
• Store below 30 °C.
• Do not take the tablets after the expiry date
clearly stated on the strips and carton after
‘EXP’. The expiry date refers to the last day of
that month.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. Contents of the pack and
other information
What Metoclopramide Hydrochloride tablets
contain
The name of your medicine is Metoclopramide
Hydrochloride tablets, and the active substance
is metoclopramide hydrochloride.
Metoclopramide Hydrochloride tablets contain
10 mg metoclopramide hydrochloride.
The tablets contain the following non-active
ingredients:
Lactose monohydrate, pre-gelatinised starch,
maize starch, anhydrous colloidal silica,
magnesium stearate.
What Metoclopramide Hydrochloride tablets
looks like and contents of the pack
White to off-white, round, biconvex tablets with
the inscription ‘BD’ on one side and a score line
on the other side.
The tablet can be divided into equal halves.
The tablets are packaged in
PVC/PVdC/aluminium blister strips.

The carton contains 20, 24, 28, 30, 40, 50, 60,
84, 100, 500 tablets.
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex HA1 4HF, United Kingdom
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Name of the
Name of the medicinal
Member State product
Cyprus
Metoclopramide Accord 10 mg
tablety
Spain
Metoclopramide Accord 10 mg
comprimidos
Italy
Metoclopramide Accord
The Netherlands Metoclopramidemonohydro
chloride Accord 10 mg
Tabletten
Malta
Metoclopramide10 mg tablets
United Kingdom Metoclopramide Hydrochloride
10 mg tablets
Austria
Metoclopramid hydrochloride
Accord 10 mg Tabletten
Denmark
Metoclopramide hydrochloride
Accord
Estonia
Metoclopramide Accord
Finland
Metoclopramide Accord 10 mg
tabletti
Ireland
Metoclopramide Hydrochloride
10 mg tablets
Norway
Metoclopramide Accord
Poland
Olamide
Sweden
Metoclopramide Accord 10 mg
tabletter
This leaflet was last approved in 02/2016.

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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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