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MYGDALON/METOCLOPRAMIDE 10MG

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MYGDALON 10 mg TABLETS
Read all of this leaflet carefully before you start
taking this medicine.
- 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 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.
What is in this leaflet
1. What MYGDALON is and what it is used for
2. What you need to know before you take MYGDALON
3. How to take MYGDALON
4. Possible side effects
5. How to store MYGDALON
6. Contents of the pack and other information
1. What MYGDALON is and what it is used for
The name of this medicine is MYGDALON, which is an
antiemetic. It contains the active ingredient Metoclopramide
Hydrochloride.
It works on a part of your brain that prevents you from feeling
sick (nausea) or being sick (vomiting).
Adult population
MYGDALON 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.
MYGDALON can be taken with oral painkillers in case of
migraine to help painkillers work more effectively.
Paediatric population
MYGDALON 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 MYGDALON
Do not take MYGDALON if:
- you are allergic to metoclopramide or any of the other
ingredients in the tablets (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 MYGDALON”)
- you have ever had an abnormal blood pigment levels
(methaemoglobinemia) or NADH cytochrome-b5 deficiency.
Do not give MYGDALON 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
MYGDALON 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.
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 MYGDALON if”).
Other medicines and MYGDALON
Tell your doctor, pharmacist or nurse if you are taking or have
recently taken or might take any other medicines. This is
because some medicines can affect the way MYGDALON
works or MYGDALON 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 MYGDALON 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).

MYGDALON with alcohol
Alcohol should not be consumed during treatment with
metoclopramide because it increases the sedative effect of
MYGDALON.

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.

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,
MYGDALON may be taken during pregnancy. Your doctor
will decide whether or not you should be given this medicine.
MYGDALON is not recommended if you are breast-feeding
because metoclopramide passes into breast milk and may
affect your baby.

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

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 MYGDALON. This
may affect your vision and also interfere with your ability to
drive and use machines.
Important information about some of the ingredients of
MYGDALON
This medicine contains lactose (a type of sugar). If you know
you have an intolerance to some sugars contact your doctor
before taking this medicine.
3. How to take MYGDALON
Always take MYGDALON exactly as your doctor has told
you. Swallow the tablets with a glass of water.
The usual doses are given below. These may be changed by
your doctor:
Adult patients
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
Dose
Frequency
Weight
1-3 years
10-14 kg
1 mg
Up to 3 times daily
3-5 years
15-19 kg
2 mg
Up to 3 times daily
5-9 years
20-29 kg
2.5 mg Up to 3 times daily
9-18 years
30-60 kg
5 mg
Up to 3 times daily
15-18 years Over 60 kg 10 mg Up to 3 times daily
You should not take this medicine for more than 5 days to
prevent delayed nausea and vomiting that may occur after
chemotherapy.
MYGDALON is not suitable for use in children weighing less
than 61 kg.
Other pharmaceutical forms/strengths may be more
appropriate for administration.

Adults with liver or kidney problems
Talk to your doctor if you have liver or kidney problems. The
dose should be reduced if you have severe liver or kidney
problems.
Children and adolescents
MYGDALON must not be used in children aged less than 1
year (see section 2).
If you take more MYGDALON 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 MYGDALON
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 MYGDALON
DO NOT STOP taking this medicine unless your doctor tells
you to. The symptoms may come back if treatment is
stopped too early.
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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
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 MYGDALON
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original container and
keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated
on the container. 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 MYGDALON contains
The active ingredient in MYGDALON is metoclopramide
hydrochloride. The other ingredients are lactose, anhydrous
lactose, pregelatinised starch, colloidal anhydrous silica and
magnesium stearate.
What MYGDALON looks like and contents of the pack
MYGDALON tablets are round bi-convex tablets scored on
one side and embossed MH108 on the other side.
They are available in packs of 28, 30, 50, 56, 60, 84, 100,
250, 500 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Ltd.
Boumpoulinas 11, 3rd Floor
Nicosia, P.C. 1060
CYPRUS
Manufacturer
Meridian Healthcare (UK) Ltd.
208-214 York Road, Battersea
London SW11 3SD
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 11/2015.

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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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