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PYRIDOSTIGMINE BROMIDE 60 MG TABLETS

Active substance(s): PYRIDOSTIGMINE BROMIDE / PYRIDOSTIGMINE BROMIDE / PYRIDOSTIGMINE BROMIDE

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PATIENT INFORMATION LEAFLET

Mestinon 60 mg Tablets
(pyridostigmine bromide)
Please 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If you experience any side effect and this
becomes serious, tell your doctor or
pharmacist.
In this leaflet:
1. What Mestinon 60 mg Tablets are and what
they are used for
2. Before you take Mestinon 60 mg Tablets
3. How to take Mestinon 60 mg Tablets
4. Possible side effects
5. How to store Mestinon 60 mg Tablets
6. Further information
1. WHAT MESTINON 60 mg TABLETS ARE
AND WHAT THEY ARE USED FOR
Mestinon 60 mg Tablets are used for the
treatment of myasthenia gravis. In patients who
suffer from myasthenia gravis the muscles
quickly become tired and weak and, in severe
cases, the muscles may become paralysed.
Myasthenia gravis is caused by excessive
activity in the body of a protein called
cholinesterase.
Mestinon 60 mg Tablets belong to a group of
medicines known as cholinesterase inhibitors.
Cholinesterase inhibitors stop the excessive
activity of cholinesterase and in this way help
muscles to work properly.
Mestinon 60 mg Tablets are also used to treat
some rare forms of constipation (paralytic
ileus) and inability to pass urine after an
operation.
2. BEFORE YOU TAKE MESTINON 60 mg
TABLETS
Do not take Mestinon 60 mg Tablets if you:
• Are allergic (hypersensitive) to
pyridostigmine, bromides or any of the other
ingredients of Mestinon 60 mg Tablets (these
are listed in section 6, ˝Further Information˝).
• Are constipated or cannot urinate, unless
your doctor has told you to use this medicine.
This is because Mestinon 60 mg Tablets are
only for some types of constipation and
inability to pass urine (see Section 1).
Take special care with Mestinon 60 mg
Tablets
Before treatment with Mestinon 60 mg Tablets,
tell your doctor if you:
• Suffer from asthma or have other chest
problems such as wheeziness, difficulty in
breathing or chronic cough.
• Have recently had coronary obstruction
(heart attack), have a slow heart beat or any
other heart condition.
• Have low blood pressure.
• Have a stomach ulcer.

• Have epilepsy.
• Have Parkinson’s disease.
• Have kidney problems.
• Suffer from a condition called vagotonia (this
is a condition where overactivity of the vagus
nerve causes symptoms such as slow heart
rate, low blood pressure, constipation,
sweating and painful muscle spasms).
• Have an overactive thyroid gland
• Have had an operation to remove your
thymus gland.
There is no evidence to suggest that Mestinon
60 mg Tablets have any special effects on
elderly patients.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
This is extremely important, as using more
than one medicine at the same time can
strengthen or weaken the effect of the
medicines. In particular, tell your doctor if you
are taking any of the following medicines:
• Medicines known as steroids or other
immunosuppressant medicines.
• Medicines known as antimuscarinics (e.g.
atropine, hyoscine).
• Medicines containing methylcellulose
• Antibiotics
• Medicines to treat an irregular heart beat
• Other medicines that interfere with
transmission between nerves and muscles
If you are going to have surgery
Tell your doctor that you are taking Mestinon
60 mg Tablets.
Mestinon 60 mg Tablets can stop the effect of
some medicines used to relax muscles during
surgery (e.g. pancuronium, vencuronium).
Mestinon 60 mg Tablets can also prolong the
effect of other muscle relaxants (e.g.
suxamethonium).
Pregnancy and breast-feeding
Tell your doctor before you start treatment if you:
• Are pregnant, if you think you are pregnant,
or if you intend to become pregnant.
• Are breast-feeding, as Mestinon 60 mg
Tablets pass into breast milk in small
amounts.
Your doctor will then decide if you can take this
medicine.
Driving and using machines
Mestinon 60 mg Tablets may reduce the
sharpness of your eyesight and therefore your
ability to drive or use machines. Do not drive or
operate machines if this medicine affects your
ability to see clearly.
Important information about some of the
ingredients of Mestinon 60 mg Tablets
Mestinon 60 mg Tablets contain lactose.
Therefore, 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 MESTINON 60 mg
TABLETS
Swallow the tablets with water or another nonalcoholic drink. If you have difficulty swallowing,
you can break the tablets into pieces.
You should check with your doctor or
pharmacist if you are not sure how to take
Mestinon 60 mg Tablets.
The dose will depend on your illness, your
needs and on your age as follows:
For myasthenia gravis:
• The usual adult dose is 1/2 to 2 tablets (30 to
120 mg Mestinon) to be taken five to six
times daily, or higher doses if needed, as
recommended by your doctor.
• For children under 6 years, the usual dose is
1/2 a tablet (30 mg). For children aged 6 to
12 years, the usual starting dose is 1 tablet
(60 mg). The doctor will then gradually
increase the dose until maximum
improvement is seen. In children the total
dose per day is usually 30 to 360 mg.
The tablets take 30 to 60 minutes to start
working after you have taken them.
The effect of each dose should last about four
hours during the day and about six hours at
night.
You should try to take your medicine so that it
can work when your muscles are needed most,
for example, when you get up and about 30 to
60 minutes before a meal.
For paralytic ileus (constipation) and postoperative inability to pass urine:
• The usual adult dose is 1 to 4 tablets (60 to
240 mg Mestinon) daily and for children 1/4
to 1 tablet (15 to 60 mg) daily, depending on
the needs of the patient.

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 MESTINON 60 mg
TABLETS
Keep Mestinon 60 mg Tablets out of the
sight and reach of children.
Do not store above 25°C.
Keep the bottle tightly closed in order to protect
from moisture.
Store in the original carton in order to protect
from light.
Do not use Mestinon 60 mg Tablets after the
expiry date which is stated on the bottle label
and outer carton after the text “EXP”. The
expiry date refers to the last day of that month.
If your medicine become discoloured or show
signs of any deterioration, you should seek the
advice your doctor or pharmacist who will tell
you what to do.
Medicines must 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. FURTHER INFORMATION
What Mestinon 60 mg Tablets contain
Active substance:

Each tablet contains 60 mg
pyridostigmine bromide.

Other ingredients:

Lactose, silicic acid, maize
starch, talc, magnesium
stearate and potato starch.

If you take more Mestinon 60 mg Tablets
than you should
If you take too many tablets or someone else
accidentally takes your medicine, contact your
doctor, pharmacist or nearest hospital straight
away.

What Mestinon 60 mg Tablets look like and
contents of the pack

If you forget to take one of your daily doses,
take it as soon as you remember, and take the
next dose at the normal time. Do not take a
double dose to make up for a forgotten dose. If
you miss more than a single dose, you should
contact your doctor for advice.

Mestinon 60 mg Tablets are white to off-white,
round, biplanar, bevel-edged tablets imprinted
with ‘V’ over ‘M60’ on one side and with two
break marks forming a cross on the other side.
Mestinon 60 mg Tablets are available in an
amber glass bottle with a desiccant attached
inside the white plastic temper evident screw
cap.
The tablets come in packs of 100 and 200
(2x100 tablets).

4. POSSIBLE SIDE EFFECTS

PL: 15814/1307

Like all medicines, Mestinon 60 mg Tablets can
cause side effects, although not everybody gets
them.

Mestinon 60 mg Tablets are manufactured by
Labiana Pharmaceuticals S.L.U., Casanova 2731, 08757-Corbera de Llobregat (Barcelona),
Spain.

If you forget to take Mestinon 60 mg Tablets

Possible side effects with Mestinon 60 mg
Tablets:
Side effects of unknown frequency:
• visual disturbance, producing more tears
than usual an irregular heart beat, heart
block, low blood pressure, fainting
• producing more phlegm than usual combined
with constriction of the airways
• feeling sick, vomiting, diarrhoea, stomach
cramps, producing more saliva than usual
• rash
• excessive sweating
• muscle weakness and twitching, shaking,
muscle cramps
• sudden, compelling urge to urinate.

POM

Procured from within the EU and repackaged
by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.):
24.01.2017
Mestinon is a registered trademark of Meda AB.

To request a copy of
this leaflet in Braille,
large print or audio
please call 01923 332
796.

PATIENT INFORMATION LEAFLET

Pyridostigmine bromide 60 mg Tablets
Please 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If you experience any side effect and this
becomes serious, tell your doctor or
pharmacist.
In this leaflet:
1. What Pyridostigmine bromide 60 mg Tablets
are and what they are used for
2. Before you take Pyridostigmine bromide 60
mg Tablets
3. How to take Pyridostigmine bromide 60 mg
Tablets
4. Possible side effects
5. How to store Pyridostigmine bromide 60 mg
Tablets
6. Further information
1. WHAT PYRIDOSTIGMINE BROMIDE 60 mg
TABLETS ARE AND WHAT THEY ARE
USED FOR
Pyridostigmine bromide 60 mg Tablets are
used for the treatment of myasthenia gravis. In
patients who suffer from myasthenia gravis the
muscles quickly become tired and weak and, in
severe cases, the muscles may become
paralysed. Myasthenia gravis is caused by
excessive activity in the body of a protein called
cholinesterase.
Pyridostigmine bromide 60 mg Tablets belong
to a group of medicines known as
cholinesterase inhibitors. Cholinesterase
inhibitors stop the excessive activity of
cholinesterase and in this way help muscles to
work properly.
Pyridostigmine bromide 60 mg Tablets are also
used to treat some rare forms of constipation
(paralytic ileus) and inability to pass urine after
an operation.
2. BEFORE YOU TAKE PYRIDOSTIGMINE
BROMIDE 60 mg TABLETS
Do not take Pyridostigmine bromide 60 mg
Tablets if you:
• Are allergic (hypersensitive) to
pyridostigmine, bromides or any of the other
ingredients of Pyridostigmine bromide 60 mg
Tablets (these are listed in section 6,
˝Further Information˝).
• Are constipated or cannot urinate, unless
your doctor has told you to use this medicine.
This is because Pyridostigmine bromide
60 mg Tablets are only for some types of
constipation and inability to pass urine (see
Section 1).
Take special care with Pyridostigmine
bromide 60 mg Tablets
Before treatment with Pyridostigmine bromide
60 mg Tablets, tell your doctor if you:
• Suffer from asthma or have other chest
problems such as wheeziness, difficulty in
breathing or chronic cough.
• Have recently had coronary obstruction
(heart attack), have a slow heart beat or any
other heart condition.

• Have low blood pressure.
• Have a stomach ulcer.
• Have epilepsy.
• Have Parkinson’s disease.
• Have kidney problems.
• Suffer from a condition called vagotonia (this
is a condition where overactivity of the vagus
nerve causes symptoms such as slow heart
rate, low blood pressure, constipation,
sweating and painful muscle spasms).
• Have an overactive thyroid gland
• Have had an operation to remove your
thymus gland.
There is no evidence to suggest that
Pyridostigmine bromide 60 mg Tablets have
any special effects on elderly patients.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
This is extremely important, as using more
than one medicine at the same time can
strengthen or weaken the effect of the
medicines. In particular, tell your doctor if you
are taking any of the following medicines:
• Medicines known as steroids or other
immunosuppressant medicines.
• Medicines known as antimuscarinics (e.g.
atropine, hyoscine).
• Medicines containing methylcellulose
• Antibiotics
• Medicines to treat an irregular heart beat
• Other medicines that interfere with
transmission between nerves and muscles
If you are going to have surgery
Tell your doctor that you are taking
Pyridostigmine bromide 60 mg Tablets.
Pyridostigmine bromide 60 mg Tablets can stop
the effect of some medicines used to relax
muscles during surgery (e.g. pancuronium,
vencuronium).
Pyridostigmine bromide 60 mg Tablets can also
prolong the effect of other muscle relaxants
(e.g. suxamethonium).
Pregnancy and breast-feeding
Tell your doctor before you start treatment if you:
• Are pregnant, if you think you are pregnant,
or if you intend to become pregnant.
• Are breast-feeding, as Pyridostigmine
bromide 60 mg Tablets pass into breast milk
in small amounts.
Your doctor will then decide if you can take this
medicine.
Driving and using machines
Pyridostigmine bromide 60 mg Tablets may
reduce the sharpness of your eyesight and
therefore your ability to drive or use machines.
Do not drive or operate machines if this
medicine affects your ability to see clearly.
Important information about some of the
ingredients of Pyridostigmine bromide 60 mg
Tablets
Pyridostigmine bromide 60 mg Tablets contain
lactose. Therefore, 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 PYRIDOSTIGMINE
BROMIDE 60 mg TABLETS
Swallow the tablets with water or another nonalcoholic drink. If you have difficulty swallowing,
you can break the tablets into pieces.
You should check with your doctor or
pharmacist if you are not sure how to take
Pyridostigmine bromide 60 mg Tablets.

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.

The dose will depend on your illness, your
needs and on your age as follows:

5. HOW TO STORE PYRIDOSTIGMINE
BROMIDE 60 mg TABLETS

For myasthenia gravis:

Keep Pyridostigmine bromide 60 mg Tablets
out of the sight and reach of children.

• The usual adult dose is 1/2 to 2 tablets (30 to
120 mg Mestinon) to be taken five to six
times daily, or higher doses if needed, as
recommended by your doctor.
• For children under 6 years, the usual dose is
1/2 a tablet (30 mg). For children aged 6 to
12 years, the usual starting dose is 1 tablet
(60 mg). The doctor will then gradually
increase the dose until maximum
improvement is seen. In children the total
dose per day is usually 30 to 360 mg.
The tablets take 30 to 60 minutes to start
working after you have taken them.
The effect of each dose should last about four
hours during the day and about six hours at
night.
You should try to take your medicine so that it
can work when your muscles are needed most,
for example, when you get up and about 30 to
60 minutes before a meal.
For paralytic ileus (constipation) and postoperative inability to pass urine:
• The usual adult dose is 1 to 4 tablets (60 to
240 mg Mestinon) daily and for children 1/4
to 1 tablet (15 to 60 mg) daily, depending on
the needs of the patient.

Do not store above 25°C.
Keep the bottle tightly closed in order to protect
from moisture.
Store in the original carton in order to protect
from light.
Do not use Pyridostigmine bromide 60 mg
Tablets after the expiry date which is stated on
the bottle label and outer carton after the text
“EXP”. The expiry date refers to the last day of
that month.
If your medicine become discoloured or show
signs of any deterioration, you should seek the
advice your doctor or pharmacist who will tell
you what to do.
Medicines must 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. FURTHER INFORMATION
What Pyridostigmine bromide 60 mg Tablets
contain
Active substance:

If you take more Pyridostigmine bromide
60 mg Tablets than you should

Each tablet contains 60 mg
pyridostigmine bromide.

Other ingredients:

If you take too many tablets or someone else
accidentally takes your medicine, contact your
doctor, pharmacist or nearest hospital straight
away.

Lactose, silicic acid, maize
starch, talc, magnesium
stearate and potato starch.

What Pyridostigmine bromide 60 mg Tablets
look like and contents of the pack

If you forget to take Pyridostigmine bromide
60 mg Tablets
If you forget to take one of your daily doses,
take it as soon as you remember, and take the
next dose at the normal time. Do not take a
double dose to make up for a forgotten dose. If
you miss more than a single dose, you should
contact your doctor for advice.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pyridostigmine bromide
60 mg Tablets can cause side effects, although
not everybody gets them.
Possible side effects with Pyridostigmine
bromide 60 mg Tablets:
Side effects of unknown frequency:
• visual disturbance, producing more tears
than usual an irregular heart beat, heart
block, low blood pressure, fainting
• producing more phlegm than usual combined
with constriction of the airways
• feeling sick, vomiting, diarrhoea, stomach
cramps, producing more saliva than usual
• rash
• excessive sweating
• muscle weakness and twitching, shaking,
muscle cramps
• sudden, compelling urge to urinate.

Pyridostigmine bromide 60 mg Tablets are
white to off-white, round, biplanar, bevel-edged
tablets imprinted with ‘V’ over ‘M60’ on one side
and with two break marks forming a cross on
the other side.
Pyridostigmine bromide 60 mg Tablets are
available in an amber glass bottle with a
desiccant attached inside the white plastic
temper evident screw cap.
The tablets come in packs of 100 and 200
(2x100 tablets).
PL: 15814/1307

POM

Pyridostigmine bromide 60 mg Tablets are
manufactured by Labiana Pharmaceuticals
S.L.U., Casanova 27-31, 08757-Corbera de
Llobregat (Barcelona), Spain.
Procured from within the EU and repackaged
by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Leaflet revision
24.01.2017

and

issue

date

(Ref.):

To request a copy of
this leaflet in Braille,
large print or audio
please call 01923 332
796.

Expand Transcript

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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