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PYRIDOSTIGMINE BROMIDE 60 MG TABLETS

Active substance(s): 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.
Mestinon 60 mg Tablets will be referred to throughout this leaflet as
Mestinon.
In this leaflet:
1. What Mestinon is and what it is used for
2. Before you take Mestinon
3. How to take Mestinon
4. Possible side effects
5. How to store Mestinon
6. Further information
1. WHAT MESTINON IS AND WHAT IT IS USED FOR
Mestinon is 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 belongs 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 is also used to treat some rare forms of constipation
(paralytic ileus) and inability to pass urine after an operation.
2. BEFORE YOU TAKE MESTINON
Do not take Mestinon if you:


Are allergic (hypersensitive) to pyridostigmine, bromides or any
of the other ingredients of Mestinon (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 is only for
some types of constipation and inability to pass urine (see
Section 1)
Take special care with Mestinon
Before treatment with Mestinon, 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 has 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. Mestinon can stop the
effect of some medicines used to relax muscles during surgery (e.g.
pancuronium, vencuronium).
Mestinon 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 passes into breast milk in small
amounts.
Your doctor will then decide if you can take this medicine.
Driving and using machines
Mestinon 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

Mestinon contains 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
Swallow the tablets with water or another non-alcoholic 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.
The dose will depend on your illness, your needs and on your age as
follows:
For myasthenia gravis:

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.



Keep Mestinon out of the sight and reach of children.

The usual adult dose is ½ 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 ½ 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 post-operative inability to
pass urine:


The usual adult dose is 1 to 4 tablets (60 to 240 mg Mestinon)
daily and for children ¼ to 1 tablet (15 to 60 mg) daily,
depending on the needs of the patient.
If you take more Mestinon 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.
If you forget to take Mestinon
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, Mestinon can cause side effects, although not
everybody gets them.
Possible side effects with Mestinon:
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
excessive sweating
muscle weakness and twitching, shaking, muscle cramps
sudden, compelling urge to urinate.
rash

5. HOW TO STORE MESTINON
Do not store above 25°C.
Store in the original package.
Protect from light and moisture.
Keep container tightly closed.
Do not use this medicine after the expiry date which is stated on the
blister and the carton. The expiry date refers to the last day of the
month stated on the carton.
If your medicine become discoloured or deteriorates then seek
medical advice from a doctor or pharmacist
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 contains
The active substance of Mestinon is pyridostigmine bromide.
Each tablet contains: 60 mg pyridostigmine bromide.
The other excipients are lactose, silicic acid, talc, magnesium
stearate, potato starch and maize starch.
What Mestinon looks like and contents of the pack
The tablets are white to off-white, round, biplane, bevel-edged
tablets imprinted with ‘V M60’ across one face and with two break
marks forming a cross on the other side.
The tablets come in packs of 100 and 200.
A desiccant is enclosed in the bottles
Manufacturer: Labiana Pharmaceuticals S.L.U., Casanova, 27-31; Corbera de Llobregat (Barcelona)
Procured from within the EU by
Product Licence holder: Ecosse Pharmaceuticals Ltd., 3 Young
Place, East Kilbride, G75 0TD.
Re-packaged by Munro Wholesale Medical Supplies Ltd., 3 Young
Place, East Kilbride, G75 0TD.
PL 19065/0447
POM
This leaflet was revised: 24/10/2014
E0447L-1

Mestinon® is a registered trademark of Meda AB

PATIENT INFORMATION LEAFLET
Pyridostigmine bromide® 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.
Pyridostigmine bromide 60 mg Tablets will be referred to throughout
this leaflet as Pyridostigmine bromide
In this leaflet:
1. What Pyridostigmine bromide is and what it is used for
2. Before you take Pyridostigmine bromide
3. How to take Pyridostigmine bromide
4. Possible side effects
5. How to store Pyridostigmine bromide
6. Further information
1. WHAT PYRIDOSTIGMINE BROMIDE IS AND WHAT IT IS
USED FOR
Pyridostigmine bromide is 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 belongs 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 is 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
Do not take Pyridostigmine bromide if you:


Are allergic (hypersensitive) to pyridostigmine, bromides or any
of the other ingredients of Pyridostigmine bromide (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 is only for some types of constipation and inability to
pass urine (see Section 1)
Take special care with Pyridostigmine bromide
Before treatment with Pyridostigmine bromide, 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 has
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.
Pyridostigmine bromide can stop the effect of some medicines used
to relax muscles during surgery (e.g. pancuronium, vencuronium).
Pyridostigmine bromide 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 passes into
breast milk in small amounts.
Your doctor will then decide if you can take this medicine.
Driving and using machines
Pyridostigmine bromide 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
Pyridostigmine bromide contains 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
Swallow the tablets with water or another non-alcoholic 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.
The dose will depend on your illness, your needs and on your age as
follows:
For myasthenia gravis:

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.



Keep Pyridostigmine bromide out of the sight and reach of
children.
Do not store above 25°C.
Store in the original package.
Protect from light and moisture.
Keep container tightly closed.
Do not use this medicine after the expiry date which is stated on the
blister and the carton. The expiry date refers to the last day of the
month stated on the carton.
If your medicine become discoloured or deteriorates then seek
medical advice from a doctor or pharmacist

The usual adult dose is ½ to 2 tablets (30 to 120 mg
Pyridostigmine bromide) 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 ½ 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 post-operative inability to
pass urine:


The usual adult dose is 1 to 4 tablets (60 to 240 mg
Pyridostigmine bromide) daily and for children ¼ to 1 tablet (15
to 60 mg) daily, depending on the needs of the patient.
If you take more Pyridostigmine bromide 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.
If you forget to take Pyridostigmine bromide
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 can cause side effects,
although not everybody gets them.
Possible side effects with Pyridostigmine bromide:
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
excessive sweating
muscle weakness and twitching, shaking, muscle cramps
sudden, compelling urge to urinate.
rash

5. HOW TO STORE PYRIDOSTIGMINE BROMIDE

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 contains
The active substance of Pyridostigmine bromide is pyridostigmine
bromide.
Each tablet contains: 60 mg pyridostigmine bromide.
The other excipients are lactose, silicic acid, talc, magnesium
stearate, potato starch and maize starch.
What Pyridostigmine bromide looks like and contents of the
pack
The tablets are white to off-white, round, biplane, bevel-edged
tablets imprinted with ‘V M60’ across one face and with two break
marks forming a cross on the other side.
The tablets come in packs of 100 and 200.
A desiccant is enclosed in the bottles.
Manufacturer: Labiana Pharmaceuticals S.L.U., Casanova, 27-31; Corbera de Llobregat (Barcelona)
Procured from within the EU by
Product Licence holder: Ecosse Pharmaceuticals Ltd., 3 Young
Place, East Kilbride, G75 0TD.
Re-packaged by Munro Wholesale Medical Supplies Ltd., 3 Young
Place, East Kilbride, G75 0TD.
PL 19065/0447
POM
This leaflet was revised: 24/10/2014
E0447(pb)-1

Expand view ⇕

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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