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PYRIDOSTIGMINE BROMIDE 60MG TABLETS

Active substance(s): PYRIDOSTIGMINE BROMIDE

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Mestinon® 60mg Tablets / Pyridostigmine bromide 60mg Tablets
(pyridostigmine bromide)
Package Leaflet: Information for the User
Your medicine is known by one of the above names but will be referred to as
Mestinon Tablets throughout this leaflet.
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 is and what it is used for
2) Before you take Mestinon Tablets
3) How to take Mestinon Tablets
4) Possible side effects
5) How to store Mestinon Tablets
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 Tablets
Do not take Mestinon Tablets if you:
 Are allergic (hypersensitive) to pyridostigmine, bromides or any of the
other ingredients of Mestinon 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 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 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. pancuroniuim, 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
Tablets
Mestinon 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 Tablets
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:
 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 a forgotten. 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
 rash
 excessive sweating
 muscle weakness and twitching, shaking, muscle cramps
 sudden, compelling urge to urinate.

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 Tablets







Keep all medicines out of the sight and reach of children.
Store in the original package.
Protect from moisture.
Protect from light.
Do not store above 25°C.
If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
 Do not use Mestinon Tablets after the expiry date which is stated on the
bottle label and the outer carton after the text “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) Further information
What Mestinon contains
The active substance in Mestinon is pyridostigmine bromide.
Each tablet contains 60 mg pyridostigmine bromide.
The other ingredients are: silicic acid, maize starch, lactose, talc, magnesium
stearate and potato starch.
What Mestinon looks like and contents of the pack
Mestinon comes in an amber glass bottle with plastic screw cap and security
seal. Mestinon Tablets are white to off-white, round, biplanar, bevel-edged
tablets imprinted with “V” “M60” across one face and with two break marks
forming a cross on the other.
Mestinon 60mg Tablets and Pyridostigmine bromide 60mg Tablets are
available in packs of 100 and 200.
PL 10383/2040

Mestinon 60mg Tablets /
Pyridostigmine bromide 60mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is 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:
Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 10.07.2014
Mestinon® is a registered trademark of Valeant Pharmaceuticals International,
USA.

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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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