Skip to Content

MESTINON 60 MG TABLETS

Active substance(s): PYRIDOSTIGMINE BROMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
FRONT PAGE
T05040

Mestinon® 60 mg Tablets
(Pyridostigmine bromide)

Patient Information Leaflet
The name of this medicine is Mestinon 60 mg
Tablets but will be referred to as Mestinon
Tablets throughout the following leaflet.
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 Tablets are and what they
are 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 Tablets are and what

they are used for

Mestinon 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 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 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 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 Tablets
are only for some types of constipation and
inability to pass urine (see Section 1).
Take special care with Mestinon Tablets
Before treatment with Mestinon 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
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
Tablets. Mestinon Tablets can stop the effect of
some medicines used to relax muscles during
surgery (e.g. pancuronium, vencuronium).
Mestinon 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 Tablets
pass into breast milk in small amounts.
Your doctor will then decide if you can take this
medicine.
Driving and using machines
Mestinon 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 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 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 Tablets) 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
post-operative inability to pass urine:
• The usual adult dose is 1 to 4 tablets (60 to
240 mg Mestinon Tablets) daily and for
children 1/4 to 1 tablet (15 to 60 mg) daily,
depending on the needs of the patient.
If you take more Mestinon 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.

BACK PAGE
If you forget to take Mestinon 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, Mestinon Tablets can cause
side effects, although not everybody gets them.
Possible side effects with Mestinon 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.
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 out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package.
• Protect from light.
• Keep the bottle tightly closed in order to
protect from moisture.
• Do not use Mestinon 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 the medicine becomes discoloured or
shows any other signs of deterioration, you
should seek the advice of 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 Tablets contain
Each tablet contains 60 mg pyridostigmine
bromide.
Other ingredients: lactose, silicic acid, maize
starch, talc, magnesium stearate and potato
starch.
What Mestinon Tablets look like and
contents of the pack
White to off-white, round, biplanar, bevel-edged
V
tablets imprinted with '' M60
'' across one face
and with two break marks forming a cross on
the other.
Mestinon Tablets are available in pack sizes of
100 and 200 tablets.
Manufacturer and Product Licence Holder
This product is manufactured by Labiana
Pharmaceuticals S.L.U., Casanova, 27-31;
08757-Corbera de Llobregat, Barcelona, Spain.
It is procured from within the EU by the Product
Licence Holder: Swinghope Ltd, Brandon
House, Marlowe Way, Croydon CR0 4XS and
repackaged by Interport Ltd, Brandon House,
Marlowe Way, Croydon CR0 4XS.
POM
PL No: 10380/1523
Leaflet revision date: 06/08/2014
Mestinon® is a registered trademark of Valeant
Pharmaceuticals International, United States of
America.

T05040

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.

Hide