United Kingdom - English - eMC (Electronic Medicines Compendium)
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
Have an overactive thyroid
Have had an operation to remove your thymus
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
doctor if you are taking any of the following
Medicines known as steroids or other
Medicines known as antimuscarinics
(e.g. atropine, hyoscine).
Medicines containing methylcellulose
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,
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
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
estinon Tablets contain lactose. Therefore, if you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
efore taking this medicinal product.
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 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
WHAT MESTINON IS AND WHAT IT IS
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.
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
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 consti-
pation and inability to pass urine (see Section 1).
ake special care with Mestinon
Before treatment with Mestinon, tell your doctor
Suffer from asthma or have other chest problems
such as wheeziness, difficulty in breathing or chronic
Have recently had coronary obstruction (heart
attack), have a slow heart beat or any other heart
Have low blood pressure.
Have a stomach ulcer.
Have Parkinson’s disease.
Have kidney problems.
PATIENT INFORMATION LEAFLET
Mestinon 60 mg Tablets
effects not listed in this leaflet.
You can also report side
effects directly via the
Yellow Card Scheme at:
By reporting side effects you
can help provide more infor-
mation on the safety of this
5. HOW TO STORE
Keep Mestinon Tablets out
of the reach and sight of
Store the bottle in the
Keep the bottle tightly closed in
order to protect
Do not store above 25 °C.
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.
Medicines must not be disposed of via wastewater
or household waste. Ask your pharmacist how to
ispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Mestinon contains
Each tablet contains 60 mg
of pyridostigmine bromide.
Colloidal hydrated silica, maize
starch, lactose monohydrate,
talc and magnesium stearate.
What Mestinon looks like and contents
of the pack
he tablets are scored on one side so that they can
be broken into halves or quarters and ˝
imprinted on the other side.
The tablets come in packs of 200.
A desiccant is enclosed in the bottle.
Marketing Authorisation Holder
Mylan Products Ltd. Station Close,
Potters Bar, Hertfordshire, EN6 1TL,
Labiana Pharmaceuticals S.L.U., Casanova 27-31,
08757-Corbera de Llobregat (Barcelona), Spain.
or any information about this medicine, please
contact the Marketing Authorisation Holder or
his leaflet was last revised in
upport and information for patients with
myasthenia and their families in the UK and
Ireland can be obtained from:
Tel: +44(0)1332 290219
HOW TO TAKE MESTINON
Swallow the tablets with water or another non-
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.
he dose will depend on your illness, your needs and
on your age as follows:
For myasthenia gravis:
The usual adult dose is
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
For children under 6 years, the usual dose is
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
to 1 tablet
(15 to 60 mg) daily, depending on the needs of the
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.
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
producing more phlegm than usual combined with
constriction of the airways
feeling sick, vomiting, diarrhoea, stomach cramps,
producing more saliva than usual
muscle weakness and twitching, shaking, muscle
sudden, compelling urge to urinate.
Reporting of side effects
If you get any side effects, talk to your doctor, phar-
nurse. This includes any possible
Meda Pharma GmbH & Co. KG
Mestinon 60 mg
135 x 240 mm
8 pt / 9 pt
United Kindom UK
07. 03. 2018
Studio Oberländer GmbH · Rubensstr. 33 · 60596 Frankfurt a. M. · Germany
Phone: +49 69 631520-85 · Fax: - 87 · E-Mail: info
SPECIFICATION BOX: Leaflet
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Mestinon 60 mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg pyridostigmine bromide.
For the full list of excipients, see section 6.1
Tablet for oral administration.
White to off-white, round, biplanar, bevel-edged tablets imprinted with “ V ”
across one face and with two break marks forming a cross on the other.
Myasthenia gravis, paralytic ileus and post-operative urinary retention.
Posology and method of administration
Doses of 30 to 120mg are given at intervals throughout the day when maximum
strength is needed (for example, on rising and before mealtimes). The usual duration
of action of a dose is 3 to 4 hours in the daytime but a longer effect (6 hours) is often
obtained with a dose taken on retiring for bed.
The total daily dose is usually in the range of 5 – 20 tablets but doses higher than
these may be needed by some patients.
Children under 6 years old should receive an initial dose of half a tablet (30mg) of
Mestinon; children 6 – 12 years old should receive one tablet (60mg). Dosage should
be increased gradually, in increments of 15 – 30mg daily, until maximum
improvement is obtained. Total daily requirements are usually in the range to 30 –
Other Indications (paralytic ileus, post-operative urinary retention)
The usual dose is 1 to 4 tablets (60 – 240mg) per day.
The usual dose is 15 – 60mg per day.
The frequency of these doses may be varied according to the needs of the patient.
There are no specific dosage recommendations for Mestinon in elderly patients.
Mestinon is mainly excreted unchanged by the kidney, therefore lower doses may be
required in patients with renal disease and treatment should be based on titration of
drug dosage to effect.
There are no specific dosage recommendations for Mestinon in patients with hepatic
Method of administration
For oral use
Mestinon is contra-indicated in patients with:
- Hypersensitivity to the active substance, bromides or to any of the excipients listed
in section 6.1.
- Mechanical gastro-intestinal or urinary obstruction
Special warnings and precautions for use
Extreme caution is required when administering Mestinon to patients with obstructive
respiratory diseases like bronchial asthma and chronic obstructive pulmonary disease
Care should also be taken in patients with:
- Arrhythmias such as bradycardia and AV block(elderly patients may be more
susceptible to dysrhythmias than the young adult)
- Recent coronary occlusion
- Peptic ulcer
- Epilepsy or Parkinsonism
When relatively large doses of Mestinon are taken by myasthenic patients it may be
necessary to give atropine or other anticholinergic drugs to counteract the muscarinic
effects. It should be noted that the slower gastro-intestinal motility caused by these
drugs may affect the absorption of Mestinon.
In all patients the possibility of "cholinergic crisis", due to overdosage of Mestinon ,
and its differentiation from "myasthenic crisis", due to increased severity of the
disease, must be borne in mind. Both types of crisis are manifested by increased
muscle weakness, but whereas myasthenic crisis may require more intensive
anticholinesterase treatment, cholinergic crisis calls for immediate discontinuation of
this treatment and institution of appropriate supportive measures, including
The requirement for Mestinon is usually markedly decreased after thymectomy or
when additional therapy (steroids, immunosuppressant drugs) is given.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.
Interaction with other medicinal products and other forms of interaction
The requirement for pyridostigmine bromide could be decreased when additional
therapy (steroids, immunosuppressant drugs) is given although peak plasma
concentration and AUC of pyridostigmine may decrease by high doses of
Methylcellulose and medicine containing methylcellulose as excipients can
completely inhibit absorption of pyridostigmine bromide.
Atropine and hyoscine antagonise the muscarinic effects of pyridostigmine bromide.
It should be noted that the slower gastro-intestinal motility caused by these drugs may
affect the absorption of pyridostigmine bromide.
Pyridostigmine antagonises the effect of non-depolarising muscle relaxants (e.g.
pancuronium and vecuronium). Pyridostigmine may prolong the effect of
depolarising muscle relaxants (e.g. suxamethonium).
Aminoglycoside antibiotics, local and some general anesthetics, antiarrhythmic
agents, and other drugs that interfere with neuromuscular transmission may interact
with pyridostigmine bromide.
Fertility, pregnancy and lactation
The safety of Mestinon during pregnancy or lactation has not been established.
Although the possible hazards to mother and child must be weighed against the
potential benefits in every case, experience with Mestinon in pregnant patients with
myasthenia gravis has revealed no untoward effect of the drug on the course of
Pyridostigmine bromide crosses the placenta barrier. Excessive doses of
pyridostigmine bromide should be avoided; the newborn child should be monitored
for possible effects.
Intravenous application of pyridostigmine bromide can induce contraction of the
uterus (especially in the last period of pregnancy).
As the severity of myasthenia gravis often fluctuates considerably, particular care is
required to avoid cholinergic crisis, due to overdosage of the drug, but otherwise
management is no different from that in non-pregnant patients.
Observations indicate that only negligible amounts of Mestinon are excreted in breast
milk; nevertheless, due regard should be paid to possible effects on the breast-feeding
Effects on ability to drive and use machines
Due to miosis and accommodation disorders caused by pyridostigmine bromide or an
inadequate treatment of Myasthenia gravis, Mestinon may impair visual acuity and
consequently the ability to react as well as the ability to drive and use machines.
As with all cholinergic products, Mestinon may have unwanted functional effects on
the autonomic nervous system. Muscarine-like adverse effects may be exhibited as
nausea, vomiting, diarrhoea, abdominal cramps, increased peristaltic and increased
bronchial secretion, salivation, bradycardia and miosis.
The primary nicotinic effects are muscle spasms, fasciculation and muscular
Adverse reactions are listed below according to system organ class and frequency.
Frequencies are defined according to the following convention:
Very common (
1/10), Common (
1/100 to <1/10), Uncommon (
<1/100), Rare (
1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be
estimated from the available data)
Frequency not known: Miosis, increased lacrimation, accommodation disorders
Frequency not known: Arrhythmia (including bradycardia, tachycardia, AV block), as
well as syncope and hypotension (see section 4.9)
Respiratory, thoracic and mediastinal disorders
Frequency not known: Increased bronchial secretion combined with
Frequency not known: Nausea, vomiting, diarrhoea, abdominal cramps,
gastrointestinal hypermotility, salivary hypersecretion
Skin and subcutaneous tissue disorders
Frequency not known: Rash (disappears usually soon after ceasing of medication.
Bromide containing medicines should no longer be used.) Hyperhydrosis
Musculoskeletal and connective tissue disorders
Frequency not known: Increased muscle weakness fasciculation, tremors and muscle
cramps or muscle hypotonia (see section 4.9)
Renal and urinary disorders
Frequency not known: Urinary urgency
Because these symptoms may be an indication of cholinergic crisis, the physician
should be notified immediately to clarify the diagnosis (see section 4.9)
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
Overdosage may lead to “cholinergic crisis” characterised by severe muscarinic and
nicotinic symptoms of marked muscle weakness. Cardiovascular and respiratory
failure may occur.
Signs of overdosage due to muscarinic effects may include abdominal cramps,
increased peristalsis, diarrhoea, nausea and vomiting, increased bronchial secretions,
salivation, hyperhydrosis and miosis. Nicotinic effects consist of muscular cramps,
fasciculations and general weakness up to paralysis.
Hypotension up to cardiovascular collapse, bradyarrhythmia, up to cardiac arrest may
Central nervous system effects may include agitation, confusion, slurred speech,
nervousness, irritation, visual hallucinations.
Artificial ventilation should be instituted if respiration is severely depressed.
Atropine sulphate 1 to 2mg intravenously is an antidote to the muscarinic effects.
Doses may be repeated every 5 to 30 minutes as needed.
Pharmacotherapeutic group: Nervous system, parasympathomimetics,
anticholinesterases, pyridostigmine , ATC code: N07AA02
Mestinon is an antagonist to cholinesterase, the enzyme which normally destroys
acetylcholine. The action of Mestinon can briefly be described, therefore, as the
potentiation of naturally occurring acetylcholine. Mestinon has a more prolonged
action than Prostigmin (neostigmine) although it is somewhat slower to take effect
(generally taking 30 – 60 minutes). Because it has a weaker "muscarinic" action than
Prostigmin, it is usually much better tolerated by myasthenic patients in whom the
longer action is also an advantage
Oral pyridostigmine bromide is poorly absorbed. Maximum plasma concentrations
occur at 1 to 2 hours and it is eliminated by the kidney largely unchanged with a half-
life of 3 to 4 hours.
Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to
those already included in other sections of the SmPC.
List of excipients
Each tablet contains:
Special precautions for storage
Store below 25°C. Store in the original package in order to protect from light and
Nature and contents of container
Amber glass bottles with aluminium screw or low density polyethylene caps and
desiccant containing 200 tablets.
Special precautions for disposal
No special requirements for disposal.
MARKETING AUTHORISATION HOLDER
Mylan Products Ltd,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT