Mestinon 60mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Pyridostigmine bromide
Available from:
CST Pharma Ltd
ATC code:
N07AA02
INN (International Name):
Pyridostigmine bromide
Dosage:
60mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 10020100; GTIN: 5055946801575

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 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

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 consti-

pation and inability to pass urine (see Section 1).

T

ake 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

ondition.

Have low blood pressure.

Have a stomach ulcer.

Have epilepsy.

Have Parkinson’s disease.

Have kidney problems.

PATIENT INFORMATION LEAFLET

Mestinon 60 mg Tablets

Pyridostigmine bromide

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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 infor-

mation on the safety of this

medicine.

5. HOW TO STORE

MESTINON TABLETS

Keep Mestinon Tablets out

of the reach and sight of

children.

Store the bottle in the

original

outer carton.

Keep the bottle tightly closed in

order to protect

from moisture.

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

Active substance:

Each tablet contains 60 mg

of pyridostigmine bromide.

ther ingredients:

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 ˝

˝ is

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,

United Kingdom.

M

anufacturer

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

local distributor.

T

his leaflet was last revised in

February 2018.

S

upport and information for patients with

myasthenia and their families in the UK and

Ireland can be obtained from:

Myaware

Tel: +44(0)1332 290219

www.myaware.org

33010E0EU-G00

56UK1962260-01

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.

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

doctor.

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

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

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, phar-

macist or

nurse. This includes any possible

side

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MANUFACTURER:

Meda Pharma GmbH & Co. KG

PRODUCT:

Mestinon 60 mg

MATERIAL-NO.:

56UK1962260-01

ITEM-CODE:

33010E0EU-G00

PHARMA-CODE:

10E0EUG

PACK SIZE:

135 x 240 mm

FONT SIZE:

8 pt / 9 pt

COLOURS USED:

Black

COUNTRY:

United Kindom UK

LANGUAGE:

English

CORRECTION: 1.

DATE:

07. 03. 2018

Studio Oberländer GmbH · Rubensstr. 33 · 60596 Frankfurt a. M. · Germany

Phone: +49 69 631520-85 · Fax: - 87 · E-Mail: info

@

studio-oberlaender.de

SPECIFICATION BOX: Leaflet

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Mestinon 60 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 60 mg pyridostigmine bromide.

For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM

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.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Myasthenia gravis, paralytic ileus and post-operative urinary retention.

4.2

Posology and method of administration

Posology

Myasthenia gravis

Adults

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.

Paediatric population

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 –

360mg.

Other Indications (paralytic ileus, post-operative urinary retention)

Adults

The usual dose is 1 to 4 tablets (60 – 240mg) per day.

Paediatric population

The usual dose is 15 – 60mg per day.

The frequency of these doses may be varied according to the needs of the patient.

Special populations

Elderly

There are no specific dosage recommendations for Mestinon in elderly patients.

Renal impairment

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.

Hepatic impairment

There are no specific dosage recommendations for Mestinon in patients with hepatic

impairment.

Method of administration

For oral use

4.3

Contraindications

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

4.4

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

(COPD).

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

- Hypotension,

- Vagotonia

- Peptic ulcer

- Epilepsy or Parkinsonism

- Hyperthyroidism

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

respiratory assistance.

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.

4.5

Interaction with other medicinal products and other forms of interaction

Immunosuppressant drugs

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

corticosteroids.

Methylcellulose

Methylcellulose and medicine containing methylcellulose as excipients can

completely inhibit absorption of pyridostigmine bromide.

Antimuscarinics

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.

Muscle Relaxants

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).

Others

Aminoglycoside antibiotics, local and some general anesthetics, antiarrhythmic

agents, and other drugs that interfere with neuromuscular transmission may interact

with pyridostigmine bromide.

4.6

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

pregnancy.

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

infant.

4.7

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.

4.8

Undesirable effects

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

weakness.

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 (

1/1,000 to

<1/100), Rare (

1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be

estimated from the available data)

Eye disorders

Frequency not known: Miosis, increased lacrimation, accommodation disorders

Cardiac 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

bronchoconstriction

Gastrointestinal disorders

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

4.9

Overdose

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

also occur.

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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

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

5.2

Pharmacokinetic properties

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.

5.3

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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Each tablet contains:

Lactose

Starch

Precipitated Silica

Talc

Magnesium Stearate

Purified Water

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

3 years.

6.4

Special precautions for storage

Store below 25°C. Store in the original package in order to protect from light and

moisture.

6.5

Nature and contents of container

Amber glass bottles with aluminium screw or low density polyethylene caps and

desiccant containing 200 tablets.

6.6

Special precautions for disposal

No special requirements for disposal.

7

MARKETING AUTHORISATION HOLDER

Mylan Products Ltd,

Station Close,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)

PL 46302/0133

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

10

DATE OF REVISION OF THE TEXT

13/04/2018

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