MESTINON DRAGEES 60 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PYRIDOSTIGMINE BROMIDE

Available from:

MEGAPHARM LTD

ATC code:

N07AA02

Pharmaceutical form:

DRAGEE

Composition:

PYRIDOSTIGMINE BROMIDE 60.0 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ICN POLFA RZESZOW S.A., POLAND

Therapeutic group:

PYRIDOSTIGMINE

Therapeutic area:

PYRIDOSTIGMINE

Therapeutic indications:

Treatment of myasthenia gravis.

Authorization date:

2016-03-31

Patient Information leaflet

1
_ _
PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS - 1986_ _
This medicine is dispensed with a physician’s prescription only
MESTINON DRAGEES 60 MG
EACH DRAGEE CONTAINS:
PYRIDOSTIGMINE BROMIDE 60 MG
FOR A LIST OF INACTIVE AND ALLERGENIC INGREDIENTS, SEE SECTION 6 -
“ADDITIONAL
INFORMATION”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE._ _This leaflet contains
concise information about the medicine._ _If you have further
questions, consult your physician
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others._ _It may harm them
even if it seems to you that their medical condition is similar._ _
1.
WHAT IS THIS MEDICINE INTENDED FOR?_ _
Treatment of myasthenia gravis.
THERAPEUTIC GROUP:_ _
Cholinesterase inhibitors.
MESTINON DRAGEES 60 MG contain the active ingredient Pyridostigmine
bromide which
acts as an inhibitor of the cholinesterase enzyme. This in turn blocks
excessive
breakdown of acetylcholine, a substance that transmits nerve impulses
to the muscles.
Patients who have myasthenia gravis feel that their muscles are weak
and tire easily. In
severe cases, they may even decline to muscle paralysis.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE STARTING TREATMENT WITH MESTINON DRAGEES 60 MG, TELL YOUR
PHYSICIAN IF:
•
You suffer from diseases of the respiratory tract such as asthma,
bronchospasm or
chronic obstructive pulmonary disease (COPD)
•
You suffer from heart diseases such as: worsening of heart failure
(symptoms at
rest), cardiac conduction disorders (AV block) or heart rhythm
disorders such as
slow heart rhythm, or you have recently had a heart attack (arrhythmia
is more
common in the older population)
•
You suffer from low blood pressure
•
You suffer from a stomach ulcer
•
You have had gastrointestinal surgery
•
You suffer from epilepsy
•
You suffer from Parkinson's disease
•
You are sensitive (allergic) to the active ingredient Pyri

Summary of Product characteristics

Page 1 of
9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MESTINON DRAGEES 60 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 coated tablet (dragee) contains 60 mg pyridostigmine bromide.
Excipient(s) with known effect:
Sucrose
161.6 mg/coated tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet (dragee) for oral use
Round, biconvex,
orange-white or pale orange coloured
sugar coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of myasthenia gravis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults _
Oral dosage forms:
Multiple doses of 30 to 120 mg are given at intervals throughout the
day.
MESTINON DRAGEES
60 MG
MUST NOT
be divided. If available, use a tablet containing 30
mg pyridostigmine
bromide for 30mg dose.
The total daily dose is usually in the range of 120 – 1200 mg but
doses higher than these may
be needed by some patients according to dose titration.
_Children _
Children under 6 years old should receive an initial dose of 30 mg of
pyridostigmine bromide.
MESTINON DRAGEES 60 MG
MUST NOT
be divided. If available, use a tablet containing 30 mg
pyridostigmine bromide for 30 mg dose.
Children 6 – 12 years old should receive 60 mg. Dosage should be
increased gradually, in
increments of 30 mg daily, until maximum improvement is obtained.
Total daily
requirements are usually in the range to 30 – 360 mg.
Page 2 of
9
SPECIAL POPULATIONS
_Elderly _
There are no specific dosage recommendations for
MESTINON DRAGEES 60 MG
in elderly
patients.
_Renal impairment _
MESTINON DRAGEES 60 MG
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 DRAGEES 60 MG
in patients with
hepatic impairment.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance, other bromides or to any of
the excipients listed
in section 6.1.
-