PYRIDOSTIGMINE 30

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PYRIDOSTIGMINE BROMIDE

Available from:

RAFA LABORATORIES LTD

ATC code:

N07AA02

Pharmaceutical form:

TABLETS

Composition:

PYRIDOSTIGMINE BROMIDE 30 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic group:

PYRIDOSTIGMINE

Therapeutic area:

PYRIDOSTIGMINE

Therapeutic indications:

Pyridostigmine belongs to the cholinesterase inhibitor group and is indicated for the treatment of myasthenia gravis.

Authorization date:

2021-06-30

Patient Information leaflet

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is sold with a doctor's prescription only
PYRIDOSTIGMINE 30
PYRIDOSTIGMINE 60
TABLETS
ACTIVE INGREDIENT:
Each tablet of Pyridostigmine 30 contains: Pyridostigmine bromide 30
mg
Each tablet of Pyridostigmine 60 contains: Pyridostigmine bromide 60
mg
For a list of the other ingredients, please see section 6.
See also 'Important information about some of the medicine's
ingredients in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to
others. It may harm them, even if it seems to you that their illness
is similar to yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of myasthenia gravis.
THERAPEUTIC GROUP: cholinesterase inhibitors.
The tablets contain the active ingredient pyridostigmine bromide which
acts as an inhibitor
of the enzyme cholinesterase and thus prevents the increased
degradation of acetyl
choline, a substance which transmits pulses from the nerve to the
muscle.
In patients who suffer from myasthenia gravis the muscles quickly
become tired and weak.
In severe cases, they even reach a state of muscle paralysis.
2.
BEFORE YOU TAKE THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients
this medicine contains (for a list of the other ingredients, please
see section 6).
•
You suffer from a mechanical obstruction of the intestines or the
urinary tract.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
:
•
If you are about to undergo surgery, notify the medical team that you
are taking this
medicine.
BEFORE STARTING THE TREATMENT WITH PYRIDOSTIGMINE TELL YOUR DOCTOR IF:
•
You suffer from asthma or other problems of the respiratory system
such a

Summary of Product characteristics

1
Pyridostigmine
-DL-SPC-November 2023-02
SAMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pyridostigmine 30, Pyridostigmine 60
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Pyridostigmine 30 contains 30mg pyridostigmine bromide
Each tablet of Pyridostigmine 60 contains 60mg pyridostigmine bromide
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets for oral use
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.
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.
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.
Special populations
_Elderly_
There are no specific dosage recommendations in elderly patients.
Renal impairment
Pyridostigmine 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 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
-
Mechanical obstruction of the digestive or urinary tract
2
4.4
Special warnings and precautions for use
Pyridostigmine is to be used with particular caution in:
-Patients with obstructive respiratory illnesses such as bronchial
asthma and chronic obstructive pulmonary
disease (COPD).
Pyridostigmine is to be used with caution in:
-
Patients with arrhythmias such as bradycardia a