Mestinon 60mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pyridostigmine bromide

Available from:

Mylan IRE Healthcare Limited

ATC code:

N07AA; N07AA02

INN (International Name):

Pyridostigmine bromide

Dosage:

60 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Anticholinesterases; pyridostigmine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MESTINON 60 MG TABLETS
Pyridostigmine bromide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Mestinon tablets are and what they are used for
2.
What you need to know before you take Mestinon tablets
3.
How to take Mestinon tablets
4.
Possible side effects
5.
How to store Mestinon tablets
6.
Contents of the pack and other information
1.
WHAT MESTINON TABLETS ARE AND WHAT THEY ARE USED FOR
Mestinon tablets contain the active ingredient pyridostigmine, which
belongs to a group of medicines
called anticholinesterases, which improve the communication between
the nerves and muscles.
Mestinon tablets are used for:

Treatment of myasthenia gravis – a disease of the immune system
causing muscle weakness

Paralytic ileus – a condition where the digestive tract does not
work because its muscles are
paralysed

Urinary retention after surgery – failure to urinate caused by an
anaesthetic or certain types of
surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MESTINON TABLETS
DO NOT TAKE MESTINON TABLETS:
-
If your digestive tract is twisted or blocked by an obstruction.
-
If you cannot pass urine because of an obstruction.
-
If you are allergic to pyridostigmine, bromine, or any of the other
ingredients of this medicine
(listed in section 6). An allergic reaction may include rash, itching,
difficulty breathing or
swelling of the face, lips, throat or tongue.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Mestinon tablets if
y

Summary of Product characteristics

Health Products Regulatory Authority
30 November 2020
CRN00C21N
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mestinon 60mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tablet contains 60.0mg pyridostigmine bromide.
Each Tablet contains 60.75mg lactose monohydrate.
_For excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round, biplanar, bevel-edged tablets imprinted
with “V” M60 across one face and with two break marks
forming a cross on the other.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Myasthenia gravis, paralytic ileus and post-operative urinary
retention.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_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.
_Children_
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 of 30 -
360mg
_Other Indications (paralytic ileus)_
_Adults_
The usual dose is 1 to 4 tablets (60 to 240mg) per day.
_Children_
The usual dose is 15 to 60mg per day.
The frequency of these doses may be varied according to the needs of
the patient.
_Special Populations_
_ _
_Elderly patients_
There are no specific dosage recommendations for Mestinon in elderly
patients.
_ _
Health Products Regulatory Authority
30 November 2020
CRN00C21N
Page 2 of 7
_Renal impairment _
Pyridostigmine bromide is mainly excreted unchanged by the kid