Mestinon 60 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pyridostigmine bromide

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

N07AA; N07AA02

INN (International Name):

Pyridostigmine bromide

Dosage:

60 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Anticholinesterases; pyridostigmine

Authorization date:

2020-06-12

Patient Information leaflet

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:
What Mestinon tablets are and what they are used for
What you need to know before you take Mestinon tablets
How to take Mestinon tablets
Possible side effects
How to store Mestinon tablets
Contents of the pack and other information
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.
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
you have
any of the following conditions:
- Obstructive respiratory diseases such as bron

Summary of Product characteristics

Health Products Regulatory Authority
16 March 2022
CRN00CV8V
Page 1 of 2
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.
Each Tablet contains lactose monohydrate.
_For excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Tablet
_ _
Product imported from Spain
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
As per PA2010/052/001.
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/052/001.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Silicic acid
Corn starch
Talc
Magnesium stearate
Potato starch
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store in the original package. Keep the
bottle tightly closed.
Health Products Regulatory Authority
16 March 2022
CRN00CV8V
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottles with low density polyethylene caps and desiccant
containing 2 x 100 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/028/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12
th
June 2020
10 DATE OF REVISION OF THE TEXT
October 2021