Mestinon 60 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pyridostigmine bromide

Available from:

PCO Manufacturing Ltd.

ATC code:

N07AA; N07AA02

INN (International Name):

Pyridostigmine bromide

Pharmaceutical form:

Tablet

Therapeutic area:

Anticholinesterases; pyridostigmine

Authorization date:

2022-01-07

Patient Information 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 yo

Summary of Product characteristics

Health Products Regulatory Authority
11 January 2022
CRN00CPZ1
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.
Excipient(s) with known effect: lactose monohydrate.
For the full list of 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
Maize Starch
Colloidal Hydrated Silica
Talc
Magnesium stearate
Potato starch
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of 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.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
11 January 2022
CRN00CPZ1
Page 2 of 2
Amber glass bottles with low density polyethylene caps and desiccant
containing 100 tablets. Each pack of 200 tablets contains
2 bottles of 100 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.,
Unit 10,
Ashbourne Business Park,
Rath,
Ashbourne,
Co. Meath,
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/492/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7
th
January 2022
10 DATE OF REVISION OF THE TEXT
January 2022