Mestinon 60mg Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Pyridostigmine bromide

זמין מ:

LTT Pharma Limited

קוד ATC:

N07AA; N07AA02

INN (שם בינלאומי):

Pyridostigmine bromide

כמות:

60 milligram(s)

טופס פרצבטיות:

Tablet

מסלול נתינה (של תרופות):

Oral use

יחידות באריזה:

200 tablets

סוג מרשם:

Product subject to prescription which may be renewed (B)

תוצרת:

Labiana Pharmaceuticals S.L.U.

קבוצה תרפויטית:

Anticholinesterases

איזור תרפויטי:

Anticholinesterases; pyridostigmine

סממני תרפויטית:

Myasthenia gravis, paralytic ileus and post-operative urinary retention

מצב אישור:

Authorised

תאריך אישור:

2015-08-13

עלון מידע

MESTINON 60MG TABLETS
(pyridostigmine bromide)
PATIENT INFORMATION LEAFLET
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, brominde, 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 respi

מאפייני מוצר

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 lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK_
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 tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA1332/034/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1332/034/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Colloidal hydrated silica
maize starch
lactose monohydrate
talc
magnesium stearate
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.
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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
Amber glass bottles with a desiccant enclosed, containing 200 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MED