Mestinon 60mg Tablets

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

PYRIDOSTIGMINE BROMIDE

Dostępny od:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Kod ATC:

N07AA02

INN (International Nazwa):

PYRIDOSTIGMINE BROMIDE 60 mg

Forma farmaceutyczna:

TABLET

Skład:

PYRIDOSTIGMINE BROMIDE 60 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

OTHER NERVOUS SYSTEM DRUGS

Status autoryzacji:

Authorised

Data autoryzacji:

2007-04-05

Ulotka dla pacjenta

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 you have any of t

Charakterystyka produktu

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.
_ _
_Renal impairment _
Pyridostigmine bromide 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.
_