Mestinon 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pyridostigmine bromide

Available from:

DE Pharmaceuticals

ATC code:

N07AA02

INN (International Name):

Pyridostigmine bromide

Dosage:

60mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10020100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
MESTINON® 60 MG TABLETS
(
Pyridostigmine bromide
)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
•
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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
•
If you experience any side effect and this becomes serious, tell
your doctor or pharmacist.
Mestinon 60 mg Tablets will be referred to throughout this leaflet as
Mestinon.
IN THIS LEAFLET:
1. What Mestinon is and what it is used for
2. Before you take Mestinon
3. How to take Mestinon
4. Possible side effects
5. How to store Mestinon
6. Further information
1.
WHAT MESTINON IS AND WHAT IT IS USED FOR
Mestinon is used for the treatment of myasthenia gravis. In patients
who suffer from myasthenia gravis the muscles quickly become tired
and weak and, in severe cases, the muscles may become
paralysed. Myasthenia gravis is caused by excessive activity in the
body of a protein called cholinesterase.
Mestinon belongs to a group of medicines known as cholinesterase
inhibitors. Cholinesterase inhibitors stop the excessive activity of
cholinesterase and in this way help muscles to work properly.
Mestinon is also used to treat some RARE FORMS OF CONSTIPATION
(paralytic ileus) and inability to pass urine after an operation.
2.
BEFORE YOU TAKE MESTINON
DO NOT TAKE MESTINON IF YOU:
•
Are allergic (hypersensitive) to pyridostigmine, bromides or any
of the other ingredients of Mestinon (these are listed in section 6,
‘Further Information’).
•
Are constipated or cannot urinate, unless your doctor has told
you to use this medicine. This is because Mestinon is only for
some types of constipation and inability to pass urine (see
Section 1)
TAKE SPECIAL CARE WITH MESTINON
Before treatment with Mestinon, tell your doctor if you:
•
Suffer from asthma or have other chest problems such as
wheeziness, difficul

Summary of Product characteristics

_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.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet for oral administration.
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Myasthenia gravis, paralytic ileus and post-operative urinary
retention.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
Paediatric population
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 to 30 –
360mg.
Other Indications (paralytic ileus, post-operative urinary retention)
Adults
The usual dose is 1 to 4 tablets (60 – 240mg) per day.
Paediatric population
The usual dose is 15 – 60mg per day.
The frequency of these doses may be varied according to the needs of
the patient.
Special populations
Elderly
There are no specific dosage recommendations for Mestinon in elderly
patients.
Renal impairment
Mestinon 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.
Hepatic impairment
There a