Mestinon 60mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

即購入

ダウンロード 製品の特徴 (SPC)
13-04-2018

有効成分:

Pyridostigmine bromide

から入手可能:

Lexon (UK) Ltd

ATCコード:

N07AA02

INN(国際名):

Pyridostigmine bromide

投薬量:

60mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 10020100

情報リーフレット

                                MESTINON 60MG TABLETS
(pyridostigmine bromide)
PATIENT INFORMATION LEAFLET
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.
Your medicine is called Mestinon 60mg Tablets but will be referred to
as
Mestinon Tablets throughout the leaflet.
IN THIS LEAFLET:
What Mestinon is and what it is used for
Before you take Mestinon Tablets
How to take Mestinon Tablets
Possible side effects
How to store Mestinon Tablets
Further information
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.
BEFORE YOU TAKE MESTINON TABLETS
DO NOT TAKE MESTINON TABLETS IF YOU:
*
Are allergic (hypersensitive) to pyridostigmine, bromides or any of
the
other ingredients of Mestinon Tablets (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
                                
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製品の特徴

                                _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
                                
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