MESTINON pyridostigmine bromide 60mg tablet bottle

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

pyridostigmine bromide, Quantity: 60 mg

Fáanlegur frá:

iNova Pharmaceuticals (Australia) Pty Ltd

Lyfjaform:

Tablet, sugar coated

Samsetning:

Excipient Ingredients: iron oxide yellow; colloidal anhydrous silica; Acacia; magnesium stearate; maize starch; povidone; liquid paraffin; purified talc; rice starch; hard paraffin; iron oxide red; sucrose; pregelatinised potato starch

Stjórnsýsluleið:

Oral

Einingar í pakka:

150 tablets

Tegund:

Medicine Registered

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

INDICATIONS AS AT 3 AUGUST 1992: Mestinon is useful in the treatment of myasthenia gravis.

Vörulýsing:

Visual Identification: Cylindrical, biconvex, pale orange coated tablet. unmarked.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Registered

Leyfisdagur:

1991-08-23

Upplýsingar fylgiseðill

MESTINON
®
_Pyridostigmine Bromide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MESTINON. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
MESTINON is a prescription
medicine, it should be used only
under strict medical supervision.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking MESTINON
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MESTINON IS
USED FOR
MESTINON is used to treat
myasthenia gravis. This is a
condition whereby you have muscle
weakness and tiredness especially on
repeated use.
MESTINON belongs to a group of
medicines called cholinergic
antimyasthenics. It works by
preventing the breakdown of a
chemical called acetylcholine. This
chemical is needed to stimulate
muscle movement.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU TAKE
MESTINON
In deciding to use a medicine, the
risks of taking the medicine must be
weighed against the good it will do.
This is a decision you and your
doctor will make.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MESTINON IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
pyridostigmine bromide
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE MESTINON IF YOU
HAVE INTESTINAL BLOCKAGE OR URINARY
TRACT BLOCKADE OR URINARY TRACT
INFECTION.
This medicine may make the
condition worse.
DO NOT TAKE THIS MEDICINE AF

Vara einkenni

1
AUSTRALIAN PRODUCT INFORMATION – MESTINON
(PYRIDOSTIGMINE BROMIDE) TABLET
1
NAME OF THE MEDICINE
Pyridostigmine Bromide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mestinon contains, as active substance, pyridostigmine bromide.
Mestinon 10 mg tablets also contain the excipients
lactose monohydrate, magnesium stearate,
colloidal anhydrous silica, maize starch, pregelatinised potato starch
and
purified talc.
Mestinon 60 mg tablets also contain the excipients acacia, iron oxide
red, iron oxide yellow,
magnesium stearate, hard paraffin, liquid paraffin, povidone,
colloidal anhydrous silica, maize
starch, pregelatinised potato starch, rice starch, sucrose, and
purified talc.
Mestinon Timespan 180 mg tablets also contains the excipients calcium
phosphate, carnauba
wax, magnesium stearate, colloidal anhydrous silica and zein.
Excipient with known effect:
Lactose monohydrate and sucrose.
3
PHARMACEUTICAL FORM
Mestinon 10 mg
Round, biconvex, white to off-white tablet with no markings.
Mestinon 60 mg
Round, biconvex, pale orange, sugar coated tablet with no markings.
Mestinon 180 mg
Round, biplanar, grey-yellow tablet with a marking ‘V M180’ on one
side
and scored on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Mestinon is useful in the treatment of myasthenia gravis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Myasthenia gravis: 1 to 3 tablets (60 mg) two to four times daily;
more in severe cases.
1 to 3 "Timespan" tablets (180 mg) once or twice daily; the needs of
individuals may vary
markedly from this average, but the interval between doses should be
at least six hours.
The dosage and frequency of administration depend upon the clinical
response of the patient and
may vary from day to day, according to remissions and exacerbations of
the disease and the
physical and emotional stress suffered by the patient. Dosage should
be adjusted so that patients
take larger doses at times of greatest fatigue e.g. 30-45 minutes
before meals in patients who have
difficulty in eating.
2
Patients should be advi