APO-BIMATOPROST bimatoprost 0.3 mg/mL eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bimatoprost

Available from:

Apotex Pty Ltd

INN (International Name):

Bimatoprost

Authorization status:

Registered

Patient Information leaflet

APO- BIMATOPROST EYE
DROPS
_Bimatoprost_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about bimatoprost. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Bimatoprost is used to lower raised
pressure in the eye and to treat
glaucoma.
Glaucoma is a condition in which the
pressure of fluid in the eye may be
higher than normal. It is usually
caused by a build-up of the fluid
which flows through the eye. This
build up occurs because the fluid
drains out of your eye more slowly
than it is being pumped in, causing
the pressure to rise. This raised
pressure may damage the back of the
eye resulting in gradual loss of sight.
Damage can progress so slowly that
the person is not aware of this
gradual loss of sight.
There are usually no symptoms of
glaucoma. The only way of knowing
that you have glaucoma is to have
your eye pressure, optic nerve and
visual field checked by an eye
specialist or optometrist. If glaucoma
is not treated it can lead to serious
problems, including total blindness.
_HOW IT WORKS_
Bimatoprost belongs to a group of
medicines called prostaglandin
analogues. It lowers the pressure in
the eye by helping the flow of fluid
out of the eye chamber.
Bimatoprost eye drops can be used
alone or together with other
medicines to lower the pressure
within your eyes.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addi

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-BIMATOPROST (BIMATOPROST) EYE DROPS
1
NAME OF THE MEDICINE
Bimatoprost
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bimatoprost 0.3 mg/mL.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-Bimatoprost 0.3 mg/mL eye drops are a sterile, clear, colourless
solution supplied in a
plastic dropper bottle with a plastic screw cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The reduction of elevated intraocular pressure, or open angle
glaucoma, as first line therapy
or monotherapy or as adjunctive therapy to topical beta-blockers.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Bimatoprost is NOT intended for oral administration and is for
individual patient use only.
DOSAGE
Monotherapy: The recommended dose is one drop in the affected eye(s)
once daily,
administered in the evening.
Adjunctive Therapy: The recommended dose is one drop in the affected
eye(s) once daily,
administered in the evening.
More frequent administration has not been shown to provide increased
efficacy.
If more than one topical ophthalmic medication is to be used, the
other medication should not
be used within 5 minutes of using bimatoprost eye drops.
In order to minimise systemic absorption, patients should be
instructed to apply pressure to
the tear duct immediately following administration of the drug.
To avoid contamination of the solution, keep container tightly closed.
Do not touch dropper tip
to any surface. Discard contents 4 weeks after opening the bottle.
Contents are sterile if seal
is intact.
4.3
CONTRAINDICATIONS
Patients with known hypersensitivity to bimatoprost or any of the
excipients of the medication.
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
GENERAL
Bimatoprost has not been studied in patients with heart block more
severe than first degree or
uncontrolled congestive heart failure. There have been a limited
number of spontaneous
reports of bradycardia or hypotension with bimatoprost eye drops.
Bimatoprost should be used
with caution in patients pr