BIMATOPROST SANDOZ 300 microgram/mL eye drops solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bimatoprost, Quantity: 0.3 mg/mL

Available from:

Sandoz Pty Ltd

INN (International Name):

Bimatoprost

Pharmaceutical form:

Eye Drops

Composition:

Excipient Ingredients: sodium hydroxide; benzalkonium chloride; citric acid monohydrate; hydrochloric acid; dibasic sodium phosphate heptahydrate; purified water; sodium chloride

Administration route:

Ophthalmic

Units in package:

1 x 3 mL bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bimatoprost eye drops are indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

Product summary:

Visual Identification: White plastic dropper bottles with a plastic tamper-proof screw cap. Each bottle has a fill volume of 3 mL.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-11-03

Patient Information leaflet

190626-BIMATOPROST-SANDOZ
1
BIMATOPROST SANDOZ
®
_bimatoprost 300 micgrogram/mL Eye Drops Solution Bottle _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Bimatoprost Sandoz.
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 taking this medicine
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 with the medicine.
You may need to read it again.
WHAT BIMATOPROST
SANDOZ IS USED
FOR
This medicine 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
high. However, some people with
glaucoma may have normal eye
pressure. Glaucoma 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. Since new fluid continues
to enter the eye, joining the fluid
already there, the pressure continues
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. Sometimes
even normal eye pressure is
associated with damage to the back
of the eye.
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.
In fact, untreated glaucoma is one of
the most common causes of
blindness.
Bimatoprost Sandoz eye drops lower
the pressure in the eye by helping the
flow of fluid out of the eye chamber.
Bimatoprost Sandoz eye drops can be
used alone or together with other
eyedrops/medicines to lower raise

Summary of Product characteristics

220119-bimatoprost-pi
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
BIMATOPROST SANDOZ
® (BIMATOPROST)
1
NAME OF THE MEDICINE
Bimatoprost
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bimatoprost Sandoz 300 µg/mL is a sterile ophthalmic solution. Each
mL of Bimatoprost
Sandoz solution contains active ingredient bimatoprost 0.3 mg.
Bimatoprost is a prostamide with potent ocular hypotensive activity.
Bimatoprost is a white or
almost white crystalline powder and is very soluble in ethyl alcohol
and methyl alcohol and
slightly soluble in water. Bimatoprost is a clear, isotonic,
colourless, sterile ophthalmic solution
with an osmolality of approximately 260 to 330 mOsmol/kg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Bimatoprost Sandoz 300 µg/mL eye drops sterile solution is packed in
plastic dropper bottles
with a plastic tamper-proof screw cap. Each bottle has a fill volume
of 3 mL.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Bimatoprost eye drops is indicated for 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
D
OSE AND METHOD OF ADMINISTRATION
Monotherapy: The recommended dose is one drop of bimatoprost eye drops
in the affected
eye(s) once daily, administered in the evening.
Adjunctive Therapy: The recommended dose is one drop of bimatoprost
eye drops 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 of bimatoprost eye drops,
patients should be
instructed to apply pressure to the tear duct immediately following
administration of the drug.
4.3
C
ONTRAINDICATIONS
Bimatoprost eye drops are contraindicated in patients with
hypersensitivity to bimatoprost or
to any compo