SAFLUTAN tafluprost 15micrograms per/mL single dose eye drop ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tafluprost, Quantity: 0.015 mg/mL

Available from:

Mundipharma Pty Ltd

INN (International Name):

Tafluprost

Pharmaceutical form:

Eye Drops

Composition:

Excipient Ingredients: polysorbate 80; glycerol; sodium hydroxide; monobasic sodium phosphate dihydrate; water for injections; disodium edetate; hydrochloric acid

Administration route:

Ophthalmic

Units in package:

30 unit pack, 10 unit starter pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SAFLUTAN is indicated for the reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension, as monotherapy or as adjunctive therapy to beta blockers.

Product summary:

Visual Identification: Clear, colourless solution in a single dose container.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-02-14

Patient Information leaflet

SAFLUTAN
®
1
SAFLUTAN
®
Tafluprost
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about SAFLUTAN.
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 or pharmacist
has weighed the risks of you using
SAFLUTAN 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 need to read it again.
What SAFLUTAN is
used for
SAFLUTAN belongs to a group of
medicines called prostaglandin
analogues. It 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. Also, some
people with raised eye pressure may
not have glaucoma.
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.
Although SAFLUTAN helps control
your glaucoma it does not cure it so
you must keep using SAFLUTAN
until your doctor tells you to stop.
For more information about
glaucoma,

Summary of Product characteristics

SAFLUTAN
®
EYE DROPS
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION – SAFLUTAN
®
(TAFLUPROST)
EYE DROPS
1
NAME OF THE MEDICINE
Tafluprost
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SAFLUTAN is available as an ophthalmic solution (eye drops) containing
15 micrograms of
tafluprost per mL. One single-dose container (0.3 mL) contains 4.5
micrograms of tafluprost.
SAFLUTAN does not contain preservatives such as benzalkonium chloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops.
Clear and colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SAFLUTAN is indicated for the reduction of elevated intraocular
pressure in open-angle glaucoma
or ocular hypertension, as monotherapy or as adjunctive therapy to
beta blockers.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of SAFLUTAN in the conjunctival sac
of the affected eye(s)
once daily in the evening.
The dose should not exceed once daily as more frequent administration
may lessen the intraocular
pressure lowering effect.
SAFLUTAN is a sterile solution that does not contain a preservative.
For single use only, one
container is sufficient to treat both eyes. Any unused solution should
be discarded immediately
after use.
If more than one topical ophthalmic product is being used, each one
should be administered at
least 5 minutes apart.
To reduce the risk of darkening of the eyelid skin patients should
blot off any excess solution from
the skin. As with any other eye drops, nasolacrimal occlusion or
gently closing the eyelid after
administration
is
recommended.
This
may
reduce
the
systemic
absorption
of
products
administered via the ocular route.
Use in Elderly Patients
No dosage adjustment is required for elderly patients.
SAFLUTAN
®
EYE DROPS
Page 2 of 12
4.3
C
ONTRAINDICATIONS
Hypersensitivity to tafluprost or to any of the excipients.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
Before treatment is initiated, patients should be informed of the
possibility of eyelash grow