XALAMOL 50/5 latanoprost 50 microgram/mL + timolol (as maleate) 5 mg/mL eye drops bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

timolol maleate, Quantity: 6.83 mg/mL (Equivalent: timolol, Qty 5 mg/mL); latanoprost, Quantity: 50 microgram/mL

Available from:

Viatris Pty Ltd

INN (International Name):

Latanoprost,Timolol maleate

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: dibasic sodium phosphate; water for injections; monobasic sodium phosphate monohydrate; benzalkonium chloride; sodium chloride; hydrochloric acid; sodium hydroxide

Administration route:

Ophthalmic

Units in package:

2.5 mL in 5 mL bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. XALAMOL 50/5 should not be used to initiate therapy.

Product summary:

Visual Identification: Clear, colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-09-19

Patient Information leaflet

XALAMOL 50/5
_latanoprost and timolol (as maleate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about XALAMOL 50/5. 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 XALAMOL
50/5 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 XALAMOL 50/5
IS USED FOR
XALAMOL 50/5 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
buildup 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. 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.
XALAMOL 50/5 is made up of 2
active ingredients, latanoprost and
timolol maleate. Latanoprost works
by allowing more fluid to flow out
from within your eye(s). Timolol
maleate lowers the pressure in the
eye by reducing the production of
fluid.
Latanoprost belongs to a family of
medicines called prostaglandin
agonists. Timolol maleate belongs to
a family of medicines called beta-
blockers.
Although XALAMOL 50/5 helps
control your glaucom

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
XALAMOL 50/5
_latanoprost and timolol (as maleate) eye drops solution _
1
NAME OF THE MEDICINE
Latanoprost and timolol (maleate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of XALAMOL 50/5 eye drop solution contains 50

g of latanoprost and 5 mg of timolol (6.83 mg
timolol maleate) as the active ingredients.
Each bottle contains 2.5 mL eye drop solution corresponding to a
minimum of 80 drops of solution. One
drop contains approximately 1.5

g latanoprost and 150

g timolol. For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
XALAMOL 50/5 is a clear and colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open-angle
glaucoma and ocular hypertension who
are
insufficiently
responsive
to
beta-blockers,
prostaglandins
or
other
intraocular
pressure
lowering
medications. XALAMOL 50/5 should not be used to initiate therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
For individual patient use only.
RECOMMENDED DOSAGE FOR ADULTS (INCLUDING THE ELDERLY)
Recommended therapy is one eye drop in the affected eye(s) once daily.
If one dose is missed, treatment
should continue with the next dose as normal.
The use of XALAMOL 50/5 may be considered in patients who require both
timolol and latanoprost, but
it
is
unknown
whether
patients
who
are
adequately
controlled
with
timolol
given
twice daily plus
latanoprost
given
once
daily
will
be
as
well
controlled
with
XALAMOL 50/5 given
once daily.
XALAMOL 50/5 should not be used to initiate therapy.
XALAMOL 50/5 should not be given more than once daily because
latanoprost is most effective at this
dosage. If there is inadequate response to XALAMOL 50/5, consideration
should be given to using the
individual agents with timolol dose twice daily.
METHOD OF ADMINISTRATION
If more than one topical ophthalmic drug is being used, the eye drop
products should be administered at
least 5 minutes apart.
Systemic absorption can be minimised