XALACOM latanoprost 50 microgram/mL, timolol (as maleate) 5 mg/mL eye drops

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

latanoprost, Quantity: 0.05 mg/mL; timolol maleate, Quantity: 6.83 mg/mL (Equivalent: timolol, Qty 5 mg/mL)

Tilgængelig fra:

Aspen Pharmacare Australia Pty Ltd

Lægemiddelform:

Eye Drops, solution

Sammensætning:

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

Indgivelsesvej:

Ophthalmic

Enheder i pakken:

3 x 2.5 mL, 1 x 2.5 mL

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

The 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. Xalacom should not be used to initiate therapy.

Produkt oversigt:

Visual Identification: clear, colourless liquid; Container Type: Bottle; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Licence status A

Autorisation dato:

2002-01-02

Indlægsseddel

1
XALACOM
®
_Latanoprost/Timolol maleate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xalacom. 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 Xalacom
against the benefits it is expected to
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 XALACOM IS USED
FOR
Xalacom 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. 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.
Xalacom 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 Xalacom helps control
your glaucoma it does not cure it. So
you must keep

Produktets egenskaber

Page 1 of 17
AUSTRALIAN
PRODUCT
INFORMATION
–
XALACOM
(LATANOPROST
AND
TIMOLOL
MALEATE) EYE DROPS
1.
NAME OF THE MEDICINE
Latanoprost and timolol maleate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Xalacom is a combination eye drop containing latanoprost and timolol
maleate.
Latanoprost is a prostaglandin F
2α
analogue.
Xalacom is a sterile, isotonic solution containing 50 micrograms/mL of
latanoprost and
5 mg/mL of timolol (6.83 mg timolol maleate) in an aqueous buffer
solution of pH 6.0.
Each 5 mL bottle contains 2.5 mL eye drop solution corresponding to a
minimum of 80 drops
of solution. One drop contains approximately 1.5 µg latanoprost and
150 µg timolol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear and colourless liquid, filled in a
polyethylene container.
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. Xalacom should not be used
to initiate therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_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 Xalacom 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
Page 2 of 17
daily plus latanoprost given once daily will be as well controlled
with Xalacom given once
daily. Xalacom should not be used to initiate therapy.
Xalacom should not be given more than once daily because latanoprost
is most effective at this
dosage. If there is inadequate response to Xalacom, consideration
should be given to using the
individual agents with timolol dose twice daily.
METHOD OF ADMINISTRATION