XALAPROST latanoprost 50 microgram/mL eye drops bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
08-09-2020
Summary of Product characteristics
(SPC)
08-09-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
latanoprost, Quantity: 50 microgram/mL
Available from:
Viatris Pty Ltd
INN (International Name):
Latanoprost
Pharmaceutical form:
Eye Drops, solution
Composition:
Excipient Ingredients: dibasic sodium phosphate; sodium chloride; benzalkonium chloride; monobasic sodium phosphate monohydrate; water for injections; 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 or ocular hypertension.
Product summary:
Visual Identification: Clear colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-09-19
Patient Information leaflet
XALAPROST
_Latanoprost_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about XALAPROST. 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 XALAPROST
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 XALAPROST IS
USED FOR
XALAPROST 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.
XALAPROST belongs to a family of
medicines called prostaglandin
agonists.
It lowers the pressure in the eye by
allowing more fluid to flow out from
within your eye.
Although XALAPROST helps
control your glaucoma it does not
cure it. So you must keep using it
until your doctor tells you to stop.
XALAPROST is used, either alone
or in combination with other eye
medicines, to lower raised pressure
within your eye.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
XALAPROST HA
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION
XALAPROST
_latanoprost eye drops solution _
1
NAME OF THE MEDICINE
Latanoprost
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of the XALAPROST eye drop solution contains 50 micrograms of
latanoprost as the active
ingredient.
Each bottle contains 2.5 mL eye drop solution corresponding to a
minimum of 80 drops of solution. One
drop contains approximately 1.5 micrograms latanoprost.
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 solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open-angle
glaucoma or ocular hypertension.
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.
Optimal effect is obtained if
latanoprost eye drops is administered in the evening. Systemic
absorption can be minimised by pressure on
the tear duct immediately after application of the eye drop.
If one dose is missed treatment should continue with the next dose as
normal.
The dosage of XALAPROST should not exceed once daily since it has been
shown that more frequent
administration decreases the intraocular pressure lowering effect.
ADMINISTRATION
Latanoprost eye drops is effective as a single drug therapy but can
also be used in combination with beta-
adrenergic
antagonists
(timolol),
adrenergic
agonists
(dipivefrine
hydrochloride),
cholinergic
agonists
(pilocarpine) and carbonic anhydrase inhibitors (acetazolamide) to
achieve an additive effect. In case of
combined therapy the eye drop products should be administered with an
interval of at least five minutes.
Use with contact lenses: The contact lenses should be removed before
instillation of the eye drops and may
be reinserted after 15 minutes (see section 4.4 Special Warnings and
Precautions for Use).
4.3
CONTRAINDICATIONS
Known hypersensitivity
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