Latanoprost (Teva)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Latanoprost 0.05 mg/mL

Available from:

Teva Pharma (New Zealand) Limited

Dosage:

50 mcg/mL

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Latanoprost 0.05 mg/mL Excipient: Benzalkonium chloride Dibasic sodium phosphate Monobasic sodium phosphate monohydrate Sodium chloride Water for injection

Prescription type:

Prescription

Therapeutic indications:

Indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, LDPE with HDPE cap, in outer cardboard carton, 1 x 2.5 mL - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at or below 25°C protect from light - Bottle, dropper, LDPE with HDPE cap, in outer cardboard carton, 3 x 2.5 mL - 3 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days opened stored at or below 25°C protect from light

Authorization date:

2017-10-02

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
LATANOPROST
EYE DROPS 50 MICROGRAMS/ML
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Latanoprost
eye drops.
This leaflet answers some common questions about Latanoprost eye
drops. 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
Latanoprost eye drops 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 LATANOPROST EYE DROPS ARE USED FOR
Latanoprost eye drops are 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.
_HOW LATANOPROST EYE DROPS WORK _
Latanoprost 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 Latanoprost eye drops help control your glaucoma, it does not
cure it. So you must
keep using it until your doctor tells yo

Summary of Product characteristics

Version 1.2
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
LATANOPROST (Teva), 50 micrograms /mL, Eye Drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains latanoprost 50 micrograms.
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 micrograms latanoprost.
Excipient of known effect:
benzalkonium chloride
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution. The solution is a clear, colourless liquid.
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
Dose
_Adults and elderly _
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is obtained if
Latanoprost (Teva) 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 Latanoprost (Teva) should not exceed once daily since it
has been shown that more
frequent administration decreases the IOP lowering effect.
_Paediatric population _
Latanoprost is not recommended for use in children. Use in children
has not been studied.
Method of administration
Latanoprost 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. (see 6.2 Incompatibilities)
Use with contact lenses: The contact lenses should be removed before
instillation of the eye drops
and may be reinserted after 15 minutes (see
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
4.3
CONTRAINDICATI