Skip to Content

LATANOPROST 50 MICROGRAMS / ML EYE DROPS SOLUTION

Active substance(s): LATANOPROST

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the patient

Latanoprost 50 micrograms/ml
eye drops, solution
latanoprost

Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask your
doctor , or the doctor treating your child or
your pharmacist.
• This medicine has been prescribed for you
or for your child only. Do not pass it on to
others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your
doctor or the doctor treating your child, or
your pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Latanoprost is and what it is used for
2. What you need to know before you use
Latanoprost
3. How to use Latanoprost
4. Possible side effects
5. How to store Latanoprost
6. Contents of the pack and other information
1. What Latanoprost is and what it is
used for
Latanoprost contains the active ingredient
latanoprost which belongs to a group of
medicines known as prostaglandin analogues. It
works by increasing the natural outflow of fluid
from inside the eye into the bloodstream.
Latanoprost is used to treat conditions
known as open angle glaucoma and ocular
hypertension. Both of these conditions are
linked with an increase in the pressure within
your eye, eventually affecting your eyesight.
Latanoprost is also used to treat increased eye
pressure and glaucoma in all ages of children
and babies.
2. What you need to know before you
use Latanoprost
Latanoprost can be used in adult men and
women (including the elderly) and in children
from birth to 18 years of age. Latanoprost has
not been investigated in prematurely born
infants (less than 36 weeks gestation).
Do not use Latanoprost:
• if you are allergic to latanoprost or any of the
other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or the doctor treating
your child, or your pharmacist before you use
Latanoprost or before treatment in case you or
your child:
• are about to have or have had eye surgery
(including cataract surgery).
• suffer from eye problems (such as eye pain,
irritation or inflammation, blurred vision).
• suffer from dry eyes or have a disease
affecting the front of the eye (the cornea).
• have severe asthma or asthma that is not well
controlled.
• have certain forms of glaucoma known as
'chronic angle-closure' or 'congenital' glaucoma.
• have glaucoma caused by pigments forming
within the eye’s angle chamber.
• have glaucoma caused by eye inflammation
or new blood vessels forming within the eye.
• have glaucoma at the same time as having
no lens or an artificial lens, or if your eye is
aphakic (the lens in your eye is missing) or
pseudoaphakic with a torn posterior lens
capsule or anterior chamber lens.
• have known risk factors for swelling at the
back of the eye (macular oedema) or for
inflammation of the iris (iritis/uveitis) such as
if you have a vascular disorder affecting the
eye or abnormalities of the retina as a result
of diabetes.
• have suffered or are currently suffering from a
viral infection of the eye caused by the herpes
simplex virus (HSV), especially if this was
caused by use of prostaglandin analogues.
• wear contact lenses. You or your child can still
use Latanoprost, but follow the instruction for
contact lens wearers in Section 3.

• If you are pregnant or trying to become
pregnant.
• If you are breastfeeding.
Other medicines and Latanoprost
Latanoprost may interact with other medicines.
Tell your doctor, the doctor treating your child
or pharmacist if you or your child are taking
or using, have recently taken or used or might
take or use any other medicines including
medicines (or eye drops) obtained without
a prescription.
The effect of other prostaglandins or
prostaglandin derivatives (used to treat increased
eye pressure) can be influenced by Latanoprost.
Combining these with Latanoprost is not
recommended, as the eye pressure may increase.
Pregnancy and breast-feeding
Do not use Latanoprost when you are pregnant.
Tell your doctor immediately if you are pregnant,
think you may be pregnant, or are planning to
have a baby.
Do not use Latanoprost when you are
breast-feeding. Latanoprost may pass into breast
milk and therefore the child might be affected.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
When you use Latanoprost you might have
blurred vision, for a short time. If this happens to
you, do not drive or use any tools or machines
until your vision becomes clear again.
Latanoprost contains benzalkonium chloride
This preservative may cause eye irritation
or disruption to the surface of the eye.
Benzalkonium chloride can be absorbed by
contact lenses and is known to discolour soft
contact lenses. Therefore, avoid contact with
soft contact lenses.
If you or your child wear contact lenses, you
should remove them before using Latanoprost.
After using Latanoprost you should wait
15 minutes before putting your contact lenses
back in. See the instructions for contact lens
wearers in Section 3.
3. How to use Latanoprost
Always use this medicine exactly as your doctor,
or the doctor treating your child, or your
pharmacist has told you. Check with your doctor,
or the doctor treating your child or pharmacist if
you are not sure.
The recommended dose for adults (including
the elderly) and children is one drop once a day
in the affected eye(s). The best time to do this is
in the evening.
Do not use Latanoprost more than once a day,
because the effectiveness of the treatment can
be reduced if you administer it more often.
Use Latanoprost as instructed by your doctor,
or the doctor treating your child until your
doctor tells you to stop.
Contact lens wearers
If you or your child wear contact lenses, you
should remove them before using Latanoprost.
After using Latanoprost you should wait
15 minutes before putting your contact lenses
back in.
Instructions for use
1. Wash your hands and sit or stand comfortably.
2. Unscrew the protective cap. The protective
cap should be retained.
3. Use your finger to gently pull down the lower
eyelid of your affected eye.
4. Place the tip of the bottle close to, but not
touching your eye.
5. Squeeze the bottle gently so that only one
drop goes into your eye, then release the
lower eyelid.

6. Press a finger against the corner of the
affected eye by the nose. Hold for 1 minute
whilst keeping the eye closed.

7. Repeat in your other eye if your doctor has
told you to do this.
8. Put the protective cap back on the bottle.
If you use Latanoprost with other eye drops
Wait at least 5 minutes between using
Latanoprost and other eye drops.
If you use more Latanoprost than you should
If you put too many drops into your eye, you
may experience some minor irritation in your
eye and your eyes may water and turn red.
This should pass, but if you are worried contact
your doctor or the doctor treating your child
for advice.
Contact your doctor as soon as possible if you
or your child swallows Latanoprost accidentally.
If you forget to use Latanoprost
Carry on with the usual dose at the usual time.
Do not use a double dose to make up for the
dose you have forgotten. If you are unsure about
anything talk to your doctor or pharmacist.
If you stop using Latanoprost
You should speak to your doctor or the doctor
treating your child if you want to stop using
Latanoprost.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you get any of the following side effects,
stop using the medicine and contact your
doctor or go to your nearest hospital
emergency department as soon as possible:
• Inflammation of the surface of the eye
(the cornea).
• Inflammation of the iris or the coloured part
of the eye (iritis/uveitis).
• Swelling of the retina - the back of the eye
(macular oedema).
• a viral infection of the eye caused by the
herpes simplex virus, associated with
inflammation/irritation of the surface of the
eye (keratitis).
The following side effects have also been
reported:
Very common (may affect more than 1 in
10 people):
• A gradual change in your eye colour by
increasing the amount of brown pigment in
the coloured part of the eye known as the iris.
If you have mixed-colour eyes (blue-brown,
grey-brown, yellow-brown or green-brown)
you are more likely to see this change
than if you have eyes of one colour (blue,
grey, green or brown eyes). Any changes in
your eye colour may take years to develop
although it is normally seen within 8 months
of treatment. The colour change may be
permanent and may be more noticeable if
you use Latanoprost in only one eye. There
appears to be no problems associated with
the change in eye colour. The eye colour
change does not continue after Latanoprost
treatment is stopped.
• Redness of the eye.
• Eye irritation (a feeling of burning, grittiness,
itching, stinging or the sensation of a foreign
body in the eye).
• A gradual change to eyelashes of the treated
eye and the fine hairs around the treated eye,
seen mostly in people of Japanese origin.
These changes involve an increase of the
colour (darkening), length, thickness and
number of your eye lashes.
Common (may affect up to 1 in 10 people):
• Irritation or disruption to the surface of the
eye, eyelid inflammation (blepharitis), eye pain
and light sensitivity (photophobia).
Uncommon (may affect up to 1 in 100 people):
• Eyelid swelling, dryness of the eye, blurred
vision and conjunctivitis.
• Skin rash.
Rare (may affect up to 1 in 1000 people):
• Symptoms of swelling or scratching/damage to
the surface of the eye, swelling around the eye
(periorbital oedema) misdirected eyelashes or
an extra row of eyelashes.
• Skin reactions on the eyelids, darkening of the
skin of the eyelids.
• Asthma, worsening of asthma and shortness
of breath (dyspnoea).

Very rare (may affect up to 1 in 10,000 people):
• Angina (chest pain).
• Sunken eye appearance (eye sulcus deepening).
• In some patients with severe damage to the
clear layer at the front of the eye (the cornea),
the use of eye drops containing a source
of phosphate, such as this medicine, the
development of cloudy patches on the cornea
has been seen due to a build-up of calcium
during treatment.
Other side effects which have been reported
since latanoprost was marketed (frequency
cannot be estimated from the available data):
• Fluid filled area within the coloured part of
the eye (iris cyst).
• Headache, dizziness.
• Awareness of heart rhythm (palpitations).
• Muscle pain and joint pain.
Additional side effects in children and
adolescents
Side effects seen more often in children
compared to adults are runny itchy nose
and fever.
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Latanoprost
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton and bottle label
after 'EXP'. The expiry date refers to the last day
of that month.
Do not use this medicine if you notice that
the tamper evident seal has been broken or
damaged before you first open it.
Store the unopened bottle in a refrigerator
(between 2 °C – 8 °C). After first opening the
bottle it is not necessary to store the bottle in a
refrigerator but do not store it above 25°C. Use
within 4 weeks of opening.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.
6. Contents of the pack and other
information
What Latanoprost contains
• The active substance is latanoprost.
• Each ml eye drops solution contains
50 micrograms of latanoprost.
• The other ingredients are: benzalkonium
chloride, sodium chloride, sodium dihydrogen
phosphate monohydrate, anhydrous disodium
phosphate and water for injections.
What Latanoprost looks like and contents of
the pack
Latanoprost is a clear colourless, aqueous solution.
Latanoprost is packaged in a round translucent
plastic dropper bottle with translucent plastic
dropper plug and turquoise plastic screw cap
with tamper evident sealing ring.
Each bottle contains 2.5 ml of Latanoprost eye
drops, solution.
Latanoprost is available in the following
pack sizes:
1 bottle of 2.5 ml, eyes drops solution,
3 bottles of 2.5 ml, eye drops solution,
6 bottles of 2.5 ml, eye drops solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan
Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Manufacturer
Mylan S.A.S (Saint Priest) 117 Allee des Parcs,
69 800 Saint Priest, France.

This leaflet was last revised in
July 2014.

24 Jun 2014

441060

09:46
2/2

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide