Skip to Content

XALATAN 0.005% W/V EYE DROPS SOLUTION

Active substance(s): LATANOPROST

View full screen / Print PDF » Download PDF ⇩
Transcript
Ref: 1316/160614/1/F

Xalatan ® 0.005% w/v Eye drops, Solution
(latanoprost)
Patient Information Leaflet
Read all of this leaflet carefully before you start
using this medicine. Even if you have already
used Xalatan or a similar medicine before, we
advise you to read this text carefully. The
information may have been changed.
- 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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as
yours.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or the doctor treating your
child or your pharmacist. See section 4.
Your medicine is called Xalatan 0.005% w/v Eye
drops, Solution but will be referred to as Xalatan
throughout this leaflet.

In this leaflet:
1
What Xalatan is and what it is used for
2
Before you use Xalatan
3
How to use Xalatan
4
Possible side effects
5
How to store Xalatan
6
Further information

Pregnancy
Do not use Xalatan when you are pregnant. Tell
your doctor immediately if you are pregnant, think
you are pregnant, or are planning to become
pregnant.
Breast-feeding
Do not use Xalatan when you are breast-feeding.
Driving and using machines
When you use Xalatan 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.
Important information about some of the
ingredients of Xalatan
Xalatan contains a preservative called 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, they
should be removed before using Xalatan. After using
Xalatan you should wait 15 minutes before putting
the contact lenses back in. See the instructions for
contact lens wearers in Section 3.

3

1

What Xalatan is and what it is used for

Xalatan 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.
Xalatan 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
eye sight.
Xalatan is also used to treat increased eye pressure
and glaucoma in all ages of children and babies.
2

Before you use Xalatan

Xalatan can be used in adult men and women
(including the elderly) and in children from birth to 18
years of age. Xalatan has not been investigated in
prematurely born infants (less than 36 weeks
gestation).
Do not use Xalatan if you are
• Allergic (hypersensitive) to latanoprost or any of
the other ingredients of Xalatan (see section 6 for
the list of ingredients in your medicine)
• Pregnant or trying to become pregnant
• Breast feeding
Take special care with Xalatan
Talk to your doctor or the doctor treating your child
or your pharmacist before you take Xalatan or
before you give this to your child if you think any of
the following apply to you or your child:
• If you or your child are about to have or have had
eye surgery (including cataract surgery)
• If you or your child suffer from eye problems (such
as eye pain, irritation or inflammation, blurred
vision)
• If you or your child suffers from dry eyes
• If you or your child have severe asthma or the
asthma is not well controlled
• If you or your child wear contact lenses. You can
still use Xalatan, but follow the instruction for
contact lens wearers in Section 3
• If you have suffered or are currently suffering from
a viral infection of the eye caused by the herpes
simplex virus (HSV).
Taking other medicines
Xalatan may interact with other medicines. Please
tell your doctor, the doctor treating your child or
pharmacist if you or your child are taking or have
taken any other medicines including those
medicines (or eye drops) obtained without a
prescription.

How to use Xalatan

Always use Xalatan exactly as your doctor or the
doctor treating your child has told you. You should
check with your doctor or the doctor treating your
child or pharmacist if you are not sure.
The usual dosage 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 Xalatan more than once a day, because
the effectiveness of the treatment can be reduced if
you administer it more often.
Use Xalatan as instructed by your doctor or the
doctor treating your child until they tell you to stop.
Contact lens wearers
If you or your child wear contact lenses, they should
be removed before using Xalatan. After using
Xalatan you should wait 15 minutes before putting
the contact lenses back into the eyes.
Instructions for use
1.Wash your hands and sit or stand
comfortably.
2.Twist off the outer cap (which can
be thrown away).

3.Unscrew the protective inner cap.
The protective cap should be
retained.

4.Use your finger to gently pull down the lower
eyelid of your affected eye.
5.Place the tip of the bottle
close to, but not touching
your eye.
6.Squeeze the bottle gently
so that only one drop goes
into your eye, then release
the lower eye lid.
7.Press a finger against the
corner of the affected eye
by the nose. Hold for 1 minute
whilst keeping the eye closed.

8. Repeat in your other eye if your doctor has told
you to do this.
9. Put the protective inner cap back on the bottle.
If you use Xalatan with other eye drops
Wait at least 5 minutes between using Xalatan and
taking other eye drops
If you use more Xalatan than you should
If you put too many drops into the eye, it may lead to
some minor irritation in the eye and the 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 Xalatan accidentally.
If you forget to use Xalatan
Carry on with the usual dosage at the usual time. Do
not take 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 Xalatan
You should speak to your doctor or the doctor
treating your child if you want to stop taking Xalatan.

Patients have also reported the following
side-effects: fluid filled area within the coloured
part of the eye (iris cyst), headache, dizziness,
awareness of heart rhythm (palpitations),
muscle pain, joint pain and developing a viral
infection of the eye caused by the herpes
simplex virus (HSV).
Side effects seen more often in children compared
to adults are runny itchy nose and fever.
In very rare cases, some patients with severe
damage to the clear layer at the front of the
eye (the cornea) have developed cloudy patches on
the cornea due to calcium build-up during treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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


4 Possible side effects
Like all medicines, Xalatan can cause side effects,
although not everybody gets them:
The following are known side effects of using
Xalatan:
Very common (likely to 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 Xalatan 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 Xalatan 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 (likely to affect less than 1 in 10 people):
• Irritation or disruption to the surface of the eye,
eyelid inflammation (blepharitis), eye pain and
light sensitivity (photophobia).
Uncommon (likely to affect less than 1 in every 100
people):
• Eyelid swelling, dryness of the eye, inflammation
or irritation of the surface of the eye
(keratitis), blurred vision and conjunctivitis.
• Skin rash.
Rare (likely to affect less than 1 in every 1000
people):
• Inflammation of the iris, the coloured part of the
eye (iritis/uveitis); swelling of the retina
(macular oedema), 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).








How to store Xalatan
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Store at room temperature (below 25°C)
Keep container in outer carton in order to protect
from light.
Discard bottle after 4 weeks of opening.
Do not use this medicine after the expiry date
shown on the carton or bottle label.
If your doctor tells you to stop using this medicine,
return any unused solution to your pharmacist for
safe disposal. Only keep this medicine, if your
doctor tells you to.
If your eye drops become discoloured or show
any other signs of deterioration, consult your
pharmacist who will tell you what to do.

6

Further Information

What Xalatan contains
Each millilitre contains 50 micrograms of the active
ingredient latanoprost (this is written as 0.005% w/v
on the bottle).
Your eye drops also contains the following inactive
ingredients: benzalkonium chloride, sodium chloride,
sodium dihydrogen phosphate monohydrate
(E339a), anhydrous disodium phosphate (E339b)
and water for injections.
What Xalatan looks like and contents of the pack
Each 2.5ml plastic dropper bottle contains a clear,
colourless solution. Each carton contains one bottle
of Xalatan.
Manufacturer and Licence Holder
This medicine is manufactured by Pfizer
Manufacturing Belgium NV, Rijksweg 12, 2870,
Puurs, Belgium, and are procured from within the
EU and repackaged by the Product Licence Holder:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire. B98 0RE

POM

PL 15184/1316

Xalatan is a registered trademark of Pfizer Health
AB.
Leaflet revision date: 16/06/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Very rare (likely to affect less than 1 in 10,000
people):
• Worsening of angina in patients who also have
heart disease, chest pain, sunken eye
appearance (eye sulcus deepening).
Ref: 1316/160614/1/B

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