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XALATAN EYE DROPS

Active substance: LATANOPROST

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486 LEAFLET Xalatan 20150126

PACKAGE LEAFLET: INFORMATION FOR THE USER

XALATAN EYE DROPS 0.005% w/v
LATANOPROST EYE DROPS 0.005% w/v
(latanoprost)
Your medicine is known by either of the above names but will be
referred to as Xalatan throughout the following 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.

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.
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



Keep this leaflet. You may need to read it again.

Do not use Xalatan when you are breast-feeding.



If you have any further questions, ask your doctor or the doctor
treating your child or your pharmacist.



Driving and using machines

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.



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.

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.

Important information about some of the ingredients of Xalatan

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

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.

6. Further information
3. HOW TO USE XALATAN
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.

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.

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

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.

Allergic (hypersensitive) to latanoprost or any of the other
ingredients of Xalatan (see section 6 for the list of ingredients in
your medicine)

Instructions for use



Pregnant or trying to become pregnant



Breast feeding

2. Twist off the outer cap (which can be
thrown away).



1. Wash your hands and sit or stand
comfortably.

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).

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.

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.

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 eyelid.
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.

Asthma, worsening of asthma and shortness of breath
(dyspnoea).
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).

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).

If you use more Xalatan than you should

Side effects seen more often in children compared to adults are
runny itchy nose and fever.

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.

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

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 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. HOW TO STORE XALATAN


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Before opening the bottle, Do not store above 25°C, store the
bottle in the original carton in order to protect from light.



After opening the bottle, Do not store above 25°C and use
within 4 weeks of opening.

4. POSSIBLE SIDE EFFECTS



Like all medicines, Xalatan can cause side effects, although not
everybody gets them.

When you are not using Xalatan, keep the bottle in the outer
carton, in order to protect it from light.



Do not use the drops after the expiry date shown on the pack.

The following are known side effects of using Xalatan:



If your doctor tells you to stop using the drops, please take
them back to the pharmacist for safe disposal. Only keep them
if your doctor tells you to.



If the drops become discoloured or show any other signs of
deterioration speak to the pharmacist before using them.

If you stop using Xalatan
You should speak to your doctor or the doctor treating your child if
you want to stop taking 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.

6. FURTHER INFORMATION
What Xalatan contains


The solution contains the active ingredient, 0.005% w/v
latanoprost.



The solution also contains sodium chloride, benzalkonium
chloride (a preservative), sodium dihydrogen phosphate
monohydrate, disodium hydrogen phosphate anhydrous and
water for injections.

What Xalatan looks like and contents of the pack
Xalatan is a clear, colourless solution in a plastic bottle with a white
plastic applicator cap.
The bottles contain 2.5ml of solution.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by Pfizer Manufacturing Belgium N.V.
Rijksweg, 12 Puurs, Belgium.
POM

PL No: 08747/0486

Leaflet revision date: 26 January 2015
Xalatan is a registered trade mark of Pfizer Ltd, UK.
486 LEAFLET Xalatan 20150126

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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.

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