XALATAN 0.005% EYE DROPS SOLUTION

Active substance: LATANOPROST

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Xalatan 0.005% Eye Drops, Solution
(Latanoprost)
PACKAGE LEAFLET: INFORMATION FOR THE USER
The name of your medicine is Xalatan 0.005% Eye Drops, Solution
but will be referred to as Xalatan throughout the Package 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.
 In this leaflet:
1) What Xalatan is and what it is used for
 2) any of the side effects gets serious, or if you notice any side effects
If Before you use Xalatan
not listed use Xalatan
3) How to in this leaflet, please tell your doctor or pharmacist.
4) Possible side effects
5) How to store Xalatan
6) Further information

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

 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).
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).

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.

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.

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 effect 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 all medicines out of the sight and reach of children.
 Do not use Xalatan after the expiry date which is stated on the
carton and bottle. The expiry date refers to the last day of that
month.
 Store the unopened bottle in a refrigerator (between 2°C and 8°C),
protected from light.
 After 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. When you are not using Xalatan, keep the bottle in the
outer carton, in order to protect from light.
 If the eye drops become discoloured or show signs of any
deterioration, you should seek the advice of your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6) Further information
What Xalatan contains
The active substance is latanoprost 50 micrograms/ml. (0.005 % w/v.)
The other ingredients are: benzalkonium chloride, sodium chloride,
sodium dihydrogen phosphate monohydrate, disodium phosphate
anhydrous and water for injections.
What Xalatan looks and contents of the pack
Xalatan Eye Drops, Solution is a clear, colourless liquid.
Each carton contains one bottle of Xalatan. Each bottle contains 2.5ml
of Xalatan Eye Drops, Solution.
Marketing Authorisation Holder and Manufacturer
PL 10383/1917

Xalatan 0.005% Eye Drops, Solution

POM

This medicine is manufactured by Pfizer Manufacturing Belgium NV.,
Rijksweg 12 2870 Puurs, Belgium and is procured from within the EU
and repackaged by the Product Licence holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 28.04.2014.

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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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