LATANOPROST 0.005% EYE DROPS

Active substance: LATANOPROST

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3. HOW TO USE XALATAN

XALATAN® 0.005% EYE DROPS / LATANOPROST 0.005% EYE DROPS
(latanoprost)

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.

PATIENT INFORMATION LEAFLET

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.

This product is available using the names Xalatan 0.005% Eye Drops / Latanoprost 0.005% Eye Drops
but will be referred to as Xalatan throughout the leaflet.

Do not use Xalatan more than once a day, because the effectiveness of the treatment can be reduced
if you administer it more often.

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
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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.

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.

this leaflet:
What Xalatan is and what it is used for
Before you use Xalatan
How to use Xalatan
Possible side effects
How to store Xalatan
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 in
adults. 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.
4.

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).

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.

Do not use Xalatan if you are

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.

2. BEFORE YOU USE XALATAN



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

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

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.

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.

Very common effects (likely to affect more than 1 in 10 people):


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.





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, yellowbrown 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 effects (likely to affect less than 1 in 10 people):


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Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis) and eye pain.

Uncommon effects (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 effects (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, light sensitivity
(photophobia).
Skin reactions on the eyelids, darkening of the skin of the eyelids.
Asthma, worsening of asthma and shortness of breath (dyspnoea).

Very rare effects (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, 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.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please contact your doctor or pharmacist.

5. HOW TO STORE XALATAN









Keep all medicines in a safe place, out of the sight and reach of children.
Do not use after the expiry date which is stated on the carton and bottle. The expiry date refers to
the last day of that month.
Before Xalatan is first opened keep it in a fridge (between 2°C and 8°C / 36°F and 46°F), out of
direct light.
Once the bottle has been opened, it is not necessary to put it in the fridge; Xalatan can be kept at
normal room temperature (below 25°C / 77°F).
Each bottle should be thrown away four weeks after first opening.
If your medicine appears to be discoloured, or shows any other signs of deterioration, take it back
to your pharmacist who will advise you.
If your doctor tells you to stop using your medicine, please take it back to the pharmacist for safe
disposal. Only keep it if your doctor tells you to.
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 50 microgrames/ml (0.005% w/v) latanoprost.
The other ingredients are: benzalkonium chloride Ph Eur, sodium chloride Ph Eur, sodium dihydrogen
phosphate monohydrate, disodium phosphate anhydrous and water for injections Ph Eur.

What Xalatan looks like and contents of the pack
Xalatan is a clear, colourless liquid.

Each bottle contains 2.5ml of solution.

Manufacturer

This product is manufactured by: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0349

POM

Leaflet review and issue date (Ref): 26.03.13
Xalatan® is a registered trademark of Pfizer Ltd.

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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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