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LATANOPROST 0.005% W/V EYE DROPS SOLUTION

Active substance: LATANOPROST

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500000/PL1a

Xalatan®
0.005% eye drops, solution
Latanoprost

The name of your medicine is Xalatan 0.005% eye drops, solution.
Throughout the remainder of this leaflet, it will be referred to as Xalatan.
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
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

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 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.

Continued overleaf

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.
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.
• 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).
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 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 at room temperature (do not store above 25°C), protect from
light.
After opening the bottle store it at room temperature (do not store above 25°C) and 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.
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.
If you notice any discolouration or deterioration of your medicine, please tell your doctor or
pharmacist immediately.

6. Further information

What Xalatan contains
Xalatan contains latanoprost 50 micrograms/ml.
The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen
phosphate monohydrate and anhydrous disodium phosphate (E339) dissolved in
water for injections.
What Xalatan looks like and contents of the pack
Xalatan eye drops, solution is a clear, colourless liquid.
Xalatan is available in a pack size of one carton.
Each carton contains one bottle of Xalatan. Each bottle contains 2.5 ml of Xalatan eye
drops, solution.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova
UK Ltd both at St James’ House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.
Xalatan® 0.005% eye drops, solution
PL No: 18067/0474 POM
This leaflet was last revised on 20th March 2015

Xalatan® is a registered trademark of Pfizer Health AB.

500000/PL1a

500000/PL1a

Latanoprost
0.005% w/v eye drops, solution
The name of your medicine is Latanoprost 0.005% w/v eye drops, solution.
Throughout the remainder of this leaflet, it will be referred to as Latanoprost.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine.
Even if you have already used Latanoprost 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.
In this leaflet:
1. What Latanoprost is and what it is used for
2. Before you use Latanoprost
3. How to use Latanoprost
4. Possible side effects
5. How to store Latanoprost
6. Further information

1. What Latanoprost is and what it is used for?

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

2. 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 (hypersensitive) to latanoprost or any of the other ingredients of Latanoprost
(see section 6 for the list of ingredients in your medicine)
• Pregnant or trying to become pregnant
• Breast feeding
Take special care with Latanoprost
Talk to your doctor or the doctor treating your child or your pharmacist before you take
Latanoprost 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 Latanoprost, 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
Latanoprost 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 Latanoprost 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 Latanoprost when you are breast-feeding.
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.
Important information about some of the ingredients of Latanoprost
Latanoprost 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 Latanoprost.
After using Latanoprost 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 Latanoprost

Always use Latanoprost 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 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 they tell
you to stop.
Contact lens wearers
If you or your child wear contact lenses, they should be removed before using Latanoprost.
After using Latanoprost 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.

Continued overleaf

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.
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 Latanoprost with other eye drops
Wait at least 5 minutes between using Latanoprost and taking other eye drops.
If you use more Latanoprost 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 Latanoprost
accidentally.
If you forget to use Latanoprost
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 Latanoprost
You should speak to your doctor or the doctor treating your child if you want to stop
taking Latanoprost.

4. Possible side effects

Like all medicines, Latanoprost can cause side effects, although not everybody gets them.
The following are known side effects of using Latanoprost:
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 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 (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).
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).
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 Latanoprost

Keep out of the sight and reach of children.
Do not use Latanoprost 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 at room temperature (do not store above 25°C), protect from
light.
After opening the bottle store it at room temperature (do not store above 25°C) and use
within 4 weeks of opening. When you are not using Latanoprost, keep the bottle in the
outer carton, in order to protect from light.
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.
If you notice any discolouration or deterioration of your medicine, please tell your doctor or
pharmacist immediately.

6. Further information

What Latanoprost contains
Latanoprost contains latanoprost 50 micrograms/ml.
The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen
phosphate monohydrate and anhydrous disodium phosphate (E339) dissolved in
water for injections.
What Latanoprost looks like and contents of the pack
Latanoprost eye drops, solution is a clear, colourless liquid.
Latanoprost is available in a pack size of one carton.
Each carton contains one bottle of Latanoprost. Each bottle contains 2.5 ml of Latanoprost
eye drops, solution.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova
UK Ltd both at St James’ House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.

Latanoprost 0.005% w/v eye drops, solution
PL No: 18067/0474 POM
This leaflet was last revised on 20th March 2015
500000/PL1a

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.

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