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XALATAN 0.005% EYE DROPS

Active substance(s): LATANOPROST

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

XALATAN® 0.005% w/v EYE DROPS
(Latanoprost)
Patient Information Leaflet

This product is known as the above name but will be referred to as Xalatan throughout this leaflet.

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ARIAL REGULAR BOLD FONT SIZE 8
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SERETIDE 6464/2342 6464/2343

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).

DATE:

CUSTOMER
APPROVED:

4. Possible side effects
5. How to store Xalatan
6. Further information

WARNING!

Notes:

In this leaflet:
1. What Xalatan is and what it is used for
2. Before you use Xalatan
3. How to use Xalatan

PROOF HISTORY:
v.1 - waymade - 19/06/14

Leaflet Flat Size = 148 x 400

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.

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.

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.

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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.

UK PIL DATED DECEMBER 2013
REPORTING SIDE EFFECTS
AMBIENT STORAGE

DATE:

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.

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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.

CODE:

DT
ARTWORKER:
Xalatan 0.005% eye drops
PRODUCT:

DATE OF PROOF:

Q.A.
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

Breast-feeding
Do not use Xalatan when you are breast-feeding.

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 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.

Colour
Swatch

Black

WARNING!

27mm

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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).

WARNING!

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.

UK PIL DATED DECEMBER 2013
REPORTING SIDE EFFECTS

TVT CHECKED

DATE:

By reporting side effects you can help provide more information on the safety of this medicine.

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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.

CODE:

DT
ARTWORKER:
Xalatan 0.005% eye drops
PRODUCT:

DATE OF PROOF:

Q.A.
APPROVED:
CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

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.

5. HOW TO STORE XALATAN
• Unopened bottle: Do not store above 25°C, protect from light.
• Opened Bottle: Do not store above 25°C.
• When you are not using the eye drops, keep the bottle in the outer carton, in order to protect from light.
• The bottle should be discarded four weeks after opening.
• Do not use after the expiry date printed on the bottle or carton or label. The expiry date refers to the last
day of that month.
• Keep all medicines out of the sight and reach of children.
• If your doctor tells you to stop using the drops, please take them back to the pharmacist for safe
disposal. Only keep the medicine if your doctor tells you to.
• If the drops become discoloured or show any other signs of deterioration, you should seek the advice of
your pharmacist before using them.
• 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
Your medicine is called Xalatan 0.005% eye drops. Each millilitre of eye drops, solution contains 50
micrograms of the active ingredient Latanoprost in a clear, colourless solution.
Xalatan 0.005% eye drops also contain the following: Benzalkonium chloride, sodium chloride, sodium
dihydrogen phosphate monohydrate, disodium phosphate anhydrous and water for injections.
Xalatan 0.005% eye drops are available as bottles of 2.5mls of solution.
POM

PL No: 06464/2752

This product is manufactured by Pfizer Manufacturing Belgium NV., Rijksweg, 12 Puurs, Belgium and is
procured within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

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Leaflet revision and issue date (Ref.) 19.06.2014
Xalatan is a registered trademark of Pfizer Health AB.

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WARNING!

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).
DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

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:

PROOF HISTORY:
v.1 - waymade - 19/06/14

Leaflet Flat Size = 148 x 400

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

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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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