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XALACOM EYE DROPS

Active substance(s): LATANOPROST / TIMOLOL / TIMOLOL MALEATE

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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.

XALACOM® EYE DROPS
(latanoprost and timolol maleate)
Patient Information Leaflet

This product is known as the above name but will be referred to as Xalacom throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Please
tell your doctor or pharmacist.

Xalacom is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension.
Both these conditions are linked to an increase in the pressure within your eye, eventually affecting your eyesight. Your doctor will
usually prescribe you Xalacom when other medicines have not worked adequately.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE XALACOM
Xalacom can be used in adult men and women (including the elderly), but is not recommended for use if you are less than 18 years
of age.
Do not use Xalacom eye drops solution:
• if you are allergic (hypersensitive) to either of the medicines in Xalacom (latanoprost or timolol), beta-blockers, or any of the
other ingredients of Xalacom (listed in section 6)
• if you have now or have had in past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe
lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough)
• if you have serious heart problems or heart rhythm disorders
• if you are pregnant (or trying to become pregnant)
• if you are breast feeding

DATE:

WARNING!

Warnings and precautions
Before you use this medicine, tell your doctor if you have now or have had in the past:
• coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood
pressure
• disturbances of heart rate such as slow heart beat
• breathing problems, asthma or chronic obstructive pulmonary disease
• poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)
• diabetes as timolol may mask signs and symptoms of low blood sugar
• overactivity of the thyroid gland as timolol may mask signs and symptoms
• you are about to have any kind of eye surgery (including cataract surgery) or have had any kind of eye surgery in the past
• you suffer from eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)
• you know that you suffer from dry eyes
• you wear contact lenses. You can still use Xalacom but follow the instructions for contact lens wearers in Section 3
• you know that you suffer from angina (particularly a type known as Prinzmetal angina)
• you know that you suffer from severe allergic reactions that would usually require hospital treatment
• you have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV)
Tell your doctor before you have an operation that you are using Xalacom as timolol may change effects of some medicines used
during anaesthesia.

In particular, speak to your doctor or pharmacist if you know that you are taking any of the following types of medicine:
• Prostaglandins, prostaglandin analogues or prostaglandin derivates
• Beta-blockers
• Epinephrine
• Drugs used to treat high blood pressure such as oral calcium channel blockers, guanethidine, antiarrythmics, digitalis
glycosides or parasympathomimetics
• Quinidine (used to treat heart conditions and some types of malaria)
• Antidepressants known as fluoxetine and paroxetine
Xalacom with food and drink
Normal meals, food or drink have no effect on when or how you should use Xalacom.
Pregnancy and breast-feeding
Do not use Xalacom if you are pregnant unless your doctor considers it necessary.
Tell your doctor immediately if you are pregnant, think you are pregnant or are planning to become pregnant.
Do not use Xalacom if you are breast-feeding. Xalacom may get into your milk. Ask your doctor for advice before taking any
medicine during breast-feeding.

UK PIL DATED JUNE 2013
REPORTING OF SIDE EFFECTS

6464/1679 1680F

Driving and using machines
When you use Xalacom your vision may become blurred 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:

15/01/14
DATE OF PROOF:

DATE:

DT
ARTWORKER:
PRODUCT: Xalacom Eye drops

04-1957
CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

Other medicines and Xalacom
Xalacom can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell
your doctor if you are using or intend to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (including using eye drops).

Xalacom contains
Xalacom contains a preservative called benzalkonium chloride. This preservative may cause eye irritation or disruption to the
surface of the eye. It can be absorbed by contact lenses and is known to discolour soft contact lenses. Therefore, avoid contact with
soft contact lenses. See the instructions for contact lens wearers in Section 3.
3. HOW TO USE XALACOM
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual dosage for adults (including the elderly) is one drop once a day in the affected eye(s).
Do not use Xalacom more than once a day, because the effectiveness of the treatment can be reduced if you administer it more
often.
Use Xalacom as instructed by your doctor until your doctor tells you to stop.
Your doctor may want you to have extra checks on your heart and circulation if you use Xalacom.
Contact lens wearers
If you wear contact lenses, you should remove them before using Xalacom. After using Xalacom you should wait 15 minutes before
putting your contact lenses back in.
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. After using Xalacom, press a finger into the corner of your eye, by the nose
(figure 4) for 2 minutes. This helps to stop latanoprost + timolol getting into
the rest of the body.
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.

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Figure 1

Figure 2

Figure 3

If you use Xalacom with other eye drops
Wait at least 5 minutes between using Xalacom and using the other eye drops.

Figure 4
If you use more Xalacom than you should
If you put too many drops in your eye you may experience some minor irritation in your eye and your eyes may water and turn red.
This should pass but if you are worried contact your doctor for advice.
If you swallow Xalacom
If you swallow Xalacom accidentally you should contact your doctor for advice. If you swallow a lot of Xalacom you may feel sick,
have stomach pains, feel tired, flushed and dizzy and start to sweat.

WARNING!

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CUSTOMER
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4. Possible side effects
5. How to store Xalacom
6. Contents of the pack and other information

1. WHAT XALACOM IS AND WHAT IT IS USED FOR
Xalacom contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin
analogues. Timolol belongs to a group of medicines known as beta-blockers.
Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the
formation of fluid in the eye.

PROOF HISTORY:
v 1 - waymade - 15/01/14

Leaflet Flat Size = 180 x 429

What is in this leaflet:
1. What Xalacom is and what it is used for
2. What you need to know before you use Xalacom
3. How to use Xalacom

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.

27mm

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 forget to use Xalacom
Carry on with the usual dosage at the usual time. Do not take a double dose to make up to the dose you have forgotten. If you are
unsure about anything talk to your doctor or pharmacist.

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4. POSSIBLE SIDE EFFECTS
Like all medicines this medicine can cause side effects, although not everybody gets them.
You can usually carry on taking the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist. Do not
stop using Xalacom without speaking to your doctor.
Listed below are the known side effects of using Xalacom. The most important side-effect is the possibility of a gradual, permanent
change in your eye colour. It is also possible that Xalacom might cause serious changes in the way your heart works. If you notice
changes in your heart rate or heart function you should speak to a doctor and tell them you have been using Xalacom.

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Uncommon effects (may affect up to 1 in 100 people):
• Headache
• Redness of the eye, eye infection (conjunctivitis), blurred vision, watery eyes, inflammation of the eyelids, irritation or disruption of
the surface of the eye
• Skin rashes or itching (pruritus)
Other side effects
Although not seen with Xalacom, the following additional side effects have been seen with the medicines in Xalacom (latanoprost
and timolol) and therefore might occur when you use Xalacom:
The following side effects have been seen with latanoprost:
Infections and Infestations:
• Developing a viral infection of the eye caused by the herpes simplex virus (HSV).
Immune System Disorders:
• Symptoms of allergic reaction (swelling and redness of the skin and rash).
Psychiatric Disorders:
• Depression, memory loss, decreased sex drive, inability to sleep, nightmares.
Nervous System Disorders:
• Dizziness, tingling or numbness in the skin, changes in blood flow to the brain, worsening of symptoms of myasthenia gravis (if
you already suffer from this condition), sudden fainting or feeling you may faint (syncope).

WARNING!

Eye Disorders:
• Changes to the eyelashes and fine hairs around the eye (increased number, length, thickness and darkening), changes to the
direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitus), swelling at the back of
the eye (macular oedema), inflammation/irritation of the surface of the eye (keratitis), dry eyes, fluid filled cyst within the coloured
part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance (deepening of the eye sulcus).

Heart (Cardiac) Disorders:
• Worsening of angina, awareness of heart rhythm (palpitations).
Breathing (Respiratory) Disorders:
• Asthma, worsening of asthma, shortness of breath.
Skin Disorders:
• Darkening of the skin around the eyes.
Muscle and Skeletal Disorders:
• Joint pain, muscle pain
General Disorders:
• Chest pain

UK PIL DATED JUNE 2013
REPORTING OF SIDE EFFECTS

6464/1679 1680F
CODE:

DATE:

DT

15/01/14

ARTWORKER:

DATE OF PROOF:

PRODUCT: Xalacom Eye drops

Q.A.
APPROVED:
PRE-PRESS NO.:
CUSTOMER: Waymade

04-1957

Like other medicines applied into eyes, Xalacom is absorbed into the blood. The timolol portion of this combination may cause
similar side effects as seen with intravenous and/or oral beta-blocking agents. Incidence of side effects after topical ophthalmic
application is lower than when medicines are, for example, taken by mouth or injected. Listed side effects include reactions seen
within the class of beta-blockers when used for treating eye conditions:
• Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can
obstruct the airway which may cause difficulty swallowing or breathing, hives or itchy rash, localized and generalized rash,
itchiness, severe sudden life-threatening allergic reaction.
• Low blood glucose levels.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss.
• Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder),
dizziness, unusual sensations like pins and needles, and headache.
• Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in
the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following filtration surgery
which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the
eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision.
• Slow heart rate, chest pain, palpitations, oedema (fluid build up), changes in the rhythm or speed of the heartbeat, congestive
heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), a type of heart rhythm
disorder, heart attack, heart failure.
• Low blood pressure, Raynaud's phenomenon, cold hands and feet.
• Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough.
• Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Muscle pain not caused by exercise.
• Sexual dysfunction, decreased libido.
• Muscle weakness/tiredness.
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.
If you get any side effects talk to your doctor. This includes any possible side effects not mentioned in this leaflet.
Reporting of side effects
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 XALACOM
• Keep out of the sight and reach of children.
• 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.
• After opening the bottle it is not necessary to store it in a refrigerator but do not store above 25°C. After opening do not use this
bottle for more than 4 weeks.
• Before Xalacom eye drops are first opened they should be stored in a refrigerator between 2-8°C, out of direct light.
• Keep the container in the outer carton.
• If the drops become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist before
using them.
• 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.
• 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. CONTENTS OF THE PACK AND OTHER INFORMATION
Your medicine is called Xalacom eye drops. Each millilitre of solution contains 50 micrograms of the active ingredient Latanoprost
and 5mg of the active ingredient timolol (as the maleate) in a clear, colourless solution.
Xalacom eye drops also contain the following:
Benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous and water for
injections. To bring the solution to the correct pH level, very small amounts of hydrochloric acid or sodium hydroxide may be added
to the solution during manufacture.
Xalacom eye drops are available as bottles of 2.5mls of solution.
POM

PL No: 6464/1679
PL No: 6464/1680

These products are manufactured by Pfizer Manufacturing Belgium NV, Rijksweg, 12 Puurs, Belgium and procured within the EU
and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 15.01.2014
Xalacom is a registered trademark of Pfizer Health AB.

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Ear Disorders:
• Whistling/ringing in the ears (tinnitus).

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.

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Common effects (may affect up to 1 in 10 people):
• Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye) and eye pain.

PROOF HISTORY:
v.1 - waymade - 15/01/14

Leaflet Flat Size = 180 x 429

The following are known side effects of using Xalacom:
Very common effects (may 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.
The colour change may be permanent and may be more noticeable if you use Xalacom 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 Xalacom treatment is stopped.

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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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