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XALACOM EYE DROPS SOLUTION

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

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Xalacom Eye Drops Solution
(Latanoprost and timolol)
PACKAGE LEAFLET: INFORMATION FOR THE USER
The name of your medicine is Xalacom Eye Drops Solution but will be
referred to as Xalacom throughout the Package 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. See
section 4.
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
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.
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 longstanding 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
Warnings and precautions
Talk to your doctor or pharmacist before using Xalacom 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)

• 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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before taking
this medicine.
Latanoprost and timolol have been found to have no effect on male or
female fertility in animal studies.
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.
Xalacom contains benzalkonium chloride
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 or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose 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).
Figure 1
3. Unscrew the protective inner cap. The protective cap should be
retained.

Figure 2
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.
Figure 3
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.

Tell your doctor before you have an operation that you are using
Xalacom as timolol may change effects of some medicines used
during anaesthesia.
Other medicines and Xalacom
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, including using eye drops and
medicines obtained without a prescription.
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.
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

Figure 4
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 Xalacom with other eye drops
Wait at least 5 minutes between using Xalacom and using the other
eye drops.
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.
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.

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.
The following are known side effects of using Xalacom:
Very common (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.
Common (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.
Uncommon (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).

• 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.
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 all medicines out of the sight and reach of children.
• Do not use Xalacom 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 Xalacom, 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) Contents of the pack and other information
Psychiatric Disorders:
• Depression, memory loss, decreased sex drive, inability to sleep,
nightmares.

What Xalacom contains
The active substance is latanoprost 50 micrograms/ml and timolol (as
timolol maleate) 5 mg/ml.

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).

The other ingredients are:
Sodium chloride
Benzalkonium chloride
Sodium dihydrogen phosphate monohydrate
Disodium phosphate anhydrous
Hydrochloric acid solution (for adjustment to pH 6.0)
Sodium hydroxide solution (for adjustment to pH 6.0)
Water for injections

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).
Ear Disorders:
• Whistling/ringing in the ears (tinnitus).
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
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 betablockers when used for treating eye conditions:

What Xalacom looks like and contents of the pack
This pack contains one bottle containing 2.5 ml of Xalacom Eye
Drops, Solution.
Xalacom is a clear, colourless liquid.
Each carton contains one bottle of Xalacom. Each bottle contains
2.5ml of Xalacom Eye Drops.
Marketing Authorisation Holder and Manufacturer
PL 10383/1928

Xalacom 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: 17.11.2015

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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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