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XALACOM EYE DROPS SOLUTION

Active substance(s): LATANOPROST / TIMOLOL MALEATE

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PATIENT INFORMATION LEAFLET

2516
12.02.16[6]

Xalacom® Eye Drops, Solution
(latanoprost/timolol maleate)
This medicine is available using 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. 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:
 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)

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
 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.

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.

Figure 3

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.

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.

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.

The recommended dose for adults (including the elderly) is one drop
once a day in the affected eye(s).

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.

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).

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 greenbrown) 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.

Figure 1

3. Unscrew the protective inner cap. The protective
cap should be retained.

Tell your doctor before you have an operation that you are using Xalacom
as timolol may change effects of some medicines used during
anaesthesia.
Figure 2

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).
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).
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

 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 out of the sight and reach of children.
Do not use Xalacom after the expiry date which is stated after EXP on the
carton and bottle label. The expiry date refers to the last day of that
month.
Store the unopened bottle of Xalacom in a refrigerator (between 2°C to
8°C). Keep bottle in the outer carton in order to protect from light. After
opening the bottle it is not necessary to store it in a refrigerator but do not
store it above 25°C. Use within 4 weeks of opening.
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
What Xalacom contains
Each 1ml solution contains 50 micrograms latanoprost and 5 mg timolol
(as maleate).
Other ingredients: benzalkonium chloride, sodium chloride, sodium
dihydrogen phosphate monohydrate, disodium phosphate anhydrous,
sodium hydroxide solution, hydrochloric acid solution and water for
injection.
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 solution.
Manufacturer and Product Licence Holder
Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, Puurs,
B-2870, Belgium and procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd., 5, Sandridge Close, Harrow, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

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.

PL 20636/2516

Leaflet revision and issue date (Ref.) 12.02.16[6]
Xalacom is a trademark of Pfizer Enterprises Sarl

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