XALACOM 5 mg /Ml Krople Do Oczu, Roztwór

Treść ulotki

1. Xalacom 50 micrograms/ml and 5 mg/ml eye drops, solution
   1. What is Xalacom and what is it used for
   2. What you need to know before using Xalacom
   3. How to use Xalacom
   4. Possible side effects
   5. How to store Xalacom
   6. Contents of the pack and other information

Xalacom 50 micrograms/ml and 5 mg/ml eye drops, solution

Latanoprost + Timolol
Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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 is Xalacom and what is it used for

Xalacom contains two medicines: latanoprost and timolol. Latanoprost belongs to the category of medicines known as prostaglandin analogues. Timolol belongs to the category of medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from inside the eye into the bloodstream.
Timolol works by slowing down the production of fluid inside the eye.
Xalacom is used to reduce pressure inside the eye if it is affected by conditions known as open-angle glaucoma or ocular hypertension. Both of these conditions are linked to an increase in intraocular pressure, ultimately altering vision.
The doctor usually prescribes this medicine when other medicines have not worked adequately.

2. What you need to know before using Xalacom

Xalacom can be used in women and adult men (including the elderly) but is not
recommended if you are under 18 years of age.

Do not use Xalacom

• If you are allergic (hypersensitive) to any of the active substances contained in Xalacom (latanoprost or timolol), to beta-blockers or to any of the other components of Xalacom (listed in section 6).
• If you have or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (a severe lung disease that can cause wheezing, difficulty breathing and/or persistent cough).
• If you have severe heart problems or heart rhythm disorders.

Warnings and precautions
Tell your doctor or pharmacist before using Xalacom if you have or have had in the past:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or a feeling of suffocation), heart failure, low blood pressure
• heartbeat disorders such as a slowed heartbeat
• respiratory problems, asthma or chronic obstructive lung disease
• a disease associated with poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes because timolol can mask the signs and symptoms of low blood sugar
• hyperactivity of the thyroid gland because timolol can mask its signs and symptoms
• are about to undergo any eye surgery (including cataract surgery) or if you have had any eye surgery in the past
• have eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)
• know that you suffer from dry eyes
• use contact lenses. You can still use Xalacom following the instructions for contact lens wearers in section 3
• know that you suffer from angina (especially a form of angina known as Prinzmetal's angina)
• know that you suffer from severe allergic reactions that generally require hospital treatment
• have suffered or are currently suffering from a viral eye infection caused by the herpes simplex virus (HSV). Before undergoing surgery, tell your doctor that you are using Xalacom because timolol can alter the effects of some medicines used during anesthesia.

Other medicines and Xalacom
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including eye drops and over-the-counter medicines.
The effect of Xalacom may be altered or Xalacom may alter the effect of other medicines you are
using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or if
you intend to use medicines to lower blood pressure, for the heart or for the treatment of
diabetes.
In particular, tell your doctor or pharmacist if you are taking a medicine belonging to the
following classes:

• Prostaglandins, prostaglandin analogues or prostaglandin derivatives
• Beta-blockers
• Epinephrine
• Medicines used to treat high blood pressure such as oral calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides or parasympathomimetics
• Quinidine (used to treat heart conditions and some types of malaria)
• Known antidepressants such as fluoxetine and paroxetine

Xalacom with food and drink
Taking your normal meals, food or drinks does not affect how and when to take Xalacom.

For athletes:the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Xalacom if you are pregnant unless your doctor considers it necessary. Tell your doctor
immediately before taking this medicine if you are pregnant, think you might be pregnant or if you are
planning a pregnancy.
Breastfeeding
Do not use Xalacom if you are breastfeeding. Xalacom can pass into your milk. Ask your doctor to be
informed before taking any medicine while breastfeeding.
Fertility
In animal studies, latanoprost and timolol have not been shown to have any effect on male or female fertility.

Driving and using machines
When using Xalacom you may experience transient blurred vision. If this happens, do not
drive vehicles or use equipment or machinery until your vision is clear again.

Xalacom contains benzalkonium chloride and phosphate buffers
This medicine contains 0.2 mg / ml of benzalkonium chloride in each millilitre.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
a change in their colour. Remove your contact lenses before using this medicine and wait 15
minutes before re-applying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the clear layer at the front of the eye). If you experience an
abnormal sensation in the eye, burning or pain after using this medicine, talk to your
doctor.
This medicine contains 6.3 mg / ml of phosphates in each millilitre equivalent to 0.2 mg / per drop.
If you suffer from severe damage to the transparent layer at the front of the eye (the cornea), phosphates
can, in very rare cases, cause cloudy spots on the cornea due to calcium accumulation during
treatment.

3. How to use Xalacom

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose in adults (including the elderly) is one drop once a day
in the eye(s) to be treated.
Do not use Xalacom more than once a day, as the effectiveness of the treatment may be reduced if the
medicine is administered more frequently.
Use Xalacom as directed by your doctor, until your doctor tells you to stop the
treatment.
If you are using Xalacom, your doctor may request further monitoring of your heart and circulation.

Contact lens wearers
If you wear contact lenses, you must remove them before applying Xalacom. After applying
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. Remove the outer cap with a slight twist (the outer cap can be discarded).

Figure 1

• 3. Unscrew the inner protective cap. The cap

of protection must be kept.
Figure 2

• 4. Gently pull down the lower eyelid

of the eye to be treated.

• 5. Position the tip of the bottle close to the eye without touching it.
• 6. Apply slight pressure to the bottle so that only one drop goes inside the eye, then release the lower eyelid.
• 7. After using Xalacom, press with a finger on the corner Figure 3 of the eye, near the nose (figure 4) for 2 minutes. This helps to prevent latanoprost + timolol from passing into the rest of the body.

• 8. Repeat the operation in the other eye as well, if your doctor Figure 4 has told you to do so.
• 9. Close the bottle with the inner protective cap.

If you are using Xalacom with another eye drop
Wait at least 5 minutes between administering Xalacom and administering another
eye drop.

If you use more Xalacom than you should
If you put too many drops in your eyes, you may experience mild irritation, tearing, and redness
of the eyes. These effects are transient, but if you are concerned, contact your doctor for advice.

If you swallow Xalacom
Consult your doctor if you accidentally swallowed Xalacom. If you have swallowed a large amount of
Xalacom, you may feel unwell, have stomach pain, feel tired, hot, dizzy
and start to sweat.
If you forget to use Xalacom
Continue to take the usual dosage at the usual time. Do not use a double dose to make up for the
missed dose. If you have any doubts, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Generally you can continue to use the drops, unless the effects experienced are serious. If you are
worried, contact your doctor or pharmacist. Do not stop using Xalacom without talking to your
doctor.
Below are listed the known side effects associated with the use of Xalacom. The most important side
effect is the possible gradual and permanent change in the color of the eye. It is
also possible that Xalacom may cause serious changes in heart function. If you experience
a change in heartbeat or heart function, you should contact your doctor and inform them
that you are taking Xalacom.
The known side effects associated with the use of Xalacom are:

Very common(may affect more than 1 in 10 people):

• Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye called the iris. This change is more likely to occur if your eyes are of mixed color (blue-brown, gray-brown, yellow-brown, or green-brown) rather than a uniform color (blue, gray, green, or brown). Any change in eye color may occur after years. The color change may be permanent and may be more noticeable if you use Xalacom in only one eye. There do not appear to be any problems associated with the change in eye color. After stopping treatment with Xalacom, no further change in eye color has been observed. Common(may affect up to 1 in 10 people):
• Eye irritation (burning sensation, gritty feeling, itching, stinging pain, or foreign body sensation in the eyes) and eye pain. Uncommon(may affect up to 1 in 100 people):
• Headache.
• Red eyes, eye infection (conjunctivitis), blurred vision, shiny eyes, inflammation of the eyelids, irritation or abrasion of the eye surface.
• Skin rashes or itching.

Other side effects
Like other medicines applied to the eyes, Xalacom (latanoprost and timolol) is absorbed into the
bloodstream. The incidence of adverse reactions after using eye drops is lower than that
observed when medicines are taken, for example, by mouth or by injection.
Although not associated with the use of Xalacom, the following side effects have been observed with the use
of the medicines contained in Xalacom (latanoprost and timolol). These effects may therefore occur
when you use Xalacom. The side effects listed include reactions observed in the beta-blocker class (e.g., timolol) when these are used to treat eye conditions:

• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalized allergic reactions including swelling under the skin that can occur in areas such as the face and limbs and can obstruct the airways causing difficulty swallowing and breathing, hives or itchy rash, localized and generalized rash, itching, severe life-threatening allergic reaction.
• Low blood glucose levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss.
• Fainting, heart attack, reduced blood supply to the brain, increased signs and symptoms of myasthenia gravis (muscle disease), unusual sensations such as tingling, and headache.
• Swelling of the back of the eye (macular edema), cyst filled with fluid inside the colored part of the eye (iridic cyst), sensitivity to light (photophobia), sunken eyes (deepening of the palpebral groove).
• Signs and symptoms of eye irritation (such as burning, stinging pain, itching, tearing, redness), inflammation of the eyelids, inflammation of the cornea, blurred vision and detachment of the layer beneath the retina containing blood vessels following filtering surgery which can cause visual disturbances, decreased corneal sensitivity, dry eye, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye half-closed), double vision.
• Darkening of the skin around the eyes, changes to eyelids and eyelashes around the eye (increase in number, length, thickness, pigmentation), changes in the direction of eyelash growth, swelling around the eye, swelling of the colored part of the eye (iritis/uveitis), scarring of the eye surface.
• Whistling/Ringing in the ears (tinnitus).
• Angina, worsening of angina in patients already suffering from heart disease.
• Slowed heartbeat, chest pain, palpitations (perception of heartbeat rhythm), edema (fluid accumulation), changes in the rhythm or rate of heartbeat,

congestive heart failure (heart disease associated with shortness of breath and swelling of the
feet and legs due to fluid accumulation), a type of heart rhythm disturbance,
heart attack, heart failure.

• Low blood pressure, poor blood circulation that numbs and turns the fingers of hands and feet pale, cold hands and feet.
• Shortness of breath, narrowing of the airways in the lungs (mainly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Changes in taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash that appears with a silvery-white color (psoriasiform rash) or worsening of psoriasis, rash.
• Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer in the front
of the eye (the cornea) have developed cloud-like spots on the cornea due to
calcium accumulation during treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse..
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Xalacom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after
Exp. and on the bottle. The expiry date refers to the last day of the month.
Before opening, store the Xalacom bottle in a refrigerator (2°C - 8°C). After the first
opening, it is not necessary to store the bottle in a refrigerator but it must not be stored at a
temperature higher than 25°C. Use within 4 weeks of first opening. When you are not using
Xalacom, keep the bottle in the outer packaging to protect it from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Xalacom contains
The active ingredients are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.
The other ingredients are:
Sodium chloride
Benzalkonium chloride
Sodium phosphate monobasic monohydrate (E339i)
Sodium phosphate dibasic (E339ii)
Hydrochloric acid solution (for pH adjustment to 6.0)
Sodium hydroxide solution (for pH adjustment to 6.0)
Water for injections

Description of Xalacom and contents of the pack
Each bottle contains 2.5 ml of Xalacom eye drops, solution.
Xalacom is a clear, colorless liquid.
Xalacom is available in packs of 1 and 3 bottles. Not all pack sizes may be
marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Established Medicine Italy S.r.l., via Isonzo,71-04100 Latina

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs
Belgium.

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Xalacom in Austria, Belgium, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands,
Portugal, Spain and Great Britain.
Xalcom in Denmark, Finland, Iceland, Norway, and Sweden.

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