Xalacom

Package leaflet: Information for the user

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

Latanoprost + Timolol
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform 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 using 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 active substances: latanoprost and timolol. Latanoprost belongs to a class of medicines known as prostaglandin analogues. Timolol belongs to a class 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 reducing the production of fluid within the eye.
Xalacom is used to reduce intraocular pressure when you suffer from conditions such as open-angle glaucoma or ocular hypertension. Both of these conditions are associated with elevated intraocular pressure, which may eventually impair vision.
Your doctor usually prescribes this medicine when other treatments have not been sufficiently effective.

2. What you need to know before using Xalacom

Xalacom can be used by adult women and men (including elderly patients), but it is not recommended for individuals under 18 years of age.
Do not use Xalacom

• If you are allergic (hypersensitive) to either of the two active ingredients 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 previously had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that may cause wheezing, difficulty breathing, and/or persistent cough).
• If you have severe heart problems or cardiac rhythm disorders.

Warnings and precautions
Inform your doctor or pharmacist before using Xalacom if you have or have previously had:

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure
• Heart rhythm disorders such as slow heart rate
• 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 may mask the signs and symptoms of low blood sugar
• Overactive thyroid gland, because timolol may mask its signs and symptoms
• Are about to undergo any eye surgery (including cataract surgery) or have previously undergone eye surgery
• Eye problems (such as eye pain, eye irritation, eye inflammation, or blurred vision)
• Dry eye syndrome
• Wear contact lenses. You may still use Xalacom, following the instructions for contact lens wearers provided in section 3
• Angina (particularly a type known as Prinzmetal's angina)
• Severe allergic reactions that usually require hospital treatment
• A viral eye infection caused by the herpes simplex virus (HSV), either currently or in the past. Before undergoing surgery, inform your doctor that you are using Xalacom, as timolol may alter the effects of certain medications used during anesthesia.

Other medicines and Xalacom
Inform your doctor or pharmacist if you are currently 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 glaucoma. Inform your doctor if you are using or plan to use medicines to lower blood pressure, for heart conditions, or for diabetes treatment.
In particular, inform 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 orally administered calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides, or parasympathomimetics
• Quinidine (used to treat heart conditions and certain types of malaria)
• Known antidepressants such as fluoxetine and paroxetine

Xalacom with food and drink
Normal meals, food, or drinks do not affect how or when you should use Xalacom.
For athletes: Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Pregnancy, breastfeeding, and fertility
Pregnancy
Do not use Xalacom if you are pregnant unless your doctor considers it necessary. Inform your doctor immediately before taking this medicine if you are pregnant, think you might be pregnant, or are planning a pregnancy.
Breastfeeding
Do not use Xalacom if you are breastfeeding. Xalacom may pass into your breast milk. Ask your doctor for advice before taking any medicine while breastfeeding.
Fertility
Animal studies have shown that latanoprost and timolol do not affect male or female fertility.

Driving and using machines
When using Xalacom, you may experience temporary blurred vision. If this occurs, do not drive or operate machinery until your vision clears.
Xalacom contains benzalkonium chloride and phosphate buffer
This medicine contains 0.2 mg/mL of benzalkonium chloride per milliliter.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the clear layer at the front of the eye). If you experience unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.
This medicine contains 6.3 mg/mL of phosphates per milliliter, equivalent to 0.2 mg per drop.
If you have severe damage to the transparent layer at the front of the eye (the cornea), phosphates may, in very rare cases, cause cloudy spots on the cornea due to calcium accumulation during treatment.

3. How to use Xalacom

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults (including elderly patients) is one drop once daily in the eye(s) to be treated.
Do not use Xalacom more than once a day, as the effectiveness of treatment may be reduced if the medicine is administered more frequently.
Continue using Xalacom as directed by your doctor until your doctor tells you to stop treatment.
If you are using Xalacom, your doctor may require additional monitoring of your heart and circulation.

Contact lens wearers
If you wear contact lenses, you must remove them before applying Xalacom. After applying Xalacom, wait 15 minutes before reinserting your contact lenses.

Instructions for use

1. Wash your hands and sit or stand comfortably.

2. Remove the outer cap by gently twisting it off (the outer cap can be discarded).

Figure 1

3. Unscrew the inner protective cap. The protective cap must be kept.

Figure 2

4. Gently pull down with one finger the lower eyelid of the eye to be treated.

Figure 3

5. Position the tip of the bottle close to the eye without touching it.
6. Gently press the bottle so that one single drop enters the eye, then release the lower eyelid.
7. After using Xalacom, press with one finger at the inner corner of the eye near the nose (see Figure 4) for 2 minutes. This helps prevent latanoprost + timolol from passing into the rest of the body.

Figure 4

8. Repeat the procedure in the other eye if your doctor has instructed you to do so.
9. Close the bottle with the inner protective cap.

If you use Xalacom with another eye drop
Wait at least 5 minutes between administering Xalacom and any other eye drop.

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

If you swallow Xalacom
Contact your doctor if you have accidentally swallowed Xalacom. If you have swallowed a large amount of Xalacom, you may feel unwell, have stomach pain, feel tired, feel hot, experience dizziness, and begin to sweat.

If you forget to use Xalacom
Continue with your usual dose at your usual time. Do not use a double dose to make up for the missed dose. If you have any doubts, consult 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 continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Xalacom without first discussing it with your doctor.

Listed below are the known side effects associated with the use of Xalacom. The most important side effect is the possible gradual and permanent change in eye colour. Xalacom may also cause serious disturbances in heart function. If you notice any changes in your heartbeat or heart function, consult your doctor and inform him/her 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 colour due to increased brown pigment in the coloured part of the eye (iris). This change is more likely if your eyes are of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown) rather than uniform colour (blue, grey, green or brown). Any change in eye colour may occur after several years. The colour change may be permanent and may be more noticeable if you use Xalacom in only one eye. There appear to be no problems associated with this change in eye colour. After stopping treatment with Xalacom, no further change in eye colour has been observed.

Common (may affect up to 1 in 10 people):

• Eye irritation (burning sensation, sensation of sand in the eyes, 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, watery eyes, inflammation of the eyelids, irritation or abrasion of the eye surface.
• Skin rash or itching.

Other side effects
Like other eye medicines, Xalacom (latanoprost and timololo) is absorbed into the bloodstream. The incidence of adverse reactions after using eye drops is lower than when medicines are taken orally or by injection.
Although not specifically associated with the use of Xalacom, the following side effects have been observed with the medicines contained in Xalacom (latanoprost and timolol). Therefore, these effects may occur when you use Xalacom. The listed side effects include reactions observed within the class of beta-blockers (e.g., timolol) when used to treat eye disorders:

• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalised allergic reactions including swelling under the skin that may occur in areas such as the face and limbs and may block the airways causing difficulty in swallowing and breathing, urticaria or itchy rash, localised and generalised rash, itching, sudden severe life-threatening allergic reaction (anaphylaxis).
• Low blood sugar levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss.
• Fainting, heart attack, reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), unusual sensations such as tingling, and headache.
• Swelling at the back of the eye (macular edema), fluid-filled cyst inside the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eyes (deepening of the eyelid groove).
• Signs and symptoms of eye irritation (such as burning, stinging pain, itching, tearing, redness), inflammation of the eyelids, corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels following filtering 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 (causing the eye to be half-closed), double vision.
• Darkening of the skin around the eyes, changes in eyelids and fine hair around the eye (increased number, length, thickness, pigmentation), changes in the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitis), scarring of the eye surface.
• Ringing or buzzing in the ears (tinnitus).
• Angina, worsening of angina in patients already suffering from heart disease.
• Slow heartbeat, chest pain, palpitations (awareness of heartbeat), oedema (fluid accumulation), changes in heart rate or rhythm, congestive heart failure (heart disease associated with shortness of breath and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, poor blood circulation causing numbness and paleness of fingers and toes, cold hands and feet.
• Shortness of breath, narrowing of the lung airways (mainly in patients with pre-existing lung disease), difficulty breathing, cough, asthma, worsening of asthma.
• Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Joint pain, muscle pain not caused by physical exercise, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed cloudy spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects 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 carton 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 first opening,
it is not necessary to store the bottle in a refrigerator, but it must not be stored at a temperature above 25°C.
Use within 4 weeks of first opening. When not in use, keep the bottle in the outer packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Xalacom and pack contents
Each bottle contains 2.5 ml of Xalacom eye drops, solution.
Xalacom is a clear, colourless liquid.
Xalacom is available in pack sizes 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, Italy

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 names:
Xalacom in Austria, Belgium, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, and the United Kingdom.
Xalcom in Denmark, Finland, Iceland, Norway, and Sweden.

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