Xalacom

Patient Information Leaflet

Xalacom, (0.05 mg + 5 mg)/ml, eye drops, solution
Latano­prost + Timolol
Please read all of this 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 further questions, please 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

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 group of medicines called prostaglandin analogues, and timolol belongs to a group of medicines called beta-blockers. Latanoprost works by increasing the outflow of fluid from the eyeball into the bloodstream. Timolol works by reducing the amount of fluid produced in the eye.
Xalacom is used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Both conditions are associated with elevated intraocular pressure and may affect vision. Your doctor will usually recommend Xalacom if other medicines have not been sufficiently effective.

2. Important information before using Xalacom

Xalacom may be used in adult patients (including elderly individuals), but it is not recommended for use in individuals under 18 years of age.
When not to use Xalacom

• if the patient is allergic (hypersensitive) to the active substances (latanoprost and (or) timolol), beta-blocking agents, or any of the other ingredients of this medicine (listed in section 6),
• if the patient currently has or has previously had respiratory disorders such as asthma or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or prolonged cough),
• if the patient has severe heart disease or cardiac arrhythmias.

Warnings and precautions
Before starting treatment with Xalacom, inform your doctor or pharmacist if the patient currently has or has previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, or low blood pressure,
• heart rate disorders such as bradycardia (slow heart rate),
• breathing difficulties, asthma, or chronic obstructive pulmonary disease (COPD),
• circulatory disorders such as Raynaud's disease or Raynaud's syndrome,
• diabetes, because timolol may mask the subjective and objective symptoms of hypoglycemia,
• hyperthyroidism, because timolol may mask subjective and objective symptoms,
• planned eye surgery (including cataract surgery), or if such surgery has previously been performed,
• eye problems (such as eye pain, ocular surface irritation, eye inflammation, or blurred vision),
• dry eye syndrome,
• if the patient wears contact lenses. Xalacom may still be used, but instructions for contact lens use described in section 3 must be followed,
• angina pectoris (especially Prinzmetal's angina),
• severe allergic reactions requiring hospital treatment,
• a history of herpetic keratitis or herpetic keratitis caused by the Herpes Simplex virus (HSV).

Before surgery, inform the doctor about the use of Xalacom, as timolol may affect the action of certain drugs used during anesthesia.
Xalacom and other medicines
Tell your doctor or pharmacist about all medicines (including eye drops) currently used or recently used, even those available without a prescription, as well as any medicines the patient plans to take.
Xalacom may interact with, or be affected by, other medicines, including eye drops used in the treatment of glaucoma. Inform your doctor if you are using or plan to use medicines that lower blood pressure, heart medications, or medicines used in the treatment of diabetes.
Inform your doctor or pharmacist if you are taking any medicine belonging to the following groups:

• prostaglandins, prostaglandin analogs or derivatives,
• beta-blockers,
• epinephrine,
• blood pressure-lowering medicines such as oral calcium channel blockers, guanethidine, antiarrhythmics, cardiac glycosides, or parasympathomimetics,
• quinidine (used in the treatment of heart disorders and certain types of malaria),
• antidepressants such as fluoxetine, paroxetine.

Xalacom with food and drink
Eating regular meals, food, or drinks does not affect when or how to use Xalacom.
Pregnancy, breastfeeding, and fertility
Pregnancy
Xalacom should not be used during pregnancy unless your doctor decides it is necessary.
Inform your doctor immediately if you are pregnant, suspect you may be pregnant, or are planning to become pregnant.
Breastfeeding
Xalacom should not be used during breastfeeding. Xalacom may pass into human milk. Before taking any medicine during breastfeeding, consult your doctor.
Fertility
Animal studies have shown no effect of latanoprost and timolol on fertility in males or females.
Driving and using machines
Blurred vision may occur shortly after using Xalacom. If the patient experiences such symptoms, they should not drive or operate machinery until these symptoms resolve.
Xalacom contains benzalkonium chloride and phosphate buffers
The medicine contains 0.2 mg of benzalkonium chloride per milliliter.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their color. Contact lenses should be removed before instilling the drops and at least 15 minutes should elapse before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye syndrome or corneal disorders (the transparent front layer of the eye). If abnormal eye sensations, stinging, or eye pain occur after using the medicine, contact your doctor.
The medicine contains 6.3 mg of phosphates per milliliter, equivalent to 0.2 mg per drop.
In patients with severe damage to the transparent front part of the eye (cornea), phosphates may, very rarely, during treatment, cause corneal calcification and clouding due to calcium accumulation.

3. How to use Xalacom

This medicine should always be used exactly as your doctor or pharmacist has told you.
If you are unsure, you should consult your doctor or pharmacist.
The recommended dose for adult patients (including elderly patients) is 1 drop in the affected eye(s) once daily.
Xalacom should not be used more frequently than once daily, as this may reduce the effectiveness of treatment.
Xalacom should be used in accordance with your doctor's instructions, who will decide when treatment should be discontinued.
If you are using Xalacom, your doctor may recommend additional examinations of the heart and circulatory system.
Use of contact lenses
If you wear contact lenses, they must be removed before instilling Xalacom. After instilling Xalacom, wait 15 minutes before reinserting contact lenses.
Instructions for using Xalacom

1. Wash your hands and sit or stand comfortably. 2. Unscrew the colourless protective cap (the cap can be discarded).	Fig. 1
3. Unscrew the cap. Keep the cap for later use.	Fig. 2
4. Gently pull down the lower eyelid of the affected eye with your finger. 5. Place the tip of the bottle close to the eye, but do not let it touch the eye. 6. Gently squeeze the bottle so that one drop enters the eye, then release the lower eyelid.	Fig. 3
7. After administering Xalacom, press with your finger the inner corner of the eye where the eye meets the nose (Fig. 4) for two minutes. This helps prevent latanoprost and timolol from entering the bloodstream.	Fig. 4

8. If your doctor has advised you, repeat the procedure in the other eye.
9. After use, close the cap tightly.

Using Xalacom with other eye drops
If the patient is using other eye drops at the same time, they should be administered at least 5 minutes apart.

Use of more than the recommended dose of Xalacom
If more drops than recommended are used, eye irritation, tearing, and redness of the eye may occur.
These symptoms should resolve on their own, but if the patient is concerned, they should contact their doctor for advice.

Accidental ingestion of Xalacom
If Xalacom is accidentally swallowed, contact a doctor. In case of swallowing a large amount of Xalacom eye drops, symptoms such as feeling unwell, stomach pain, fatigue, facial flushing, dizziness, and sweating may occur.

Missed dose of Xalacom
If a dose is missed, take the next dose at the scheduled time. Do not use a double dose to make up for the missed dose. If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Eye drops are usually continued unless adverse effects are serious.
If in doubt, consult a doctor or pharmacist. Do not stop treatment with Xalacom without consulting your doctor.
Listed below are known adverse effects occurring after use of Xalacom.
The most important adverse effect is the possibility of a gradual, permanent change in eye colour. Xalacom may possibly cause serious disturbances in heart function. Inform the doctor if the patient notices any changes related to normal heart action or heart function, and inform them about the use of Xalacom.

Known adverse effects occurring after use of Xalacom:
Very common (may occur in more than 1 in 10 people):

• gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye called the iris. In patients whose iris colour is a mixture of colours (such as blue-brown, grey-brown, yellow-brown or green-brown), these changes may be observed significantly more frequently than in people with uniformly coloured eyes (blue, grey, green or brown). Changes in eye colour may develop over several years. The change in eye colour may be permanent and significantly more noticeable if only one eye is treated with Xalacom. The eye colour change appears to be harmless. After discontinuation of Xalacom, the change in eye colour does not progress.

Common (may occur in not more than 1 in 10 people):

• eye irritation (including burning sensation, grittiness, itching, stinging or sensation of a foreign body in the eye),
• eye pain,
• headache,
• eye redness,
• eye infection (conjunctivitis),
• blepharitis (inflammation of the eyelids),
• inflammation or irritation of the surface of the eye (cornea),
• high blood sugar levels (diabetes),
• high blood cholesterol levels,
• long and thick eyelashes,
• depression,
• light sensitivity (photophobia).

Uncommon (may occur in not more than 1 in 100 people):

• blurred vision,
• excessive tearing,
• skin rash,
• itching (pruritus).

Other adverse effects
Like other eye medicines, Xalacom (latanoprost with timolol) is absorbed into the bloodstream. The frequency of adverse effects after administration of eye drops is lower than with orally or intravenously administered medicines.
Listed below are adverse effects which, although not observed after use of Xalacom, have occurred after use of individual components of this medicine (latanoprost and timolol), and therefore may also occur after use of Xalacom. Among these adverse effects are also those observed during use of beta-adrenergic blocking agents (e.g. timolol) in the treatment of eye diseases.

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

• Changes in eyelashes and vellus hair (increased number, length, thickness and darkening).

Common (may occur in not more than 1 in 10 people):

• Irritation or damage to the surface of the eye, dry eyes, eyelid swelling.

Uncommon (may occur in not more than 1 in 100 people):

• Angina pectoris, worsening of angina pectoris in patients with existing heart disease, chest pain, nausea, vomiting.

Frequency not known (cannot be estimated from available data):

• Development of eye inflammation caused by infection with herpes simplex virus.
• General allergic reactions including subcutaneous swelling (angioedema) which may occur on the face and limbs and may obstruct airflow, causing difficulty in swallowing and breathing, urticaria or itchy rash, localised and generalised rash, pruritus, severe cases of life-threatening acute allergic reactions.
• Low blood sugar levels.
• Dizziness, shortness of breath.
• Difficulty falling asleep (insomnia), depression, nightmares, memory loss, hallucinations.
• Confusion, delusions, anxiety, disorientation, nervousness.
• Sudden fainting or feeling faint, stroke, reduced blood flow to the brain, worsening of myasthenia symptoms (muscle weakness and pain in patients with this disease), tingling or numbness and headache.
• Swelling of the back of the eye (macular oedema), formation of fluid-filled cysts in the iris (iris cysts), light sensitivity (photophobia), changes in the eye socket and eyelids leading to deepening of the eyelid sulcus.
• Eye irritation symptoms (burning, stinging, itching, tearing, redness), blepharitis, corneal inflammation, blurred vision and choroidal detachment following filtration surgery, which may cause visual disturbances, reduced corneal sensitivity, corneal erosion (defects of the outer surface of the eyeball), eyelid drooping (causing eyes to be half-closed), double vision.
• Darkening of the skin around the eyes, misdirected eyelashes, swelling around the eyes, iris swelling – the coloured part of the eye (iritis and/or uveitis), cicatrizing conjunctivitis.
• Ringing in the ears (tinnitus).
• Slowed heart rate, palpitations (awareness of heartbeat), oedema (fluid accumulation), disturbances in heart rhythm and rate, congestive heart failure (a condition characterised by shortness of breath and swelling of feet and legs due to fluid accumulation), cardiac arrhythmias, cardiac arrest, heart failure.
• Formation of tissue around kidneys and other internal organs, decreased blood pressure, poor blood circulation causing numbness and paleness of fingers and toes, sensation of cold hands and feet.
• Shallow breathing, bronchoconstriction (mainly in patients with pre-existing conditions), difficulty breathing, fluid in the lungs (pulmonary oedema), cough, nasal congestion, asthma, worsening of asthma.
• Taste disturbances, dyspepsia, diarrhoea, dry mouth sensation, abdominal pain.
• Hair loss, rash with white-silvery lesions (psoriasiform) or worsening of psoriasis symptoms, skin rash.
• Joint pain, muscle pain not caused by physical exertion, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

Very rarely, in some patients with significantly damaged corneas (the transparent membrane covering the front part of the eyeball), corneal opacities due to calcium deposits occurred during treatment.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects may also be reported to the marketing authorisation holder or its representative.
Reporting adverse effects helps to 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 Xalacom after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Before opening, store the medicine in a refrigerator (2°C - 8°C). Protect from light.
After first opening the bottle, Xalacom can be stored for a period of 4 weeks at a temperature below 25°C.
After this time, the medicine must be discarded.
The bottle should be kept in the outer packaging to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What Xalacom contains

• The active substances are latanoprost and timolol. 1 ml of eye drops contains 0.05 mg of latanoprost and 5 mg of timolol (as timolol maleate).
• Other ingredients are: benzalkonium chloride, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate, sodium chloride, hydrochloric acid 10% (for pH adjustment to 6.0), sodium hydroxide 10% (for pH adjustment to 6.0), water for injections.

One drop of the solution contains approximately 1.5 micrograms of latanoprost and 150 micrograms of timolol.
What Xalacom looks like and contents of the pack
The pack contains one or three bottles, each containing 2.5 ml of Xalacom eye drop solution.
Xalacom is a clear, colourless solution.
Marketing Authorisation Holder:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland
Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium
For further information, contact the representative of the
Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00