XALACOM 50 micrograms/ml + 5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

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

Latanoprost / Timolol

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).

Contents of the pack and other information

1. What is Xalacom and what is it used for
2. What you need to know before you use Xalacom
3. How to use Xalacom
4. Possible side effects
5. Storage of Xalacom

Contents of the pack and further information

1. What is Xalacom and what is it used for

Xalacom contains two active substances: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines called beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by reducing the production of fluid in the eye.

Xalacom is used to reduce the pressure in the eye in cases of conditions such as open-angle glaucoma or ocular hypertension. Both of these conditions are linked to an increase in pressure within the eye, which can lead to problems with your sight. Your doctor will normally prescribe Xalacom when other medicines have not worked well enough.

2. What you need to know before you use Xalacom

Xalacom can be used in adults (including the elderly) but it is not recommended for use in children under 18 years of age.

Do not use Xalacom

• If you are allergic (hypersensitive) to any of the active substances of Xalacom (latanoprost or timolol), to beta-blockers or to any of the other ingredients of Xalacom (listed in section 6).
• If you have or have had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that may cause wheezing, difficulty breathing and/or coughing over a long period).
• If you have or have had severe heart problems or heart rhythm disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Xalacom if you have or have had:

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or difficulty breathing), heart failure, low blood pressure.
• Abnormal heart rhythms such as a slow heart beat.
• Breathing problems, asthma or chronic obstructive pulmonary disease.
• Diseases characterised by poor circulation of blood (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timolol may mask signs and symptoms of low blood sugar levels.
• Overactive thyroid gland, as timolol may mask signs and symptoms.
• If you are going to have eye surgery (including cataract surgery) or have had any type of eye surgery.
• If you have eye problems (such as pain, irritation or inflammation in the eye or blurred vision).
• If you have dry eye.
• If you use contact lenses. You can continue to use Xalacom but you should follow the instructions in section 3 for contact lens wearers.
• If you have angina (in particular a type known as Prinzmetal's angina).
• If you have severe allergic reactions that usually require hospital treatment.
• If you have had a viral infection in the eye caused by the herpes simplex virus (HSV).

Tell your doctor that you are using Xalacom before you have an operation, as timolol may affect the way some medicines used during anaesthesia work.

Using Xalacom with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including eye drops and medicines obtained without a prescription.

Xalacom may 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 plan to use medicines to lower blood pressure, heart medicines or medicines to treat diabetes.

In particular, consult your doctor or pharmacist if you are taking any of the following types of medicines:

• Prostaglandins, prostaglandin analogues or prostaglandin derivatives.
• Beta-blockers.
• Adrenaline.
• Medicines used to treat high blood pressure such as calcium channel blockers, guanethidine, anti-arrhythmics, digitalis glycosides or parasympathomimetics.
• Quinidine (used to treat heart conditions and certain types of malaria).
• Antidepressants such as fluoxetine and paroxetine.

Using Xalacom with food and drink

Normal meals, food and drink have no effect on when or how you should use Xalacom.

Pregnancy, breast-feeding and fertility

Pregnancy

Do not use Xalacom if you are pregnant unless your doctor considers it necessary. Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant.

Breast-feeding

Do not use Xalacom if you are breast-feeding. Xalacom may pass into breast milk. Ask your doctor for advice before taking any medicine during breast-feeding.

Fertility

In animal studies, latanoprost and timolol have not been found to have any effect on male or female fertility.

Driving and using machines

When using Xalacom, you may experience blurred vision for a short time. If this happens, do not drive or use tools or machines until your vision is clear again.

Xalacom contains benzalkonium chloride and phosphate buffer solution.

This medicine contains 0.2 mg/ml of benzalkonium chloride.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before putting them back in.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the transparent layer on the front of the eye). If you have an unusual feeling in your eyes, itching or pain in the eyes after using this medicine, consult your doctor.

This medicine contains 6.3 mg/ml of phosphates, which is equivalent to 0.2 mg per drop.

If you have severe damage to the transparent layer on the front of the eye (cornea), phosphates may, in very rare cases, cause cloudy areas in the cornea due to calcium deposits during treatment.

Use in athletes

This medicine contains timolol, which may produce a positive result in doping tests.

3. How to use Xalacom

Follow exactly the instructions given to you by your doctor or pharmacist for using this medicine. If you are not sure, ask your doctor or pharmacist again.

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

Do not use Xalacom more than once a day, as the effectiveness of the treatment may decrease if it is used more frequently.

Use Xalacom as your doctor has told you until they tell you to stop.

Your doctor may want to perform additional heart and circulatory tests if you are using Xalacom.

For contact lens wearers

If you use contact lenses, you should remove them before using Xalacom. After applying Xalacom, wait 15 minutes before putting your contact lenses back in.

Instructions for use

If you are using Xalacom with other eye drops

Wait at least 5 minutes between using Xalacom and any other eye drops.

If you use more Xalacom than you should

If you have put too many drops in your eye, you may feel a slight irritation in the eye and your eyes may water. This should go away on its own, but if you are worried, contact your doctor.

If you swallow Xalacom

If you accidentally swallow Xalacom, contact your doctor. If you swallow a large amount of Xalacom, you may feel unwell, have stomach pain, feel tired, feel hot, dizzy and start to sweat.

If you forget to use Xalacom

Carry on with the next dose as normal. Do not use a double dose to make up for the forgotten dose. If you are unsure, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xalacom can cause side effects, although not everybody gets them.

You can usually carry on using the eye drops as normal, unless the side effects are serious. If you are worried, talk to your doctor or pharmacist. Do not stop using Xalacom without talking to your doctor.

The following are known side effects of using Xalacom. The most important side effect is the possibility of a gradual, permanent change in the colour of your eyes. It is also possible that Xalacom may cause serious changes in the way your heart works. If you notice any change in your heart beat or heart function, you should talk to your doctor and tell them you have been using Xalacom.

The following side effects may occur with Xalacom:

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

• A gradual change in the colour of your eyes, due to an increase in the amount of brown pigment in the coloured part of your eye, known as the iris. If you have mixed-colour eyes (e.g. blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to get this change than if your eyes are single-coloured (e.g. blue, grey, green or brown). The change in eye colour may take months to years to develop. The colour change may be permanent and may be more noticeable if you use Xalacom in one eye only. The change in eye colour does not seem to be linked to any problems. The change in eye colour does not progress once Xalacom treatment is stopped.

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

• Irritation of the eye (feeling of stinging, feeling of grit in the eye, itching, burning and sensation of foreign body in the eye) and eye pain.

Uncommon (may affect up to 1 in 100 people):

• Headache.
• Redness of the eyes, eye infection (conjunctivitis), blurred vision, watery eyes, inflammation of the eyelids, irritation or erosion of the surface of the eye.
• Rash or itching of the skin (pruritus).

Other side effects

As with other eye medicines, Xalacom (latanoprost and timolol) is absorbed into the bloodstream. The incidence of side effects after using eye drops is lower than when medicines are taken by mouth or injected.

Although not seen with Xalacom, the following side effects have been seen with one of the ingredients of Xalacom (latanoprost and timolol) and may potentially occur with this medicine. These side effects include reactions seen with the group of beta-blockers (e.g. timolol) when used for eye conditions:

• Nausea, vomiting (uncommon).
• Development of a viral infection of the eye caused by the herpes simplex virus (HSV).

• Generalised allergic reactions including swelling under the skin which can occur in areas such as the face and limbs and can obstruct the airway, causing difficulty in swallowing or breathing, hives or itchy rash, localised or generalised rash, itching, sudden, severe and potentially life-threatening allergic reaction.

• Low blood sugar levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, loss of memory, hallucinations.
• Fainting, stroke, inadequate blood supply to the brain, worsening of symptoms of myasthenia gravis (muscle disorder), unusual sensation like pins and needles and headache.
• Swelling of the back of the eye (macular oedema), fluid-filled cyst in the coloured part of the eye (iris cyst), sensitivity to light (photophobia), appearance of sunken eyes (increased depth of the eyelid sulcus).
• Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, feeling of foreign body in the eye), inflammation of the eyelids, inflammation of the cornea, blurred vision and detachment of the layer underneath the retina after filtration surgery which can cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the outer layer of the eyeball), drooping of the upper eyelid (making the eye half closed), double vision.
• Darkening of the skin around the eyes, changes in the eyelashes and fine hair around the eye (increased number, length, thickness and darkening), changes in the direction of growth of the eyelashes, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitis), scarring of the surface of the eye.
• Ringing or buzzing in the ears (tinnitus).

• Angina, worsening of angina in patients who already have heart disease.

• Slow heart rate, chest pain, palpitations (feeling your heartbeat), swelling (build-up of fluid), changes in heart rate or rhythm, congestive heart failure (heart disease with difficulty breathing and swelling of feet and legs due to fluid build-up), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, poor circulation of blood which can cause fingers and toes to be pale, cool and painful, cold hands and feet.

• Breathing difficulties, narrowing of the airways in the lungs (mainly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Abnormal taste, indigestion, diarrhoea, dry mouth, abdominal pain.
• Hair loss, skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin rash.

• Pain in the joints, muscle pain not caused by exercise, muscle weakness, tiredness.
• Sexual dysfunction, decreased libido.

In very rare cases, some patients with severe damage to the transparent layer on the front of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits 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 Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xalacom

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the bottle after the letters EXP. The expiry date refers to the last day of that month.

Store the unopened bottle of Xalacom in a refrigerator (between 2°C and 8°C). Once the bottle is opened, it is not necessary to store it in the refrigerator, but do not store it above 25°C. Once the bottle is opened, do not use it for more than 4 weeks. When you are not using Xalacom, keep the bottle in the outer carton to protect it from light.

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. Container Content and Additional Information

Xalacom Composition

The active ingredients are latanoprost 50 micrograms/ml and timolol (in the form of timolol maleate) 5 mg/ml.

The other components are:

Sodium chloride

Benzalkonium chloride

Sodium dihydrogen 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 injectable preparations

Product Appearance and Container Content

Each bottle contains 2.5 ml of Xalacom eye drops.

Xalacom is a clear and colorless liquid.

Xalacom is available in pack sizes of 1, 3, or 6 bottles. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12, 2870 Puurs-Sint-Amands

Belgium.

Local Representative

Viatris Pharmaceuticals, S.L.U.

Calle General Aranaz, 86

28027 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Xalacom in Germany, Austria, Belgium, Spain, France, Greece, Netherlands, Ireland, Italy, Luxembourg, Portugal, and the United Kingdom (Northern Ireland).

Xalcom in Denmark, Finland, Iceland, Norway, and Sweden.

Date of the last revision of this leaflet: 06/2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/