Xalacom 50 micrograms / ml + 5 mg / ml eye drops solution – patient leaflet, side effects, dosage

What Xalacom is and what it is used for

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 are pregnant or are planning to become pregnant.

Breast-feeding

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

Fertility

Latanoprost and timolol have been found to have no effect on male or female fertility in animal studies.

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.

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 and phosphate buffers

This medicine contains 0.2 mg benzalkonium chloride in each millilitre.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor. This medicine contains 6.3 mg phosphates in each millilitre which is equivalent to 0.2 mg per drop. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

What you need to know before you use Xalacom

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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 long-standing cough)

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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.

• if you have serious heart problems or heart rhythm disorders

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

Warnings and precautions

Do not use Xalacom more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.

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

  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.

• disturbances of heart rate such as slow heart beat

• breathing problems, asthma or chronic obstructive pulmonary disease

  Contact lens wearers

• poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)

  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.

• diabetes as timolol may mask signs and symptoms of low blood sugar

• overactivity of the thyroid gland as timolol may mask signs and symptoms

  Instructions for use

• you are about to have any kind of eye surgery (including cataract surgery) or have had any kind of eye surgery in the past

  1. 1. Wash your hands and sit or stand comfortably.
  2. 2. Twist off the outer cap (which can

• you suffer from eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)

  be thrown away).

• 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)

  Figure 1

  1. 3.

     Unscrew the protective inner cap.

     The protective cap should be

     retained.

• 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)

  Figure 2

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

1. 4.

   Use your finger to gently

   pull down the lower eyelid

   of your affected eye.

2. 5. Place the tip of the bottle

Other medicines and Xalacom

close to, but not touching

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.

your eye.

1. 6.

   Squeeze the bottle gently

   so that only one drop goes

   into your eye, then release

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.

the lower eyelid.

1. 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

In particular, speak to your doctor or pharmacist if you know that you are taking any of the following types of medicine:

latanoprost + timolol

getting into the rest of the

body.

Figure 4

1. 8. Repeat in your other eye if your doctor has told you to do this.
2. 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 use a double dose to make up to the dose you have forgotten. If you are unsure about anything talk to your doctor or pharmacist.

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Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them. You can usually carry on using 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.

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.

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 green-brown) 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.

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

Like other medicines used in the eyes, Xalacom (latanoprost and timolol) is absorbed into the blood. The incidence of side effects after using eye drops is lower than when medicines are, for example, taken by mouth or injected.

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 listed side effects include reactions seen within the class of beta-blockers (e.g. timolol) when used for treating eye conditions:

• Nausea, vomiting (uncommon).
• Developing a viral infection of the eye caused by the herpes simplex virus (HSV).
• 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.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations like pins and needles, and headache.
• Swelling at the back of the eye (macular oedema), fluid filled cyst within the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance (deepening of the eye sulcus).
• 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.

• Darkening of the skin around the eyes, 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/uveitis), scarring of the surface of the eye.

  • Whistling/ringing in the ears (tinnitus).
  • Angina, worsening of angina in patients who already have heart disease.
  • Slow heart rate, chest pain, palpitations (awareness of heart rhythm), 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, poor blood circulation which makes the fingers and toes numb and pale, cold hands and feet.
  • Shortness of breath, constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
  • Taste disturbances, indigestion, diarrhoea, dry mouth, abdominal pain.
  • Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
  • Joint pain, muscle pain not caused by exercise, muscle weakness, tiredness.
  • Sexual dysfunction, decreased libido.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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How to store Xalacom

• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Store in a refrigerator.
• After opening the bottle store it at room temperature (do not store above 25°C)
• Keep container in outer carton in order to protect from light. Use within 4 weeks of opening.
• Do not use this medicine after the expiry date shown on the carton or bottle label. The expiry date refers to the last day of that month.
• If your eye drops become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
• Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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Contents of the pack and other information

What Xalacom contains

Xalacom contains 50 micrograms/ml latanoprost and 5mg/ml timolol (as maleate).

Other ingredients are sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate monohydrate (E339i),

disodium phosphate anhydrous (E339ii), hydrochloric acid solution (for adjustment to pH 6.0), sodium hydroxide solution (for adjustment to pH 6.0) and water for injections.

What Xalacom looks like and contents of the pack

Xalacom is a clear colourless solution. Each bottle contains 2.5ml of solution.

Manufacturer and Licence Holder

Manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs Belgium, and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire. B98 0RE

Ref: 1646/080426/1/B POM

PL 15184/1646 Xalacom 50 micrograms/ml + 5mg/ml Eye Drops, Solution

Xalacom is a registered trademark of Viatris Specialty LLC.

Leaflet revision date: 08/04/2026

Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet in a format suitable for you