Xalacom 50 micrograms/ml + 5 mg/ml eye drops solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Xalacom 50 micrograms/ml + 5 mg/ml eye drops solution
Latanoprost / Timolol
Read the entire leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet as 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 other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. (See section 4.)
Leaflet Contents
- What Xalacom is and what it is used for
- What you need to know before using Xalacom
- How to use Xalacom
- Possible side effects
- How to store Xalacom
Pack contents and additional 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 known as prostaglandin analogues. Timolol belongs to a group of medicines called 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 in the eye.
Xalacom is used to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Both conditions are associated with increased pressure within the eye, which may eventually damage vision. Your doctor will usually prescribe Xalacom when other medications have not worked adequately.
2. What you need to know before using Xalacom
Xalacom can be used in adults (including elderly patients), but its use is not recommended in individuals under 18 years of age.
Do not use Xalacom
- If you are allergic (hypersensitive) to any of the active substances 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 bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-lasting cough).
- If you have serious heart problems or disorders of heart rate.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Xalacom if you have or have 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 disturbances such as slow heartbeat.
- Breathing problems, asthma, or chronic obstructive pulmonary disease.
- Conditions characterized by poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
- Diabetes, as timolol may mask the signs and symptoms of low blood sugar levels.
- Overactive thyroid gland, as timolol may mask signs and symptoms.
- If you are scheduled to undergo eye surgery (including cataract surgery) or have previously undergone any type of eye surgery.
- Eye problems (such as eye pain, irritation, inflammation, or blurred vision).
- Dry eye syndrome.
- If you wear contact lenses. You may continue using Xalacom, but you must follow the instructions provided in section 3 for contact lens wearers.
- If you suffer from angina (particularly a type known as Prinzmetal's angina).
- If you experience severe allergic reactions that usually require hospital treatment.
- If you have had or currently have a viral eye infection caused by the herpes simplex virus (HSV).
Inform your doctor that you are using Xalacom before undergoing any surgical procedure, as timolol may alter the effects of certain medications used during anesthesia.
Use of Xalacom with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including eye drops and medicines obtained without a prescription.
Xalacom may affect or be affected by other medicines you are taking, including other eye drops for glaucoma treatment. Inform your doctor if you are using or plan to use medicines to lower blood pressure, heart medications, or medicines for diabetes.
In particular, consult your doctor or pharmacist if you are taking any of the following types of medicines:
- Prostaglandins, prostaglandin analogs, or prostaglandin derivatives.
- Beta-blockers.
- Epinephrine.
- Medicines used to treat high blood pressure such as calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides, or parasympathomimetics.
- Quinidine (used to treat heart conditions and certain types of malaria).
- Antidepressants such as fluoxetine and paroxetine.
Use of Xalacom with food and drink
Regular meals, food, and beverages do not affect when or how you should use Xalacom.
Pregnancy, breastfeeding, and fertility
Pregnancy
Do not use Xalacom if you are pregnant unless your doctor considers it necessary. Inform your doctor immediately if you are pregnant, think you might be pregnant, or are planning to become pregnant.
Breastfeeding
Do not use Xalacom while breastfeeding. Xalacom may pass into breast milk. Seek advice from your doctor before taking any medication during breastfeeding.
Fertility
Animal studies have not shown that latanoprost or timolol have any effect on male or female fertility.
Driving and use of machines
Blurred vision may occur for a short period after using Xalacom. If this happens, do not drive or operate tools or machinery until your vision returns to normal.
Xalacom contains benzalkonium chloride and phosphate buffer solution.
This medicine contains 0.2 mg/ml of benzalkonium chloride.
Benzalkonium chloride can be absorbed by soft contact lenses and may change the color of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eyes or corneal disorders (the transparent front part of the eye). If you experience unusual sensations, stinging, or eye pain after using this medicine, consult your doctor.
This medicine contains 6.3 mg/ml of phosphates, equivalent to 0.2 mg per drop.
If you have a severe injury to the transparent front part of the eye (the 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 cause a positive result in doping control tests.
3. How to use Xalacom
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults (including elderly people) is one drop in the affected eye or eyes once daily.
Do not use Xalacom more than once a day, as the effectiveness of treatment may decrease if administered more frequently.
Use Xalacom exactly as your doctor has instructed, until he or she tells you to stop.
Your doctor may want to carry out additional heart and circulatory tests if you are using Xalacom.
Contact lens wearers
If you use contact lenses, you must remove them before using Xalacom. After applying Xalacom, you must wait 15 minutes before reinserting your contact lenses.
Instructions for use
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If you use Xalacom with other eye drops
Wait at least 5 minutes between applying Xalacom and using other eye drops.
If you use more Xalacom than you should
If you have applied more eye drops than you should, you may feel mild eye irritation, and your eyes may become red and watery. This should resolve on its own, but if you are concerned, contact your doctor.
If you swallow Xalacom
In case of accidental ingestion of Xalacom, contact your doctor. If you swallow a large amount of Xalacom, you may feel unwell, have stomach pain, feel tired, hot, dizzy, and begin to sweat.
If you forget to use Xalacom
Continue with your next dose as usual. 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 adverse effects
Like all medicines, Xalacom can cause adverse effects, although not everyone experiences them.
You may continue using the eye drops as usual unless the adverse effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Xalacom without first talking to your doctor.
The known adverse effects associated with the use of Xalacom are listed below. The most important adverse effect is the possibility of a gradual and permanent change in eye colour. Xalacom may also cause serious changes in the way the heart functions. If you notice any changes in your heart rhythm or cardiac function, you should consult your doctor and inform them that you have been using Xalacom.
The following adverse effects may occur with Xalacom:
Very common (may affect 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 known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to experience this change than if your eyes are of a single colour (blue, grey, green or brown). The change in 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. The change in eye colour does not appear to be associated with any eye problems. The change in eye colour does not progress once treatment with Xalacom is discontinued.
Common (may affect up to 1 in 10 people):
- Eye irritation (burning sensation, gritty feeling in the eye, itching, stinging, and foreign body sensation in the eye) and eye pain.
Uncommon (may affect up to 1 in 100 people):
- Headache.
- Eye redness, eye infection (conjunctivitis), blurred vision, tearing, eyelid swelling, eye surface irritation or erosion, skin rash or itching (pruritus).
Other adverse effects
Like other eye medications, Xalacom (latanoprost and timolol) is absorbed into the bloodstream. The incidence of adverse effects after using eye drops is lower than when medicines are taken orally or injected.
Although not observed with Xalacom, the following adverse effects have been reported with one of the components of Xalacom (latanoprost and timolol) and therefore could potentially occur with the use of Xalacom. The adverse effects listed include reactions observed within the beta-blocker group (e.g., timolol) when used to treat eye conditions:
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Nausea, vomiting (uncommon).
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Development of a viral eye infection caused by the herpes simplex virus (HSV).
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Generalized allergic reactions including swelling under the skin that may occur in areas such as the face and limbs and may obstruct the airway causing difficulty in swallowing or breathing, urticaria or itchy rash, localized or generalized rash, itching, sudden and severe allergic reaction potentially leading to life-threatening anaphylaxis.
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Low blood glucose levels.
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Dizziness.
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Sleep disturbances (insomnia), depression, nightmares, memory loss, hallucinations.
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Fainting, stroke, insufficient blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (a muscle disorder), unusual sensations such as tingling and headache.
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Swelling at the back of the eye (macular edema), fluid-filled cyst in the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken appearance of the eyes (increased depth of the eyelid groove).
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Signs and symptoms of ocular irritation (e.g., burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels following filtration surgery, which may lead to 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 appear partially closed), double vision.
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Darkening of the skin around the eyes, changes in eyelashes and fine hair around the eyes (increased number, length, thickness, and darkening), 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.
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Ringing or buzzing in the ears (tinnitus).
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Angina, worsening of angina in patients who already have heart disease.
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Slow heart rate, chest pain, palpitations (awareness of heartbeat), edema (fluid accumulation), changes in heart rate or rhythm, congestive heart failure (heart disease with breathing difficulties and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
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Low blood pressure, poor blood circulation causing numbness and paleness in fingers and toes, cold hands and feet.
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Breathing difficulties, narrowing of the airways in the lungs (predominantly in patients with pre-existing respiratory disease), shortness of breath, cough, asthma, worsening of asthma.
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Altered taste, indigestion, diarrhea, dry mouth, abdominal pain.
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Hair loss, skin rash with a silvery appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
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Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.
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Sexual dysfunction, decreased libido.
In very rare cases, some patients with severe damage to the clear front part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits during treatment.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the outer packaging and on the label of the bottle following the initials CAD. The expiry date refers to the last day of the month indicated.
Store the unopened Xalacom bottle in the refrigerator (between 2ºC and 8ºC). After opening the bottle, refrigeration is not required, but do not store above 25ºC. Once opened, do not use the medicine after 4 weeks have passed. When not in use, keep the bottle in the outer carton to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, please consult your pharmacist on how to properly dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Xalacom
The active substances are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.
The other components are:
Sodium chloride
Benzalkonium chloride
Monohydrate monosodium dihydrogen phosphate (E339i)
Disodium phosphate (E339ii)
Hydrochloric acid solution (for adjustment to pH 6.0)
Sodium hydroxide solution (for adjustment to pH 6.0)
Water for injections
Presentation of the product and contents of the container
Each bottle contains 2.5 ml of Xalacom eye drops.
Xalacom is a clear, colourless liquid.
Xalacom is available in pack sizes of 1, 3 or 6 bottles. Some pack sizes may not 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, the Netherlands, Ireland, Italy, Luxembourg, Portugal and the United Kingdom (Northern Ireland).
Xalcom in Denmark, Finland, Iceland, Norway and Sweden.
Date of the most recent revision of this leaflet: 06/2022
Detailed and up-to-date 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/