50 micrograms/ml + 5 mg/ml eye drops, solution
latanoprost + timolol
What Xalcom is and what it is used for
Xalcom contains two medicines: latanoprost and timolol . Latanoprost belongs to the drug group prostaglandin analogs. Timolol belongs to the drug group beta blockers. Latanoprost increases the natural outflow of aqueous humor inside the eye into the blobloodstreamimolol reduces the formation of fluid inside the eye.
Xalcom is used to reduce the pressure in the eye if you have glaucoma or ocular hypertension ( glaucoma ). Both of these diseases cause increased pressure in the eye that can eventually affect vision. Usually, your doctor prescribes Xalcom when other medicines do not have a sufficient effect.
The latanoprost and timolol contained in Xalcom may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Xalcom
Do not use Xalcom
Xalcom can be used by adults (including the elderly) but is not recommended if you are under 18.
Do not use Xalcom
- if you are allergic (hypersensitive) to any of the medicines (latanoprost or timolol ), beta blockers or any of the other ingredients of Xalcom (listed in section 6).
- if you have or have previously had breathing problems such as asthma or severe chronic bronchitis (severe lung disease that may cause wheezing, difficulty breathing or prolonged coughing).
- if you have severe heart problems or heart arrhythmias .
Warnings and precautions
Talk to your doctor or pharmacist before using Xalcom if you have or have ever had:
- coronary heart disease (symptoms may include chest pain, chest pressure, shortness of breath or feeling of suffocation), heart failure , low blood pressure .
- heart rhythm disturbances such as slow heart rate.
- problems with breathing such as asthma or chronic obstructive pulmonary disease (COPD).
- disease with poor blood circulation (such as Reynaud’s disease or Reynaud’s syndrome).
- diabetes , as timolol can mask symptoms of low blood sugar.
- overactive thyroid gland as timolol may mask symptoms of disease.
- if you are going to undergo any type of eye surgery (including cataract surgery ) or if you have undergone any eye surgery in the past.
- if you suffer from eye problems (such as eye pain, eye irritation or inflammation or blurred vision).
- if you know you suffer from dry eyes.
- if you wear contact lenses. You can still use Xalcom, but follow the instructions for contact lens wearers in section 3.
- if you suffer from chest pain (especially Prinzmetal’s angina).
- if you suffer from more severe allergic reactions that usually require hospital treatment.
- if you have suffered or are suffering from a viral infection of the eye caused by the herpes simplex virus ( HSV ).
Before undergoing surgery, tell your doctor that you are using Xalcom because timolol can change the effects of drugs used for anaesthesia.
Other medicines and Xalcom
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including the use of eye drops and over-the-counter medicines.
Xalcom can affect or be affected by other medicines you use, including other eye drops for glaucoma . Tell your doctor if you use or intend to use medicines that lower blood pressure , heart medicines or medicines for diabetes .
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Prostaglandins , prostaglandin analogues or prostaglandin derivatives.
- Beta blockers .
- Adrenaline .
- Medicines that treat high blood pressure such as oral calcium antagonists, guanethidine; antiarrhythmics , digitalis glycosides or parasympathomimetics.
- Quinidine (used in heart disease and some types of malaria ).
- Medicines for depression that contain fluoxetine and paroxetine .
Xalcom with food, drink and alcohol
Normal meals, food and drink have no effect on how and when you should use Xalcom.
Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Xalcom if you are pregnant, unless your doctor considers it necessary. Consult a doctor immediately if you are pregnant, think you may be pregnant or plan to have a baby.
Breast-feeding
Do not use Xalcom if you are breastfeeding, Xalcom can pass into breast milk. Consult a doctor before using this medicine while breastfeeding.
Fertility
Latanoprost and timolol have not been shown to have any effect on male or female fertility in animal studies.
Driving ability and use of machinery
When using Xalcom, your vision may become cloudy for a short time. If this happens to you, do not drive or use tools or machines until your vision is clear again.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Xalcom contains benzalkonium chloride and phosphate buffer
This medicine contains 0.2 mg of benzalkonium chloride per ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before putting them back in.
Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you feel irritation, tingling or pain in the eye after using the medicine, consult a doctor.
This medicine contains 6.3 mg of phosphate per ml, corresponding to 0.2 mg per drop.
If you have a severely damaged cornea , phosphate can in very rare cases cause cloudy spots on the cornea due to the accumulation of calcium during treatment.
How to use Xalcom
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Recommended dosage for adults (including the elderly) is one drop daily in the affected eye(s).
Do not use Xalcom more than once a day, as the effect of the treatment may be reduced if you dose more often.
Use Xalcom as directed by your doctor and until your doctor tells you to stop treatment.
Your doctor may want to do extra checks on your heart and circulation during treatment with Xalcom.
For those who wear contact lenses
If you wear contact lenses, they should be removed before dosing with Xalcom. After taking Xalcom, you should wait 15 minutes before putting contact lenses in your eyes.
Instructions for use
If you use Xalcom and other eye drops
Wait at least 5 minutes between dosing one with Xalcom and another eye drop treatment.
If you have used too much Xalcom
If you have used too many drops in the eye, you may experience slight irritation in the eye and the eyes may start to run and become red. The reaction should be transient but if you are concerned, contact your doctor for advice.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you swallow Xalcom
If you accidentally swallow Xalcom, contact a doctor for advice. If you swallow large amounts of Xalcom, you may feel nauseous, have stomach pains, feel tired, flushed and dizzy, and begin to sweat.
If you have forgotten to use Xalcom
Continue with your usual dosage at the usual time. Do not use a double dose to make up for a forgotten dose . If you are unsure about something, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
You can usually continue to use the drops, unless the side effects are severe. If you are worried, talk to your doctor or pharmacist. Do not stop using Xalcom without talking to your doctor.
Below is a list of known side effects of treatment with Xalcom. The most important side effect is the risk of a gradual and permanent change in your eye color. It is also possible that Xalcom can cause serious effects on your heart function. If you notice a change in heart rhythm or heart function, contact a doctor and tell them that you have been using Xalcom.
The following are known side effects of treatment with Xalcom:
Very common (may affect more than 1 in 10 users):
- A gradual change in eye color through an increasing amount of brown pigment in the colored part of the eye called the iris . If you have a mixed eye color (blue-brown, gray-brown, yellow-brown, or green-brown), the color change is more likely to occur than if you have solid eyes (blue, gray, green, or brown eyes). The change in eye color can take several years to develop. The color change may be permanent and may be more obvious if you use Xalcom in only one eye. No eye problems have been detected due to the color change. The change in eye color does not continue after treatment with Xalcom is stopped.
Common (may affect up to 1 in 10 users):
- Eye irritation (a feeling of burning, grittiness, itching, stinging or sensation of debris in the eye) or eye pain.
Uncommon (may affect up to 1 in 100 users):
- Headache.
- Red eye, eye infection ( conjunctivitis ), blurred vision, watery eyes, inflammation of the eyelids, irritation or changes on the surface of the eye.
- Skin rash or itching ( pruritus ).
Other side effect ar
Like other medicines used in the eyes, Xalcom (latanoprost and timolol ) is absorbed into the blood. The frequency of side effects after using eye drops is lower than if, for example, the medicine is taken orally or by injection .
Even if the side effects below have not been seen in connection with treatment with Xalcom, they can occur with the drugs included in Xalcom (latanoprost and timolol ) and thus they can occur in connection with treatment with Xalcom. The side effects listed below are reactions seen with the beta-blocker class of drugs ( eg, timolol ) when used to treat eye diseases:
- Nausea, vomiting (uncommon).
- Development of viral infection of the eye caused by herpes simplex virus ( HSV ).
- Allergic reactions affecting the whole body with swelling under the skin that can appear on the face, arms and legs, and can lead to difficulty swallowing or breathing, hives or itchy skin rash, local and widespread rash, itching , sudden severe life-threatening allergic reaction .
- Low blood sugar.
- Dizziness.
- Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
- Fainting, stroke , reduced blood supply to the brain, worsening signs and symptoms of myasthenia gravis (muscle disease), abnormal sensations (tingling or crawling in the skin) and headache.
- Swelling of the back of the eye (macular oedema), fluid-filled cyst within the colored part of the eye (iris cyst), sensitivity to light ( photophobia ), sunken eyes (deepening of the furrow).
- Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, red eyes), eyelid inflammation, corneal inflammation , blurred vision and detachment after filtration surgery of the blood vessel-containing membrane under the retina which can cause visual disturbances, reduced sensitivity of the cornea, dry eyes, damage to the cornea (damage to the outer layer of the eye), drooping upper eyelid (which causes the eye to be half-closed all the time), double vision.
- Darkening of the skin around the eyes, changes in the eyelashes and fine hairs around the eye (increased number, length and thickness and darker colour), changes in the direction of the eyelash hairs, swelling around the eye, swelling of the colored part of the eye (iritis/uveitis), scarring on the surface of the eye.
- Whistling/ringing sounds in the ears ( tinnitus ).
- Angina, worsening of angina in patients who already have heart problems.
- Slow heartbeat, chest pain, palpitations (which you feel), edema (fluid build-up), changes in pulse or heart rhythm, chronic heart failure (heart disease with shortness of breath, swollen feet and legs due to fluid build-up), a type of heart rhythm disorder, heart attack, heart failure .
- Low blood pressure , poor blood circulation that makes fingers and toes numb and pale, cold hands and feet.
- Shortness of breath, narrowing of the airways in the lungs (mainly in patients with pre-existing disease), difficulty breathing, cough, asthma , aggravated asthma .
- Taste changes, indigestion, diarrhoea, dry mouth , abdominal pain.
- Hair loss, rash with a white to silvery appearance (psoriasis-like rash) or worsening psoriasis , skin rash.
- Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.
- Impaired sexual function, decreased sex drive.
In very rare cases, some patients with severe damage to the thin, clear membrane of the front part of the eye (cornea) have developed cloudy spots on the cornea due to calcium build -up during treatment with phosphate-containing eye drops .
How Xalcom should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and bottle after EXP. The expiration date is the last day of the specified month.
Store unopened bottle in refrigerator (2 o C-8 o C). Once the bottle has been opened, it is not necessary to store it in a refrigerator, but it must be stored at a maximum of 25 o C.
Opened bottle must be used within 4 weeks. When not using Xalcom, store the bottle in the outer carton. Light sensitive.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substances are latanoprost 50 micrograms/ml and timolol 5 mg/ml as timolol maleate.
Other ingredients are:
sodium chloride
benzalkonium chloride
sodium dihydrogen phosphate monohydrate (E339i)
disodium phosphate (E339ii)
hydrochloric acid (for adjustment to pH 6.0)
sodium hydroxide (for adjustment to pH 6.0)
Xalcom appearance and packaging sizes
Each bottle contains 2.5 ml of Xalcom eye drops .
Xalcom is a clear and colorless liquid.
Xalcom is available in pack sizes of 1, 3 and 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands
Local representative
Viatris AB
Box 23033
104 35 Stockholm
Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs, Belgium