50 micrograms/ml + 5 mg/ml eye drops, solution
latanoprost/timolol
What Xatabloc is and what it is used for
Xatabloc 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 bloodstream. Timolol reduces the formation of fluid inside the eye.
Xatabloc 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 Xatabloc when other medicines do not have a sufficient effect.
The latanoprost and timolol contained in Xatabloc 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 you use Xatabloc
Xatabloc can be used by adult men and women (including the elderly) but is not recommended if you are under 18 years of age.
Do not use Xatabloc
- if you are allergic (hypersensitive) to latanoprost, timolol, or any of the other ingredients of this medicine (listed in section 6)
- if you have or have previously had problems with breathing such as asthma or severe chronic bronchitis (severe lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing)
- if you have severe heart problems or heart arrhythmias
Warnings and precautions
Talk to your doctor or pharmacist before using Xatabloc if you have or have had in the past:
- coronary heart disease (symptoms may include chest pain, chest pressure, shortness of breath, or feeling of suffocation), heart failure, low blood pressure ( hypotension )
- heart rhythm disturbances such as slow heart rate ( bradycardia )
- breathing problems such as asthma or chronic obstructive pulmonary disease (COPD)
- disease with poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
- diabetes, as timolol can mask symptoms of low blood sugar
- overactive thyroid gland as timolol may mask symptoms of the disease
- if you are going to undergo any type of eye surgery (including cataract surgery ) or if you have had any eye surgery in the past.
- if you suffer from eye problems (such as eye pain, eye irritation, eye inflammation, or blurred vision).
- if you know you suffer from dry eyes.
- if you wear contact lenses. You can still use Xatabloc, 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 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 )
Tell your doctor that you are using Xatabloc before you have an operation because timolol can change the effects of medicines used for anesthesia.
Other medicines and Xatabloc
Xatabloc can affect or be affected by other medicines you use, including other glaucoma eye drops. Tell your doctor if you use or intend to use medicines that lower blood pressure, heart medicines, or medicines for diabetes.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Prostaglandins, prostaglandin analogs, or prostaglandin derivatives
- Beta-blockers
- Adrenaline
- Medicines used to treat high blood pressure such as calcium antagonists, guanethidine
- Antiarrhythmics (drugs that normalize heart rhythm)
- Digitalis glycosides (used to treat heart failure )
- Parasympathomimetics (eg for the treatment of high blood pressure )
- Quinidine (used in heart disease and some types of malaria )
- Medicines for depression contain fluoxetine and paroxetine.
Xatabloc with food, drink, and alcohol
Normal meals, food, and drink do not affect how and when you should use Xatabloc.
Pregnancy, breastfeeding, and fertility
Pregnancy
Do not use Xatabloc 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 Xatabloc if you are breastfeeding. Xatabloc can pass into breast milk. Ask your doctor for advice before taking any 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 Xatabloc, 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 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. A 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.
Xatabloc 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 irritate 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. 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 Xatabloc
Always use Xatabloc as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Dosage
The recommended dosage for adults (including the elderly) is one drop daily in the affected eye(s).
Do not use Xatabloc more than once a day, as the effect of the treatment may be reduced if you dose it more often.
Use Xatabloc as directed by your doctor until your doctor tells you to stop treatment.
Your doctor may want to do extra checks on your heart and circulation during treatment with Xatabloc.
For those who wear contact lenses
If you wear contact lenses, remove them before administering Xatabloc. Then wait at least 15 minutes before putting them back in.
Instructions for use
Always wash your hands before using eye drops.
Apply the eye drops as follows:
- Remove the protective cover.
- Tilt your head back and look up at the ceiling.
- Gently pull down the lower eyelid until a small pocket is formed, as shown in image 1. Picture 1
- Press the upside-down dropper bottle so that a drop enters the eye.
- While closing the affected eye, press a finger against the corner of the closed eye (on the side where the eye meets the nose) as shown in picture 2, and hold for 2 minutes. This helps prevent Xatabloc from reaching the rest of your body. Picture 2
Avoid contact of the dropper tip with the eye or anything else. Replace and screw on the cap immediately after use.
If you use Xatabloc with other eye drops
Wait at least 5 minutes after using Xatabloc before using other eye drops.
If you have used too much Xatabloc
If you have taken too many drops in the eye, you may experience slight eye irritation 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, 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 Xatabloc
If you swallow large amounts of Xatabloc, you may feel nauseous, have stomach pains, feel tired, feel flushed and dizzy and begin to sweat. If you accidentally swallow Xatabloc, contact your doctor for advice.
If you forget to use Xatabloc
Continue with your usual dosage at the usual time. Do not take a double dose to make up for a missed dose. If you are unsure about something, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Xatabloc eye drops can cause side effects, although not everybody needs 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 Xatabloc without talking to your doctor.
Below is a list of known side effects from treatment with Xatabloc. The most important side effect is the risk of a gradual and permanent change in your eye color. It is also possible that Xatabloc 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 used Xatabloc.
The following are known side effects of treatment with Xatabloc:
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). It may take several years for the change in eye color to develop. The color change may be permanent and may be more obvious if you use Xatabloc in only one eye. No eye problems have been demonstrated in connection with the color change. The change in eye color does not continue after treatment with Xatabloc 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 to the surface of the eye
- Skin rash or itching ( pruritus ).
Other side effects are
Like other medicines used in the eyes, Xatabloc (latanoprost and timolol ) is absorbed into the blood. This can cause side effects similar to those seen with systemic beta-blockers. 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 Xatabloc, they can occur with the drugs included in Xatabloc (latanoprost and timolol ), and thus they can occur in connection with treatment with Xatabloc.
The side effects listed below are reactions seen with the drug class beta blockers (eg timolol ) when they are used to treat eye diseases.
- 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 block the airways and make it difficult to swallow and breathe ( angioedema ), hives or itchy rash, localized and widespread rashes, itching, sudden severe life-threatening allergic reaction ( anaphylactic reaction ).
- Low blood sugar level.
- 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), dizziness, abnormal sensations (tingling or crawling in the skin), and headache.
- Swelling of the back of the eye (macular edema), 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 of the blood vessel-containing membrane that lies beneath the retina after filtration surgery which may cause visual impairment, reduced corneal sensitivity, dry eyes, damage to the cornea (damage to the outer layer of the eye), droopy 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 color), 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, congestive heart failure (heart disease with shortness of breath and 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, and cold hands and feet (Raynaud’s phenomenon).
- Narrowing of the airways in the lungs (mainly in people with the existing disease), breathing difficulties, cough, asthma, aggravated asthma.
- Taste changes, nausea, indigestion, diarrhea, dry mouth, abdominal pain, and vomiting.
- 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 clear membrane at the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium build-up during treatment.
How to store Xatabloc
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and the carton after “Exp. date:”. The expiration date is the last day of the specified month.
Store the unopened bottle in a refrigerator (2 °C – 8 °C). After opening the bottle, it is not necessary to refrigerate the bottle, but it should not be stored above 25 °C. Do not use the bottle for more than 4 weeks after the first opening.
Store the bottle in the outer carton. Light sensitive.
Medicines must not be thrown into the drain or among the 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 and timolol maleate. 1 ml of solution contains 50 micrograms of latanoprost and 6.8 mg of timolol maleate corresponding to 5 mg of timolol.
- Other ingredients are Sodium chloride benzalkonium chloride sodium dihydrogen phosphate monohydrateAnhydrous disodium phosphateHydrochloric acid sodium hydroxide water for injections.
See section 2 “Xatabloc contains benzalkonium chloride and phosphate buffer” for further information.
Appearance and package sizes of the medicine
Xatabloc is a clear, colorless solution in a polyethylene (LDPE) bottle with a dropper applicator, PP screw cap, and safety-sealed LDPE cover.
Package sizes:
1 bottle × 2.5 ml
3 vials × 2.5 ml
6 vials × 2.5 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Blumont Ofta Trading Ltd
103 Stuart Street
Gzira GZR1054,
Malta
Manufacturer
Tubilux Pharma SpA
Via Costarica 20/22
00071 Pomezia (Rome)
Italy
This medicine is approved in the European Economic Area under the names:
UK
Latanoprost+Timolol 50 micrograms/ml + 5 mg/ml eye drops, solution