ALDUOVIZ 40 MCG/ML + 5 MG/ML Krople do oczu, roztwór

Treść ulotki

1. ALDUOVIZ 40 micrograms/ml + 5 mg/ml eye drops, solution
   1. What is ALDUOVIZ and what is it used for
   2. What you need to know before using ALDUOVIZ
   3. How to use ALDUOVIZ
   4. Possible side effects
   5. Contents of the pack and other information
2. ALDUOVIZ 40 micrograms/ml + 5 mg/ml eye drops, solution
   1. What is ALDUOVIZ and what is it used for
   2. What you need to know before using ALDUOVIZ
   3. How to use ALDUOVIZ
   4. Possible side effects
   5. How to store ALDUOVIZ
   6. Contents of the pack and other information

ALDUOVIZ 40 micrograms/ml + 5 mg/ml eye drops, solution

travoprost/timolol
Generic medicine

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What ALDUOVIZ is and what it is used for
• 2. What you need to know before you use ALDUOVIZ
• 3. How to use ALDUOVIZ
• 4. Possible side effects
• 5. How to store ALDUOVIZ
• 6. Contents of the pack and other information

1. What is ALDUOVIZ and what is it used for

ALDUOVIZ eye drops solution is a combination of two active substances (travoprost and timolol).
Travoprost is a prostaglandin analogue whose mechanism of action consists of increasing the outflow
of fluid from the eye, reducing its pressure. Timolol is a beta-blocker whose mechanism of action
consists of reducing the production of fluid inside the eye. The two active substances act
simultaneously in order to reduce the pressure inside the eye.
ALDUOVIZ eye drops are used for the treatment of elevated intraocular pressure in adults,
including the elderly. Such pressure levels can lead to a condition called glaucoma.

2. What you need to know before using ALDUOVIZ

Do not use ALDUOVIZ

• if you are allergic to travoprost, to prostaglandins, to timolol, to beta-blockers or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have had in the past problems with your airways such as asthma, severe chronic obstructive bronchitis (a severe lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough) or other types of respiratory problems.
• in case of severe hay fever.
• in case of slowed heartbeats, heart failure or a heart rhythm disorder (irregular heartbeat).
• in case of clouding of the transparent surface of the eye. Ask your doctor if you are subject to any of these conditions.

Warnings and precautions
Consult your doctor before using ALDUOVIZ if you suffer from or have suffered in the past from

• coronary artery disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure.
• changes in heart rate such as slow heartbeat.
• breathing problems, asthma or chronic obstructive pulmonary disease.
• disease with poor circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes (because timolol may mask the signs and symptoms of low blood sugar).
• hyperactivity of the thyroid gland (because timolol can mask signs and symptoms of a thyroid disease).
• myasthenia gravis (chronic muscle weakness).
• cataract surgery.
• eye inflammation.

If you need to undergo any type of surgery, inform your doctor that you are using
ALDUOVIZ because timolol may alter the effects of some medicines used during anesthesia.
If you should experience any serious allergic reaction (skin rash, redness and itching
of the eye) during the use of ALDUOVIZ, regardless of the cause, treatment with adrenaline
may not be sufficiently effective. Therefore, if you are undergoing any other
treatment, tell your doctor that you are using ALDUOVIZ.
ALDUOVIZ may change the color of your iris (the colored part of the eye). This change
may be permanent.
ALDUOVIZ may increase the length, thickness, color and/or number of your eyelashes and may cause
an unusual growth of hairs on your eyelids.
Travoprost may be absorbed through the skin, so it should not be used by pregnant
women or those planning to become pregnant. If any medicine comes into contact with the skin, wash
immediately.
Children
ALDUOVIZ should not be used in children and adolescents under the age of 18 years.
Other medicines and ALDUOVIZ
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines.
ALDUOVIZ may interact with other medicines you are taking, including other eye drops for the treatment
of glaucoma. Tell your doctor if you are taking or intend to use medicines to lower blood
pressure, heart medications including quinidine (used to treat heart problems and some types of
malaria), or medicines for the treatment of diabetes or the antidepressants fluoxetine or paroxetine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before taking this medicine.
Do not use ALDUOVIZ during pregnancy unless your doctor considers it necessary. If there is
a possibility of becoming pregnant, you should use adequate contraception while using this medicine.
Do not use ALDUOVIZ while breastfeeding. ALDUOVIZ may be excreted in breast milk.
Driving and operating machinery
You may experience blurred vision for a certain period after using ALDUOVIZ. Do not drive or use
machinery until these symptoms have disappeared. ALDUOVIZ may also cause hallucinations, dizziness,
nervousness or fatigue in some patients.
Do not drive or use machinery until these types of symptoms have subsided.
For those who engage in sports: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.
ALDUOVIZ contains hydrogenated castor oil which may cause irritation and skin reactions.
ALDUOVIZ contains 0.15 mg/ml of benzalkonium chloride.
Benzalkonium chloride is a preservative that can be absorbed by soft contact lenses and can lead
to a change in their color.
Remove your contact lenses before using this medicine and wait at least 15 minutes before reinserting them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.

3. How to use ALDUOVIZ

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop in the affected eye(s) once a day, in the morning or evening.
Take the dose every day at the same time.
Use ALDUOVIZ in both eyes only as prescribed by your doctor.
ALDUOVIZ can only be used as an eye drop.

• Immediately before using the bottle for the first time, write the date of opening the bottle in the appropriate space on the label.
• Make sure you have a mirror available.
• Wash your hands.
• Unscrew the cap of the bottle.
• Hold the bottle in your hand, between your thumb and other fingers, with the bottle pointing downwards.
• Tilt your head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop should be inserted there (figure 1).
• Hold the tip of the bottle close to the eye. Using the mirror may be helpful.
• Do not touch the eye or eyelid, surrounding areas, or other surfaces with the tip of the bottle. This could infect the eye drops.
• Gently press the bottle to release one drop of ALDUOVIZ at a time (figure 2). If a drop does not enter the eye, try again.
• After using ALDUOVIZ, press a finger on the corner of the eye near the nose for 2 minutes (figure 3). This helps to prevent ALDUOVIZ from spreading throughout the body.
• If you need to put the eye drops in both eyes, repeat the previous steps for the other eye.
• Screw the cap back on immediately after use.

Use ALDUOVIZ for the period of time recommended by your doctor.
If you use more ALDUOVIZ than you should
If you take more ALDUOVIZ than you should, remove it by rinsing with lukewarm water. Do not take any more drops until the time scheduled for the next administration.
If you forget to use ALDUOVIZ
If you forget to take ALDUOVIZ, continue treatment with the next scheduled dose. Do not take a double dose to make up for the forgotten dose. The dose should not exceed one drop per day per affected eye(s).
If you stop using ALDUOVIZ
If you stop taking ALDUOVIZ without talking to your doctor, the pressure in the eye will be uncontrolled, which may result in loss of vision.
If you are using other eye drops in addition to ALDUOVIZ, allow at least 5 minutes between applying ALDUOVIZ and applying the other eye drops.
If you wear soft contact lenses, do not use the eye drops while wearing the lenses. Wait 15 minutes after using the eye drops before putting the lenses back in.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Generally you can continue to use the drops unless the effects experienced are serious. If you are
worried, ask your doctor or pharmacist. Do not stop using ALDUOVIZ without talking to your doctor.
Very common side effects (may affect more than 1 in 10 people)

Effects on the eye
Redness.
Common side effects (may affect up to 1 in 10 people)

Effects on the eye
Inflammation of the eye surface with damage to the surface, eye pain, blurred vision, abnormal vision, dry eye, itchy eye, eye discomfort, signs and symptoms of eye irritation (e.g. burning, stinging).
Uncommon side effects (may affect up to 1 in 100 people)

Effects on the eye
Inflammation of the eye surface, inflammation of the eyelids, swollen conjunctiva, increased
growth of eyelashes, inflammation of the iris, eye inflammation, sensitivity to light, reduced vision,
tired eyes, eye allergy, eye swelling, increased tear production, redness of the
eyelid, changes in eyelid color, darkening of the skin (around the eye).
General side effects
Allergy to the active ingredient, dizziness, headache, increase or decrease in blood pressure, shortness of
breath, excessive hair growth, runny nose, skin inflammation and itching, reduced heart rate.
Rare side effects (may affect up to 1 in 1,000 people)

Effects on the eye
Thinning of the eye surface, inflammation of the eyelid glands, rupture of blood vessels
in the eye, formation of crusts on the eyelid, abnormal positioning of eyelashes, abnormal eyelash growth.
General side effects
Nervousness, irregular heartbeat, hair loss, voice disturbances, difficulty breathing,
cough, sore throat, hives, abnormal liver blood tests, skin color change,
thirst, fatigue, discomfort inside the nose, colored urine, pain in hands and feet.
Not known (frequency cannot be estimated from the available data)

Effects on the eye
Drooping eyelid (eye remains half-closed), sunken eyes (eyes appear more
recessed), changes in the color of the iris (colored part of the eye).

General side effects
Skin rashes, heart failure, chest pain, stroke, fainting, depression, asthma, increased
heart rate, sensation of numbness or tingling, palpitations, swelling of the lower limbs, bad taste.
In addition:
ALDUOVIZ is a combination of two active ingredients, travoprost and timolol. Like other medicines
administered to the eyes, travoprost and timolol (a beta-blocker) are absorbed into the blood. This can
cause side effects similar to those that occur with the administration of beta-blocker medicines
orally or by injection. The amount of side effects after administration to the eyes is
lower than with oral or injection administration.
The side effects listed below include reactions observed for the class of beta-blockers used
in the treatment of eye problems or reactions observed with travoprost alone:

Effects on the eye
Inflammation of the eyelid, inflammation of the cornea, detachment of the layer under the retina containing the
blood vessels following filtering surgery, which can cause visual disturbances, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge,
swelling around the eye, itchy eyelids, outward rotation of the eyelid with redness,
irritation and excessive tearing, blurred vision (sign of blurring of the eye's lenses),
swelling of a part of the eye (uvea), eczema of the eyelids, vision with halo, decreased
eye sensitivity, pigmentation inside the eye, dilated pupils, change in eyelash color,
change in eyelash texture, abnormal visual field.

General side effects
Ear and labyrinth disorders: dizziness with a sensation of rotation, ringing in the ears.
Heart and circulation: slowed heart rate, palpitations, edema (fluid retention), changes in
heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, low blood pressure, Raynaud's phenomenon, cold hands and feet, reduced
blood supply to the brain.
Respiratory: constriction of the airways in the lungs (mainly in patients with pre-existing
disease), runny or blocked nose, sneezing (due to allergy), difficulty breathing, nosebleeds,
dry nose.
Nervous system and systemic disorders: difficulty sleeping (insomnia), nightmares, memory loss,
hallucinations, loss of strength and energy, anxiety (excessive emotional discomfort).
Gastrointestinal: taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting and
constipation.
Allergy: increased allergy symptoms, generalized allergic reactions including swelling under the
skin that can occur in areas such as the face and limbs and can obstruct the airways causing
difficulty swallowing or breathing, localized and generalized skin rash, itching, severe life-threatening unexpected allergic reactions.
Skin: silvery-white rash (psoriasiform erythema) or worsening of psoriasis,
peeling of the skin, abnormal hair structure, inflamed skin with itching and 6
redness, change in hair color, loss of eyelashes, itching, abnormal hair growth,
redness of the skin.
Muscular: increased signs and symptoms of myasthenia gravis (muscle disease), unusual sensations
like pins and needles, muscle weakness/fatigue, muscle pain not caused by exercise, joint pain.
Kidney and urinary disorders: difficulty and pain when urinating, involuntary loss of urine. Reproduction:
sexual dysfunction, decreased libido.
Metabolism: low blood sugar levels, increased indicator (marker) of prostate cancer.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

• 5. How to storeALDUOVIZ Keep this medicine out of the sight and reach of children. Do not use this medicine after the date of expiry that is stated on the label and the carton after “EXP” and “Scad.”. The date of expiry refers to the last day of that month. Do not store above 25°C.

To prevent the risk of infection, you must discard the bottle 4 weeks after first opening. Each time
you open a new bottle for the first time, write the date of opening in the appropriate space on the label and
on the carton.
Do not dispose of any medicine in the water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALDUOVIZ contains

• The active ingredients are travoprost and timolol. Each ml of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).
• The other ingredients are: benzalkonium chloride, mannitol, trometamol, hydrogenated castor oil polyoxyl 40(Cremophor RH40), boric acid, disodium edetate, water for injections.

Description of the appearance of ALDUOVIZ and contents of the pack
Low density polyethylene bottle equipped with a polyethylene dropper and closed with a
polypropylene cap.
Pack of 1 bottle containing 2.5 ml.

Marketing Authorisation Holder
Genetic S.p.A.
Via Della Monica n. 26
84083 Castel San Giorgio
(SA) Italy

Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano
(SA) Italy

ALDUOVIZ 40 micrograms/ml + 5 mg/ml eye drops, solution

travoprost/timolol

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 7. What ALDUOVIZ is and what it is used for
• 8. What you need to know before you use ALDUOVIZ
• 9. How to use ALDUOVIZ
• 10. Possible side effects
• 11. How to store ALDUOVIZ
• 12. Contents of the pack and other information

1. What is ALDUOVIZ and what is it used for

ALDUOVIZ eye drops solution is a combination of two active ingredients (travoprost and timolol).
Travoprost is a prostaglandin analogue whose mechanism of action consists of increasing the outflow
of fluid from the eye, reducing its pressure. Timolol is a beta-blocker whose mechanism of action
consists of reducing the production of fluid inside the eye. The two active ingredients act
simultaneously in order to reduce the pressure inside the eye.
ALDUOVIZ eye drops are used for the treatment of elevated intraocular pressure in adults,
including the elderly. These pressure levels can lead to a condition called glaucoma.

2. What you need to know before using ALDUOVIZ

Do not use ALDUOVIZ

• if you are allergic to travoprost, to prostaglandins, to timolol, to beta-blockers or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough) or other types of respiratory problems.
• in case of severe hay fever.
• in case of slowed heartbeats, heart failure or a heart rhythm disorder (irregular heartbeats).
• in case of clouding of the transparent surface of the eye. Ask your doctor if you are subject to any of these conditions.

Warnings and precautions
Consult your doctor before using ALDUOVIZ if you suffer from or have suffered in the past from

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure.
• alterations in heart rate such as slow heartbeat.
• breathing problems, asthma or chronic obstructive lung disease.
• disease with poor circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes (because timolol may mask the signs and symptoms of low blood sugar).
• hyperactivity of the thyroid gland (because timolol can mask signs and symptoms of a thyroid disease).
• myasthenia gravis (chronic muscle weakness).
• cataract surgery.
• eye inflammation.

If you need to undergo any type of surgery, inform your doctor that you are using
ALDUOVIZ because timolol may alter the effects of some medicines used during anesthesia.
If you should experience any serious allergic reaction (skin rash, redness and itching
of the eye) during the use of ALDUOVIZ, whatever the cause, treatment with adrenaline
may not be sufficiently effective. Therefore, if you are undergoing any other
treatment, tell your doctor that you are using ALDUOVIZ.
ALDUOVIZ may change the color of your iris (the colored part of the eye). This change
may be permanent.
ALDUOVIZ may increase the length, thickness, color and/or number of your eyelashes and may cause
an unusual growth of hairs on your eyelids.
Travoprost may be absorbed through the skin, so it should not be used by pregnant
women or those intending to become pregnant. If any of the medicine comes into contact with the skin, wash
immediately.
Children
ALDUOVIZ should not be used in children and adolescents under the age of 18 years.
Other medicines and ALDUOVIZ
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including over-the-counter medicines.
ALDUOVIZ may interact with other medicines you are taking, including other eye drops for the treatment
of glaucoma. Tell your doctor if you are taking or intend to use medicines to lower blood
pressure, heart medications including quinidine (used to treat heart problems and some types of
malaria), or medicines for the treatment of diabetes or the antidepressants fluoxetine or paroxetine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.
Do not use ALDUOVIZ in case of pregnancy, unless your doctor considers it necessary. If there
is a possibility of becoming pregnant, while using this medicine you should adopt adequate contraception.
Do not use ALDUOVIZ in case of breastfeeding. ALDUOVIZ may be excreted in breast milk.
Driving and operating machinery
You may have blurred vision for a certain period after using ALDUOVIZ. Do not drive or use
machinery until such symptoms have disappeared. ALDUOVIZ may also cause hallucinations, dizziness,
nervousness or fatigue in some patients.
Do not drive or use machinery until such symptoms have subsided.
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.
ALDUOVIZ contains hydrogenated castor oil which may cause irritation and skin reactions.

3. How to use ALDUOVIZ

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor
or pharmacist.
The recommended dose is one drop in the affected eye(s) once a day, in the morning or evening.
Take the dose every day at the same time.
Use ALDUOVIZ in both eyes only as prescribed by your doctor.
ALDUOVIZ can only be used as an eye drop.

• First, wash your hands and sit or stand in a comfortable position, then open the aluminum pouch containing a strip of 5 single-dose containers.
• Remove a single-dose container from the strip by applying slight pressure from the opposite side of the vial opening (fig. 1).
• Open the single-dose container by rotating the cap completely, making a 360° turn (fig. 2).
• Tilt your head back and gently pull down your lower eyelid with a finger to form a pocket between your eyelid and your eye.
• Position the tip of the single-dose container close to the eye, without touching it; apply slight pressure on the single-dose container so that a single drop goes into the affected eye(s) as indicated by your doctor (fig. 3).
• After using the product, close your eye and press with a finger on the corner of your eye (the point where the eye meets the nose) and hold for one minute (fig. 4).
• After inserting the drop into the eye, discard the used single-dose container even if some solution remains inside to avoid contamination of the preservative-free solution.
• Store the remaining containers in the original package and in the aluminum pouch; after the first opening of the aluminum pouch, use the containers within 7 days; after this period, any remaining containers must be discarded. It is important to continue using the eye drops as prescribed by your doctor.

Use ALDUOVIZ for the period of time recommended by your doctor.
If you use more ALDUOVIZ than you should
If you use more ALDUOVIZ than you should, remove it by rinsing with lukewarm water. Do not take any more
drops until the time scheduled for the next administration.
If you forget to use ALDUOVIZ
If you forget to take ALDUOVIZ, continue treatment with the next scheduled dose. Do not use
a double dose to make up for the forgotten dose. The dose should not exceed one drop per
day per affected eye(s).
If you stop using ALDUOVIZ
If you stop taking ALDUOVIZ without talking to your doctor, the pressure in your eye will
be uncontrolled, which may lead to loss of vision.
If you are using other eye drops in addition to ALDUOVIZ, allow at least 5 minutes between applying
ALDUOVIZ and the other eye drops.
If you wear soft contact lenses, do not use the eye drops while wearing the lenses. Wait 15 minutes after using the
eye drops before putting the lenses back in.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Generally you can continue to use the drops, unless the effects experienced are serious. If you are
worried, talk to your doctor or pharmacist. Do not stop using ALDUOVIZ without talking to
your doctor.
Very common side effects (may affect more than 1 in 10 people)

Effects on the eye
Redness.
Common side effects (may affect up to 1 in 10 people)

Effects on the eye
Inflammation of the eye surface with damage to the surface, eye pain, blurred vision, abnormal vision, dry eye, eye itching, eye discomfort, signs and symptoms of eye irritation (e.g. burning, stinging).
Uncommon side effects (may affect up to 1 in 100 people)

Effects on the eye
Inflammation of the eye surface, inflammation of the eyelids, swollen conjunctiva, increased
growth of eyelashes, inflammation of the iris, eye inflammation, sensitivity to light, reduced vision,
tired eyes, eye allergy, eye swelling, increased tear production, redness of the
eyelid, changes in eyelid color, darkening of the skin (around the eye).
General side effects
Allergy to the active ingredient, dizziness, headache, increased or decreased blood pressure, shortness of
breath, excessive hair growth, nasopharyngeal drip, skin inflammation and itching, reduced heart rate.
Rare side effects (may affect up to 1 in 1,000 people)

Effects on the eye
Thinning of the eye surface, inflammation of the eyelid glands, rupture of blood
vessels in the eye, formation of crusts on the eyelid, abnormal positioning of the eyelashes, abnormal eyelash growth.
General side effects
Nervousness, irregular heartbeat, hair loss, voice disturbances, difficulty breathing,
cough, sore throat, hives, abnormal liver blood tests, altered skin color,
thirst, fatigue, discomfort inside the nose, colored urine, pain in hands and feet.
Not known (frequency cannot be estimated from available data)

Effects on the eye
Drooping eyelid (the eye remains half-closed), sunken eyes (the eyes appear more
recessed), changes in the color of the iris (colored part of the eye).

General side effects
Skin rashes, heart failure, chest pain, stroke, fainting, depression, asthma, increased
heart rate, sensation of numbness or tingling, palpitations, swelling of the lower limbs, bad taste.
In addition:
ALDUOVIZ is a combination of two active ingredients, travoprost and timolol. Like other medicines
administered to the eyes, travoprost and timolol (a beta-blocker) are absorbed into the blood. This can
cause side effects similar to those that occur with the administration of beta-blocker
medicines orally or by injection. The amount of side effects after administration to the eyes is
lower than that for oral or injection administration.
The side effects listed below include reactions observed for the class of beta-blockers used
in the treatment of eye problems or reactions observed with travoprost alone:

Effects on the eye
Inflammation of the eyelid, inflammation of the cornea, detachment of the layer under the retina containing the
blood vessels following filtering surgery, which can cause visual disturbances, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge,
swelling around the eye, itching of the eyelids, outward rotation of the eyelid with redness,
irritation and excessive tearing, blurred vision (sign of blurring of the lenses of the eye),
swelling of a part of the eye (uvea), eczema of the eyelids, vision with halos, decreased
eye sensitivity, pigmentation inside the eye, dilated pupils, altered eyelash color,
change in eyelash texture, abnormal visual field.

General side effects
Ear and labyrinth disorders: dizziness with a sensation of rotation, ringing in the ears.
Heart and circulation: slowed heart rate, palpitations, edema (fluid accumulation), changes in
heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, low blood pressure, Raynaud's phenomenon, cold hands and feet, reduced
blood supply to the brain.
Respiratory: constriction of the airways in the lungs (mainly in patients with pre-existing
disease), runny or blocked nose, sneezing (due to allergy), difficulty breathing, nosebleeds,
dry nose.
Nervous system and systemic disorders: difficulty sleeping (insomnia), nightmares, memory loss,
hallucinations, loss of strength and energy, anxiety (excessive emotional distress).
Gastrointestinal: taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting and
constipation.
Allergy: increased allergy symptoms, generalized allergic reactions including swelling under the
skin that can occur in areas such as the face and limbs and that can obstruct the airways causing
difficulty swallowing or breathing, localized and generalized skin rash, itching, severe allergic
reactions unexpectedly life-threatening.
Skin: skin rash with a silvery-white appearance (psoriasiform erythema) or worsening of psoriasis,
skin flaking, abnormal hair structure, skin inflammation with itching and 6
redness, change in hair color, loss of eyelashes, itching, abnormal hair growth,
redness of the skin.
Muscular: increased signs and symptoms of myasthenia gravis (muscle disease), unusual sensations
like pins and needles, muscle weakness/fatigue, muscle pain not caused by exercise, joint pain.
Kidney and urinary disorders: difficulty and pain when urinating, involuntary loss of urine. Reproduction:
sexual dysfunction, decreased libido.
Metabolism: low blood sugar levels, increased indicator (marker) of prostate cancer.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store ALDUOVIZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the package after “EXP”
and “Scad.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
After the first opening of the aluminium sachet, use the medicine within 7 days; after this period
any remaining containers must be discarded.
The single-dose container must be used immediately after opening; any remaining medicine must
be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ALDUOVIZ contains

• The active ingredients are travoprost and timolol. Each ml of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).
• The other ingredients are: mannitol, trometamol, hydrogenated castor oil polyoxyethyl 40(Cremophor RH40), boric acid, disodium edetate, water for injections.

Description of the appearance of ALDUOVIZ and contents of the pack
Single-dose container in polyethylene.
Pack containing 6 strips, each consisting of 5 single-dose containers, placed in PET/Al/PE pouches
(one strip per pouch) for a total of 30 containers of 0.1 ml.

Marketing Authorisation Holder
Genetic S.p.A.
Via Della Monica n. 26
84083 Castel San Giorgio
(SA) Italy

Manufacturer
Genetic S.p.A.
Contrada Canfora
84084 Fisciano
(SA) Italy