Alduoviz

Package leaflet: Information for the user

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

travoprost/timolol
Equivalent medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 using 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 ALDUOVIZ is and what it is 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 in increasing the outflow
of fluid from the eye, thereby reducing intraocular pressure. Timolol is a beta-blocker whose mechanism of action
consists in reducing the production of fluid within the eye. The two active substances act
simultaneously to reduce the pressure inside the eye.
ALDUOVIZ eye drops are used to treat elevated intraocular pressure in adults,
including the elderly. Such pressure levels may lead to a condition known as glaucoma.

2. What you should know before using ALDUOVIZ

Do not use ALDUOVIZ

• if you are allergic to travoprost, prostaglandins, timolol, beta-blockers, or to any of the other ingredients of this medicine (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) or other types of breathing disorders.
• in case of severe hay fever.
• in case of slow heart rate, 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 affected by any of these conditions.

Warnings and precautions
Talk to your doctor before using ALDUOVIZ if you suffer or have previously suffered from:

• coronary heart 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.
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome).
• diabetes (since timolol may mask the signs and symptoms of low blood sugar).
• overactivity of the thyroid gland (since timolol may mask signs and symptoms of thyroid disease).
• myasthenia gravis (chronic muscle weakness).
• cataract surgery.
• ocular inflammation.

If you need to undergo any type of surgical procedure, inform your doctor that you are using ALDUOVIZ, as timolol may alter the effects of certain medicines used during anaesthesia.
If you experience any severe allergic reaction (skin rash, redness and itching of the eye) while using ALDUOVIZ, regardless of the cause, treatment with adrenaline may not be sufficiently effective. Therefore, if you are undergoing any other treatment, inform your doctor that you are using ALDUOVIZ.
ALDUOVIZ may change the colour of your iris (the coloured part of the eye). This change could be permanent.
ALDUOVIZ may increase the length, thickness, colour and/or number of your eyelashes and may cause unusual hair growth on your eyelids.
Travoprost can be absorbed through the skin; therefore, it should not be used by pregnant women or women who intend to become pregnant. If any amount of the medicine comes into contact with the skin, wash immediately.

Children
ALDUOVIZ must not be used in children and adolescents under 18 years of age.

Other medicines and ALDUOVIZ
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including medicines without a prescription.
ALDUOVIZ may interact with other medicines you are taking, including other eye drops for glaucoma treatment. Inform your doctor if you are taking or plan to take medicines to lower blood pressure, heart medications including quinidine (used to treat heart problems and certain types of malaria), or medicines for diabetes or the antidepressants fluoxetine or paroxetine.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor 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 must use adequate contraception while using this medicine.
Do not use ALDUOVIZ while breastfeeding. ALDUOVIZ may be excreted in breast milk.

Driving and using machines
You may experience blurred vision for a period after using ALDUOVIZ. Do not drive or operate machinery until these symptoms have resolved. ALDUOVIZ may also cause hallucinations, dizziness, nervousness or fatigue in some patients.
Do not drive or operate machinery until such symptoms have disappeared.

For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-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 may be absorbed by soft contact lenses and may cause a change in their colour.
Remove your contact lenses before using this medicine and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience an unusual sensation in the eye, burning or pain after using this medicine, speak with your doctor.

3. How to use ALDUOVIZ

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop into the affected eye(s) once daily, in the morning or evening.
Take the dose at the same time each day.
Use ALDUOVIZ in both eyes only if specifically instructed by your doctor.
ALDUOVIZ may only be used as an eye drop.

• Immediately before using the bottle for the first time, write the date of opening on the label in the space provided.
• Make sure you have a mirror available.
• Wash your hands.
• Unscrew the cap of the bottle.
• Hold the bottle between your thumb and other fingers, keeping it upright.
• Tilt your head back. Pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye. The drop should be placed here (figure 1).
• Hold the tip of the bottle close to the eye. Using a mirror may help.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the tip of the bottle. This could contaminate the eye drop solution.
• 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 against the corner of the eye near the nose for 2 minutes (figure 3). This helps prevent ALDUOVIZ from spreading into the rest of the body.
• If you need to apply the eye drops to both eyes, repeat the previous steps for the other eye.
• Immediately screw the cap back on after use.

Use ALDUOVIZ for as long as your doctor has advised.
If you use more ALDUOVIZ than you should
If you use more ALDUOVIZ than prescribed, rinse your eye(s) with lukewarm water. Do not use further drops until the next scheduled dose.
If you forget to use ALDUOVIZ
If you forget to use ALDUOVIZ, continue treatment with the next scheduled dose. Do not use a double dose to make up for a missed one. The dose must not exceed one drop per day per affected eye(s).
If you stop using ALDUOVIZ
If you stop using ALDUOVIZ without discussing it with your doctor, the pressure inside your eye may become uncontrolled, which could lead to loss of vision.
If you are using other eye drops in addition to ALDUOVIZ, wait 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 them. Wait 15 minutes after using the eye drops before reinserting your contact lenses.
If you have any questions about how to use 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.
You can generally continue using the drops unless the side effects are severe. If you are concerned, speak to your doctor or pharmacist. Do not stop using ALDUOVIZ without first discussing it with your doctor.

Very common side effects (may affect more than 1 in 10 people)
Eye effects
Redness.

Common side effects (may affect up to 1 in 10 people)
Eye effects
Inflammation of the eye surface with surface damage, 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)
Eye effects
Inflammation of the eye surface, eyelid inflammation, swollen conjunctiva, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, reduced vision, tired eyes, eye allergy, eye swelling, increased tear production, eyelid redness, changes in eyelid colour, darkening of the skin (around the eye).

General side effects
Allergy to the active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, nasopharyngeal dripping, skin inflammation and itching, reduced heart rate.

Rare side effects (may affect up to 1 in 1,000 people)
Eye effects
Thinning of the eye surface, inflammation of the eyelid glands, broken blood vessels in the eye, crust formation on the eyelid, abnormal eyelash positioning, abnormal eyelash growth.

General side effects
Nervousness, irregular heartbeat, hair loss, voice discomfort, breathing difficulties, cough, sore throat, hives, abnormal liver blood tests, change in skin colour, thirst, fatigue, nasal discomfort, coloured urine, pain in hands and feet.

Not known (frequency cannot be estimated from available data)
Eye effects
Drooping eyelid (eye remains half-closed), sunken eyes (eyes appear more deeply set), changes in iris colour (coloured part of the eye).

General side effects
Skin rashes, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or tingling sensation, palpitations, swelling of the lower limbs, bad taste.

In addition:
ALDUOVIZ is a combination of two active substances, travoprost and timolol. Like other medicines administered into the eyes, travoprost and timolol (a beta-blocker) are absorbed into the bloodstream. This may cause side effects similar to those seen with oral or injected beta-blocking medicines. However, the amount absorbed after eye administration is lower than with oral or injected administration.

The following side effects include reactions observed with the class of beta-blockers used in eye treatments or reactions observed with travoprost alone:

Eye effects
Eyelid inflammation, corneal inflammation, detachment of the layer beneath the retina containing blood vessels following filtering surgery which may cause vision disturbances, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, outward turning of the eyelid with redness, irritation and excessive tearing, blurred vision (sign of lens clouding), swelling of a part of the eye (uvea), eyelid eczema, seeing halos around lights, decreased eye sensitivity, pigmentation inside the eye, dilated pupils, changes in eyelash colour, changes in eyelash texture, abnormal visual field.

General side effects
Ear and labyrinth disorders: dizziness with spinning sensation, ringing in the ears.
Heart and circulation: slowed heart rate, palpitations, oedema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of 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: narrowing of airways in the lungs (mainly in patients with pre-existing lung disease), runny or blocked nose, sneezing (due to allergy), breathing difficulties, 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, diarrhoea, dry mouth, abdominal pain, vomiting, constipation.
Allergic reactions: worsening of allergic symptoms, generalized allergic reactions including swelling under the skin which may occur in areas such as the face and limbs and which may block the airways causing difficulty in swallowing or breathing, localized and generalized skin rash, itching, severe unexpected life-threatening allergic reactions.
Skin: silvery-white rash (psoriasiform erythema) or worsening of psoriasis, skin peeling, abnormal hair structure, skin inflammation with itching and redness, change in hair colour, eyelash loss, itching, abnormal hair growth, skin redness.
Musculoskeletal: worsening of signs and symptoms of myasthenia gravis (a muscle disorder), unusual sensations such as pins and needles, muscle weakness, muscle pain not caused by exercise, joint pain.
Renal and urinary disorders: difficulty and pain when urinating, involuntary loss of urine.
Reproduction: sexual dysfunction, decreased libido.
Metabolism: low blood sugar levels, increased prostate cancer marker.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects 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 stated on the label and carton after “EXP” and “Scad.”. The expiry date refers to the last day of that month. Do not store above 25°C.

To prevent the risk of infection, 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 designated space on the label and carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What ALDUOVIZ contains

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

Description of the appearance of ALDUOVIZ and pack contents
Low-density polyethylene bottle with a low-density polyethylene dropper cap and closed with a polypropylene cap.
Pack size: 1 bottle containing 2.5 ml.
Marketing Authorization 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
This summary of product characteristics was last approved on:

Patient Information Leaflet: Information for the User

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

travoprost/timolol
Please read this entire leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 using 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 ALDUOVIZ is and what it is 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 in increasing the outflow of fluid from the eye, thereby reducing intraocular pressure. Timolol is a beta-blocker whose mechanism of action consists in reducing the production of fluid within the eye. The two active substances act simultaneously to reduce intraocular pressure.
ALDUOVIZ eye drops are used to treat elevated intraocular pressure in adults, including the elderly. Such pressure levels may lead to a condition known as glaucoma.

2. What you need to know before using ALDUOVIZ

Do not use ALDUOVIZ

• if you are allergic to travoprost, prostaglandins, timolol, beta-blockers, or any of the other ingredients of this medicine (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), or other types of breathing disorders.
• in case of severe hay fever.
• in case of slow heart rate, heart failure, or a heart rhythm disorder (irregular heartbeat).
• in case of corneal opacity (clouding of the transparent surface of the eye). Ask your doctor if you are affected by any of these conditions.

Warnings and precautions
Consult your doctor before using ALDUOVIZ 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.
• changes in heart rate such as slow heartbeat.
• breathing problems, asthma, or chronic obstructive pulmonary disease.
• poor circulation disorders (such as Raynaud's disease or Raynaud's syndrome).
• diabetes (since timolol may mask the signs and symptoms of low blood sugar).
• overactive thyroid gland (since timolol may mask signs and symptoms of thyroid disease).
• myasthenia gravis (chronic muscle weakness).
• cataract surgery.
• ocular inflammation.

If you need to undergo any type of surgical procedure, inform your doctor that you are using ALDUOVIZ, as timolol may alter the effects of certain medicines used during anesthesia.
If you develop any severe allergic reaction (skin rash, eye redness and itching) while using ALDUOVIZ, regardless of the cause, treatment with adrenaline may not be sufficiently effective. Therefore, if you receive any other treatment, inform your doctor that you are using ALDUOVIZ.
ALDUOVIZ may change the color of your iris (the colored part of the eye). This change could be permanent.
ALDUOVIZ may increase the length, thickness, color, and/or number of your eyelashes and may cause unusual eyelid hair growth.
Travoprost can be absorbed through the skin; therefore, it should not be used by pregnant women or women who intend to become pregnant. If any amount of the medicine comes into contact with the skin, wash immediately.

Children
ALDUOVIZ must not be used in children and adolescents under 18 years of age.

Other medicines and ALDUOVIZ
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including over-the-counter medicines.
ALDUOVIZ may interact with other medicines you are taking, including other eye drops for glaucoma. Inform your doctor if you are taking or plan to take medicines to lower blood pressure, heart medications including quinidine (used to treat heart problems and some types of malaria), or medicines for diabetes or the antidepressants fluoxetine or paroxetine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Do not use ALDUOVIZ during pregnancy unless your doctor considers it necessary. If there is any possibility of becoming pregnant, you must use adequate contraception while using this medicine.
Do not use ALDUOVIZ while breastfeeding. ALDUOVIZ may be excreted in breast milk.

Driving and using machines
You may experience blurred vision for a period of time after using ALDUOVIZ. Do not drive or operate machinery until these symptoms have disappeared. ALDUOVIZ may also cause hallucinations, dizziness, nervousness, or fatigue in some patients.
Do not drive or operate machinery until such symptoms have subsided.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

ALDUOVIZ contains hydrogenated castor oil, which may cause irritation and skin reactions.

3. How to use ALDUOVIZ

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop into the affected eye(s) once daily, in the morning or evening.
Take the dose at the same time every day.
Use ALDUOVIZ in both eyes only if prescribed by your doctor.
ALDUOVIZ is for ophthalmic use only.

• First, wash your hands and sit or stand in a comfortable position. Then open the aluminium pouch containing a strip of 5 single-dose containers.
• Remove one single-dose container from the strip by gently pressing on the side opposite to the opening of the vial (fig. 1).
• Open the single-dose container by fully twisting the cap completely around (360°) (fig. 2).
• Tilt your head backward and gently pull down the lower eyelid with one finger to create a small pocket between your eyelid and eye.
• Hold the tip of the single-dose container close to the eye without touching it. Gently squeeze the container so that one drop is instilled into the affected eye(s), as instructed by your doctor (fig. 3).
• After using the product, close your eye and press gently with one finger on the inner corner of the eye (where the eye meets the nose) for one minute (fig. 4).
• After instilling the drop, discard the single-dose container even if some solution remains, to avoid contamination of the preservative-free solution.
• Store the remaining containers in the original carton and aluminium pouch. After first opening the aluminium pouch, use the containers within 7 days; any unused containers must be discarded after this period. It is important to continue using the eye drops as prescribed by your doctor.

Use ALDUOVIZ for the length of time recommended by your doctor.
If you use more ALDUOVIZ than you should
If you use more ALDUOVIZ than prescribed, rinse your eye(s) thoroughly with lukewarm water. Do not use the next dose until the next scheduled time.
If you forget to use ALDUOVIZ
If you forget to use ALDUOVIZ, continue treatment with the next scheduled dose. Do not use a double dose to make up for the missed dose. The dose should not exceed one drop per day per affected eye(s).
If you stop using ALDUOVIZ
If you stop using ALDUOVIZ without consulting your doctor, the pressure inside your eye may become uncontrolled, which could lead to vision loss.
If you are using other eye drops in addition to ALDUOVIZ, wait 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 them. Wait at least 15 minutes after using the eye drops before reinserting your contact lenses.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
You can generally continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using ALDUOVIZ without first talking to your doctor.

Very common side effects (may affect more than 1 in 10 people)
Eye effects
Redness.

Common side effects (may affect up to 1 in 10 people)
Eye effects
Inflammation of the surface of the eye 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)
Eye effects
Inflammation of the surface of the eye, eyelid inflammation, swollen conjunctiva, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, reduced vision, tired eyes, eye allergy, eye swelling, increased tear production, eyelid redness, changes in eyelid appearance, skin discoloration (around the eye).

General side effects
Allergy to the active substance, 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)
Eye effects
Thinning of the surface of the eye, inflammation of the eyelid glands, broken blood vessels in the eye, crust formation on the eyelid, abnormal eyelash positioning, abnormal eyelash growth.

General side effects
Nervousness, irregular heart rate, hair loss, voice discomfort, breathing difficulties, cough, sore throat, hives, abnormal liver blood tests, change in skin color, thirst, fatigue, nasal discomfort, colored urine, pain in hands and feet.

Not known (frequency cannot be determined from available data)
Eye effects
Drooping of the eyelid (eye remains half-closed), sunken eyes (eyes appear more deeply set), changes in iris color (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.

Additional information:
ALDUOVIZ is a combination of two active substances, travoprost and timolol. Like other medicines administered into the eyes, travoprost and timolol (a beta-blocker) are absorbed into the bloodstream. This may cause side effects similar to those seen with oral or injectable beta-blocker medicines. However, the amount causing side effects after eye administration is lower than with oral or injectable administration.

The following side effects include reactions observed with the class of beta-blockers used in eye treatments or reactions observed with travoprost alone:

Eye effects
Eyelid inflammation, corneal inflammation, detachment of the layer beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, outward turning of the eyelid with redness, irritation and excessive tearing, blurred vision (sign of lens clouding), swelling of a part of the eye (uvea), eyelid eczema, seeing halos, decreased eye sensitivity, pigmentation inside the eye, dilated pupils, changes in eyelash color, changes in eyelash texture, abnormal visual field.

General side effects
Ear and labyrinth disorders: dizziness with sensation of spinning, 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 causing shortness of breath and swelling of feet and legs due to fluid buildup), 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: narrowing of the airways in the lungs (mainly in patients with pre-existing disease), runny or blocked nose, sneezing (due to allergy), breathing difficulties, 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, constipation.
Allergy: worsening of allergic symptoms, generalized allergic reactions including swelling under the skin which may occur in areas such as the face and limbs and which may block the airways causing difficulty swallowing or breathing, localized and generalized skin rash, itching, severe unexpected life-threatening allergic reactions.
Skin: silvery-white rash (psoriasiform erythema) or worsening of psoriasis, skin peeling, abnormal hair structure, skin inflammation with itching and redness, hair color change, eyelash loss, itching, abnormal hair growth, skin redness.
Musculoskeletal: increased signs and symptoms of myasthenia gravis (a muscle disorder), unusual sensations such as pins and needles, muscle weakness, muscle pain not caused by exercise, joint pain.
Renal and urinary disorders: difficulty and pain when urinating, involuntary loss of urine.
Reproductive: sexual dysfunction, decreased libido.
Metabolism: low blood sugar levels, increased marker of prostate cancer.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the label and the carton after "EXP" and "Scad.". The expiry date refers to the last day of that month.
Do not store above 25°C.
After first opening the aluminium pouch, 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 leftover medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ALDUOVIZ contains

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

Description of the appearance of ALDUOVIZ and pack contents
Single-dose container made of 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 Authorization 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
This instruction leaflet was last approved on: