Loyada

Package leaflet: Information for the patient

Loyada 15 micrograms/ml + 5 mg/ml

eye drops, solution
tafluprost/timolol
Read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Loyada is and what it is used for

What type of medicine is it and how does it work?
Loyada eye drops contains tafluprost and timolol. Tafluprost belongs to a group of medicines called prostaglandin analogues, and timolol belongs to a group of medicines called beta-blockers.
Tafluprost and timolol work together to reduce the pressure inside the eye. Loyada is used when the pressure inside the eye is too high.
What is this medicine used for?
Loyada is used to treat a type of glaucoma called open-angle glaucoma, as well as a condition known as ocular hypertension in adults. Both conditions are associated with increased pressure inside the eye, which over time may damage vision.

2. What you should know before using Loyada

Do not use Loyada

• if you are allergic to tafluprost, 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 pulmonary disease (a serious lung disease that may cause wheezing, difficulty breathing and/or persistent cough)
• if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular beats).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Loyada.
Tell your doctor before using this medicine if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure
• heart rate disorders such as a slow heartbeat
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• a disease characterized by poor blood circulation (e.g. Raynaud’s disease or Raynaud’s syndrome)
• diabetes, as timolol may mask the signs and symptoms of low blood sugar levels
• overactive thyroid gland, as timolol may mask the signs and symptoms of thyroid disease
• any type of allergies or anaphylactic reactions
• myasthenia gravis (a rare disease causing muscle weakness)
• other eye diseases; for example, corneal disease (the transparent tissue covering the front of the eye) or a condition requiring eye surgery.

Tell your doctor if you have

• kidney problems
• liver problems.

Please note that Loyada may cause the following effects, some of which may be permanent:
Loyada may

• increase the length, thickness, pigmentation, and/or number of eyelashes and may cause unusual growth of eyelid hair.
• Cause darkening of the skin around the eyes. Remove any residual solution from the skin. This will help reduce the risk of skin darkening.
• Change the colour of the iris (the coloured part of the eye). If Loyada is applied to only one eye, the colour of the treated eye may become permanently different from the other eye.
• Cause growth of hair in areas where the solution repeatedly comes into contact with the skin surface.

Before undergoing surgery, inform your doctor that you are using Loyada, as timolol may alter the effect of certain medicines used during anaesthesia.
Children and adolescents
The use of Loyada is not recommended in children and adolescents under 18 years of age due to the lack of data on safety and efficacy in this age group.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Loyada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Loyada may alter the effect of other medicines, or its effect may be altered by other medicines.
In particular, inform your doctor if you are using or plan to use:

• other eye drops for the treatment of glaucoma
• medicines to reduce blood pressure
• medicines for the heart
• medicines for treating diabetes
• quinidine (used to treat heart conditions and certain types of malaria)
• antidepressants known as fluoxetine and paroxetine.

If you are applying other medicines to the eye, wait at least 5 minutes between the administration of Loyada and the other medicine.
Contact lenses
Remove contact lenses before using the eye drops and wait at least 15 minutes before reinserting them.
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. If you can become pregnant, you must use an effective method of contraception during treatment with Loyada. Do not use Loyada if you are pregnant, unless your doctor has specifically instructed you to do so. Do not use Loyada if you are breastfeeding.
Driving and using machines
The use of Loyada may be associated with side effects such as blurred vision, which may affect your ability to drive or operate machinery. Wait until you feel well and your vision has cleared before driving or operating machinery.
Loyada contains phosphates
This medicine contains 1.3 mg of phosphates per ml. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Loyada

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop of Loyada in the eye or eyes, once daily. Do not
use more drops or use the medicine more frequently than prescribed by your doctor.
Doing so may reduce the effectiveness of Loyada. Use Loyada in both eyes only if
your doctor has specifically instructed you to do so.
For ophthalmic use only. Do not swallow.
Avoid letting the tip of the multidose container touch the eye or surrounding areas. This could
cause eye injury. It may also become contaminated with bacteria that can lead to eye infections,
potentially causing serious eye damage, including loss of vision. To avoid possible
contamination of the multidose container, keep the tip of the container away from contact
with any surface.

Instructions for use
When used for the first time, before instilling a drop into the eye, practice using the bottle by gently pressing it to release one drop away from the eye.
Once you feel confident that you can release a single drop, choose the position that is most comfortable for instilling the eye drops (you may sit, lie on your back, or stand in front of a mirror).

When starting a new bottle:
Do not use the bottle if the pouch is damaged or if the plastic tamper-evident ring around the neck of the bottle is missing or broken. Open the pouch along the dotted line. Record the date you opened the bottle in the space provided on the outer carton.

Each time you use Loyada:

1. Wash your hands.
2. When using the bottle for the first time, remove the tamper-evident ring from the cap by pulling the tab.
3. Open the bottle by removing the cap.

4. When using the bottle for the first time, discard the first drop.
5. Hold the bottle between your thumb and index finger.
6. Tilt your head backward or lie down. Place your hand on your forehead. Your index finger should be aligned with your eyebrow.

Take particular care to ensure that the tip of the dropper
does not touch the eye, the skin around the eye,
or your fingers, to prevent potential contamination
of the solution.

7. With your other hand, pull down the lower eyelid and look upward. Gently press the bottle to release one drop into the space between the lower eyelid and the eye. Note that there may be a slight delay between pressing and the drop coming out. Do not press too hard.

8. Close your eye and press gently on the inner corner of the eye with your finger for about one minute. This helps prevent the eye drop from draining through the tear duct.
9. Wipe away any excess solution from the skin around the eye to reduce the risk of skin darkening of the eyelids.
10. Shake the bottle once downward to remove any residual solution from the tip. Do not touch or wipe the tip.
11. Replace the cap and close the bottle securely.

There will be approximately 1 ml of residual volume remaining in the bottle that cannot be dispensed. Do not attempt to empty the bottle.
If the drop does not enter the eye, repeat the procedure.
If your doctor has prescribed you to apply the eye drops in both eyes, repeat steps 7 to 9 for the other eye.
If you are using other eye medications, wait at least 5 minutes between applying Loyada and the other medication.
If you use more Loyada than you should, you may experience dizziness, headache, heart-related symptoms, or breathing problems. If necessary, consult your doctor.
If the medicine is accidentally swallowed, seek advice from your doctor.
If you forget to use Loyada, apply one drop as soon as you remember, then return to your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose. Do not use a double dose to make up for the forgotten dose.
Do not stop using Loyada without first consulting your doctor. If you stop treatment with Loyada, the pressure inside the eye will rise again, which may cause permanent eye damage.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Most side effects are not serious.
You can usually continue using the eye drops if the side effects are not severe. If you are concerned about anything, speak to your doctor or pharmacist.
The following are known side effects associated with the use of Loyada:
Common side effects (may affect up to 1 in 10 people):
Eye disorders
Eye itching. Eye irritation. Eye pain. Eye redness. Changes in the length, thickness, and number of eyelashes. Foreign body sensation in the eye. Change in eyelash colour. Light sensitivity. Blurred vision.
Uncommon side effects (may affect up to 1 in 100 people):
Nervous system disorders
Headache
Eye disorders
Dry eyes. Redness of the eyelids. Small pinpoint areas of inflammation on the eye surface. Increased tearing. Swollen eyelids. Tired eyes. Inflammation of the eyelids. Intraocular inflammation. Eye discomfort. Eye allergy. Eye inflammation. Abnormal eye sensitivity.
The following additional side effects have been observed during the use of the medicines
contained in Loyada (tafluprost and timolol) and may therefore also occur with the use of
Loyada:
The following side effects have been observed with tafluprost:
Eye disorders
Reduced ability of the eye to see fine details. Change in iris colour (sometimes permanent). Change in skin colour around the eyes. Swelling of the superficial membranes of the eye. Eye discharge. Pigmentation of the superficial membranes of the eye. Follicles on the superficial membranes of the eye. Sunken eye. Iritis/uveitis (inflammation of the coloured part of the eye). Macular edema/macular cystoid edema (swelling of the retina inside the eye leading to worsening of vision).
Skin disorders
Unusual growth of eyelash hair.
Effects on the respiratory system
Worsening of asthma, shortness of breath.
The following side effects have been observed with timolol:
Immune system disorders
Allergic reactions, including swelling of the subcutaneous tissues, urticaria, and skin rash. Sudden onset of a severe, life-threatening allergic reaction. Itching.
Metabolism and nutrition disorders
Low blood sugar levels.
Psychiatric disorders
Depression. Difficulty sleeping. Nightmares. Memory loss. Nervousness. Hallucination.
Nervous system disorders
Dizziness. Fainting. Unusual sensations (such as pins and needles). Worsening of signs and symptoms of severe myasthenia (a muscle disorder). Stroke. Reduced blood supply to the brain.
Eye disorders
Corneal inflammation. Reduced corneal sensitivity. Visual disturbances including changes in refraction (in some cases due to discontinuation of miotic therapy). Drooping of the upper eyelid. Double vision. Blurred vision and detachment of the layer beneath the retina containing blood vessels following filtering surgery, possibly leading to subsequent visual disturbances. Corneal erosion.
Ear disorders
Tinnitus (perception of a high-pitched sound in the ears).
Cardiac disorders
Slow heartbeat. Chest pain. Palpitations. Edema (fluid accumulation). Changes in heart rate or rhythm. Congestive heart failure (a heart condition characterized by shortness of breath and swelling of feet and legs due to fluid accumulation). A type of heart rhythm disorder. Heart attack. Heart failure.
Vascular disorders
Low blood pressure. Limping. Raynaud's phenomenon, cold hands and feet.
Respiratory disorders
Narrowing of the airways in the lungs (mainly in patients with pre-existing disease). Difficulty breathing. Cough.
Gastrointestinal disorders
Nausea. Indigestion. Diarrhea. Dry mouth. Taste alterations. Abdominal pain. Vomiting.
Skin disorders
Hair loss. Rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis. Rash.
Musculoskeletal disorders
Muscle pain not due to physical exercise. Joint pain.
Reproductive system and breast disorders
Peyronie's disease (may cause curvature of the penis). Sexual dysfunction. Decreased libido.
General disorders
Muscle weakness/tiredness. Thirst.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: 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 Loyada

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle, on the pouch and on the carton after "Exp.". The expiry date refers to the last day of that month.
Store the bottles in a refrigerator (2°C - 8°C). Do not freeze.
Keep the bottle in its original packaging to protect it from light.

After first opening of the bottle:

• Do not store above 25°C. Do not freeze.
• Keep the bottle without the pouch in the original packaging to protect the medicine from light.
• After first opening, to prevent infections, discard the bottle no later than 3 months. The bottle with a fill volume of 3 mL is intended for a 1-month period of use, the bottle with a fill volume of 5 mL for a 2-month period, and the bottle with a fill volume of 7 mL for a 3-month period.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Loyada contains

• The active substances are tafluprost and timolol. 1 ml of solution contains 15 micrograms of tafluprost and 5 mg of timolol.
• The other components are glycerol, disodium phosphate dodecahydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH), and water for injections.

Description of the appearance of Loyada and contents of the pack
Loyada is a clear, colourless liquid (solution), practically free from visible particles. It is supplied
in a pack containing 1 transparent plastic bottle with 3 mL, 5 mL or 7 mL, or 3 transparent plastic bottles
each containing 3 mL of solution. The plastic bottles are closed with a cap.
Each bottle is packed in a pouch.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Santen Italy S.r.l.
Via Roberto Lepetit, 8/10
20124 Milano
ITALY

Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
FINLAND

This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Taptiqom
Austria, Belgium, Bulgaria, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece,
Iceland, Ireland, Latvia, Lithuania, Luxembourg, Norway, Netherlands, Poland, Portugal, United
Kingdom, Czech Republic, Slovakia, Slovenia, Spain, Sweden, Hungary.
Taptiqom Multi: Poland
Loyada: Italy

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency.

Patient Information Leaflet

Loyada 15 micrograms/ml + 5 mg/ml

Eye drops, solution in single-dose container
Tafluprost/Timolol
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Loyada is and what it is used for

What type of medicine is it and how does it work?
Loyada eye drops contains tafluprost and timolol. Tafluprost belongs to a group of medicines called prostaglandin analogues, and timolol belongs to a group of medicines called beta-blockers.
Tafluprost and timolol work together to reduce the pressure inside the eye. Loyada is used when the pressure inside the eye is too high.
What is this medicine used for?
Loyada is used to treat a type of glaucoma called open-angle glaucoma, as well as a condition known as ocular hypertension in adults. Both conditions are associated with increased pressure inside the eye and, over time, may impair vision.

2. What you need to know before using Loyada

Do not use Loyada

• if you are allergic to tafluprost, 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 pulmonary disease (a serious lung condition that may cause wheezing, difficulty breathing, and/or persistent cough)
• if you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeats).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Loyada.
Tell your doctor before using this medicine if you have or have previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure
• heart rate disorders such as a slow heartbeat
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• a disease characterized by poor blood circulation (e.g. Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol may mask the signs and symptoms of low blood sugar
• overactive thyroid gland, as timolol may mask signs and symptoms of thyroid disease
• allergies or any type of anaphylactic reactions
• myasthenia gravis (a rare disease causing muscle weakness)
• other eye diseases; for example, corneal disease (the transparent tissue covering the front part of the eye) or a condition requiring eye surgery.

Tell your doctor if you have

• kidney problems
• liver problems.

Please note that Loyada may cause the following effects, some of which may be permanent:

• Loyada may increase the length, thickness, pigmentation, and/or number of eyelashes and may cause unusual growth of eyelid hair.
• Loyada may cause darkening of the skin around the eyes. Remove any residual solution from the skin. This will help minimize the risk of skin darkening.
• Loyada may change the color of the iris (the colored part of the eye). If Loyada is applied to only one eye, the color of the treated eye may become permanently different from the untreated eye.
• Loyada may cause hair growth in areas where the solution repeatedly comes into contact with the skin.

Before undergoing surgery, inform your doctor that you are using Loyada, as
timolol may alter the effects of certain medicines used during anesthesia.
Children and adolescents
The use of Loyada is not recommended in children and adolescents under 18 years of age due to
lack of safety and efficacy data in this age group.
For athletes: using this medicine without therapeutic need constitutes doping and may
lead to a positive anti-doping test.
Other medicines and Loyada
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Loyada may alter the effect of other medicines, or the effect of Loyada may be altered by
other medicines.
In particular, inform your doctor if you are using or plan to use:

• other eye drops for the treatment of glaucoma
• medicines to lower blood pressure
• medicines for heart conditions
• medicines to treat diabetes
• quinidine (used to treat heart conditions and certain types of malaria)
• antidepressants known as fluoxetine and paroxetine.

If you are using other eye medicines, wait at least 5 minutes between applying
Loyada and the other medicine.
Contact lenses
Remove contact lenses before using the eye drops and wait at least 15 minutes before reinserting them.
Pregnancy, breastfeeding, and fertility
If you are of childbearing age, you must use effective contraception during treatment with Loyada. Do not use
Loyada if you are pregnant. Do not use Loyada if you are breastfeeding. Consult your doctor.
Driving and using machines
The use of Loyada may be associated with side effects such as blurred vision, which may
affect your ability to drive or operate machinery. Wait until you feel well and your vision has cleared before driving or operating machinery.

3. How to use Loyada

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop of Loyada in the eye or eyes once daily. Do not
use more drops or use the medicine more frequently than prescribed by your doctor.
Doing so may make Loyada less effective.
Use Loyada in both eyes only if your doctor has instructed you to do so. Immediately discard any opened
containers and any unused product after use.
For ocular use only. Do not swallow.

Avoid letting the single-dose container come into contact with the eye or surrounding area. This could
cause eye damage. The single-dose container may also become contaminated by bacteria that can cause
ocular infections, which may lead to serious eye injuries and even loss of vision. To prevent contamination
of the single-dose container, ensure the tip does not touch any surface.
Instructions for use:
When opening a new pouch:
Do not use the single-dose container if the pouch is damaged. Open the pouch along the dotted line.
Write the date of opening on the space provided on the pouch.
Each time you use Loyada:

1. Wash your hands.
2. Remove the strip of containers from the pouch.
3. Detach one single-dose container from the strip.
4. Return the remaining strip to the pouch and fold the edge of the pouch to reseal it.
5. To open the container, remove the tab by twisting it. (Figure A).
6. Hold the container between your thumb and index finger. Ensure the tip of the container does not extend more than 5 mm beyond the index finger. (Figure B).
7. Tilt your head backward or lie down. Rest your hand on your forehead. Your index finger should be aligned with the eyebrow or resting on the bridge of the nose. Look upward. With the other hand, gently pull down the lower eyelid. Be careful to avoid letting any part of the container touch the eye or the area around the eye. Gently squeeze the container and let one drop fall into the space between the eyelid and the eye. (Figure C).
8. Close the eye and press with your finger on the inner corner of the eye for about two minutes. This will help prevent the eye drop from draining through the tear duct. (Figure D).
9. Wipe away any solution remaining on the skin around the eye. If the drop does not enter the eye, repeat the procedure.

If your doctor has prescribed you to apply the eye drop in both eyes, repeat steps 7 to
9 for the other eye.
One single-dose container contains enough solution for both eyes. After use, immediately discard the opened
container and any remaining medicine.
If you are using other eye medications, wait at least 5 minutes between the administration of
Loyada and the application of the other medication.
If you use more Loyada than you should, you may experience dizziness or develop headache, heart-related
symptoms, or breathing problems. If necessary, consult your doctor.
If the medicine is accidentally swallowed, consult your doctor.
If you forget to use Loyada, apply one drop as soon as you remember, then return to your regular
dosing schedule. However, if the next dose is due soon, skip the missed dose. Do not use a double
dose to make up for a forgotten dose.
Do not stop using Loyada without first consulting your doctor. If you stop treatment with Loyada,
the pressure inside the eye will rise again. This may cause permanent eye damage.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
In most cases, side effects are not serious.
You can usually continue using the eye drops if the side effects are not severe. If you are concerned about anything, consult your doctor or pharmacist.

The following are known side effects associated with the use of Loyada:

Common side effects
The following side effects may affect up to 1 in 10 people:
Eye disorders
Itchy eyes. Eye irritation. Eye pain. Eye redness. Changes in the length, thickness, and number of eyelashes.
Sensation of a foreign body in the eye. Change in eyelash colour. Light sensitivity. Blurred vision.

Uncommon side effects
The following side effects may affect up to 1 in 100 people:
Nervous system disorders
Headache

Eye disorders
Dry eyes. Redness of the eyelids. Small pinpoint areas of inflammation on the surface of the eye. Increased tearing. Swollen eyelids. Tired eyes. Inflammation of the eyelids. Inflammation inside the eye. Eye discomfort. Eye allergy. Eye inflammation. Abnormal eye sensitivity.

The following additional side effects have been observed during the use of the active substances in Loyada (tafluprost and timolol) and may therefore also occur with the use of Loyada:

The following side effects have been observed with tafluprost:

Eye disorders
Reduced ability of the eye to see details. Change in iris colour (sometimes permanent). Change in skin colour around the eyes. Swelling of the superficial membranes of the eye. Eye discharge. Pigmentation of the superficial membranes of the eye. Follicles on the superficial membranes of the eye. Sunken eye. Iritis/uveitis (inflammation of the coloured part of the eye). Macular edema/cystoid macular edema (swelling of the retina inside the eye leading to worsening of vision).

Skin disorders
Unusual growth of eyelash hair.

Respiratory effects
Worsening of asthma, shortness of breath.

The following side effects have been observed with timolol:

Immune system disorders
Allergic reactions, including swelling of subcutaneous tissues, urticaria, and skin rash. Sudden onset of a severe, life-threatening allergic reaction. Itching.

Metabolism and nutrition disorders
Low blood sugar levels.

Psychiatric disorders
Depression. Difficulty sleeping. Nightmares. Memory loss. Nervousness. Hallucination.

Nervous system disorders
Dizziness. Fainting. Unusual sensations (such as pins and needles). Worsening of signs and symptoms of myasthenia gravis (a muscle disorder). Stroke. Reduced blood supply to the brain.

Eye disorders
Corneal inflammation. Reduced corneal sensitivity. Visual disturbances including changes in refraction (in some cases due to discontinuation of miotic therapy). Drooping of the upper eyelid. Double vision. Blurred vision and detachment of the layer beneath the retina containing blood vessels following filtering surgery, potentially leading to visual disturbances. Corneal erosion.

Ear disorders
Tinnitus (perception of a high-pitched sound in the ears).

Cardiac disorders
Slow heartbeat. Chest pain. Palpitations. Edema (fluid accumulation). Changes in heart rhythm or heart rate. Congestive heart failure (a heart condition characterized by shortness of breath and swelling of feet and legs due to fluid accumulation). A type of heart rhythm disorder. Heart attack. Heart failure.

Vascular disorders
Low blood pressure. Limping. Raynaud's phenomenon, cold hands and feet.

Respiratory disorders
Narrowing of the airways in the lungs (mainly in patients with pre-existing disease). Difficulty breathing. Cough.

Gastrointestinal disorders
Nausea. Indigestion. Diarrhea. Dry mouth. Taste disturbances. Abdominal pain. Vomiting.

Skin disorders
Hair loss. Skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis. Skin rash.

Musculoskeletal disorders
Muscle pain not due to physical exercise. Joint pain.

Reproductive system and breast disorders
Peyronie's disease (may cause curvature of the penis). Sexual dysfunction. Decreased libido.

General disorders
Muscle weakness/tiredness. Thirst.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (the cornea) have developed opaque spots on the cornea due to calcium deposits during treatment.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Loyada

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the single-dose container, on the
aluminium pouch, and on the outer carton after "Exp.". The expiry date refers to the last day of that month.
Keep the sealed aluminium pouches in the refrigerator (2°C - 8°C). Do not open the pouch until the time comes to start using the eye drops, as unused containers contained in an opened pouch must be discarded 28 days after the first opening of the pouch.

After opening the aluminium pouch:

• Store the single-dose containers in the original aluminium pouch to protect the medicine from light.
• Do not store above 25°C.
• Discard all unused single-dose containers 28 days after the first opening of the aluminium pouch.
• Immediately after use, dispose of any opened single-dose containers and any remaining solution.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Loyada contains

• The active substances are tafluprost and timolol. 1 ml of solution contains 15 micrograms of tafluprost and 5 mg of timolol.
• The other components are glycerol, disodium phosphate dodecahydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH), and water for injections.

Description of the appearance of Loyada and contents of the pack
Loyada is a clear, colourless liquid (solution) supplied in single-dose plastic containers, each containing 0.3 ml of solution. Each pouch contains 10 single-dose containers. Loyada is available in packs of 30 or 90 single-dose containers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Santen Italy S.r.l.
Via Roberto Lepetit, 8/10
20124 Milano (ITALY)

Manufacturer
Santen Oy - Kelloportinkatu 1, 33100 Tampere, Finland
Laboratoire Unither – ZI de la Guérie, 50211 Coutances Cedex, France

This medicinal product is authorised in the European Economic Area member states under the following names:
Taptiqom:
Austria, Belgium, Bulgaria, Cyprus, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Iceland, Latvia, Lithuania, Luxembourg, Norway, Netherlands, Poland, Portugal, United Kingdom, Czech Republic, Slovakia, Slovenia, Spain, Sweden, Hungary
Loyada: Italy

More detailed information on this medicinal product is available on the website of AIFA.