Zitodor

Patient Information Leaflet: Information for the User

ZITODOR

20mg/ml + 5mg/ml
eye drops, solution
dorzolamide + 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ZITODOR is and what it is used for

ZITODOR contains two active substances: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers". These medicines lower eye pressure in different ways. ZITODOR is prescribed to reduce pressure in the eye in the treatment of glaucoma when therapy with beta-blocker eye drops alone is not sufficient.

2. What you need to know before using ZITODOR

Do not use ZITODOR:

• if you are allergic to the active substances (dorzolamide hydrochloride, timolol maleate) 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 or severe chronic obstructive pulmonary disease (severe lung disease that may cause shortness of breath, difficulty breathing and/or long-lasting cough);
• if you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeat);
• if you have severe kidney problems or severe renal impairment, or a history of kidney stones;
• if you suffer from excess acidity in the blood caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).

Warnings and precautions
Talk to your doctor or pharmacist before using ZITODOR if you have or have previously had:

• cardiovascular diseases (coronary heart disease), whose symptoms may include chest pain or tightness, shortness of breath or suffocation, heart failure, low blood pressure; heart rate abnormalities such as slow heartbeat;
• respiratory problems, asthma, or chronic obstructive lung disease;
• poor blood circulation (such as Raynaud's disease or syndrome);
• diabetes, because timolol, one of the two active substances in ZITODOR, may mask the signs and symptoms of low blood sugar (hypoglycemia);
• overactivity of a gland called the thyroid, because timolol may mask its signs and symptoms.

Inform your doctor:

• if you are using ZITODOR and need to undergo surgery, as timolol may alter the effect of certain medicines used during anesthesia;
• if you have been diagnosed with myasthenia gravis (muscle weakness);
• if you develop eye irritation or any new eye problems, such as redness or swelling of the eyelids; in such cases, contact your doctor immediately;
• if you develop an eye infection, suffer an eye injury, undergo eye surgery, or experience other reactions including new symptoms or worsening of pre-existing symptoms.

Instillation of ZITODOR into the eye may have effects on the whole body.
Children and adolescents
Experience with ZITODOR in neonates and children is limited.
Use in the elderly
In studies with Dorzolamide Timololo, the effects of the combination of the two active substances were similar in elderly and younger patients.
Use in patients with impaired liver function (hepatic impairment)
Inform your doctor if you have any liver problems or have previously suffered from liver disease.
If you engage in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and ZITODOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
ZITODOR may affect or be affected by other medicines, including other eye drops used to treat glaucoma.
Tell your doctor if you are taking or plan to take other medicines to lower blood pressure, treat heart conditions (heart diseases), or treat diabetes.
Talk to your doctor if:

• you are taking medicines to lower blood pressure or to treat heart diseases (such as calcium antagonists, beta-blockers, or digoxin);
• you are taking medicines to treat heart rhythm disorders or irregularities (such as calcium antagonists, beta-blockers, or digoxin);
• you are using another eye drop containing an active substance belonging to the class of “beta-blockers”; consult your doctor for further information;
• you are taking another medicine used for high eye pressure (a carbonic anhydrase inhibitor, such as acetazolamide);
• you are taking medicines called “monoamine oxidase inhibitors (MAOIs)”, used to treat depression;
• you are taking a medicine belonging to the class of “parasympathomimetics” prescribed to promote fluid loss (diuresis). “Parasympathomimetics” are a specific type of medicine sometimes used to restore normal bowel movements;
• you are taking medicines called “narcotics” such as morphine, used to treat severe pain;
• you are taking medicines to treat diabetes;
• you are taking antidepressants known as fluoxetine and paroxetine;
• you are taking antibiotics called “sulfonamides”;
• you are taking “quinidine”, used to treat heart disorders and certain types of malaria.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use during pregnancy
ZITODOR must not be used during pregnancy.
Use during breastfeeding
Do not use ZITODOR if you are breastfeeding. Timolol may pass into breast milk.
Driving and using machines
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery. However, side effects associated with the use of ZITODOR, such as blurred vision, may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel better or your vision is clear.
ZITODOR contains benzalkonium chloride
ZITODOR, eye drops, solution in multidose bottle contains 0.075 mg per ml of benzalkonium chloride.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outer layer of the eye). If you experience an unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use ZITODOR

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The appropriate dose and duration of treatment will be determined by your doctor.
The recommended dose is one drop of ZITODOR in the affected eye or eyes, morning and evening.
If you are using other eye drops at the same time, ZITODOR and the other medicine
should be administered at least 10 minutes apart.
Do not change the dose of this medicine without consulting your doctor.
Avoid letting the bottle cap touch the eye or the area around the eye. It may become contaminated with bacteria
that can cause eye infections, leading to serious eye damage, including loss of vision.
To avoid possible contamination, wash your hands before using this medicine and avoid contact between the dropper bottle and any surface.
If you think the medicine may be contaminated or if you develop an eye infection, contact
your doctor immediately before continuing to use this bottle.

Instructions for use

• Wash your hands and sit or stand comfortably.
• Remove the cap with a gentle twisting motion.
• Tilt your head backward and gently pull down the lower eyelid to create a small pocket between the eyelid and the eye.
• Hold the dropper tip close to the eye without touching it.
• Gently squeeze the bottle so that a single drop falls into the eye, as prescribed by your doctor, then release the lower eyelid.
• Close the eye and press gently with one finger on the inner corner of the eye for about two minutes. This helps prevent the eye drop from draining through the tear duct and reduces the chance of the medicine entering the rest of the body.
• Repeat the procedure in the other eye, if your doctor has instructed you to do so.
• Replace the cap tightly. Do not over-tighten to avoid damaging the bottle or cap.
• The dropper is calibrated to deliver a single drop; therefore, DO NOT enlarge the dropper opening.

If you use more ZITODOR than you should
If you instill too many drops into the eye or swallow the contents of the bottle, you may feel dizzy, have difficulty breathing, or notice a slowed heartbeat. Seek immediate medical attention.

If you forget to use ZITODOR
Do not use a double dose to make up for the missed dose.
It is important that you use ZITODOR as prescribed by your doctor. If you miss a dose, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule.

If you stop using ZITODOR
If you have any questions about using this medicine, consult your doctor or pharmacist.
If you wish to discontinue treatment, discuss it with your doctor first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other eye medicines, timolol is absorbed into the bloodstream through the blood vessels and distributed throughout the body. This may cause side effects similar to those observed with medicines of the same class (beta-blocking agents) taken orally. The incidence of side effects with this medicine after ocular administration is lower than with oral or injectable administration.
If you experience allergic reactions including swelling of the face causing difficulty in breathing or swallowing, swelling of the limbs causing difficulty in breathing or swallowing, hives or itchy rash, localized and generalized skin rash, itching, or a sudden and severe life-threatening allergic reaction, you must stop using this medicine and seek immediate medical help.

The frequency of the possible side effects listed below is defined according to the following convention:
Very common (affects more than 1 in 10 people)
Common (affects from 1 to 10 in 100 people)
Uncommon (affects from 1 to 10 in 1,000 people)
Rare (affects from 1 to 10 in 10,000 people)
Not known (frequency cannot be estimated from the available data)

The following adverse reactions have been reported with dorzolamide timolol eye drops or one of its components, both during clinical studies and post-marketing experience:

Very common (may affect more than 1 in 10 people)

• burning and stinging pain in the eyes
• taste disturbance

Common (may affect up to 1 in 10 people)

• headache
• redness inside and around the eye, tearing or eye itching, corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation inside and around the eyes, sensation of a foreign body in the eye, reduced corneal sensitivity (inability to realize something is in the eye or to feel pain), eye pain, dry eyes, blurred vision
• sinusitis (feeling of pressure or fullness in the nose)
• weakness/tiredness and fatigue

Uncommon (may affect up to 1 in 100 people)

• depression
• dizziness, fainting
• inflammation of the part of the eye called the iris, visual disturbances (including changes in refraction due to discontinuation of miotic therapy in some cases)
• slow heart rate
• shortness of breath (dyspnea)
• indigestion
• kidney stones

Rare (may affect up to 1 in 1,000 people)

• allergic-type reactions such as skin rash, hives, itching, rarely swelling of lips, eyes and mouth, breathlessness or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• sleep disorders, nightmares, memory loss
• cerebral ischemia (reduced blood flow to the brain), worsening of symptoms of myasthenia gravis (a muscle disease), decreased sexual desire, tingling or numbness of hands or feet
• temporary myopia which may resolve upon discontinuation of treatment, detachment of the layer beneath the retina containing blood vessels following filtering surgery which may cause visual disturbances due to fluid accumulation, drooping of the eyelids, double vision, formation of crusts on the eyelids, corneal edema (with symptoms of visual disturbances), low eye pressure
• ringing in the ears
• changes in rhythm or rate of heartbeat, congestive heart failure (a heart condition with shortness of breath and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), chest pain, strong heartbeat which may be rapid or irregular (palpitations), heart attack, low blood pressure, excessive constriction of blood vessels (Raynaud's phenomenon), swollen and cold hands and feet, reduced circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), stroke
• shortness of breath, impaired lung function, stuffy or runny nose, nosebleeds, narrowing of airways in the lungs, cough
• throat irritation, dry mouth, diarrhea
• skin inflammation due to contact with certain substances (contact dermatitis), hair loss, skin rash with silvery appearance (psoriasiform rash)
• systemic lupus erythematosus (an immune disease that may cause inflammation of internal organs)
• Peyronie's disease (which may cause curvature of the penis)

Not known (frequency cannot be estimated from the available data)

• sensation of a foreign body in the eye (feeling that something is in the eye)
• increased heart rate
• increased blood pressure
• abnormal sensitivity of the eyes to light

The side effects listed include reactions observed within the class of ophthalmic beta-blockers:

Not known (frequency cannot be estimated from the available data)

• low blood sugar levels (hypoglycemia)
• heart failure, a type of heart rhythm disorder
• abdominal pain, vomiting
• muscle pain not due to physical exercise
• sexual dysfunction
• hallucinations

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 the website: http://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 ZITODOR

Keep this medicine out of the sight and reach of children.
Store the medicine in its original packaging to protect it from light.
Do not use this medicine after the expiry date (EXP) stated on the outer carton and on the bottle. The expiry date refers to the last day of the month.
After first opening the bottle, store the medicine at a temperature not exceeding 25°C and use it within 28 days; after this period, dispose of any remaining medicine.
Record the date of first opening in the dedicated space provided on the box.
Medicines must not be disposed of 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

1 ml of solution contains:

• The active substances are: dorzolamide 20 mg (equivalent to dorzolamide hydrochloride 22.26 mg), timolol 5.00 mg (equivalent to timolol maleate 6.83 mg).
• The other components are: mannitol, sodium citrate, hydroxyethylcellulose, benzalkonium chloride, sodium hydroxide, water for injections.

Description of the appearance of ZITODOR and contents of the pack
Polyethylene bottle. Pack containing 1 bottle of 5.0 ml.
Marketing Authorization Holder
Visufarma S.p.A., Via Alberto Cadlolo 21, 00136 Rome
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)
This leaflet was last approved on:

Package leaflet: Information for the user

ZITODOR

20mg/ml + 5mg/ml
eye drops, solution
dorzolamide + 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ZITODOR is and what it is used for

ZITODOR contains two active substances: dorzolamide and timolol.

• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers". These medicines reduce intraocular pressure in different ways. ZITODOR is prescribed to lower intraocular pressure in the treatment of glaucoma when therapy with a beta-blocker eye drop alone is not sufficient.

2. What you need to know before using ZITODOR

Do not use ZITODOR:

• if you are allergic to the active substances (dorzolamide hydrochloride, timolol maleate) 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 or severe chronic obstructive bronchitis (severe lung disease that may cause breathlessness, difficulty breathing and/or long-lasting cough);
• if you have a slow heartbeat, heart failure, or heart rhythm disorders (irregular heartbeat);
• if you have severe kidney problems or severe renal impairment, or a history of kidney stones;
• if you suffer from excess blood acidity caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).

Warnings and precautions
Talk to your doctor or pharmacist before using ZITODOR if you have or have previously had:

• cardiovascular diseases (coronary heart disease), whose symptoms may include chest pain or tightness, shortness of breath or suffocation, heart failure, low blood pressure; heart rate abnormalities such as slow heartbeat;
• respiratory problems, asthma, or chronic obstructive lung disease;
• poor blood circulation (such as Raynaud's disease or syndrome);
• diabetes, as timolol, one of the two active substances in ZITODOR, may mask the signs and symptoms of low blood sugar (hypoglycaemia);
• overactivity of a gland called the thyroid, as timolol may mask its signs and symptoms.

Inform your doctor:

• if you are using ZITODOR and need to undergo surgery, as timolol may alter the effect of certain medicines used during anaesthesia;
• if you have been diagnosed with myasthenia gravis (muscle weakness);
• if you develop eye irritation or any new eye problems, such as redness or swelling of the eyelids; in such cases, contact your doctor immediately;
• if you develop an eye infection, suffer an eye injury, undergo eye surgery, or experience other reactions including new symptoms or worsening of pre-existing symptoms.

Instillation of ZITODOR into the eye may have effects on the whole body.
Children and adolescents
Experience with ZITODOR in neonates and children is limited.
Use in the elderly
In studies with Dorzolamide Timolol, the effects of the combination of the two active substances were similar in elderly and younger patients.
Use in patients with impaired liver function (hepatic impairment)
Inform your doctor if you have any liver problems or have previously suffered from liver disease.
If you are an athlete: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and ZITODOR
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
ZITODOR may affect or be affected by other medicines, including other eye drops used to treat glaucoma.
Inform your doctor if you are taking or intend to take other medicines to lower blood pressure, to treat heart diseases, or to treat diabetes.
Talk to your doctor if:

• you are taking medicines to lower blood pressure or to treat heart diseases (such as calcium antagonists, beta-blockers, or digoxin);
• you are taking medicines to treat heart rhythm disorders or irregularities (such as calcium antagonists, beta-blockers, or digoxin);
• you are using another eye drop containing an active substance belonging to the class of “beta-blockers”; consult your doctor for further information;
• you are taking another medicine used for high eye pressure (a carbonic anhydrase inhibitor, such as acetazolamide);
• you are taking medicines called “monoamine oxidase inhibitors (MAOIs)” used to treat depression;
• you are taking a medicine belonging to the class of “parasympathomimetics” prescribed to promote fluid loss (diuresis). “Parasympathomimetics” are a specific type of medicine sometimes used to restore normal bowel movements;
• you are taking medicines known as “narcotics” such as morphine, used to treat severe pain;
• you are taking medicines to treat diabetes;
• you are taking antidepressants known as fluoxetine and paroxetine;
• you are taking antibiotics called “sulfonamides”;
• you are taking “quinidine” used to treat heart disorders and certain types of malaria.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Use during pregnancy
ZITODOR must not be used during pregnancy.
Use during breastfeeding
Do not use ZITODOR if you are breastfeeding. Timolol may pass into breast milk.
Driving and using machines
No studies have been conducted on the effects of this medicine on the ability to drive or use machines. However, side effects associated with the use of ZITODOR, such as blurred vision, may affect your ability to drive and/or use machines. Do not drive or operate machinery until you feel better or your vision is clear.

3. How to use ZITODOR

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The appropriate dose and duration of treatment will be determined by your doctor.
The recommended dose is one drop of ZITODOR in the eye or eyes to be treated, administered in the morning and in the evening.
If you are using other eye drops at the same time, ZITODOR and the other medication should be administered at least 10 minutes apart.
Do not change the dose of this medicine without consulting your doctor.
Avoid letting the container cap touch the eye or the area around the eye. It may become contaminated with bacteria that can cause eye infections, potentially leading to serious eye damage, including loss of vision.
To avoid possible contamination, wash your hands before using this medicine and avoid contact between the container and any surface.

Instructions for use

• Wash your hands and sit or stand comfortably.
• Remove one vial from the strip and unscrew the cap with a slight twist.
• Tilt your head backward and gently pull down the lower eyelid to create a small pocket between the eyelid and the eye.
• Hold the tip of the vial close to the eye without touching it.
• Gently squeeze the vial so that a single drop falls into the eye, as prescribed by your doctor, then release the lower eyelid.
• Close the eye and press gently with a finger on the inner corner of the affected eye for about two minutes. This helps prevent the eye drop from draining into the tear duct and reduces the risk of the medicine entering the rest of the body.
• Repeat the procedure in the other eye if your doctor has instructed you to do so.
• Discard the vial and any remaining contents immediately after use.

If you use more ZITODOR than you should
If you instill too many drops into the eye or accidentally swallow the contents of the vial, you may feel dizzy, have difficulty breathing, or notice a slowed heartbeat. Seek immediate medical attention.
If you forget to use ZITODOR
Do not use a double dose to make up for a forgotten dose.
It is important that you use ZITODOR as prescribed by your doctor. If you miss a dose, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule.
If you stop using ZITODOR
If you have any questions about using this medicine, consult your doctor or pharmacist.
If you wish to stop treatment, discuss it with your doctor first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
As with other eye medicines, timolol is absorbed into the bloodstream through the blood vessels and distributed throughout the body. This may cause side effects similar to those observed with medicines of the same class (beta-blockers) taken orally. The incidence of side effects with this medicine after ocular administration is lower than with oral or injectable administration.
If you experience allergic reactions including swelling of the face causing difficulty breathing or swallowing, or swelling of the limbs causing difficulty breathing or swallowing, hives or itchy skin rash, localized and generalized skin rash, itching, or a sudden severe and life-threatening allergic reaction, you must stop using this medicine and seek immediate medical help.

The frequency of the possible side effects listed below is defined according to the following convention:
Very common (affects more than 1 in 10 people)
Common (affects from 1 to 10 in 100 people)
Uncommon (affects from 1 to 10 in 1,000 people)
Rare (affects from 1 to 10 in 10,000 people)
Not known (frequency cannot be estimated from the available data)

The following adverse reactions have been reported with dorzolamide timolol eye drops or one of its components, both during clinical studies and post-marketing experience:

Very common (may affect more than 1 in 10 people)

• burning and stinging pain in the eyes
• altered taste

Common (may affect up to 1 in 10 people)

• headache

• redness inside and around the eye, tearing or eye itching, corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation inside and around the eyes, sensation of a foreign body in the eye, reduced corneal sensitivity (inability to notice something in the eye or to feel pain), eye pain, dry eyes, blurred vision

• sinusitis (feeling of pressure or fullness in the nose)

• weakness/tiredness and fatigue

Uncommon (may affect up to 1 in 100 people)

• depression
• dizziness, fainting
• inflammation of the part of the eye called the iris, visual disturbances (including changes in refraction due to, in some cases, discontinuation of miotic therapy)
• slow heart rate
• shortness of breath (dyspnea)
• indigestion
• kidney stones

Rare (may affect up to 1 in 1,000 people)

• allergic-type reactions such as skin rash, urticaria, itching, rarely swelling of lips, eyes and mouth, breathlessness or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• sleep disorders, nightmares, memory loss
• cerebral ischemia (reduced blood flow to the brain), increased manifestations and symptoms of myasthenia gravis (a muscle disease), decreased sexual desire, tingling or numbness in hands or feet
• temporary myopia which may resolve upon discontinuation of treatment, detachment of the layer beneath the retina containing blood vessels following filtering surgery, which may cause visual disturbances due to fluid accumulation, drooping eyelids, double vision, crusting of the eyelids, corneal edema (with symptoms of visual disturbances), low eye pressure
• ringing in the ears (tinnitus)
• changes in heart rhythm or heart rate, congestive heart failure (a heart condition with shortness of breath and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), chest pain, strong heartbeat which may be rapid or irregular (palpitations), heart attack, low blood pressure, excessive constriction of blood vessels (Raynaud's phenomenon), swollen and cold hands and feet, reduced circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), stroke
• shortness of breath, impaired lung function, nasal congestion or runny nose, nosebleeds, airway constriction in the lungs, cough
• sore throat, dry mouth, diarrhea
• skin inflammation due to contact with certain substances (contact dermatitis), hair loss, skin rash with a silvery appearance (psoriasiform rash)
• systemic lupus erythematosus (an autoimmune disease that may cause inflammation of internal organs)
• Peyronie's disease (which may cause curvature of the penis)

Not known (frequency cannot be estimated from the available data)

• sensation of a foreign body in the eye (feeling that something is in the eye)
• increased heart rate
• increased blood pressure
• abnormal sensitivity of the eyes to light

The listed side effects include reactions observed within the class of ophthalmic beta-blockers:

Not known (frequency cannot be estimated from the available data)

• low blood sugar levels (hypoglycaemia)
• heart failure, a type of heart rhythm disorder
• abdominal pain, vomiting
• muscle pain not due to physical exercise
• sexual dysfunction
• hallucinations

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 the following website: 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 ZITODOR

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
After first opening the aluminium sachet: store at a temperature below 25°C and
use within 7 days; any remaining containers must be discarded.
The single-dose container must be used immediately after opening; any leftover medicine must be discarded.

6. Package contents and other information

1 ml of solution contains:

• The active substances are: dorzolamide 20 mg (equivalent to dorzolamide hydrochloride 22.26 mg), timolol 5.00 mg (equivalent to timolol maleate 6.83 mg).
• The other components are: mannitol, sodium citrate, hydroxyethylcellulose, sodium hydroxide, water for injections.

Description of the appearance of ZITODOR and contents of the pack
Single-dose container made of polyethylene. Pack containing 30 single-dose containers of 0.166 ml.
Marketing Authorization Holder
Visufarma S.p.A., Via Alberto Cadlolo 21, 00136 Rome
Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)
This leaflet was last approved on: