TIDOCOMB 2% + 0.5% Eye drops, solution

Зміст інструкції

1. TIDOCOMB 20 mg/ml + 5 mg/ml
   1. What is TIDOCOMB and what it is used for
   2. What you need to know before using TIDOCOMB
   3. How to use TIDOCOMB
   4. Possible side effects
   5. How to store TIDOCOMB
   6. Contents of the pack and other information
2. TIDOCOMB 20 mg/ml + 5 mg/ml
   1. What is TIDOCOMB and what is it used for
   2. What you need to know before using TIDOCOMB
   3. How to use TIDOCOMB
   4. Possible side effects
   5. How to store TIDOCOMB
   6. Contents of the pack and other information

TIDOCOMB 20 mg/ml + 5 mg/ml

eye drops, solution
Dorzolamide and Timolol
Generic Medicine
Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is TIDOCOMB and what it is used for

TIDOCOMB contains two active substances: dorzolamide and timolol.

• Dorzolamide belongs to the group of medicines called “carbonic anhydrase inhibitors”.
• Timolol belongs to the group of medicines called “beta-blockers”. These medicines lower the pressure in the eye in different ways. TIDOCOMB is prescribed to lower the pressure in the eye 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 TIDOCOMB

Do not use TIDOCOMB:

• if you are allergic to the active ingredients (dorzolamide hydrochloride, timolol maleate) or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have had respiratory problems such as asthma or severe chronic obstructive pulmonary disease (COPD), which can cause shortness of breath, difficulty breathing and/or long-lasting cough;
• if you have a slowed heartbeat, heart failure or irregular heartbeat

(irregular heartbeat);

• if you have severe kidney problems or severe kidney impairment, or a previous history of kidney stones;
• if you suffer from an excess of 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 TIDOCOMB if you suffer or have suffered in the past from:

• cardiovascular diseases (such as coronary heart disease, whose symptoms may include chest pain or a feeling of tightness, shortness of breath or suffocation, and heart failure) and low blood pressure;
• abnormal heart rate such as slowed heartbeat;
• respiratory problems, asthma or chronic obstructive pulmonary disease (COPD);
• poor blood circulation (such as Raynaud's disease or syndrome);
• diabetes, as timolol, one of the two active ingredients of TIDOCOMB, can mask the signs and symptoms of low blood sugar (hypoglycemia);
• hyperactivity of a gland called the thyroid, as timolol can mask its signs and symptoms.

Tell your doctor:

• if you are using TIDOCOMB and need to undergo surgery, as timolol can alter the effect of some medicines used during anesthesia;
• if you have been diagnosed with a muscle disease (myasthenia gravis);
• if you develop eye irritation or any new eye problems, such as redness or swelling of the eyelids, in which case 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 a worsening of existing symptoms. Instilling TIDOCOMBinto the eye can have effects on the whole body.

Children
Experience with TIDOCOMB in newborns and children is limited.

Use in the elderly
In studies with Dorzolamide/Timolol eye drops, solution, the effects of the combination of the two
active ingredients were similar in elderly and younger patients.

Use in patients with impaired liver function (hepatic impairment)
Tell your doctor if you have any liver problems or have suffered from them in the past.
For athletes: the use of the medicine without therapeutic necessity constitutes doping
and can still result in positive anti-doping tests.

Other medicines and TIDOCOMB
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

TIDOCOMBcan influence or be influenced by the use of other medicines, including other eye drops for the
treatment of glaucoma.
Tell your doctor if you are taking or intend to take other medicines to lower your
blood pressure, for the treatment of heart disease (cardiac diseases) or for the
treatment of diabetes.
Consult your doctor if:

• you are taking medicines to lower blood pressure or for the treatment of heart disease (such as calcium antagonists, beta-blockers or digoxin);
• you are taking medicines for the treatment of disorders or irregularities of the heartbeat (such as calcium antagonists, beta-blockers or digoxin);
• you are using another eye drop that contains an active ingredient that belongs to the class of “beta-blockers”;
• you are taking another medicine used for high eye pressure (carbonic anhydrase inhibitor, such as acetazolamide);
• you are taking medicines called “monoamine oxidase inhibitors (MAOIs)”, used for the treatment of depression;
• you are taking a medicine belonging to the class of “parasympathomimetics” prescribed to you to promote fluid loss (diuresis). “Parasympathomimetics” are a particular type of medicine sometimes used to restore normal bowel movements;
• you are taking medicines called “narcotics” such as morphine, used for the treatment of severe pain;
• you are taking medicines for the treatment of diabetes;
• you are taking antidepressants called “selective serotonin reuptake inhibitors” (SSRIs) such as fluoxetine and paroxetine;
• you are taking “quinidine” used for the treatment of heart disorders and some types of malaria.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Use in pregnancy
TIDOCOMB should not be used during pregnancy.
Use in breastfeeding
Do not use TIDOCOMB if you are breastfeeding. Timolol can pass into breast milk.

Driving and using machines
Studies have not been conducted on the effects of this medicine on the ability to drive or
use machines. However, there are side effects associated with the use of TIDOCOMB, such as blurred vision,
which may alter your ability to drive and/or use machines. Do not drive or use
machinery until you feel better or your vision is clear.

TIDOCOMB contains benzalkonium chloride
This medicine contains 0.075 mg of benzalkonium chloride per ml of solution.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
changing their color. Remove your contact lenses before using this medicine and wait
15 minutes before re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the most superficial transparent layer of the eye). If you experience an abnormal
sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use TIDOCOMB

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

Instructions for use

• Wash your hands and sit, or stand, comfortably.
• Remove the cap with a light rotation.
• Tilt your head back and gently pull down the lower eyelid, so as to form a pocket between the eyelid and the eye.
• Position the tip of the bottle near the eye without touching it.
• Exert a slight pressure on the bottle so that a single drop goes inside the eye, as prescribed by your doctor, then release the lower eyelid.
• Close your eye and press with your finger on the inner corner of the eye for about two minutes. This helps to prevent the medicine from passing into the rest of the body.
• Repeat the operation also in the other eye, if your doctor has told you to do so.
• Screw the cap back on tightly. Do not tighten excessively to avoid damaging the bottle and cap.
• The dropper is calibrated for the delivery of a single drop; therefore, DO NOT enlarge the hole of the dropper.

If you use more TIDOCOMB than you should
If you instill too many drops into the eye or ingest the contents of the bottle, you may feel dizzy,
have difficulty breathing or feel a slowing of your heartbeat. Seek medical attention
immediately.

If you forget to use TIDOCOMB
Do not use a double dose to make up for a missed dose.
It is important that you take TIDOCOMB as prescribed by your doctor. If you miss a dose, proceed
with the application as soon as possible. If, however, it is almost time for the next dose, skip the missed dose
and return to your regular dosing schedule.

If you stop using TIDOCOMB
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
If you wish to stop the treatment, talk to your doctor first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience allergic reactions including swelling of the face and limbs causing difficulty
breathing or swallowing, urticaria or itchy rash, localized and widespread skin rash, itching or a
severe, life-threatening sudden allergic reaction, you should stop using this medicine and seek
immediate medical help.
The following adverse reactions have been reported with Dorzolamide/Timolol eye drops, solution or
any of its components both during clinical studies and during post-marketing experience:

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

• burning and stinging (like a prick) in the eyes
• altered taste (dysgeusia) Common(may affect up to 1 in 10 people)
• headache
• redness inside and around the eye (conjunctival injection), watering or itching of the eye, damage to the anterior layer of the eyeball (corneal erosion), swelling and/or irritation inside and around the eyes, inability to realize you have something in your eyes

and to feel pain (reduced corneal sensitivity), eye pain, dry eyes,
blurred vision

• feeling of tension or fullness in the nose (sinusitis)
• nausea
• weakness/fatigue and tiredness 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)
• slowing of the heartbeat
• shortness of breath (dyspnea)
• difficulty digesting
• kidney stones Rare(may affect up to 1 in 1000 people)
• allergic-type reactions such as skin rash, urticaria, itching, rarely swelling of lips, eyes and mouth, difficulty breathing or severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis)
• sleep disturbances, nightmares, memory loss
• reduced blood flow to the brain (cerebral ischemia), increased manifestations and symptoms of myasthenia gravis (a disease of the muscles), decreased sexual desire, tingling or numbness in the hands or feet
• temporary myopia that may resolve upon discontinuation of treatment, detachment of the underlying layer of the retina containing blood vessels following filtering surgery, which can 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
• changes in the rhythm or speed of the heartbeat (arrhythmia), heart disease, with shortness of breath and swelling of the feet and legs due to fluid accumulation (congestive heart failure), fluid accumulation (edema), chest pain, fast and/or irregular heartbeat (palpitations), heart attack, low blood pressure, excessive constriction of blood vessels (Raynaud's phenomenon), swollen and cold hands and feet, reduced circulation to arms and legs, leg cramps and/or leg pain when walking (claudication)
• shortness of breath, impaired lung function, stuffy or runny nose, nosebleeds, constriction of the airways 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-white appearance (psoriasiform rash)
• an autoimmune disease that can cause inflammation of internal organs (systemic lupus erythematosus)
• Peyronie's disease (which can cause a curvature of the penis) Not known(frequency cannot be estimated based on the available data)
• hallucinations
• foreign body sensation in the eye (feeling that something is in the eye)
• strong heartbeat that may be fast or irregular (palpitations)
• increased heart rate
• increased blood pressure As with other eye medicines, timolol is absorbed by the blood vessels which distribute it throughout the body. This can cause side effects similar to those observed with medicines of the same group (beta-blockers) taken orally. The incidence of side effects with the medicine, after administration to the eyes, is lower than with oral or injectable administration. The side effects listed include reactions observed within the class of ophthalmic beta-blockers: Not known(frequency cannot be estimated based on the available data)
• low blood sugar levels (hypoglycemia)
• heart failure, a type of heart rate disorder
• abdominal pain, vomiting
• muscle pain not due to exercise (myalgia)
• sexual dysfunction

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

5. How to store TIDOCOMB

Keep this medicine out of the sight and reach of children.
Keep the medicine in the original package to protect it from light.
Do not use this medicine after the expiry date which is stated on the pack and the vial after
“Exp”. The expiry date refers to the last day of that month.
After the first opening of the vial, store the medicine at a temperature not exceeding
25°C and use it within 28 days; after this period, discard any remaining medicine.
Record the date of first opening in the designated space on the pack.
Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What TIDOCOMB contains:

• The active ingredients are: dorzolamide and timolol. 1 ml of solution contains 20 mg of dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (equivalent to 6.83 mg of timolol maleate).
• The other ingredients are: mannitol, sodium citrate, hydroxyethylcellulose, benzalkoniumchloride, sodium hydroxide, water for injections.

Description of TIDOCOMB and contents of the pack
Polyethylene bottle. Pack of 1 bottle containing 5.0 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Omikron Italia S.r.l., Viale Bruno Buozzi, 5 – 00197 Roma
Tel: +39 – 06 80693572
Fax: +39 – 06 80665266
e-mail: [email protected]

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

This leaflet was last updated on

TIDOCOMB 20 mg/ml + 5 mg/ml

eye drops, solution
Dorzolamide and Timolol
Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is TIDOCOMB and what is it used for

TIDOCOMB contains two active substances: dorzolamide and timolol.

• Dorzolamide belongs to the group of medicines called “carbonic anhydrase inhibitors”.
• Timolol belongs to the group of medicines called “beta-blockers”. These medicines lower eye pressure in different ways. TIDOCOMB is prescribed to lower pressure in the eye 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 TIDOCOMB

Do not use TIDOCOMB:

• if you are allergic to the active ingredients (dorzolamide hydrochloride, timolol maleate) or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have had in the past respiratory problems such as asthma or severe chronic obstructive pulmonary disease (COPD), which can cause shortness of breath, difficulty breathing and/or long-lasting cough;
• if you have a slowing of the heartbeat, heart failure or irregular heartbeat (irregular heartbeat);
• if you have severe kidney problems or severe kidney impairment, or a previous history of kidney stones;
• if you suffer from an excess of 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 TIDOCOMB if you suffer or have suffered in the past from:

• cardiovascular diseases (such as coronary heart disease, whose symptoms may include chest pain or a feeling of tightness, shortness of breath or suffocation, and heart failure) and low blood pressure;
• abnormal heart rate such as slowing of the heartbeat;
• respiratory problems, asthma or chronic obstructive pulmonary disease (COPD);
• poor blood circulation (such as Raynaud's disease or syndrome);
• diabetes, as timolol, one of the two active ingredients of TIDOCOMB, can mask the signs and symptoms of low blood sugar (hypoglycemia);
• hyperactivity of a gland called the thyroid, as timolol can mask its signs and symptoms.

Tell your doctor:

• if you are using TIDOCOMB and need to undergo surgery, as timolol may alter the effect of some medicines used during anesthesia;
• if you have been diagnosed with a muscle disease (myasthenia gravis);
• if you develop eye irritation or any new eye problems, such as redness or swelling of the eyelids, in which case 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 a worsening of pre-existing symptoms. Instilling TIDOCOMBinto the eye may have effects on the whole body.

Children
Experience with TIDOCOMB in newborns and children is limited.

Use in the elderly
In studies with Dorzolamide/Timolol eye drops, solution, the effects of the combination of the two
active ingredients were similar in elderly and younger patients.

Use in patients with impaired liver function (hepatic impairment)
Tell your doctor if you have any liver problems or have suffered from them in the past.
For athletes: the use of the medicine without therapeutic need constitutes doping
and may still result in positive anti-doping tests.

Other medicines and TIDOCOMB
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

TIDOCOMBcan influence or be influenced by the use of other medicines, including other eye drops for the
treatment of glaucoma.
Tell your doctor if you are taking or intend to take other medicines to lower
blood pressure, for the treatment of heart disease (heart conditions) or for the
treatment of diabetes.
Consult your doctor if:

• you are taking medicines to lower blood pressure or for the treatment of heart disease (such as calcium antagonists, beta-blockers or digoxin);
• you are taking medicines for the treatment of disturbances or irregularities of the heartbeat (such as calcium antagonists, beta-blockers or digoxin);
• you are using another eye drop that contains an active ingredient that belongs to the class of “beta-blockers”;
• you are taking another medicine used for high pressure in the eye (carbonic anhydrase inhibitor, such as acetazolamide);
• you are taking medicines called “monoamine oxidase inhibitors (MAOIs)”, used for the treatment of depression;
• you are taking a medicine belonging to the class of “parasympathomimetics” prescribed to you to promote fluid loss (diuresis). “Parasympathomimetics” are a particular type of medicine sometimes used to restore normal bowel movements;
• you are taking medicines called “narcotics” such as morphine, used for the treatment of severe pain;
• you are taking medicines for the treatment of diabetes;
• you are taking antidepressants called “selective serotonin reuptake inhibitors” (SSRIs) such as fluoxetine and paroxetine;
• you are taking “quinidine” used for the treatment of heart disorders and some types of malaria.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Use in pregnancy
TIDOCOMB should not be used during pregnancy.
Use in breastfeeding
Do not use TIDOCOMB if you are breastfeeding. Timolol can pass into breast milk.

Driving and operating machinery
Studies have not been conducted on the effects of this medicine on the ability to drive or
operate machinery. However, there are side effects associated with the use of TIDOCOMB, such as blurred vision,
which may alter your ability to drive and/or operate machinery. Do not drive or operate
machinery until you feel better or your vision is clear.

3. How to use TIDOCOMB

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

Instructions for use

• Wash your hands and sit, or stand, comfortably.
• Remove a vial from the strip and unscrew the cap with a slight rotation.
• Tilt your head back and gently pull down your lower eyelid, creating a pocket between the eyelid and your eye.
• Position the tip of the vial close to your eye without touching it.
• Apply slight pressure to the vial so that a single drop goes inside your eye, as prescribed by your doctor, then release your lower eyelid.
• Close your eye and press on the inner corner of your eye with your finger for about two minutes. This helps prevent the medicine from passing into the rest of your body.
• Repeat the operation in the other eye, if your doctor has told you to do so.
• Dispose of the vial and any remaining contents.

If you use more TIDOCOMB than you should
If you instill too many drops into your eye or ingest the contents of the bottle, you may feel dizzy,
have difficulty breathing, or experience a slowing of your heartbeat. Seek medical attention
immediately.

If you forget to use TIDOCOMB
Do not use a double dose to make up for a missed dose.
It is important that you take TIDOCOMB as prescribed by your doctor. If you miss a dose, proceed
with the application 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 TIDOCOMB
If you have any doubts about using this medicine, consult your doctor or pharmacist.
If you want to stop treatment, talk to your doctor first.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience allergic reactions including swelling of the face and limbs causing difficulty
breathing or swallowing, hives or itchy rash, localized and widespread skin rash, itching or a severe
life-threatening allergic reaction, you should stop using this medicine and seek immediate medical help.
The following adverse reactions have been reported with Dorzolamide/Timolol eye drops, solution or
one of its components both during clinical studies and during post-marketing experience:

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

• burning and stinging (like a prick) in the eyes
• altered taste (dysgeusia) Common(may affect up to 1 in 10 people)
• headache
• redness inside and around the eye (conjunctival injection), tearing or itching of the eye, damage to the anterior layer of the eyeball (corneal erosion), swelling and/or irritation inside and around the eyes, inability to realize you have something in your eyes and feel pain (reduced corneal sensitivity), eye pain, dry eyes, blurred vision
• feeling of tension or fullness in the nose (sinusitis)
• nausea
• weakness/fatigue and tiredness 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)
• slowing of the heartbeat
• shortness of breath (dyspnea)
• difficulty digesting
• kidney stones

Rare(may affect up to 1 in 1000 people)

• allergic-type reactions such as skin rash, hives, itching, rarely swelling of lips, eyes and mouth, difficulty breathing or severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis)
• sleep disturbances, nightmares, memory loss
• reduced blood flow to the brain (cerebral ischemia), increased manifestations and symptoms of myasthenia gravis (a disease of the muscles), decreased sexual desire, tingling or numbness in the hands or feet
• temporary myopia that may resolve upon discontinuation of treatment, detachment of the underlying layer of 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
• changes in the rhythm or rate of the heartbeat (arrhythmia), heart disease, with shortness of breath and swelling of the feet and legs due to fluid accumulation (congestive heart failure), fluid accumulation (edema), chest pain, fast and/or irregular heartbeat (palpitations), heart attack, low blood pressure, excessive constriction of blood vessels (Raynaud's phenomenon), swollen and cold hands and feet, reduced circulation to arms and legs, leg cramps and/or leg pain when walking (claudication)
• shortness of breath, impaired lung function, stuffy or runny nose, nosebleeds, constriction of the airways 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-white appearance (psoriasiform rash)
• an autoimmune disease that can cause inflammation of internal organs (systemic lupus erythematosus)
• Peyronie's disease (which can cause a curvature of the penis) Not known(frequency cannot be estimated based on available data)
• hallucinations
• foreign body sensation in the eye (feeling that something is in the eye)
• strong heartbeat that may be fast or irregular (palpitations)
• increased heart rate
• increased blood pressure As with other eye medicines, timolol is absorbed by the blood vessels that distribute it throughout the body. This may cause side effects similar to those observed with medicines of the same group (beta-blockers) taken orally. The incidence of side effects with the medicine, after administration to the eyes, is lower than with oral or injectable administration. The adverse effects listed include reactions observed within the class of ophthalmic beta-blockers:

Not known(frequency cannot be estimated based on available data)

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

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

5. How to store TIDOCOMB

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the pack after “Exp”. The
expiry date refers to the last day of that month.
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 remaining medicine
must be discarded.
Do not dispose of any medicine in wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. Contents of the pack and other information

What TIDOCOMB contains:

• The active ingredients are: dorzolamide and timolol. 1 ml of solution contains 20 mg of dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride) and 5 mg of timolol (equivalent to 6.83 mg of timolol maleate).
• The other ingredients are: mannitol, sodium citrate, hydroxyethylcellulose, sodium hydroxide, water for injections.

Description of the appearance of TIDOCOMB and contents of the pack
Single-dose container in polyethylene. Pack of 30 single-dose containers of 0.166 ml

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Omikron Italia S.r.l., Viale Bruno Buozzi, 5 – 00197 Roma
Tel: +39 – 06 80693572
Fax: +39 – 06 80665266
e-mail: [email protected]

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

This leaflet was last updated on