Tidocomb

Italy
Brand name Tidocomb
Form solution, eye
Active substance / Dosage
DORZOLAMIDE
TIMOLOL MALEATE
Prescription type Prescription only
ATC code
S01ED51
Registration number 041907
Manufacturer OMIKRON ITALIA S.R.L.
Tidocomb solution, eye

Table of Contents

Package Leaflet: Information for the User

TIDOCOMB 20 mg/ml + 5 mg/ml

eye drops, solution
Dorzolamide and Timololo
Generic Medicine
Read this entire leaflet carefully before you start 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 their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effect, including 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 using 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 TIDOCOMB is and what it is used for

TIDOCOMB 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. TIDOCOMB is prescribed to reduce 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 TIDOCOMB

Do not use TIDOCOMB:

  • 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 disorders such as asthma or severe chronic obstructive pulmonary disease (COPD), which 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 have excessive blood acidity 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 have or have previously had:

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

Inform your doctor:

  • if you are using TIDOCOMB and need to undergo surgery, as timolol may alter the effect of certain medicines used during anesthesia;
  • if you have been diagnosed with a muscle disorder (myasthenia gravis);
  • 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 an eye infection develops, you experience eye trauma, undergo eye surgery, or other reactions occur, including new symptoms or worsening of existing symptoms. Instillation of TIDOCOMB into the eye may have effects on the whole body.

Children
Experience with TIDOCOMB in neonates and children is limited.
Use in the elderly
In clinical studies with Dorzolamide/Timololo ophthalmic 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)
Inform your doctor if you have any liver problems or have had them in the past.
For athletes: The use of this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
Other medicines and TIDOCOMB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
TIDOCOMB may affect or be affected by other medicines, including other eye drops used to treat glaucoma.
Inform your doctor if you are using or plan to use other medicines to lower blood pressure, to treat heart conditions, or to treat diabetes.
Talk to your doctor if you:

  • are taking medicines to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers, or digoxin);
  • are taking medicines to treat heart rhythm disorders or irregularities (such as calcium channel blockers, beta-blockers, or digoxin);
  • are using another eye drop containing an active ingredient belonging to the class of “beta-blockers”;
  • are taking another medicine used for high eye pressure (a carbonic anhydrase inhibitor, such as acetazolamide);
  • are taking medicines called “monoamine oxidase inhibitors (MAOIs)” used to treat depression;
  • 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;
  • are taking narcotic medicines such as morphine, used to treat severe pain;
  • are taking medicines to treat diabetes;
  • are taking antidepressants called “selective serotonin reuptake inhibitors (SSRIs)” such as fluoxetine and paroxetine;
  • 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, consult your doctor or pharmacist before taking this medicine.
Use during pregnancy
TIDOCOMB must not be used during pregnancy.
Use during breastfeeding
Do not use TIDOCOMB 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 machinery. However, side effects associated with the use of TIDOCOMB, such as blurred vision, may affect your ability to drive and/or use machinery. Do not drive or operate 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 may be absorbed by soft contact lenses and may cause a change in their color. 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 eye or corneal disorders (the transparent outer layer of the eye). If you experience an abnormal sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use TIDOCOMB

Use this medicine exactly as your doctor or pharmacist has told you. 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 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, TIDOCOMB drops and the other medicine
should be administered at least 10 minutes apart.
Do not change the prescribed 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 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 pouch between the eyelid and the eye.
  • Hold the tip of the bottle 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 a finger on the inner corner of the eye for about two minutes. This helps prevent the medicine from passing into the rest of the body.
  • Repeat the procedure in the other eye if your doctor has instructed you to do so.
  • Screw the cap back on 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 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 notice a slow heartbeat. Seek immediate medical attention.

If you forget to use TIDOCOMB
Do not use a double dose to make up for the missed dose.
It is important that you use TIDOCOMB 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 TIDOCOMB
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 everybody gets them.
If you experience allergic reactions including swelling of the face and limbs causing difficulty in
breathing or swallowing, hives or itchy skin rash, localized or widespread skin rash, itching, or a
sudden, severe, life-threatening allergic reaction, you must stop using this medicine and seek
immediate medical help.
The following adverse reactions have been reported with Dorzolamide/Timolol eye drops, solution,
or with 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 (dysgeusia)
    Common (may affect up to 1 in 10 people)
  • headache
  • redness inside and around the eye (conjunctival injection), tearing or eye itching, damage to the front layer of the eyeball (corneal erosion), swelling and/or irritation inside and around the eyes, inability to feel the presence of a foreign body in the eye and to feel pain (reduced corneal sensitivity), eye pain, dry eyes, blurred vision
  • sensation of pressure or fullness in the nose (sinusitis)
  • nausea
  • 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 (iritis), visual disturbances (including changes in refraction, sometimes due to discontinuation of miotic therapy)
  • slow heart rate
  • shortness of breath (dyspnea)
  • indigestion
  • 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, breathlessness, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • sleep disorders, nightmares, memory loss
  • reduced blood flow to the brain (cerebral ischemia), worsening of symptoms in 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, leading to visual disturbances due to fluid accumulation, drooping eyelids, double vision, crusting of the eyelids, corneal edema (with symptoms of visual disturbances), low intraocular pressure
  • ringing in the ears
  • changes in heart rhythm or rate (arrhythmia), heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation (congestive heart failure), fluid retention (edema), chest pain, rapid and/or irregular heartbeat (palpitations), heart attack, low blood pressure, excessive constriction of blood vessels (Raynaud phenomenon), swollen and cold hands and feet, reduced circulation in arms and legs, leg cramps and/or leg pain when walking (claudication)
  • shortness of breath, impaired lung function, stuffy or runny nose, nosebleeds, narrowing of 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 may cause inflammation of internal organs (systemic lupus erythematosus)
  • Peyronie's disease (which may cause penile curvature)
    Not known (frequency cannot be estimated from the available data)
  • hallucinations
  • sensation of a foreign body in the eye (feeling that something is in the eye)
  • strong heartbeat that may be rapid or irregular (palpitations)
  • increased heart rate
  • increased blood pressure

Like other eye medicines, timolol is absorbed into 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 ocular administration 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 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 exertion (myalgia)
  • sexual dysfunction

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

5. How to store TIDOCOMB

Keep this medicine out of the sight and reach of children.
Store the medicine in the original packaging to protect it from light.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after "Exp". The expiry date refers to the last day of that 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 carton.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What TIDOCOMB contains:

  • The active substances 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 components are: mannitol, sodium citrate, hydroxyethylcellulose, benzalkonium chloride, sodium hydroxide, water for injections.

Description of the appearance of TIDOCOMB and contents of the pack
Polyethylene bottle. Pack containing 1 bottle of 5.0 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Omikron Italia S.r.l., Viale Bruno Buozzi, 5 – 00197 Rome, Italy
Tel: +39 – 06 80693572
Fax: +39 – 06 80665266
e-mail: [email protected]
Manufacturer
Genetic S.p.A., Contrada Canfora – 84084 Fisciano (SA), Italy
This leaflet was last updated on

Package Leaflet: Information for the User

TIDOCOMB 20 mg/ml + 5 mg/ml

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

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, 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 TIDOCOMB is 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

1. What TIDOCOMB is and what it is used for

TIDOCOMB 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. TIDOCOMB is prescribed to reduce 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 TIDOCOMB

Do not use TIDOCOMB:

  • 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 disorders such as asthma or severe chronic obstructive pulmonary disease (COPD), which 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 blood acidity 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 have or have previously had:

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

Inform your doctor:

  • if you are using TIDOCOMB and need to undergo surgery, as timolol may alter the effect of certain medicines used during anaesthesia;
  • if you have been diagnosed with a muscle disorder (myasthenia gravis);
  • 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 TIDOCOMB into the eye may have effects on the whole body.

Children
Experience with TIDOCOMB in neonates and children is limited.
Use in the elderly
In clinical studies with Dorzolamide/Timolol eye drops, solution, 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 suffered from them in the past.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and TIDOCOMB
Inform your doctor or pharmacist if you are currently taking, have recently taken or might take any other medicines.
TIDOCOMB 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, to treat heart conditions (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 channel blockers, beta-blockers, or digoxin);
  • you are taking medicines to treat heart rhythm disorders or irregularities (such as calcium channel blockers, beta-blockers, or digoxin);
  • you are using another eye drop containing an active substance belonging to the class of "beta-blockers";
  • 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 particular 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 called "selective serotonin reuptake inhibitors (SSRIs)" such as fluoxetine and paroxetine;
  • 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 to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use during pregnancy
TIDOCOMB must not be used during pregnancy.
Use during breastfeeding
Do not use TIDOCOMB 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, there are side effects associated with the use of TIDOCOMB, such as blurred vision, which 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.

3. How to use TIDOCOMB

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 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, TIDOCOMB 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 container cap touch the eye or the area around the eye. It may become contaminated with
bacteria causing eye infections, which could lead to 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 one vial from the strip and unscrew the cap with a gentle twist.
  • Tilt your head backward and gently pull down the lower eyelid to form a pouch between the eyelid and the eye.
  • Position 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 your eye and press gently with your finger at the inner corner of the eye for about two minutes. This helps prevent the medicine from passing into 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.

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

If you forget to use TIDOCOMB
Do not use a double dose to make up for the missed dose.
It is important that you use TIDOCOMB 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 TIDOCOMB
If you have any doubts about using this medicine, consult your doctor or pharmacist.
If you wish to discontinue treatment, discuss this first with your treating physician.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience allergic reactions including swelling of the face and limbs causing difficulty in breathing or swallowing, hives or itchy skin rash, localized or 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 following adverse reactions have been reported with Dorzolamide/Timolol eye drops, solution, or one of its components, both during clinical studies and post-marking experience:

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

  • burning and stinging sensation 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 eye itching, damage to the front layer of the eyeball (corneal erosion), swelling and/or irritation inside and around the eyes, inability to sense the presence of a foreign body in the eye or to feel pain (reduced corneal sensitivity), eye pain, dry eyes, blurred vision
  • sensation of pressure or fullness in the nose (sinusitis)
  • nausea
  • 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 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
  • reduced blood flow to the brain (cerebral ischemia), worsening of 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 of the eyelids, double vision, crusting of the eyelids, corneal edema (with symptoms of visual disturbances), low eye pressure
  • ringing in the ears
  • changes in heart rhythm or rate (arrhythmia), heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation (congestive heart failure), fluid retention (edema), chest pain, faster 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 in arms and legs, leg cramps and/or leg pain when walking (claudication)
  • 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, rash with a silvery appearance (psoriasiform rash)
  • an autoimmune disease that may cause inflammation of internal organs (systemic lupus erythematosus)
  • Peyronie's disease (which may cause curvature of the penis)

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

  • hallucinations
  • sensation of a foreign body in the eye (feeling that something is in the eye)
  • strong heartbeat that may be rapid or irregular (palpitations)
  • increased heart rate
  • increased blood pressure

Like other eye medicines, timolol is absorbed into 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 ophthalmic administration 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 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 (myalgia)
  • sexual dysfunction

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 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 stated on the carton after “Exp”. The expiry date refers to the last day of that month.
After the first opening of 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.
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 TIDOCOMB contains:

  • The active substances 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 components are: mannitol, sodium citrate, hydroxyethylcellulose, sodium hydroxide, water for injections.

Description of the appearance of TIDOCOMB and contents of the pack
Single-dose container made of polyethylene. Pack containing 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 Rome
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