TRIGON 3 mg /Ml + 1 Mg/Ml Krople Do Oczu, Roztwór

Treść ulotki

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

TRIGON

3 mg/ml + 1 mg/ml ear drops, solution in single-dose container
Tobramycin and Desamethasone
Generic medicine
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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is TRIGON and what is it used for

TRIGON ear drops contain the active ingredients tobramycin and dexamethasone.
Tobramycin is an antibiotic that works by killing the bacteria responsible for infections, while
dexamethasone is an anti-inflammatory that helps to relieve inflammation.
TRIGON is used in adults and children over 2 years of age for the treatment of inflammation of the
external ear canal (otitis externa) when the use of an anti-inflammatory
(corticosteroid) is necessary, in the presence of infections caused by bacteria sensitive to tobramycin or when there is a risk
of infection.

2. What you need to know before using TRIGON

Do not use TRIGON

• if you are allergic to tobramycin, dexamethasone, any other similar substances or any of the other ingredients of this medicine (listed in section 6);
• if you have a type of skin infection called cutaneous tuberculosis;
• if you have a skin infection caused by the Herpes simplex virus;
• if you have skin diseases of a viral nature;
• if you have a fungal ear infection (ear mycosis);
• if you have or suspect a perforation of the eardrum;
• if you are breastfeeding.

TRIGON should not be used in children under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using TRIGON.
DO NOT use TRIGON on wounds and burns. Use TRIGON only in the ear, DO NOT inject it.

• Before applying TRIGON, clean the ear canal.
• During the use of TRIGON, follow the normal precautions related to the administration of corticosteroids that your doctor has told you about.
• Consult your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. This type of antibiotics can worsen muscle weakness.
• In patients who have taken aminoglycoside antibiotics, such as tobramycin, systemically (by injection), serious toxic effects on the nervous system, ears and kidneys have occurred. Be careful and consult your doctor if you are using TRIGON together with aminoglycoside antibiotics taken systemically (by injection).
• With local administration of corticosteroids, side effects usually described following systemic administration of corticosteroids (by mouth or by injection) may occur, including a decrease in the activity of the glands called adrenal glands, especially in children (see section “Children”).
• The tobramycin contained in TRIGON may cause toxic effects on the ear: if, after instilling TRIGON, symptoms such as dizziness, vertigo, tinnitus (ringing in the ear) and hearing loss appear, stop treatment and consult your doctor immediately.
• To reduce the risk of toxic effects, do not apply TRIGON to wounds and burns and do not use the medicine for more than 7 days.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Stop treatment and inform your doctor:

• if you experience irritation or sensitization (excessive reaction of the body to foreign substances with which it has come into contact) following the use of this medicine; sensitization can also occur with the use of other antibiotics belonging to the same class of aminoglycosides, administered both locally and systemically (by injection).
• if, especially after prolonged use, you do not observe clinical improvement as prolonged use of antibiotics such as tobramycin can promote the development of resistant microorganisms.

Use the medicine with caution and under close medical supervision in the following cases:

• if you are elderly;
• if you are already using other aminoglycoside group antibiotics, in this case you must monitor the levels of antibiotics in the blood (total serum concentration);
• if you have kidney problems (impaired renal function);
• if you are being treated with other medicines that facilitate the elimination of urine (cyclic structure diuretics).

Children
In children, over 2 years of age, TRIGON must be used with great caution and under direct
medical supervision, because it may increase the risk of side effects from corticosteroids such as:

• decrease in the amount of cortisol in the blood, due to inhibition of its release system by the adrenal gland (depression of the hypothalamus-pituitary-adrenal axis);
• increased production of cortisol (Cushing's syndrome);
• delay in weight gain and growth retardation;
• increased pressure in the brain (intracranial hypertension) which manifests with tension of the fontanelles, headache and swelling of the nerves behind the eye (bilateral papilledema).

Other medicines and TRIGON
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The medicine contains tyloxapol, a substance incompatible with some antibiotic medicines (tetracycline). Do not
use TRIGON together with other ear medicines that contain tetracyclines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with milk
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Data relating to the use in the ears of corticosteroids in pregnant women either do not exist or are in limited
number. Therefore, during pregnancy, the use of TRIGON must be decided by the doctor, who will assess the
benefits for the mother and the risks to the fetus.
Breastfeeding
It is not known whether tobramycin or dexamethasone administered in the ears are excreted in breast milk. The
corticosteroids and tobramycin are excreted in breast milk after oral or
injection administration. The risk to infants cannot be excluded.
Do not use TRIGON if you are breastfeeding.
Fertility
No studies have been conducted to evaluate the effect on human fertility of the administration of TRIGON.

Driving and operating machinery
No data are available to establish the effect of the medicine on the ability to drive and operate
machinery.

3. How to use TRIGON

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The recommended doseis 4 drops 3 times a day or as prescribed by your doctor, to be instilled into the
external auditory canal of the ear to be treated. Do not use the medicine for more than 7 days (read the
“Warnings and precautions” section).
The product is intended for application in the ear, it must NOT be injected.

Instructions for use
Make sure that the single-dose container is intact.

• 1. Wash your hands and find the most comfortable position for step no. 3.
• 2. Detach a vial from the strip and remove the cap with a slight rotation.
• 3. Tilt your head to the side so that the ear to be treated is facing as much upwards as possible.
• 4. Turn the single-dose container upside down and position the tip of the vial near the ear but without touching it. Do not touch the ear with the tip of the vial.
• 5. Apply slight pressure on the vial so that the drops go inside the ear.
• 6. Remain in the position for 2 minutes so that the drops do not leak out.
• 7. Repeat the operation also in the other ear, if your doctor has told you to do so.
• 8. Throw away the vial and any remaining contents.

If you use more TRIGON than you should
In case of ingestion or accidental application of an excessive dose of this medicine, immediately warn
your doctor or go to the nearest hospital.
Excessive or prolonged use of this medicine may cause undesirable effects due to corticosteroids
such as Cushing's syndrome, a condition in which the body produces too much cortisol, reduction of
muscle strength and marked weakness (asthenia, adynamia), increased blood pressure (arterial hypertension
), heart rhythm problems, reduced potassium levels in the blood (hypokalaemia), increased
blood pH (metabolic alkalosis).

If you forget to use TRIGON
If you forget to use TRIGON, do not worry and apply it as soon as you remember. However, if it is almost time to
administer the next dose, skip the missed dose and return to the regular dosing schedule.
Do not use a double dose to compensate for the forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist

4. Possible side effects

Like all medicines, TRIGON can cause side effects, although not everybody gets them.
Following local use of aminoglycoside antibiotics, ear toxicity reactions have occurred
(ototoxicity), whose frequency is unknown.
Cases of local allergy (hypersensitivity) may occur. In these cases, discontinue treatment and
consult your doctor.
Side effects with unknown frequency (frequency cannot be established on the basis of available
data): blurred vision.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 TRIGON

Keep this medicine out of the sight and reach of children. Do not use this medicine after the
expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
No special storage precautions.
The medicine does not contain preservatives, after administration the single-dose container should be discarded
even if only partially used.
The medicine must be used within 28 days of first opening the sachet containing the single-dose
containers.
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

• The active ingredients are tobramycin and dexamethasone. Each single-dose container contains 750 micrograms of tobramycin and 250 micrograms of dexamethasone (equivalent to 329 micrograms of dexamethasone sodium phosphate).
• The other ingredients are: tyloxapol, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injectable preparations.

Description of the appearance of TRIGON and contents of the pack
TRIGON is an otic solution available in a pack containing 20 single-dose containers of 0.25 ml.

Marketing Authorisation Holder
I.B.N. Savio Srl, Via del Mare 36 – 00071 Pomezia (RM)

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

TRIGON

3 mg/ml + 1 mg/ml ear drops, solution
Tobramycin and Desamethasone
Generic medicine
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 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 if not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is TRIGON and what is it used for

TRIGON ear drops contain the active ingredients tobramycin and dexamethasone.
Tobramycin is an antibiotic that works by killing the bacteria responsible for infections, while
dexamethasone is an anti-inflammatory that helps to relieve inflammation.
TRIGON is used in adults and children over 2 years of age for the treatment of inflammation of the
external ear canal (otitis externa) when the use of an anti-inflammatory
(corticosteroid) is necessary, in the presence of infections caused by bacteria sensitive to tobramycin or when there is a risk
of infection.

2. What you need to know before using TRIGON

Do not use TRIGON

• if you are allergic to tobramycin, dexamethasone, other similar substances or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a type of skin infection called cutaneous tuberculosis;
• if you suffer from a skin infection caused by the Herpes simplex virus;
• if you suffer from skin diseases of a viral nature;
• if you suffer from a fungal ear infection (ear mycosis);
• if you suffer from or suspect the presence of a perforated eardrum;
• if you are breastfeeding.

TRIGON should not be used in children under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using TRIGON.
DO NOT use TRIGON on wounds and burns. Use TRIGON only in the ear, DO NOT inject it.

• 1. Before applying TRIGON, clean the ear canal.
• 2. During the use of TRIGON, follow the normal precautions related to the administration of corticosteroids that your doctor has communicated to you.
• 3. Consult your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. Antibiotics of this type can worsen muscle weakness.
• 4. In patients who have taken aminoglycoside antibiotics, such as tobramycin, systemically (by injection), serious toxic effects have occurred at the level of the nervous system, ears and kidneys. Be careful and consult your doctor if you are using TRIGON together with aminoglycoside antibiotics taken systemically (by injection).
• 5. With local administration of corticosteroids, undesirable effects usually described following systemic administration of corticosteroids (by mouth or by injection) may occur, including a decrease in the activity of the glands called the adrenal glands, especially in children (see section “Children”).
• 6. Tobramycin contained in TRIGON may cause toxic effects at the ear level: if, after instillation of TRIGON, symptoms such as dizziness, vertigo, tinnitus (ringing in the ear) and hearing loss appear, stop treatment and consult your doctor immediately.
• 7. To reduce the risk of toxic effects, do not apply TRIGON to wounds and burns and do not use the medicine for more than 7 days.
• 8. Contact your doctor if you experience blurred vision or other visual disturbances.

Stop treatment and inform your doctor:

• if you experience irritation or sensitization (excessive reaction of the body to foreign substances with which it has come into contact) following the use of this medicine; sensitization can also occur with the use of other antibiotics belonging to the same class of aminoglycosides, administered both locally and systemically (by injection).
• if, especially after prolonged use, you do not observe clinical improvement as prolonged use of antibiotics such as tobramycin can promote the development of resistant microorganisms.

Use the medicine with caution and under close medical supervision in the following cases:

• if you are elderly;
• if you are already using other aminoglycoside group antibiotics, in this case you must monitor the levels of antibiotics in the blood (total serum concentration);
• if you have kidney problems (impaired renal function);
• if you are being treated with other medicines that facilitate the elimination of urine (cyclic structure diuretics).

Children
In children, over 2 years of age, TRIGON must be used with great caution and under the direct
supervision of the doctor, because it can increase the risk of undesirable effects from corticosteroids such as:

• decrease in the amount of cortisol in the blood, due to inhibition of its release system by the adrenal gland (depression of the hypothalamus-pituitary-adrenal axis);
• increased production of cortisol (Cushing's syndrome);
• delay in gaining weight and growth retardation;
• increased pressure in the brain (intracranial hypertension) which manifests with tension of the fontanelles, headache and swelling of the nerves behind the eye (bilateral papilledema).

Other medicines and TRIGON
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The medicine contains tyloxapol, a substance incompatible with some antibiotic medicines (tetracycline). Do not
use TRIGON together with other ear medicines that contain tetracyclines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding, ask your doctor or
pharmacist for advice before using this medicine.
Pregnancy
Data relating to the use in the ears of corticosteroids in pregnant women are non-existent or limited in number.
Therefore, during pregnancy, the use of TRIGON must be decided by the doctor, who will assess the
benefits for the mother and the risks to the fetus.
Breastfeeding
It is not known whether tobramycin or dexamethasone administered in the ears are excreted in breast milk.
Corticosteroids and tobramycin are excreted in breast milk after oral or
injection administration. The risk to infants cannot be excluded.
Do not use TRIGON if you are breastfeeding.
Fertility
No studies have been conducted to evaluate the effect on human fertility of the administration of TRIGON.

Driving and operating machinery
No data are available to establish the effect of the medicine on the ability to drive and operate
machinery.

TRIGONcontains 0.5 mg Benzalkonium Chloride in 5 ml which is equivalent to 0.1 mg/ml
Benzalkonium Chloride is an irritating substance, which can cause local skin reactions.

3. How to use TRIGON

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The recommended doseis 4 drops 3 times a day or as prescribed by your doctor, to be instilled into the
external auditory canal of the ear to be treated. Do not use the medicine for more than 7 days (read the
“Warnings and precautions” section).
The product is intended for application in the ear, it MUST NOT be injected.

Instructions for use
Make sure that the bottle is intact.

• 9. Wash your hands and find the most comfortable position for step no. 3.
• 10. Unscrew the cap.
• 11. Tilt your head to the side so that the ear to be treated is facing as much upwards as possible.
• 12. Turn the bottle upside down and position the tip of the bottle near the ear but without touching it. Do not touch the ear with the dropper tip.
• 13. Apply slight pressure to the bottle so that the drops go inside the ear.
• 14. Remain in the position for 2 minutes so that the drops do not leak out.
• 15. Repeat the operation also in the other ear, if your doctor has told you to do so.
• 16. Close the bottle immediately after use.

If you use more TRIGON than you should
In case of ingestion or accidental application of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital.
Excessive or prolonged use of this medicine may cause undesirable effects due to corticosteroids
such as Cushing's syndrome, a condition in which the body produces too much cortisol, reduction of
muscle strength and marked weakness (asthenia, adynamia), increased blood pressure (arterial hypertension
), heart rhythm problems, reduced potassium levels in the blood (hypokalemia), increased
blood pH (metabolic alkalosis).

If you forget to use TRIGON
If you forget to use TRIGON, do not worry and apply it as soon as you remember. However, if it is almost time to
administer the next dose, skip the missed dose and return to the regular dosing schedule.
Do not use a double dose to compensate for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist

4. Possible side effects

Like all medicines, TRIGON can cause side effects, although not everybody gets them.
Following local use of aminoglycoside antibiotics, ear toxicity reactions have occurred
(ototoxicity), whose frequency is unknown.
Cases of local allergy (hypersensitivity) may occur. In these cases, discontinue treatment and
consult your doctor.
Side effects with unknown frequency (frequency cannot be estimated on the basis of the available
data): blurred vision.

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 this medicine's safety.

5. How to store TRIGON

Keep this medicine out of the sight and reach of children. Do not use this medicine after the
expiry date which is stated on the packaging after “Scad”.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
No special precautions for storage.
The medicine must be used within 28 days of first opening the bottle.
Excess product 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 protect the environment.

6. Contents of the pack and other information

• The active ingredients are tobramycin and dexamethasone. 1 ml of solution contains 3 mg of tobramycin and 1 mg of dexamethasone (equivalent to 1.316 mg of dexamethasone sodium phosphate).
• The other ingredients are: tyloxapol, benzalkonium chloride,disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

Description of the appearance of TRIGON and contents of the pack
TRIGON is an otic solution available in a dropper bottle of 5 ml

Marketing Authorisation Holder
I.B.N. Savio Srl, Via del Mare 36 – 00071 Pomezia (RM)

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

TRIGON

3 mg/ml + 1 mg/ml eye drops, solution
Tobramycin and Desamethasone
Generic medicine
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 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 TRIGON is and what it is used for
• 2. What you need to know before you use TRIGON
• 3. How to use TRIGON
• 4. Possible side effects
• 5. How to store TRIGON
• 6. Contents of the pack and other information

1. What is TRIGON and what is it used for

TRIGON contains two substances: Dexamethasone and Tobramycin.
Dexamethasone is a corticosteroid, a hormone that performs numerous activities with an important function
in controlling inflammation.
Tobramycin is an antibiotic used to treat infections.
TRIGON belongs to a group of medicines called “Corticosteroids and antimicrobials in combination”.
TRIGON is indicated for the treatment of eye inflammation when a corticosteroid is necessary and
when there is an eye infection or a risk of eye infections in adults and children two years of age and older.

2. What you need to know before you use TRIGON

Do not use TRIGON

• if you are allergic to tobramycin, to dexamethasone, or to any of the other ingredients of this medicine (listed in section 6); if you have inflammation of the cornea (the transparent membrane covering the colored part of the eye) caused by the Herpes Simplexvirus (Herpes Simplexkeratitis); if you have infections caused by viruses such as vaccinia, chickenpox or other viral infections of the cornea and conjunctiva (the transparent membrane covering the white part of the eye and the inside of the eyelids);
• if you have eye infections caused by fungi (mycosis) or untreated parasitic eye infections;
• if you have eye infections caused by mycobacteria (tuberculosis of the eye);
• if you have high pressure inside the eye (intraocular hypertension);
• if you have eye infections with pus (acute purulent ophthalmia, purulent conjunctivitis and purulent blepharitis) and caused by the Herpesvirus, which may be hidden or worsened by medicines used against inflammation based on substances called “corticosteroids”;
• if you have an infection of the eyelid characterized by a swelling similar to a pimple (hordeolum).

Talk to your doctor or pharmacist before using TRIGON.

• In some patients, sensitization (allergic reaction) to aminoglycoside antibiotics such as tobramycin, administered to the eyes, may occur. This allergic reaction can range from localized itching or redness of the skin to severe general allergic reactions (anaphylactic reactions) or severe skin reactions. If these symptoms occur during the use of TRIGON, stop treatment and see your doctor. Also, be aware that this allergic sensitivity may also occur with other antibiotics belonging to the same class of aminoglycosides, administered either to the eyes or systemically (by injection).
• Talk to your doctor if you have or have ever had conditions such as myasthenia gravis or Parkinson's disease. These types of antibiotics may worsen muscle weakness.
• In patients treated with medicines belonging to the same class as tobramycin (systemic aminoglycoside therapy), serious side effects such as toxicity to the Nervous System (neurotoxicity), to the ears (ototoxicity) and to the kidneys (nephrotoxicity) have occurred. Be careful and see your doctor if you take TRIGON together with medicines of the same class (aminoglycoside antibiotics) taken systemically (by injection).
• Prolonged use of medicines of the same class as dexamethasone (corticosteroids) may cause increased eye pressure (ocular hypertension and/or glaucoma) with damage to the optic nerve, reduced ability to see objects clearly (visual acuity) and visual field defects, and formation of an abnormality of the eye's lens (posterior subcapsular cataract). If you use TRIGON for a long time, you should check your eye pressure regularly and frequently. This is particularly important in children, as the risk of increased pressure in the eyes caused by corticosteroids may be greater in children under six years of age and may appear sooner than it appears in adults. Ask your doctor for advice, especially if you need to use TRIGON in children. The risk of increased eye pressure induced by corticosteroids and/or cataract formation is increased in predisposed patients (e.g. in diabetic patients).
• Talk to your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a syndrome called Cushing's syndrome. Suppression

of adrenal gland function may develop after discontinuation of prolonged or
intensive treatment with TRIGON. Talk to your doctor before stopping treatment on your own. These risks are
particularly important in children and patients treated with a medicine called ritonavir or cobicistat.

• With the use of TRIGON, you may become more susceptible to eye infections caused by bacteria, viruses, fungi or parasites; if your symptoms worsen or suddenly reappear, see your doctor.
• If you have a corneal ulcer that does not heal, stop therapy and see your doctor.
• If you have diseases that lead to thinning of certain parts of the eye called “cornea” or “sclera”, see your doctor before taking TRIGON, as perforation may occur with the administration of corticosteroids to the eyes.
• Medicines belonging to the same class as dexamethasone (corticosteroids) for local use in the eyes may slow down the healing of corneal wounds. NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) applied to the eyes are also known to slow down or delay healing. Concomitant application of NSAIDs and corticosteroids to the eyes may potentially increase problems with eye wound healing (see section “Other medicines and TRIGON”).
• Do not use contact lenses during the treatment of an inflammation or eye infection. Also read the section “TRIGON contains benzalkonium chloride”.
• Use TRIGON under the direct supervision of your doctor.
• Use TRIGON only for application to the eyes.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and TRIGON
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Tell your doctor especially if you are taking other medicines for the eyes that contain
drugs belonging to the class of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). The application
concomitant of NSAIDs and corticosteroids to the eyes may potentially increase problems with healing
of the corneal wounds.
Talk to your doctor if you are taking ritonavir or cobicistat, as they may increase the level of dexamethasone
in the blood.
If you are using more than one medicine for the eye for topical (local) use, allow at least 5 minutes between
the administration of each medicine.
In particular, warn your doctor if you are taking tetracycline (an antibiotic) because TRIGON contains the
component tyloxapol which is incompatible with tetracycline.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Data relating to the use of tobramycin and dexamethasone in the eyes in pregnant women are lacking or
limited. Studies in animals have shown reproductive toxicity following systemic (oral or injection) administration
of dexamethasone and tobramycin.
TRIGON is not recommended during pregnancy. See your doctor, who will decide whether you should use
TRIGON during pregnancy.
Breastfeeding
It is not known whether tobramycin or dexamethasone used in the eyes (for topical ophthalmic use) pass into
breast milk. Tobramycin is excreted in breast milk after systemic administration (by injection).
There are no data on the passage of dexamethasone into human breast milk. The risk to infants cannot
be excluded. See your doctor, who will decide whether you should stop breastfeeding or stop
therapy with TRIGON.
Fertility
No studies have been conducted to evaluate the effect of this medicine on human or animal fertility. Clinical data
to evaluate the effect of dexamethasone on male or female fertility are limited.

Driving and using machines
TRIGON does not alter or only temporarily alters the ability to drive vehicles or use machines.
However, temporary blurred vision or other visual disturbances may occur
that may impair the ability to drive or operate machinery. If you experience these
effects after applying TRIGON, wait until your vision returns to normal before driving or
using machinery.

TRIGONcontains 0.5 mg of benzalkonium chloride per 5 ml which is equivalent to 0.1 mg/ml
Benzalkonium chloride is a preservative and can be absorbed by soft contact lenses and can
discolor soft contact lenses.
Avoid contact with soft contact lenses.
Remove the contact lenses before application and wait at least 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 your eye, burning or pain after using this medicine, talk to your doctor.

3. How to use TRIGON

Apply TRIGON only to the eyes.
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is:
1 or 2 drops 4-5 times a day as prescribed by your doctor. Use the medicine for the period of time that
your doctor has prescribed.

Instructions for use
Make sure that the bottle is intact.

• Wash your hands and sit comfortably.
• Unscrew the cap with a slight rotation.
• Tilt your head back.
• With your fingers, gently pull down the lower eyelid of the affected eye.
• Turn the bottle upside down and position the tip of the bottle close to the eye but without touching it. Do not touch the eye or eyelid with the tip of the dropper.
• Apply slight pressure on the bottle so that a single drop goes inside the eye, then release the lower eyelid.
• Close your eye and press with a finger on the corner of the affected eye, near the nose for 2 minutes.
• Repeat the operation also in the other eye, if your doctor has told you to do so.
• Close the bottle immediately after use.

Use in children
TRIGON can be used in children from two years of age and older at the same doses as for adults.
Do not use TRIGON in children under two years of age as safety and efficacy have not been
established and no data are available.

If you use more TRIGON than you should
It is difficult for cases of overdose to occur. However, if this should happen, wash
your eye thoroughly with running water.
Do not use the medicine again until the time scheduled for the next administration.

If you forget to use TRIGON
If you forget to use TRIGON, continue treatment with the next dose as scheduled.
However, if it is almost time to administer the next dose, skip the missed dose and return to the regular
dosing schedule.
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of TRIGON, the following side effects have been reported:

Uncommon side effects(may affect up to 1 in 1,000 people)

• 9. Effects on the eyes: increased pressure in the eye(s), eye pain, eye itching, eye discomfort, eye irritation.

Rare side effects(may affect up to 1 in 10,000 people)

• Effects on the eyes: inflammation of the eye surface, eye allergy, blurred vision, dry eye, eye redness.
• General side effects: unpleasant taste.

Side effects with unknown frequency(frequency cannot be estimated from available data)

• Effects on the eyes: swelling of the eyelids, redness of the eyelids, increased pupil size, increased tear production.
• Hormonal problems: increased hair growth on the body (especially in women), weakness and muscle atrophy, purple stretch marks on the skin of the body, increased blood pressure, irregular or absent periods, changes in protein and calcium levels in the body, delayed growth in children and adolescents, and swelling and weight gain of the body and face (called “Cushing’s syndrome”) (see section 2, “Warnings and precautions”).
• General side effects: severe allergic reactions (hypersensitivity), dizziness, headache, nausea, abdominal discomfort, skin rash, severe skin reactions (erythema multiforme), facial swelling, itching.

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 TRIGON

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and on the bottle.
The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
The medicine must be used within 28 days of first opening the bottle.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TRIGON contains:

• 17. The active ingredients are tobramycin and dexamethasone. One ml of eye drops contains 3 mg of tobramycin and 1 mg of dexamethasone (equivalent to dexamethasone sodium phosphate 1.316 mg).
• 18. The other ingredients are: tyloxapol, benzalkonium chloride, disodium edetate, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

Description of the appearance of TRIGON and contents of the pack
TRIGON is presented as eye drops, solution in a low-density polyethylene dropper bottle
with a polypropylene screw cap containing 5 ml

Marketing Authorisation Holder
I.B.N. Savio Srl
Via del Mare, 36 – 00071 Pomezia (RM)

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