Trigon

Package leaflet: Information for the patient

TRIGON

3 mg/ml + 1 mg/ml ear drops, solution in single-dose container
Tobramycin and Dexamethasone
Generic medicine
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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 using 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 TRIGON is and what it is used for

TRIGON ear drops contain the active substances tobramycin and dexamethasone.
Tobramycin is an antibiotic that works by killing the bacteria responsible for infections, while dexamethasone is an anti-inflammatory agent 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 auditory canal (external otitis) when the use of an anti-inflammatory agent (corticosteroid) is required, in cases of infections caused by bacteria sensitive to tobramycin or when there is a risk of infection.

2. What you should 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 have a type of skin infection called cutaneous tuberculosis;
• if you have a skin infection caused by the Herpes simplex virus;
• if you have viral skin diseases;
• if you have an ear infection caused by fungi (otomycosis);
• if you have or suspect a perforation of the eardrum;
• if you are breastfeeding.

TRIGON must not be used in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using TRIGON.
DO NOT use TRIGON on wounds or burns. Use TRIGON only in the ear; do not inject it.

• Before applying TRIGON, clean the ear canal.
• During treatment with TRIGON, follow the usual precautions related to corticosteroid use as advised by your doctor.
• Consult your doctor if you have or have ever had conditions such as severe myasthenia or Parkinson's disease. Antibiotics of this type may worsen muscle weakness.
• In patients who have received systemic (injected) aminoglycoside antibiotics such as tobramycin, serious toxic effects on the nervous system, ears, and kidneys have occurred. Be cautious and consult your doctor if you are using TRIGON together with systemic (injected) aminoglycoside antibiotics.
• With local administration of corticosteroids, adverse effects usually associated with systemic (oral or injected) corticosteroid use may occur, including reduced activity of the adrenal glands, especially in children (see section “Children”).
• The tobramycin contained in TRIGON may cause toxic effects on the ear: if, after instillation of TRIGON, symptoms such as dizziness, vertigo, tinnitus (ringing in the ear), or hearing loss occur, discontinue treatment and consult your doctor immediately.
• To minimize the risk of toxic effects, do not apply TRIGON to wounds or 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 develop irritation or sensitization (excessive reaction of the body to foreign substances it has come into contact with) following the use of this medicine; sensitization may also occur with the use of other antibiotics belonging to the aminoglycoside class, whether administered locally or systemically (by injection).
• if, especially after prolonged use, you do not observe clinical improvement, as prolonged use of antibiotics such as tobramycin may 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 antibiotics; in this case, serum antibiotic levels (total serum concentration) should be monitored;
• if you have kidney problems (impaired renal function);
• if you are being treated with other medicines that increase urine excretion (loop diuretics).

Children
In children over 2 years of age, TRIGON must be used with great caution and under direct medical supervision, as it may increase the risk of corticosteroid-related adverse effects such as:

• decreased blood cortisol levels due to suppression of its release mechanism by the adrenal glands (hypothalamic-pituitary-adrenal axis suppression);
• increased cortisol production (Cushing's syndrome);
• delayed weight gain and growth retardation;
• increased pressure in the brain (intracranial hypertension), manifested by bulging fontanelles, headache, and swelling of the optic nerves behind the eyes (bilateral papilledema).

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Data on the use of corticosteroids in the ears during pregnancy are lacking or limited. Therefore, during pregnancy, the use of TRIGON should be decided by the doctor, who will evaluate the benefits for the mother and the risks for the fetus.

Breastfeeding
It is not known whether tobramycin or dexamethasone administered into the ears are excreted in breast milk. Corticosteroids and tobramycin are excreted in breast milk following oral or injected administration. Risk to infants cannot be ruled out.
Do not use TRIGON if you are breastfeeding.

Fertility
No studies have been conducted to evaluate the effect of TRIGON administration on human fertility.

Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive or use machinery.

3. How to use TRIGON

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 4 drops, 3 times daily, or as prescribed by your doctor, to be instilled into the external auditory canal of the affected ear. Do not use the medicine for more than 7 days (see section “Warnings and precautions”).
This product is intended for ear application and must NOT be injected.

Instructions for use
Ensure the single-dose container is intact.

1. Wash your hands and find the most comfortable position for step 3.
2. Detach one vial from the strip and remove the cap with a gentle twist.
3. Tilt your head sideways so that the ear to be treated is facing upward as much as possible.
4. Turn the single-dose container upside down and place the tip near the ear, without touching it. Do not touch the ear with the tip of the vial.
5. Gently squeeze the vial so that the drops enter the ear.
6. Remain in this position for 2 minutes to prevent the drops from leaking out.
7. Repeat the procedure in the other ear if instructed by your doctor.
8. Discard the vial and any remaining contents.

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

If you forget to use TRIGON
If you forget to use TRIGON, do not worry; apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for the missed dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, TRIGON may cause side effects, although not everyone experiences them.
Following local use of aminoglycoside antibiotics, reactions involving ear toxicity (ototoxicity) have occurred, although the frequency is unknown.
Cases of local allergy (hypersensitivity) may occur. In such cases, discontinue treatment and consult your doctor.
Side effects with unknown frequency (frequency cannot be estimated from the available data): blurred vision.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following address: 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 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 its original, undamaged packaging, correctly stored.
No special storage precautions required.
This medicine does not contain preservatives; after administration, the single-dose container must be discarded,
even if it has been only partially used.
The medicine must be used within 28 days from the first opening of the sachet containing the single-dose containers.
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

• The active substances 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 components are: tyloxapol, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH regulator), water for injections.

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 Authorization Holder
I.B.N. Savio Srl, Via del Mare 36 – 00071 Pomezia (RM)
Manufacturer
Genetic S.p.A.
Contrada Canfora, 84084 Fisciano (SA)
Package leaflet: information for the patient

TRIGON

3 mg/ml + 1 mg/ml ear drops, solution
Tobramycin and Dexamethasone
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform 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 using 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 TRIGON is and what it is used for

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

2. What you should 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 have a type of skin infection called cutaneous tuberculosis;
• if you have a skin infection caused by the Herpes simplex virus;
• if you have viral skin diseases;
• if you have an ear infection caused by fungi (fungal otitis);
• if you have or suspect a perforation of the eardrum;
• if you are breastfeeding.

TRIGON must not be used in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using TRIGON.
DO NOT use TRIGON on wounds or burns. Use TRIGON only in the ear; do NOT inject it.

1. Before applying TRIGON, clean the ear canal.
2. During treatment with TRIGON, follow the usual precautions related to corticosteroid administration as advised by your doctor.
3. Consult your doctor if you have or have ever had conditions such as severe myasthenia or Parkinson's disease. This type of antibiotics may worsen muscle weakness.
4. In patients who have received systemic (by injection) aminoglycoside antibiotics such as tobramycin, serious toxic effects on the nervous system, ears, and kidneys have occurred. Be cautious and consult your doctor if you are using TRIGON together with systemic (by injection) aminoglycoside antibiotics.
5. When corticosteroids are administered locally, adverse effects usually associated with systemic (oral or injected) corticosteroid administration may occur, including reduced activity of the adrenal glands, especially in children (see section “Children”).
6. The tobramycin contained in TRIGON may cause toxic effects in the ear: if, after instillation of TRIGON, symptoms such as dizziness, vertigo, tinnitus (ringing in the ear), or hearing loss occur, stop treatment immediately and consult your doctor.
7. To minimize the risk of toxic effects, do not apply TRIGON to wounds or burns and do not use the medicine for more than 7 days.
8. Contact your doctor if blurred vision or other visual disturbances occur.

Stop treatment and inform your doctor:

• if you experience irritation or sensitization (excessive reaction of the body to foreign substances it has come into contact with) following the use of this medicine; sensitization may also occur with the use of other antibiotics belonging to the aminoglycoside class, administered either locally or systemically (by injection).
• if, especially after prolonged use, you do not observe clinical improvement, as prolonged use of antibiotics such as tobramycin may 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 antibiotics; in this case, blood levels of antibiotics (total serum concentration) should be monitored;
• if you have kidney problems (impaired renal function);
• if you are being treated with other medicines that increase urine excretion (loop diuretics).

Children
In children over 2 years of age, TRIGON must be used with great caution and under direct medical supervision, as it may increase the risk of corticosteroid-related adverse effects such as:

• decreased blood cortisol levels due to suppression of its release by the adrenal glands (hypothalamic-pituitary-adrenal axis suppression);
• increased cortisol production (Cushing's syndrome);
• delayed weight gain and growth retardation;
• increased pressure in the brain (intracranial hypertension), manifesting as bulging fontanelles, headache, and swelling of the nerves behind the eyes (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 certain antibiotic medicines (tetracyclines). Do not use TRIGON together with other ear medicines containing tetracyclines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Data on the use of corticosteroids in the ears during pregnancy are lacking or limited. Therefore, during pregnancy, the use of TRIGON should be decided by the doctor, who will weigh the benefits for the mother against the risks for 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 injectable administration. Risk to infants cannot be ruled out.
Do not use TRIGON if you are breastfeeding.

Fertility
No studies have been conducted to evaluate the effect of TRIGON administration on human fertility.
Driving and using machines
There are no data available to determine the effect of this medicine on the ability to drive or use machinery.
TRIGON contains 0.5 mg of Benzalkonium Chloride in 5 ml, equivalent to 0.1 mg/ml
Benzalkonium Chloride is an irritant substance that may cause local skin reactions.

3. How to use TRIGON

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is 4 drops, 3 times a day, or as prescribed by your doctor, to be administered into the external auditory canal of the affected ear. Do not use this medicine for longer than 7 days (see section “Warnings and precautions”).

This product is intended for ear application only and must NOT be injected.

Instructions for use

• Ensure the bottle is intact.
• Wash your hands and find the most comfortable position for step 3.
• Unscrew the cap.
• Tilt your head to the side so that the ear to be treated is facing upward as much as possible.
• Invert the bottle and place the tip near the ear without touching it. Do not touch the ear with the dropper tip.
• Gently squeeze the bottle so that the drops enter the ear.
• Remain in this position for 2 minutes to prevent the drops from leaking out.
• Repeat the procedure in the other ear if instructed by your doctor.
• Close the bottle immediately after use.

If you use more TRIGON than you should

In case of accidental ingestion or excessive application of this medicine, inform your doctor immediately 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), reduced muscle strength and marked weakness (asthenia, adynamia), increased blood pressure (arterial hypertension), heart rhythm problems, decreased potassium levels in the blood (hypokalaemia), and increased blood pH (metabolic alkalosis).

If you forget to use TRIGON

If you forget to use TRIGON, do not worry—apply it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule. Do not use a double dose to make up for the forgotten dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, TRIGON may cause side effects, although not everyone experiences them.
Local use of aminoglycoside antibiotics has been associated with ear toxicity (ototoxicity), the frequency of which is unknown.
Cases of local allergic reactions (hypersensitivity) may occur. If this happens, discontinue treatment and consult your doctor.
Side effects with unknown frequency (frequency cannot be estimated from the available data): blurred vision.
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 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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, correctly stored.
No special storage precautions are required.
The medicine must be used within 28 days of first opening the bottle.
Any unused medicine should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

• The active substances 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 components are: tyloxapol, benzalkonium chloride, edetate disodium, anhydrous sodium sulfate, sodium chloride, sulfuric acid (pH adjuster), water for injections.

Description of the appearance of TRIGON and pack contents
TRIGON is an ear solution available in 5 ml dropper bottles.
Marketing Authorization Holder
I.B.N. Savio Srl, Via del Mare 36 – 00071 Pomezia (RM)
Manufacturer
Genetic S.p.A.
Contrada Canfora, 84084 Fisciano (SA)
Patient Information Leaflet: Information for the patient

TRIGON

3 mg/ml + 1 mg/ml eye drops, solution
Tobramycin and Dexamethasone
Generic medicine
Please read this entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 using 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 TRIGON is and what it is used for

TRIGON contains two active substances: Dexamethasone and Tobramycin.
Dexamethasone is a corticosteroid, a hormone that performs numerous functions and plays an important role 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 inflammations when a corticosteroid is required, and when there is an eye infection or a risk of eye infection, in adults and children aged two years and older.

2. What you should know before using TRIGON

Do not use TRIGON

• if you are allergic to tobramycin, dexamethasone, or 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 Simplex virus (herpes simplex keratitis); if you have infections caused by viruses such as vaccinia, varicella, or other viral infections of the cornea and conjunctiva (the transparent membrane covering the white part of the eye and the inner surface of the eyelids);
• if you have fungal (mycoses) or untreated parasitic eye infections;
• if you have eye infections caused by mycobacteria (ocular tuberculosis);
• if you have elevated pressure inside the eye (endocular hypertension);
• if you have purulent eye infections (acute purulent ophthalmia, purulent conjunctivitis, and purulent blepharitis) and infections caused by the Herpes virus, which may be masked or worsened by anti-inflammatory medicines containing substances called “corticosteroids”;
• if you have a swelling of the eyelid resembling a pimple (stye).

Consult your doctor or pharmacist before using TRIGON.

• Some patients may develop hypersensitivity (allergic reaction) to aminoglycoside antibiotics such as tobramycin when administered in the eyes. This allergic reaction may range from localized itching or redness of the skin to severe generalized allergic reactions (anaphylactic reactions) or serious skin reactions. If you experience any of these symptoms while using TRIGON, stop treatment immediately and consult your doctor. Also note that this allergic sensitivity may occur with other antibiotics belonging to the aminoglycoside class, whether administered in the eyes or systemically (by injection).
• Consult your doctor if you have or have ever had conditions such as severe myasthenia gravis or Parkinson’s disease. Antibiotics of this type may worsen muscle weakness.
• In patients treated with medicines belonging to the same class as tobramycin (systemic aminoglycoside therapy), serious adverse effects such as toxicity to the nervous system (neurotoxicity), ears (ototoxicity), and kidneys (nephrotoxicity) have occurred. Be cautious and consult your doctor if you are using TRIGON together with medicines of the same class (aminoglycoside antibiotics) administered systemically (by injection).
• Prolonged use of medicines belonging to the same class as dexamethasone (corticosteroids) may cause increased eye pressure (ocular hypertension and/or glaucoma), damage to the optic nerve, reduced ability to see objects clearly (visual acuity), 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 have your eye pressure checked regularly and frequently. This is particularly important in children, as the risk of corticosteroid-induced increase in eye pressure may be higher in children under six years of age and may occur earlier than in adults. Consult your doctor, especially if TRIGON needs to be used in children. The risk of corticosteroid-induced increase in eye pressure and/or cataract formation is increased in predisposed patients (e.g., diabetic patients).
• Consult your doctor if you experience swelling and weight gain around the trunk and face, as these are usually the first signs of a condition called Cushing's syndrome. Suppression of adrenal gland function may develop after discontinuation of prolonged or intensive treatment with TRIGON. Do not stop treatment on your own—consult your doctor first. These risks are particularly important in children and in 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, consult your doctor.
• If you have a corneal ulcer that does not heal, stop treatment and consult your doctor.
• If you have diseases causing thinning of certain parts of the eye called “cornea” or “sclera,” consult your doctor before using TRIGON, as administration of corticosteroids into the eyes may lead to perforation.
• Medicines belonging to the same class as dexamethasone (corticosteroids) for local use in the eyes may delay healing of corneal wounds. It is also known that NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) applied to the eyes may slow down or delay healing. Concomitant use of NSAIDs and corticosteroids in the eyes may potentially increase problems with eye wound healing (see section “Other medicines and TRIGON”).
• Do not wear contact lenses during treatment for an eye inflammation or infection. Also read the section “TRIGON contains benzalkonium chloride”.
• Use TRIGON only under the direct supervision of a doctor.
• Use TRIGON only for ocular application.
• Contact your doctor if blurred vision or other visual disturbances occur.

Other medicines and TRIGON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Inform your doctor especially if you are using other eye medicines containing drugs belonging to the NSAID class (Non-Steroidal Anti-Inflammatory Drugs). Concomitant use of NSAIDs and corticosteroids in the eyes may potentially increase problems with corneal wound healing.
Consult your doctor if you are taking ritonavir or cobicistat, as they may increase the blood levels of dexamethasone.
If you are using more than one topical (local) eye medicine, wait at least 5 minutes between each application.
In particular, inform 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Data on the use of tobramycin and dexamethasone in the eyes during pregnancy are lacking or limited. Animal studies have shown reproductive toxicity following systemic (oral or injectable) administration of dexamethasone and tobramycin.
TRIGON is not recommended during pregnancy. Consult your doctor, who will decide whether you should use TRIGON during pregnancy.

Breastfeeding
It is not known whether tobramycin or dexamethasone, when used in the eyes (topical ophthalmic use), pass into breast milk. Tobramycin is excreted in breast milk after systemic administration (by injection). There are no data available on the passage of dexamethasone into human breast milk. The risk to breastfed infants cannot be excluded. Consult your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with TRIGON.

Fertility
No studies have been conducted to evaluate the effect of this medicine on human or animal fertility. Clinical data to assess the effect of dexamethasone on male or female fertility are limited.

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

TRIGON contains 0.5 mg of benzalkonium chloride per 5 ml, equivalent to 0.1 mg/ml
Benzalkonium chloride is a preservative that may be absorbed by soft contact lenses and may discolor soft contact lenses.
Avoid contact with soft contact lenses.
Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the outermost transparent layer of the eye). If you experience unusual sensations in the eye, such as burning or pain, after using this medicine, speak with your doctor.

3. How to use TRIGON

Apply TRIGON to the eyes only.
Always use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is:
1 or 2 drops 4–5 times a day, as prescribed by your doctor. Use the medicine for the length of time
prescribed by your doctor.
Instructions for use
Ensure the bottle is intact.

• Wash your hands and sit comfortably.
• Unscrew the cap with a gentle twist.
• Tilt your head backward.
• Gently pull down the lower eyelid of the affected eye with your fingers.
• Invert the bottle and position the tip near the eye, without touching it. Do not touch the eye or eyelid with the dropper tip.
• Gently squeeze the bottle so that a single drop enters the eye, then release the lower eyelid.
• Close the eye and press gently with a finger at the inner corner of the affected eye, near the nose, for 2 minutes.
• Repeat the procedure in the other eye, if your doctor has instructed you to do so.
• Close the bottle immediately after use.

Use in children
TRIGON may be used in children from the age of two years at the same doses as recommended 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
Cases of overdose are unlikely. However, if this occurs, thoroughly rinse the eye with running water.
Do not use the medicine again until the next scheduled dose.
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 for the next dose, skip the missed dose and return to your regular dosing schedule.
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Uncommon side effects (may affect from 1 to 10 users in 1,000)

9. Eye effects: increased pressure in the eye(s), eye pain, eye itching, eye discomfort, eye irritation.

Rare side effects (may affect from 1 to 10 users in 10,000)

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

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

• Eye effects: eyelid swelling, eyelid redness, increased pupil size, increased tear production.
• Hormonal problems: increased body hair growth (especially in women), muscle weakness and atrophy, purple stretch marks on the skin, increased blood pressure, irregular or absent menstrual cycle, 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 experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRIGON

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

6. Contents of the pack and other information

What TRIGON contains:

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

Description of the appearance of TRIGON and contents of the pack
TRIGON is a solution for eye drops supplied in a low-density polyethylene dropper bottle with a polypropylene screw cap, 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)