Tropimil

Package leaflet: Information for the user

Tropimil 5 mg/ml eye drops

Tropicamide
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 any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tropimil is and what it is used for

Tropimil contains the active substance tropicamide and belongs to a class of medicines called anticholinergic mydriatic and cycloplegic agents.
This medicine is used to cause dilation of the pupil (mydriatic effect) and to induce paralysis of the eye's ciliary muscle (cycloplegic effect).

2. What you need to know before using Tropimil

Do not use Tropimil

• if you are allergic to tropicamide or to any of the other ingredients of this medicine (listed in section 6);
• if you have closed-angle or narrow-angle glaucoma, i.e. if the angle between the iris and cornea is closed or narrower than normal;
• if you have an enlarged prostate (prostatic hypertrophy).

Warnings and precautions
Talk to your doctor or pharmacist before using Tropimil.
Use this medicine with caution if you are over 40 years of age, as it may cause previously undetected increased pressure inside the eye (glaucoma).
Children
In early infancy, this medicine should be used only when strictly necessary and under direct medical supervision.
Other medicines and Tropimil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Tropimil should be administered during pregnancy only when clearly necessary and under direct medical supervision.
Driving and using machines
Visual disturbances due to dilation of the pupil (mydriasis) and paralysis of the eye's ciliary muscle (cycloplegia) may impair your ability to drive vehicles or operate machinery.
Tropimil contains benzalkonium chloride
This medicine contains benzalkonium chloride, which may cause eye irritation. Avoid contact with soft contact lenses.
Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride is known to cause discoloration of soft contact lenses.
Tropimil eye drops contain phosphate buffer
This medicine contains 0.066 mg of phosphate buffer per drop, equivalent to 1.33 mg/ml, with a theoretical drop volume of approximately 50 µL.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits leading to opaque corneal spots during treatment.

3. How to use Tropimil

Use this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended doses are:

• when used as a mydriatic: 1-2 drops into the conjunctival sac, once only.
• when used as a cycloplegic: 1-2 drops into the conjunctival sac every 5 minutes for 3-4 times.
• when used for therapeutic purposes: according to the indications established by the doctor on a case-by-case basis.

Instructions for use of the multidose bottle:

• To open the container, press the closure cap and at the same time unscrew it.
• After use, close the container by screwing the cap tightly.

If you use more Tropimil than you should
Overdose reactions have not been reported.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
As with atropine (a medicine used to dilate the pupil as well as in the treatment of certain inflammatory eye diseases), the following side effects have been reported with the use of Tropimil:

Frequency not known (frequency cannot be estimated from the available data)

• dry mouth;
• delayed production of gastric juices;
• reduced intestinal muscle tone;
• constipation;
• reduced bladder tone and slower urinary flow (urination), with risk of acute urinary retention, especially in the elderly;
• reduced nasal, bronchial and tear secretions. This may lead to mucosal irritation;
• increased or irregular heartbeat (tachycardia) with palpitations and various forms of heartbeat disturbances (arrhythmia);
• excessive sensitivity of the eyes to light (photophobia).

Due to the presence of phosphates, very rare cases of corneal calcification have been reported with the use of eye drops containing phosphates in patients with significantly damaged corneas.

Following the instructions provided in this leaflet reduces the risk of side effects.

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 Tropimil

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 stated expiry date applies to the product in its original, unopened packaging, stored correctly.
This medicine must not be used more than 30 days after first opening the container.
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 Tropimil contains

• The active substance is tropicamide. 1 ml of eye drops solution contains 5 mg of tropicamide.
• The other components are: sodium chloride, sodium phosphate dibasic, benzalkonium chloride, edetate disodium, water for injections.

Description of the appearance of Tropimil and contents of the pack
Tropimil is a solution for eye drops.
The package contains one 5 ml dropper bottle.
Marketing Authorization Holder
Farmigea S.p.A. - Via Giovan Battista Oliva, 6/8 - 56121 Pisa
Marketing Authorization Holder's Licensee for distribution:
POLIFARMA S.p.A. - Viale dell’Arte 69 - 00144 Roma
Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 8 - 56121 Pisa

Patient Information Leaflet: Information for the user

Tropimil 5 mg/ml eye drops, solution

Tropicamide
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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tropimil is and what it is used for

Tropimil contains the active substance tropicamide and belongs to a group of medicines called anticholinergic, mydriatic (which dilate the pupil of the eye), and cycloplegic (which cause paralysis of the eye's ciliary muscle) agents.
Tropimil is used:

• as a fast-acting, short-duration mydriatic in eyes injured due to trauma or surgical procedures;
• in pre- and post-operative treatment of the eye (mainly for cataract);
• to inhibit or treat mild inflammations in the anterior part of the eye.

2. What you need to know before using Tropimil

Do not use Tropimil

• if you are allergic to tropicamide or to any of the other ingredients of this medicine (listed in section 6);
• if you have closed or narrow irido-corneal angle, meaning the angle between the iris and cornea is closed or smaller than normal;
• if you have an enlarged prostate (prostatic hypertrophy).

Warnings and precautions
Talk to your doctor or pharmacist before using Tropimil.
Use this medicine with caution if you are over 40 years of age, as it may cause an undetected increase in intraocular pressure (glaucoma).
Children
In very early infancy, this medicine should be used only when strictly necessary and under direct medical supervision.
Other medicines and Tropimil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use this medicine only when strictly necessary and under direct medical supervision.
Driving and using machines
Visual disturbances due to dilation of the pupil of the eye (mydriasis) and paralysis of the eye's ciliary muscle (cycloplegia) may impair your ability to drive or operate machinery.
Tropimil eye drops contain phosphate buffer
This medicine contains 0.066 mg of phosphate buffer per drop, equivalent to 1.33 mg/ml, with a theoretical drop volume of approximately 50 µL.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Tropimil

Use this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
This medicine is intended for a single application and for use in a single patient only.
For instillation or irrigation into the pouch located in the lower part of the eye (conjunctival sac), the recommended dose is from half to the entire contents of a single-dose container
of Tropimil, 1–2 times daily, according to the physician's judgment.
Instructions for using the single-dose container:

• Remove a single-dose container from its protective pouch
• Open the single-dose container by removing the cap covering the dropper nozzle
• By gently squeezing the body of the container, dispense the desired amount of medicine into the conjunctival sac

If you use more Tropimil than you should
No adverse effects due to overdose have been reported.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
As with atropine (a medicine used to dilate the pupil as well as in the treatment of certain inflammatory eye diseases), the following side effects have been reported with the use of Tropimil:
Frequency not known (frequency cannot be estimated from the available data)

• dry mouth;
• delayed production of gastric juices;
• reduced intestinal muscle tone;
• constipation;
• reduced bladder tone and slowed urinary flow (urination), with risk of acute urinary retention, especially in the elderly;
• inability of the bladder to empty (acute urinary retention), especially in the elderly;
• decreased nasal, bronchial, and tear secretions. This may cause mucosal irritation;
• rapid or irregular heartbeat (tachycardia) with palpitations and various forms of heartbeat disturbances (arrhythmias);
• excessive sensitivity of the eyes to light (photophobia).

Due to the presence of phosphates, very rare cases of corneal calcification have been reported with the use of phosphate-containing eye drops in patients with significantly damaged corneas.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may 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 Tropimil

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 stated expiry date applies to the product in its original, unopened packaging, correctly stored.
This medicine does not contain antimicrobial preservatives and must therefore be used immediately after opening the container, as a single dose for each individual patient. The single-dose container and any remaining medicine inside must then be discarded (see "How to use Tropimil").
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 Tropimil contains

• The active substance is tropicamide. 1 ml of solution contains 5 mg of tropicamide.
• The other components are: sodium chloride, sodium phosphate dibasic, edetate disodium, water for injections.

Description of the appearance of Tropimil and contents of the pack
Tropimil is an eye drop solution.
The package contains 5 or 25 single-dose units of 0.5 ml each. The units are arranged in strips of 5 and enclosed in protective pouches.
Marketing Authorization Holder
Farmigea S.p.A. - Via Giovan Battista Oliva, 6/8 - 56121 - Pisa
Marketing Authorization Holder's Representative for the Sale: POLIFARMA S.p.A. - Viale dell’Arte 69 - 00144 Roma
Manufacturer
Farmigea S.p.A. - Via Giovan Battista Oliva, 8 - 56121 Pisa