Trazyl

Patient Information Leaflet

TRAZYL 1% eye drops, powder and solvent for solution, 2% eye drops, powder and solvent for solution

Ibopamine hydrochloride
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TRAZYL is and what it is used for

TRAZYL, a medicine containing ibopamine hydrochloride, is used to dilate the pupil and to increase
the production of the fluid inside the eye.
TRAZYL is indicated:

• to dilate the pupil before undergoing an eye examination, either before or after eye surgery;
• in the treatment of low intraocular pressure (ocular hypotony) following eye surgery;
• as a test to detect the presence of an eye disease (ocular hypertension, glaucoma).
  Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using TRAZYL

Do not use TRAZYL

• if you are allergic to ibopamine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have a disease characterized by a severe increase in pressure inside the eye (closed-angle or narrow-angle glaucoma).

Warnings and precautions
Talk to your doctor or pharmacist before using TRAZYL:

• if you have a disease characterized by increased pressure inside the eye (open-angle glaucoma).

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
TRAZYL may be used during pregnancy or breastfeeding only if clearly needed and under direct medical supervision.

Driving and using machines
Do not use TRAZYL immediately before driving or operating machinery.

TRAZYL contains benzalkonium chloride
This medicine contains 0.0028 mg of benzalkonium chloride per drop, equivalent to 0.1 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience unusual sensations, burning, or pain in the eye after using this medicine, speak with your doctor.

TRAZYL contains disodium phosphate dodecahydrate (phosphate buffer)
This medicine contains 0.3919 mg of disodium phosphate dodecahydrate per drop, equivalent to 13.8 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause opaque corneal deposits due to calcium accumulation during treatment.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use TRAZYL

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dilation of the pupil before an examination
Adults: the recommended dose of TRAZYL 2% is 1-2 drops.
Neonates and children from 0 to 18 years: the recommended dose of TRAZYL 1% is 1-2 drops.
Dilation of the pupil before surgery
The recommended dose of TRAZYL 2% is 1-2 drops administered 60, 30 and 5 minutes before cataract surgery under local anaesthesia.
TRAZYL 2% may also be used in combination with other similar medicines, particularly during surgery under general anaesthesia.
Dilation of the pupil after surgery
The recommended dose of TRAZYL 1% or 2% is 1 drop, 2-4 times daily for 4-6 days following surgery.
Glaucoma examination
The recommended dose of TRAZYL 2% is 2 drops, given 5 minutes apart. Forty-five minutes after instillation, your doctor will check the pressure of the fluid inside your eye.
Treatment of low intraocular pressure (ocular hypotony) following surgery
The recommended dose of TRAZYL is 6-8 administrations per day, according to clinical need.

Instructions for use

1. Open the glass vial containing the

lyophilisate. Pressing the plastic vial,
pour the solvent contained therein into the
glass vial.

2. Close the glass vial again using the rubber stopper and shake.
3. Remove the rubber stopper and attach to the glass vial the dropper provided in the separate pouch.
4. Remove the plastic cap from the dropper and administer the dose.

Close the bottle immediately after each single application.
If you use more TRAZYL than you should
In case of accidental ingestion/overdose of TRAZYL, inform your doctor immediately or go to the nearest hospital.
If you forget to use TRAZYL
Do not use a double dose to make up for the missed dose.
If you stop using TRAZYL
If you have any doubts about using 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.
Eye-related side effects

• Burning sensation
• Redness
• Tearing.

If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause opaque spots on the cornea due to calcium accumulation during treatment.
Additional side effects in children

• Reduced blood flow to the edge of the eyelid (ischemia of the eyelid margin) in newborns.

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 via the 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 TRAZYL

Keep this medicine out of the sight and reach of children.
The product in its original intact packaging does not require any special storage conditions and can
be used until the expiry date stated on the label. The reconstituted product is valid for 20 days and must be
stored in a refrigerator (2°-8°C).
Do not use this medicine after the expiry date stated on the label and on the carton, following the word "Exp." The expiry date refers to the last day of that month.
Do not dispose of any 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. Package contents and other information

What TRAZYL contains

• The active substance is ibopamine hydrochloride.
• The other components are mannitol, benzalkonium chloride, hydroxypropylmethylcellulose, citric acid monohydrate, disodium hydrogen phosphate dodecahydrate, water for injections (see section 2 “TRAZYL contains benzalkonium chloride and disodium hydrogen phosphate dodecahydrate”).

Description of the appearance of TRAZYL and package contents
TRAZYL is supplied as an amber glass vial containing lyophilisate + plastic vial containing 5 ml of solvent + dropper.
Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan
Manufacturer
Tubilux Pharma S.p.A., Via Costarica 22/22 – Pomezia (Rome)