FYDRANE 0.2 mg/mL + 3.1 mg/mL + 10 mg/mL Injectable Solution

2. What you need to know before starting to use FYDRANE

FYDRANE should not be administered to you:

• if you are allergic to tropicamide, phenylephrine hydrochloride, and/or lidocaine hydrochloride monohydrate or to any of the other components of this medicine (listed in section 6),
• if you are allergic to amide-type anesthetics (such as articaine, bupivacaine, mepivacaine, prilocaine, ropivacaine),
• if you are allergic to atropine derivatives.

Warnings and Precautions

FYDRANE is not recommended:

• in cataract surgery combined with a certain type of eye surgery (vitrectomy),
• if the anterior part (anterior chamber) of your eye is shallow,
• if you have ever suffered from an acute increase in eye pressure (acute angle-closure glaucoma).

Consult your doctor if you have:

• high blood pressure (hypertension)
• thickening of the arterial walls (arteriosclerosis)
• any heart disease, and particularly if it affects heart rate,
• a contraindication to medications that increase blood pressure (vasopressor amines: epinephrine, norepinephrine, dopamine, dobutamine) by systemic route,
• overactive thyroid gland (hyperthyroidism),
• prostate gland disorders,
• seizures (epilepsy),
• any liver or kidney disease,
• any respiratory problems,
• muscle weakness and loss of muscle function (myasthenia gravis).

Using FYDRANE with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Pregnancy, Breastfeeding, and Fertility

This medicine should not be used:

• during pregnancy
• during breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and Using Machines

FYDRANE has a moderate influence on the ability to drive and use machines. Therefore, you should not drive and/or use machines until your vision is normal.

FYDRANE contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially "sodium-free".

3. How to use FYDRANE

This medicine should only be administered if you have already demonstrated, in a preoperative evaluation, satisfactory pupil dilation with a topical mydriatic.

Dose and Method of Administration

• FYDRANE injectable solution should be administered by an ophthalmic surgeon, with local anesthesia, at the start of cataract surgery.

• The recommended dose is 0.2 ml of solution in a single injection. No additional doses should be injected since no cumulative effects have been demonstrated and because an increase in endothelial cell loss has been observed.

• The same dose is used in adults and in elderly patients.

If you are given too much or too little FYDRANE:

Your medication will be administered by an ophthalmic surgeon. It is unlikely that you will be given an overdose. An overdose may cause loss of corneal endothelial cells (cells of a layer that covers the posterior surface of the cornea).

If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can have side effects, although not everyone gets them.

The most serious known complications occur during or after cataract surgery:

Uncommon: may affect up to 1 in 100 people

• Damage to the lens (posterior capsule rupture),
• Inflammation of the retina (cystoid macular edema).

Please seek urgent medical attention in these cases.

Other side effects:

Uncommon: may affect up to 1 in 100 people

• Headache,
• Inflammation of the cornea (keratitis), increased pressure in the eye, redness of the eye (ocular hyperemia),
• High blood pressure (hypertension).

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of FYDRANE

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton, blister, and ampoule after "EXP.". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

For use in a single eye. This medicine should be used immediately after opening the ampoule.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of FYDRANE

• The active substances are tropicamide 0.04 mg, phenylephrine hydrochloride 0.62 mg, and lidocaine hydrochloride monohydrate 2 mg per 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride, and 10 mg of lidocaine hydrochloride monohydrate per 1 ml.
• The other components are: sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate, disodium edetate, and water for injectable preparations.

Appearance and Packaging of the Product

FYDRANE is a clear, yellow to slightly brownish injectable solution, practically free of visible particles, packaged in a 1 ml topaz glass ampoule. Each sterile ampoule contains 0.6 ml of the injectable solution and is presented alone or with a sterile 5-micron filter needle in a sealed paper/PVC blister.

Each package contains 1, 20, or 100 sterile ampoules (with a sterile 5-micron filter needle). The 5-micron filter needle should only be used to extract the contents of the vial.

All components are for single use only.

Not all package sizes may be marketed.

Marketing Authorization Holder

LABORATOIRES THEA

RUE LOUIS BLÉRIOT, 12

F-63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Manufacturer

DELPHARM TOURS

RUE PAUL LANGEVIN

37170 CHAMBRAY LES TOURS

FRANCE

OR

LABORATOIRES THEA

RUE LOUIS BLÉRIOT, 12

F-63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Local Representative:

LABORATORIOS THEA, S.A.

C/ Enric Granados, nº 86-88, 2ª planta

08008 Barcelona

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Bulgaria, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom ………………………………. Mydrane

Ireland, Spain …………………………………………. Fydrane

Norway ………………………………………… Mydane

Date of the last revision of this package leaflet: September 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.es/

This information is intended only for healthcare professionals:

Incompatibilities

No incompatibilities of the active substances with most products used in cataract surgery have been reported in the literature, and none were found during clinical trials. For usual viscoelastics, this has also been confirmed by pharmacological interaction tests.

Warnings

Do not use if the blister is damaged or broken. Open only under aseptic conditions to ensure the sterility of the contents.

How to Prepare and Administer FYDRANE

Single use of the solution for one eye by intracameral route only.

FYDRANE should be administered by intracameral injection into the anterior chamber of the eye, by an ophthalmic surgeon, under aseptic conditions recommended for cataract surgery.

Before intracameral injection, the solution should be visually inspected and only used if it is a clear solution with a slight yellow to slightly brownish color and practically free of visible particles.

The recommended dose is 0.2 ml of FYDRANE; no additional dose should be injected since no significant cumulative effects have been demonstrated and because an increase in endothelial cell loss has been observed.

The product should be used immediately after opening the ampoule and should not be reused for the other eye or for any other patient.

Only for the kit presentation (i.e., blister containing an ampoule and a needle): attach the detachable label from the blister to the patient's medical history.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations. Dispose of used needles in a puncture-proof container.