Leaflet: information for the user

FYDRANE0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, injectable solution

tropicamide / phenylephrine hydrochloride / lidocaine hydrochloride monohydrate

Read this leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isFYDRANEand what it is used for

2. What you need to know before starting to useFYDRANE

3. How to useFYDRANE

4. Possible adverse effects

5. Storage ofFYDRANE

6. Contents of the pack and additional information

What is FYDRANE

This medication is a solution for injection into the eye.

It contains three active principles:

• Tropicamide which belongs to a group of medications that block the passage of impulses through nerves (known as anticholinergics),
• Phenylephrine (as phenylephrine hydrochloride) which belongs to a group of medications that mimic the effects of impulses transmitted through certain nerves (which belong to the alpha-sympathomimetics),
• Lidocaine (as lidocaine hydrochloride monohydrate) which belongs to a group of medications called local anesthetics of the amide type.

For what it is used

This medication is used exclusively in adults.

It will be administered by your ophthalmic surgeon through an injection into the eye at the beginning of cataract surgery (opacity of the crystalline lens) to dilate the pupil of your eye (mydriasis) and obtain anesthesia in your eye during the surgical procedure.

You should not be administered FYDRANE:

• if you are allergic to tropicamide, phenylephrine hydrochloride and/or lidocaine hydrochloride monohydrate or to any of the other components of this medication (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 combined cataract surgery with certain types of eye surgery (vitrectomy),
• if the anterior (anterior) part of your eye is shallow,
• if you have ever experienced an acute increase in eye pressure (acute angle-closure glaucoma).

Consult your doctor if you have:

• high blood pressure (hypertension)
• arterial wall thickening (atherosclerosis)
• any heart disease and, in particular, if it affects heart rate,
• a contraindication to systemic medications that increase blood pressure (vasopressor amines: epinephrine, norepinephrine, dopamine, dobutamine),
• an overactive thyroid gland (hyperthyroidism),
• prostatic gland disorders,
• seizures (epilepsy),
• any liver disease or kidney problems,
• any respiratory problems,
• muscle weakness and weakness (myasthenia gravis).

Use of FYDRANE with other medications

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

Pregnancy, breastfeeding and fertility

This medication should not be used:

• during pregnancy
• during breastfeeding

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

Driving and operating machines

FYDRANE has a moderate effect on the ability to drive and operate machines. Therefore, do not drive and/or operate machines until your vision is normal.

FYDRANE contains sodium

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

This medication should only be administered if satisfactory pupillary dilation has been demonstrated in a preoperative evaluation using a topical miotic.

Dose and method of administration

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

• The recommended dose is 0.2 mL of solution in a single injection. No additional doses should be injected as no cumulative effects have been demonstrated, and an increase in endothelial cell loss (cells of the layer covering the posterior surface of the cornea) has been observed.

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

If too much or too little FYDRANE is administered:

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

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

Like all medications, this medication may have adverse effects, although not all people may experience them.

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

Rare: may affect up to 1 in 100 people

• Lens injury (posterior capsule rupture),
• Retinal inflammation (cystoid macular edema).

Please seek urgent medical attention in these cases.

Other adverse effects:

Rare: may affect up to 1 in 100 people

• Headache,
• Corneal inflammation (keratitis), increased eye pressure, eye redness (ocular hyperemia),
• High blood pressure (hypertension).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box, blister pack, and ampule after “CAD.” The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

For use in one eye only. This medication must be used immediately after opening the ampule.

Medicines should not be disposed of through drains or in the trash.Dispose of containers and medicines you no longer need at the SIGRE collection point at your pharmacy.If in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofFYDRANE

- The active principles 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 for 1 ml.

- The other components are: sodium chloride, dodecahydrate disodium phosphate, dihydrate disodium phosphate, edetate disodium, and water for injectable preparations.

Aspect of the product and size of the packaging

FYDRANE is a transparent injection solution, yellow to slightly brown in color, and practically free of visible particles, packaged in a 1 ml amber glass vial. Each sterile vial contains 0.6 ml of the injection solution and is presented alone or with a sterile 5-micron filter needle in a sealed PVC/paper blister.

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

All components are for single use.

Not all packaging sizes may be marketed.

Holder of the marketing authorization

LABORATOIRES THEA

RUE LOUIS BLÉRIOT, 12

F-63017 CLERMONT-FERRAND CEDEX 2

FRANCE

Responsible for manufacturing

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, 2nd floor

08008 Barcelona

This medicine is authorized in the member states of the European Economic Area with the following names:

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

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

Norway……………………………………………………………........................................Mydane

Date of the last review of this leaflet: September 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.es/

This information is intended solely for healthcare professionals:

Incompatibilities

No incompatibilities of the active principles with the majority of products used in cataract surgery have been reported in the literature, nor during clinical trials. Similarly, this has been confirmed by pharmacological interaction tests for the usual viscoelastic agents.

Warnings

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

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 in the anterior chamber of the eye (intracameral injection) by an ophthalmic surgeon in the recommended aseptic conditions for cataract surgery.

Before intracameral injection, the solution must be visually inspected and only used if it is a transparent solution with a yellow to slightly brown color and practically free of visible particles.

The recommended dose is 0.2 ml of FYDRANE; do not inject an additional dose as no significant cumulative effects have been demonstrated, and an increase in endothelial cell loss was observed.

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

Only for the presentation in kit (i.e., blister containing a vial and a needle):attach the detachable label of the blister to the patient's history.

The disposal of unused medication 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 sharps container.