Prospect: information for the user

COLIROFTA ANESTÉSICO DOBLE 1 mg/ml + 4mg/ml eye drop solution

Tetracaine hydrochloride/Oxibuprocaine hydrochloride

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you, and you must not give it to other people even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is COLIROFTA ANESTÉSICO DOBLE and for what it is used

2.What you need to know before starting touse COLIROFTA ANESTÉSICO DOBLE

3.How to use COLIROFTA ANESTÉSICO DOBLE

4.Possible adverse effects

5Storage of COLIROFTA ANESTÉSICO DOBLE

6.Contents of the package andadditional information

It is an eye drop that contains two active components, tetracaine and oxybuprocaine, which are local anesthetics (medications that temporarily remove sensitivity at the site of administration).

Colirofta Anestésico Doble is indicated forpainful eye conditions, minor eye surgery (short ophthalmic procedures), during and after the removal of foreign bodies.

No use Colirofta Anestésico Doble

If you are allergic to oxybuprocaine, tetracaine, or other local anesthetics of the same type derived from para-aminobenzoic acid, or to any of the other componentsof this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Colirofta Anestésico Doble.

• Use this medication only in the eye(s).
• The repeated use of this medication may cause corneal ulcers.
• With the continued use of one of the components, tetracaine, a decrease in the duration of anesthesia and delay in healing, among other adverse visual effects, may occur.
• Due to the anesthetics, your eyes will lose sensitivity and, therefore, you should be careful to avoid accidental injuries to the eyes.
• Use with caution if you have heart disease or hyperthyroidism.
• This medication should only be used under the direct supervision of a healthcare professional.

Use in elderly patients

See section 3.

Children

The efficacy and safety have not been established in children.

Other medications and Colirofta Anestésico Doble

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

Especially consult your doctor if you are using:

• Sulfonamides in eye drops or ointment.
• St. John's Wort (may cause a drop in blood pressure).

Pregnancy, breastfeeding, and fertility

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

You should not use Colirofta Anestésico Doble during pregnancy.

If you are breastfeeding a baby, consult your doctor who should decide whether to interrupt breastfeeding or interrupt treatment after considering the benefit versus the possible risk.

Driving and operating machinery

You may notice that your vision becomes blurry for a while after applying the eye drops. Do not drive or use machines until this effect has disappeared.

Colirofta Anestésico Doble contains phosphates

This medication contains 10.1 mg of phosphates in each ml.

If you suffer from severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurry vision due to calcium accumulation.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The normal dose is:

Adults

Generally instill 1 or 2 drops in the affected eye as needed.

Use in children

The safety and efficacy of this medication have not been established in children.

Use in elderly patients

It is recommended to start treatment with the lowest recommended dose, as these patients may have a variable response to one of the components of the medication, tetracaine.

Use in case of liver and/or renal insufficiency

The safety and efficacy have not been established in patients with liver and/or renal insufficiency.

Usage recommendations:

Ophthalmic route (in the/both eyes).

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1. Wash your hands.
2. Take the bottle (dropper bottle).
3. After opening the bottle for the first time, remove the plastic ring from the cap.
4. Hold the bottle, upside down, between your fingers.
5. Incline your head back. Gently separate your eyelid from your eye with a finger until a pouch forms, in which the drop should fall (figure 1).
6. Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
7. Do not touch your eye or eyelid, nearby areas or other surfaces with the dropper. The eye drops could become contaminated.
8. Gently press the base of the bottle to release one drop at a time (figure 2).
9. After using this eye drop, press the corner of your eye near your nose with your finger. This helps prevent the medication from passing into the rest of your body (figure 3).
10. If you apply drops to both eyes, repeat all previous steps for the other eye.
11. Close the bottle tightly immediately after using the medication.

If a drop falls outside the eye, try again.

If you are using other eye medications, wait at least 5 minutes between administering this eye drop and the other eye medications. Eye ointments should be administered last.

If you use more COLIROFTA ANESTÉSICO DOBLE than you should

A drop overdose in the eyes can be treated by rinsing the eyes with warm water. Do not apply more drops until the next dose.

In case of severe overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

Severe reactions affecting the nervous system or cardiovascular system, among others (especially in children), may occur.

If you forgot to use COLIROFTA ANESTÉSICO DOBLE

Do not apply a double dose to compensate for the missed doses.

Apply a single dose as soon as you remember. However, if it is almost time for your next dose, continue with your regular schedule.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Excessive use of this medication may cause injury to the cornea or damage to the eye.

There have been reports of some cases of iris discoloration and corneal swelling.

On rare occasions, allergic reactions may occur.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. 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.

Keepthis medication out of sight andreach of children.

Do not use this medication after the expiration date that appears on the packaging and on the box after CAD. The expiration date is the last day of the month indicated.

Before opening, store in the refrigerator (between 2°C and 8°C). Once opened,do not store at a temperature above 25°C.

To prevent infections, discard the bottle 4weeks after first opening.

Record the date of opening the bottle in the reserved box on the box.

Medications should not be thrown away through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of COLIROFTA ANESTÉSICO DOBLE

• The active principles are tetracaine hydrochloride and oxybuprocaine hydrochloride. Each milliliter of eye drop solution contains 1mg of tetracaine hydrochloride (0.1%) and 4mg ofoxybuprocaine hydrochloride(0.4%).
• The other components are chlorobutanol, potassium dihydrogen phosphate, sodium dodecahydrate hydrogen phosphate, and purified water.

Appearance of the product and contents of the packaging

Colirofta Anestésico Doble is an eye drop solution; a transparent and colorless or slightly yellowish liquid.

It is presentedin a box containing a dropper bottle (plastic vial)of10ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Alcon Healthcare, S.A.

World Trade Center Almeda Park

Plaça de la Pau s/n, Edificio 6, planta 3

08940 – Cornellà de Llobregat (Barcelona)

Spain

Responsible for manufacturing

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 – El Masnou (Barcelona)

Spain

or

Alcon Laboratories Belgium

Lichterveld 3

2870 Puurs-Sint-Amands

Belgium

Last review date of this leaflet: January 2023

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