COLIROFTA ANESTHETIC DOUBLE 1 mg/ml + 4 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

COLIROFTA ANESTHETIC DOUBLE 1 mg/ml + 4 mg/ml eye drops solution

Tetracaine hydrochloride/Oxybuprocaine hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What COLIROFTA ANESTHETIC DOUBLE is and what it is used for
2. What you need to know before starting to use COLIROFTA ANESTHETIC DOUBLE
3. How to use COLIROFTA ANESTHETIC DOUBLE
4. Possible side effects

5 Conservation of COLIROFTA ANESTHETIC DOUBLE

1. Contents of the pack and additional information

1. What COLIROFTA ANESTHETIC DOUBLE is and what it is used for

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

Colirofta Anesthetic Double is indicated for painful conditions of the eye, minor eye surgery (short ophthalmological procedures), and during and after the removal of foreign bodies.

2. What you need to know before starting to use COLIROFTA ANESTHETIC DOUBLE

Do not use Colirofta Anesthetic Double

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Colirofta Anesthetic Double.

• Use this medication only in the eye(s).
• Repeated use of this medication can cause corneal ulcers.
• Prolonged use of one of the components, tetracaine, can lead to decreased duration of anesthesia and delayed healing, among other visual side effects.
• Due to the effect of anesthetics, your eyes will lose sensitivity, and you should be careful to avoid accidental injuries to the eyes.
• It should be used 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 of this medication have not been established in children.

Other medications and Colirofta Anesthetic Double

Tell your doctor or pharmacist if you are using, have recently used, 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use Colirofta Anesthetic Double during pregnancy.

If you are breastfeeding, consult your doctor, who will decide whether to interrupt breastfeeding or treatment after considering the benefits and risks.

Driving and using machines

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 Anesthetic Double contains phosphates

This medication contains 10.1 mg of phosphates per ml.

If you have severe corneal damage (the transparent layer on the front of the eye), treatment with phosphates, in very rare cases, can cause blurry vision due to calcium accumulation.

3. How to use COLIROFTA ANESTHETIC DOUBLE

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

The normal dose is:

Adults

Usually, 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 hepatic and/or renal insufficiency

The safety and efficacy of this medication have not been established in patients with hepatic and/or renal insufficiency.

Recommendations for use:

Ophthalmic route (in the eye(s)).

1 2 3

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

If a drop falls outside the eye, try again.

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

If you use more COLIROFTA ANESTHETIC DOUBLE than you should

An overdose in the eyes can be eliminated 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

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

If you forget to use COLIROFTA ANESTHETIC DOUBLE

Do not apply a double dose to make up for forgotten doses.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Excessive use of this medication can cause corneal injury or eye damage.

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

In rare cases, allergic reactions may occur.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of COLIROFTA ANESTHETIC DOUBLE

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and carton after EXP. 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 above 25°C.

To avoid infections, the bottle should be discarded 4 weeks after it was first opened.

Write the opening date of the bottle in the space provided on the carton for this purpose.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and additional information

Composition of COLIROFTA ANESTHETIC DOUBLE

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

Appearance of the product and contents of the pack

Colirofta Anesthetic Double is an eye drop solution; a clear, colorless, or slightly yellowish liquid.

It is presented in a carton containing a dropper bottle (10 ml plastic bottle).

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

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

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

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