Colirofta Anestesico Doble 1 mg/ml + 4 mg/ml eye drops solution

Package leaflet: Information for the user

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 leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

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

2. What you need to know before using COLIROFTA ANAESTHETIC DOUBLE

Do not use Colirofta Anaesthetic Double

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

Warnings and precautions

Consult your doctor or pharmacist before using Colirofta Anaesthetic Double.

• Use this medicine only in the eye(s).
• Repeated use of this medicine may cause corneal injury.
• Prolonged use of one of the components, tetracaine, may lead to reduced duration of anaesthesia and delayed healing, among other adverse visual effects.
• Due to the effect of anaesthetics, your eyes will lose sensitivity and therefore you should be careful to avoid accidental eye injuries.
• Use with caution if you have heart disease or overactivity of the thyroid gland.
• This medicine 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 medicines and Colirofta Anaesthetic Double

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Especially consult your doctor if you are using:

• Sulphonamides in eye drops or eye ointment.
• St John's wort (may cause low blood pressure).

Pregnancy, breastfeeding and fertility

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

You must not use Colirofta Anaesthetic Double during pregnancy.

If you are breastfeeding, consult your doctor, who will decide whether breastfeeding should be stopped or the treatment discontinued, weighing the benefit against the potential risk.

Driving and use of machines

You may notice blurred vision for a short time after instilling the eye drops. Do not drive or operate machinery until this effect has disappeared.

Colirofta Anaesthetic Double contains phosphates

This medicine contains 10.1 mg of phosphates per ml.

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

3. How to use COLIROFTA ANESTÉSICO DOBLE

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults

Generally, instill 1 or 2 drops into the affected eye as required.

Use in children

The safety and efficacy of this medicine 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 medicine, tetracaine.

Use in hepatic and/or renal impairment

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

Instructions for use:

Ophthalmic use (in the eye[s]).

1 2 3

1. Wash your hands.
2. Take the bottle (dropper container).
3. After opening the bottle for the first time, remove the plastic seal ring.
4. Hold the bottle upside down between your fingers.
5. Tilt your head backward. Gently pull down the eyelid to form a pouch, into which the drop should be instilled (figure 1).
6. Bring the tip of the bottle close to the eye. A mirror may be helpful.
7. Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip. The eye drops could become contaminated.
8. Gently squeeze the base of the bottle so that one drop falls at a time (figure 2).
9. After using these eye drops, press with your finger on the inner corner of the eye next to the nose. This helps prevent the medicine from passing into the rest of the body (figure 3).
10. If applying drops to both eyes, repeat all the previous steps for the other eye.
11. Close the bottle tightly immediately after using the medicine.

If a drop misses the eye, try again.

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

If you use more COLIROFTA ANESTÉSICO DOBLE than you should

An overdose in the eyes can be removed by rinsing the eyes with lukewarm water. Do not apply additional drops until the next scheduled dose.

In case of severe overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

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

If you forget to use COLIROFTA ANESTÉSICO DOBLE

Do not use a double dose to make up for missed doses.

Use a single dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Excessive use of this medicine may cause corneal injury or damage to the eye.

There have been reports of cases affecting the coloured part of the eye (the iris) and corneal swelling.

Allergic reactions may occur occasionally.

Reporting of 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of COLIROFTA ANESTÉSICO DOBLE

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

Do not use this medicine after the expiry date stated on the container and the carton after EXP. The expiry date refers to the last day of the month indicated.

Before opening, store in a refrigerator (between 2°C and 8°C). After opening, do not store at temperatures above 25°C.

To prevent infections, the bottle must be discarded 4 weeks after first opening.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of COLIROFTA ANESTHETIC DOUBLE

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

Appearance of the medicine and contents of the pack

Colirofta Anestésico Doble is an eye drop solution; a clear, colourless or slightly yellowish liquid.

It is presented in a box containing one dropper bottle (plastic bottle) of 10 ml.

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

Alcon Laboratories Belgium

Lichterveld 3

2870 Puurs-Sint-Amands

Belgium

Date of the most recent revision of this leaflet: January 2023

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