Colirofta anestesico 5 mg/ml + 0,5 mg/ml colirio en solucion

Prospect: information for the user

COLIROFTA ANESTÉSICO 5 mg/ml + 0.5mg/ml eye drop solution

Tetracaine hydrochloride/Naphazoline 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 should 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 and for what it is used

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

3.How to use COLIROFTA ANESTÉSICO

4.Possible adverse effects

5Storage of COLIROFTA ANESTÉSICO

6.Contents of the package andadditional information

It is an eye drop that contains two active components, tetracaine,a local anesthetic (temporarily removes sensitivity at the site of administration) and naphazoline with decongestant action (produces vasoconstriction or narrowing of visible blood vessels in the eye) that prolongs the anesthetic activity.

Colirofta Anestésico is indicated for treatingpainful eye conditions, foreign body removal, ocular examination, tonometry (measurement of pressure within the eyes), gonioscopy (measures the angle of union of the iris with the cornea, whether it is wide or narrow) and fundus examination with contact lens.

No use Colirofta Anestésico

• If you are allergic to nafazolina, tetracaine, or other local anesthetics of the same type, or to any of the other componentsof this medication (listed in section 6).
• If you have narrow-angle glaucoma.

Warnings and precautions

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

Use this medication only in the eye(s).

You must be careful if you are in any of the following cases:

• If you are being treated with monoamine oxidase inhibitors (MAOIs) (usually antidepressants) or during the two weeks after stopping this treatment
• If you are being administered certain anesthetics (e.g., halothane, which makes the heart more sensitive to medications like nafazolina)
• If you have bronchial asthma
• If you have heart or circulation disease.
• If you have cerebral arteriosclerosis
• If you have hypertension
• If you have hyperthyroidism (excessive functioning of the thyroid gland)
• If you have diabetes

The repeated use of this medication (due to tetracaine) may cause corneal ulcers.

With the continued use of tetracaine, a decrease in the duration of anesthesia and delay in healing, among other adverse visual effects, may occur.

• Due to the anesthetic effect, your eyes will lose sensitivity and, therefore, you should be careful to avoid accidental injuries to the eyes
• This medication should only be used under the direct supervision of a healthcare professional
• Do not use for more than 3 to 5 days
• Do not wear contact lenses during the use of this medication.

Use in elderly patients

See section 3.

Care should be taken in patients over 65 years old, particularly those with severe heart or circulation diseases (such as arrhythmias or hypertension), as nafazolina may worsen these conditions.

Children

Do not use this medication in children; its efficacy and safety have not been established in children.

Other medications and COLIROFTA ANESTÉSICO

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:

• MAOIs (you may experience a severe hypertensive crisis).
• Sulfonamides in eye drops or ointment.
• St. John's Wort.

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 Anestésico during pregnancy.

Your doctor should decide whether to interrupt breastfeeding or interrupt treatment after considering the benefit against the possible risk.

Driving and operating machinery

You may notice that your vision becomes blurry or you experience other discomforts for a while after applying the eye drops. Do not drive or operate machinery until these effects have disappeared.

COLIROFTA ANESTÉSICOcontains phosphates

This medication contains 5.8 mg of phosphates in each ml.

If you suffer from severe corneal damage (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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

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

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 kidney insufficiency

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

Use in children

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

Usage recommendations:

Ophthalmic route (in the 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 if it is loose.
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 between your eyelid and eye, where the drop should fall (figure 1).
6. Bring the tip of the bottle close to your eye. A mirror may be helpful.
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 drops are applied 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 than you should

A 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 the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

Severe reactions such as a drop in body temperature, drowsiness or other symptoms of central nervous system depression (especially in children) and severe reactions affecting the cardiovascular system may occur.

After ingestion, especially in children, symptoms such as nausea, vomiting, lethargy, palpitations, difficulty breathing, among others, may appear.

If you forgot to use COLIROFTA ANESTÉSICO

Do not use 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 the next dose and continue with the next dose of your regular regimen.

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 all people may experience them.

The following adverse effects have been reported, although their frequency is not precisely known:

Due to the anesthetic, excessive use of this medication may cause corneal injuries or eye damage.

In rare cases, allergic reactions may occur.

Due to the presence of naphazoline in the medication, you may experience pupil dilation and increased eye pressure. General side effects may include headache, increased blood pressure, irregular heart rhythm, increased heart rate, nausea, dizziness, and stroke.

Other Adverse Effects in Children

Excessive use of naphazoline in infants and young children may cause central nervous system depression and a significant reduction in body temperature.

In rare cases, itching after application has been observed.

Continued redness and eye irritation, conjunctivitis, and eye pain have also been reported.

In general, predisposed patients and those using the medication in larger quantities and more frequently than recommended may experience tremors, weakness, and sweating.

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.Reporting adverse effects can help provide 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 the first 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 it has been opened for the first time.

Note the date of opening of the bottle in the reserved box for this purpose on the box.

Medications should not be thrown away through drains or in the trash. Dispose of the packaging and medications that you do not need at the SIGREpoint of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help to protect the environment.

Composition of COLIROFTA ANESTÉSICO

• The active principles are tetracaine hydrochloride and naphazoline hydrochloride. Each milliliter of eye drop solution contains 5mg of tetracaine hydrochloride (0.5%) and 0.5mg ofnaphazoline hydrochloride (0.05%).
• The other components are chlorobutanol, monosodium phosphate monohydrate, sodium hydrogen phosphate dodecahydrate, sodium chloride, and purified water.

Appearance of the product and content of the container

Colirofta Anestésico is an eye drop solution; transparent and colorless liquid.

It is presentedin a box that contains 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 medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/