Leaflet: information for the user

COLIROFTA TROPICAMIDA 10mg/ml eye drop solution

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What COLIROFTA TROPICAMIDA is and what it is used for

2.What you need to know before using COLIROFTA TROPICAMIDA

3.How to use COLIROFTA TROPICAMIDA

4.Possible side effects

5.Storage of COLIROFTA TROPICAMIDA

1. Contents of the pack and additional information

This medication is an eye drop that contains an active substance (tropicamide) which is an anticholinergic drug that dilates the pupil (has a mydriatic action) and paralyzes the ability to focus of the eyes (cycloplegic action).

It is used, generally under the supervision of a healthcare professional, for refraction examination (to measure errors in eye focus and detect refractive defects, such as myopia, hyperopia, astigmatism, and presbyopia) and for fundus exploration when a rapid and short-lasting mydriatic and/or cycloplegic effect is required.

Do not use COLIROFTA TROPICAMIDA

• If you are allergic to tropicamide or any of the other components of this medication (listed in section 6).
• If you have or think you may have narrow-angle glaucoma.

Warnings and precautions

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

• Only use this medication in your eye(s).
• Consult your doctor. The use of this medication may cause:
• • Increased eye pressure. Eye pressure should be controlled before starting treatment, especially in older patients.

• Changes in behavior (especially in infants and children).

Children

• Use with great caution in children in general.
• This medication is not recommended in newborns and infants (especially premature infants and low-birth-weight infants) due to the risk of severe adverse reactions.

For this reason, it should also be used with extreme caution in children with Down syndrome, spastic paralysis, or brain injury. Consult your doctor to inform you about the severe adverse reactions that may occur with the use of this medication. See also the section “How to use COLIROFTA TROPICAMIDA”.

• Prevent children from putting the eye drops in their mouth. Wash your hands and the children's hands immediately after administering it.

Other medications and COLIROFTA TROPICAMIDA

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

Especially, inform your doctor if you are using:

• Amantadine (used for Parkinson's disease and flu)
• Antihistamines (allergies)
• Antipsychotics (for mental illnesses)
• Antidepressants (for depression)

Pregnancy, breastfeeding, and fertility

Consult your doctor before using any medication.

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.

This medication is not recommended during pregnancy or breastfeeding.

Driving and operating machines

This medication may cause drowsiness, blurred vision, and light sensitivity. Do not drive or use machines until your vision is clear.

COLIROFTA TROPICAMIDA contains benzalkonium chloride

This medication contains 0.0035 mg of benzalkonium chloride in each drop equivalent to 0.1 mg/ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color.Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication..

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

However, the application of this medication is usually performed under the supervision of a healthcare professional.

• To limit the amount of medication that passes into the blood after the application of the eye drop, keep your eyes closed while gently pressing with a finger on the tear duct for at least 2 minutes (figure 4).

The recommended dose is:

Adults and elderly patients:

Instill 1 or 2 drops in the eye to be examined. Repeat after 5 minutes. If the examination is not performed within a 20-30 minute interval, administer another 1 drop to prolong its effect.

Be cautious when using this medication in elderly patients and in cases of increased eye pressure.

Use in children:

Be cautious when using this medication in children (see section 2).

However, this medication is not recommended in newborns and infants (especially premature infants and low-weight infants) due to the risk of severe adverse reactions. See also the sections “Warnings and precautions”, “If you use more COLIROFTA TROPICAMIDA than you should” and “Possible side effects”.

Usage recommendations:

1. 234

• Wash your hands.
• Take the bottle.
• After opening the bottle for the first time, remove the plastic ring from the cap if it is loose.
• Hold the bottle, upside down, between your fingers (figure 1).
• Incline your head backward. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and your eye, where the drop should fall (figure 2).
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
• Do not touch your eye or eyelid, nearby areas or other surfaces with the dropper. The drops may become contaminated.
• Gently press the base of the bottle to release one drop at a time (figure 3).
• After using this eye drop, press with your finger the edge of your eye near your nose for 2 minutes. This helps to prevent this medication from passing into the rest of your body (figure 4).
• If drops are applied to both eyes, repeat all previous steps with the other eye.
• 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 the administration of this medication and the other eye medications. Eye ointments should be administered last.

If you use more Colirofta Tropicamida than you should

You can remove it by washing your eyes with warm water. Do not apply more drops until it is back in use.

The symptoms of ocular overdose may include: skin redness and dryness (may appear in children), blurred vision, rapid and irregular pulse, fever, abdominal swelling in infants, convulsions, hallucinations or loss of coordination. Any severe reaction due to tropicamide is rapid in onset and short in duration. It is recommended to administer immediately an IV injection of an alpha-adrenergic blocker, for example 5 to 10 mg of fentolamine mesylate, followed by a beta blocker, such as propranolol at a dose of 2.5 mg.

In case of 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, as severe adverse reactions may occur (especially in children).

If you forgot to use Colirofta Tropicamida

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

Apply a single dose as soon as you remember and continue with the next dose that was scheduled. However, if it is almost time for the next dose, do not apply the missed 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 observed with the use of this medication:

Adverse effects of unknown frequency (cannot be estimated from available data)

• Eye effects:blurred vision, light sensitivity, increased pupil size (prolonged effect of the medication), eye pain, eye irritation, eye redness.

• General effects: dizziness, headache, fainting, decreased blood pressure, nausea, rash.

Additional adverse effects in children

Psychotic reactions (abnormal perception and thought) and behavioral disorders have been reported with this type of medication, especially in children. See also the “Warnings and precautions” section.

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. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

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

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

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

Medicines should not be thrown down the drain or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of COLIROFTA TROPICAMIDA

• The active ingredient is tropicamide. One milliliter of solution contains 10 mg of tropicamide.
• The other components are benzalkonium chloride, concentrated hydrochloric acid (to adjust the pH), disodium edetate, sodium chloride, and purified water.

Appearance of the product and contents of the packaging

Colirofta Tropicamida is a liquid (transparent and colorless) that is presented in a box containing a dropper bottle (plastic bottle with a dispensing dropper) with a cap. Each container contains 5 ml of eye drops.

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:November 2017.

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