COLIROFTA TROPICAMIDE 10 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

COLIROFTA TROPICAMIDA 10mg/ml eye drops solution

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 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 further information

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

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

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

2. What you need to know before using COLIROFTA TROPICAMIDA

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.

• Use this medication only in your eye(s).
• Consult your doctor. The use of this medication may cause:
• • Increased pressure in the eye. Eye pressure should be monitored before starting treatment, especially in elderly patients.

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

Children

• This medication should be used with great caution in children in general.
• This medication is not recommended in newborns and infants (especially premature and low-birth-weight infants) due to the risk of serious side effects.

For this reason, it should also be used with extreme caution in children with Down syndrome, spastic paralysis, or brain damage. Consult your doctor to inform you about the serious side effects that may occur with the use of this medication. See also the section "How to use COLIROFTA TROPICAMIDA".

• Avoid letting children put the eye drops in their mouth. Wash your hands and the child's hands immediately after administration.

Other Medications and COLIROFTA TROPICAMIDA

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

Especially, tell your doctor if you are using:

• Amantadine (used for Parkinson's disease and flu)
• Antihistamines (antiallergics)
• 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 Using Machines

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

COLIROFTA TROPICAMIDA contains benzalkonium chloride

This medication contains 0.0035 mg of benzalkonium chloride per 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 putting them back.

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

3. How to use COLIROFTA TROPICAMIDA

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in 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 enters the bloodstream after applying the eye drops, keep your eyes closed while gently pressing the lacrimal canal with your finger for at least 2 minutes (figure 4).

The recommended dose is:

Adults and Elderly Patients:

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

Caution should be exercised when using this medication in elderly patients and in cases of increased eye pressure.

Use in Children:

Caution should be exercised when using this medication in children (see section 2).

However, this medication is not recommended in newborns and infants (especially premature and low-birth-weight infants) due to the risk of serious side effects. See also the sections "Warnings and Precautions", "If you use more COLIROFTA TROPICAMIDA than you should", and "Possible side effects".

Recommendations for Use:

1. 2 3 4

• Wash your hands.
• Take the bottle.
• After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.
• Hold the bottle, upside down, between your fingers (figure 1).
• Tilt your head back. Gently separate the eyelid from the eye with your finger until a pocket forms between the eyelid and your eye, where the drop should fall (figure 2).
• Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
• Do not touch the eye or eyelid, or surrounding areas with the dropper. The drops may become contaminated.
• Gently squeeze the base of the bottle to release one drop at a time (figure 3).
• After using this eye drop, press the edge of the eye near the nose with your finger for 2 minutes. This helps prevent the medication from entering the rest of the body (figure 4).
• If you are applying drops to both eyes, repeat all the 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. Ophthalmic ointments should be administered last.

If you use more Colirofta Tropicamida than you should

You can eliminate it by rinsing your eyes with warm water. Do not apply more drops until it is time for your next dose.

Symptoms of ocular overdose may include: redness and dryness of the skin (rash may occur 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-lived. It is recommended to administer immediately an intravenous injection of an alpha-adrenergic blocker, such as 5 to 10 mg of phentolamine mesylate, followed by a beta-blocker, such as propranolol, at a dose of 2.5 mg.

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, as serious side effects may occur (especially in children).

If you forget to use Colirofta Tropicamida

Do not apply a double dose to make up for forgotten 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 forgotten dose and 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 gets them.

The following side effects have been observed with the use of this medication:

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

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

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

Additional side effects in children

Psychotic reactions (abnormal perception and thinking) and behavioral disorders have been reported with this type of medication, especially in children. See also the section "Warnings and Precautions".

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 Medicines Agency's online system: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of COLIROFTA TROPICAMIDA

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

Do not store above 25°C.

Do not use this medication after the expiration date stated on the bottle and carton after "EXP". The expiration date is the last day of the month indicated.

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

Write the date of opening on the space provided on the carton.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. If in doubt, consult your pharmacist about how to dispose of the packaging and medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of COLIROFTA TROPICAMIDA

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

Appearance of the product and contents of the pack

Colirofta Tropicamida is a liquid (clear and colorless) that comes in a carton containing a dropper bottle (plastic bottle with a dispenser) with a cap. Each bottle contains 5 ml of eye drops.

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:November 2017.

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/