COLIROFTA ATROPINE 5 mg/ml EYE DROPS SOLUTION

Introduction

Prospective:information for the user

COLIROFTA ATROPINA 5 mg/ml eye drops in solution

Contents of the prospectus

1. What COLIROFTA ATROPINA 5 mg/ml is and what it is used for
2. What you need to know before starting to use COLIROFTA ATROPINA 5 mg/ml
3. How to use COLIROFTA ATROPINA 5 mg/ml
4. Possible adverse effects

5 Conservation of COLIROFTA ATROPINA 5 mg/ml

1. Package contents and additional information

1. What COLIROFTA ATROPINA 5 mg/ml is and what it is used for

It is an eye drop that contains atropine, an anticholinergic agent (blocks some of the acetylcholine receptors, a neurotransmitter) that, when administered in the eyes, produces mydriasis (pupil dilation) and cycloplegia (paralysis of the muscle that produces accommodation).

Colirofta Atropina 5 mg/ml is indicated:

• In eye exams, to dilate the pupil and prevent ocular focus.
• For the treatment of acute inflammatory eye conditions in the anterior part of the eye, such as inflammation of the colored part of the eye (iritis) and of the iris and ciliary body (iridocyclitis).

2. What you need to know before starting to use COLIROFTA ATROPINA 5 mg/ml

Do not use COLIROFTA ATROPINA 5 mg/ml

• If you are allergic to atropine or any of the other components of this medication (listed in section 6).
• If you have or think you may have primary glaucoma or a predisposition to narrow-angle glaucoma (increased pressure in the eye).
• Children with Down syndrome, spastic paralysis (a type of cerebral palsy), or brain injury.
• Infants under 3 months of age.
• Children who have had a previous severe reaction to the active ingredient of this medication, atropine.

(See section 2, subsection "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Colirofta Atropina 5 mg/ml.

• Use this medication only in your eye(s).
• After application, keep your eyes closed while gently pressing the lacrimal canal with your finger for at least 1 minute. See section 3 "How to use...".
• The use of this medication may cause:

• Increased pressure in the eye and glaucoma, especially in elderly patients. Eye pressure should be monitored frequently and also before starting treatment, under medical supervision.
• Changes in behavior (such as delirium), especially in children and elderly patients, although these reactions can occur at any age.
• Sensitivity to light. Protect your eyes from intense light (sunglasses).

• Blurred vision that can last up to 2 weeks.
  • If you have a fever or are exposed to high temperatures, especially in children, caution is required, as this medication can increase body temperature.
  • Great caution is needed in patients with heart disease, arrhythmias, or recent myocardial infarction, as tachycardias (increased heart rate) may occur. It is recommended to reduce the dose.

It may cause an increase in blood pressure.

• Cautious use is required in patients with:

• significant kidney disease
• chronic pulmonary diseases
• or symptoms of the lower urinary tract, such as prostate hyperplasia.

• This medication should not be used at the same time as treatment with MAOI medications (usually antidepressants) (see subsection "Other medications...").

Children

• This medication will be used with caution in infants over 3 months of age.

• Premature children and those with low birth weight, or patients with Down syndrome, spastic paralysis, brain injury, or children with fair skin and blue eyes are especially sensitive to the adverse effects of this medication. Consult your doctor to inform you about the serious adverse reactions that may occur with the use of this medication.
• Avoid children putting this medication in their mouth or cheeks. Wash your hands and the child's cheeks or hands immediately after administration.

Other medications and COLIROFTA ATROPINA 5 mg/ml

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

Especially, inform your doctor if you are using:

Medications that share properties with the active ingredient of the medication, such as:

• Amantadine (antiviral medication and for Parkinson's disease, which stimulates the central nervous system)
• For obstructive pulmonary diseases, such as: tiotropium, glycopyrronium, or revefenacin
• Scopolamine (used previously to anesthesia)
• Certain antihistamines (medications used to treat allergies)
• Antipsychotics (used to treat psychiatric conditions)
• Tricyclic antidepressants (medications used to treat depression).

Other medications:

• Donepezil (used in Alzheimer's disease)
• Heart stimulants
• MAOI medications (generally used to treat depression).

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.

This medication is not recommended during pregnancy or breastfeeding.

Driving and using machines

The influence of this medication on the ability to drive and use machines is significant

This medication may cause blurred vision and sensitivity to light for an extended period, which can last several days. Do not drive or use machines or tools until your vision is clear.

COLIROFTA ATROPINA 5 mg/ml containsmethyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216) and phosphates

This medication may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medication contains 3.3 mg of phosphates per ml.

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

3. How to use COLIROFTA ATROPINA 5 mg/ml

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

The recommended dose is:

Adults

When a sustained effect is intended, three daily applications of 2 drops are usually performed.

For refraction examination, 1 or 2 drops will be instilled in each eye twice a day, 1 to 3 days before the examination.

Use in children

Children (over 3 months of age)

Due to the risk of producing severe systemic adverse effects, this medication is contraindicated in infants under 3 months of age and is recommended to be used with caution in infants over 3 years of age. The lowest effective dose possible is recommended to reduce the risk of systemic adverse effects (see subsection "Warnings and precautions").

When a sustained effect is intended, three daily applications of 1 drop are usually performed.

For refraction examination, 1 or 2 drops will be instilled in each eye twice a day, 1 to 3 days before the examination.

Remember to apply your medication according to your doctor's instructions.

Use in elderly patients

Use with caution in elderly patients, as they may have a higher risk of undiagnosed glaucoma and behavioral disorders.

Your doctor will indicate the duration of your treatment with Colirofta Atropina 5 mg/ml. Do not stop treatment before, unless your doctor indicates it.

Usage recommendations:

Ophthalmic route (in the eyes).

1 2 3

1. Wash your hands.
2. Take the bottle.
3. After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.
4. Hold the bottle, upside down, between your fingers.
5. Tilt your head back. Gently separate the eyelid of the eye with your finger until a pocket forms between the eyelid and your eye, 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 drops may become contaminated.
8. Gently press the base of the bottle with your index finger to release one drop at a time (figure 2).
9. After using this eye drop, release the lower eyelid, close your eye, and gently press the edge of the eye, next to the nose, for at least 1 minute. 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 use.
12. Remember to wash your hands after administering this 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 ATROPINA 5 mg/ml than you should

You can eliminate it by washing your eyes with warm water. Do not apply more drops until it is time for your next dose. Overdose symptoms may include redness and dryness of the skin (in children, it may present as a rash), blurred vision, rapid and irregular pulse, fever, abdominal swelling in children, convulsions, hallucinations, loss of coordination, and rapid progressive respiratory depression.

In case of 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.

If you forgot to use COLIROFTA ATROPINA 5 mg/ml

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 scheduled dose. 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 other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

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

The following reactions have been reported during post-marketing experience:

Frequency not known(cannot be estimated from the available data):

• Ocular effects: blurred vision, increased pupil size (prolonged effect of the medication), eyelid swelling, sensitivity to light.
• General effects: allergy, increased or decreased heart rate, headache, dizziness, hallucination, confusion, disorientation, intestinal obstruction, abdominal swelling, vomiting, redness or inflammation of the skin, rash, fever.

Other adverse effects in children

Children are more likely to exhibit the general adverse effects described above, especially in premature children and those with low birth weight, or patients with Down syndrome, spastic paralysis, or brain injury (see section 2, subsection "Do not use...").

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of COLIROFTA ATROPINA 5 mg/ml

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

Store below 25°C.

Do not use this medication after the expiration date shown on the bottle and carton after CAD. 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 opening date of the bottle in the box provided for this purpose on the carton.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of COLIROFTA ATROPINA 5 mg/ml

• The active ingredient is atropine. One ml of eye drops in solution contains 5 mg of atropine (as sulfate) (0.5%).
• The other components are: methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium chloride, disodium hydrogen phosphate dodecahydrate, potassium dihydrogen phosphate, and purified water.

Appearance of the product and package contents

Colirofta Atropina 5 mg/ml is an eye drop solution; it is a clear and colorless liquid that comes in a 10 ml dropper bottle (plastic bottle) with a sealed cap.

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 prospectus:May 2020

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