Prospect:information for the user

COLIROFTA ATROPINA 5 mg/ml eye drops in solution

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

5Storage of COLIROFTA ATROPINA 5 mg/ml

6.Contents of the pack and additional information

It is an eye drop thatcontains 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 for:

• Eye examination, to dilate the pupil and prevent ocular focusing.
• Treatment of acute anterior segment eye inflammatory conditions, such as anterior uveitis and iridocyclitis.

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 eye pressure).
• 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 severe previous reaction to the active ingredient of this medication, atropine.

(See section 2 for the subsection “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

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

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

• Increased eye pressure and glaucoma, especially in elderly patients. Eye pressure should be monitored frequently, and also before starting treatment, under the supervision of a doctor.
• 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 may 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 may increase body temperature.
• Great caution is required in patients with heart disease, arrhythmias or recent myocardial infarction, as it may cause tachycardia (increased heart rate). It is recommended to reduce the dose.

Elevated blood pressure may occur.

• Caution is required in patients with:

• Significant kidney disease
• Chronic lung diseases
• or symptoms of the lower urinary tract, such as benign prostatic hyperplasia.

• This medication should not be used at the same time as an IMAO treatment (antidepressants in general) (see subsection “Other medications…”).

Children

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

• Preterm infants and low birth weight infants 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 severe adverse reactions that may occur with the use of this medication.
• Avoid having children put this medication in their mouth or cheeks. Wash your hands and the children's hands and cheeks immediately after administering it.

Other medications andCOLIROFTA ATROPINA 5 mg/ml

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:

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

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

Other medications:

• Donepezil (used in Alzheimer's disease)
• Heart stimulants
• IMAO medications (in general, for depression).

Pregnancy, breastfeeding and fertility

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

This medication is not recommended during pregnancy or breastfeeding.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is important

This medication may cause blurred vision and light sensitivity for an extended period that may last several days. Do not drive or operate machinery until your vision is clear.

COLIROFTA ATROPINA 5 mg/ml containsparahydroxybenzoic acid methyl ester (E-218) and parahydroxybenzoic acid propyl ester (E-216) and phosphates

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

This medication contains 3.3 mg of phosphates in each ml.

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

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

The recommended dose is:

Adults

To achieve a sustained effect, three applications of 2 drops are generally made per day.

For refraction examination, 1 or 2 drops are instilled in each eye twice a day, from 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 should be used with caution in infants over 3 years of age. It is recommended to use the lowest effective dose possible to reduce the risk of systemic adverse effects (see "Warnings and precautions").

To achieve a sustained effect, three applications of 1 drop are generally made per day.

For refraction examination, 1 or 2 drops are instilled in each eye twice a day, from 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 discontinue treatment unless your doctor instructs you to.

Usage recommendations:

Ophthalmic route (in the eyes).

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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. Incline your head back. 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 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, surrounding areas, or other surfaces with the dropper. The drops may become contaminated.
8. Gently press the base of the bottle with your index finger to allow one drop to fall at a time (figure 2).
9. After using this eye drop, release your lower eyelid, close your eye, and gently press the edge of your eye, near your nose, for at least 1 minute. 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 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 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 ATROPINA 5 mg/ml than you should

You can remove it by washing your eyes with warm water. Do not apply more drops until you touch it again. Symptoms of overdose may include skin redness and dryness (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 Toxicological 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 compensate for the missed doses.

Apply a single dose as soon as you remember and continue with the next dose 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 will experience them.

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

Unknown frequency(cannot be estimated from available data):

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

Other adverse effects in children

Children are more prone to manifesting the general adverse effects described above, especially in premature children and those born with low birth weight or patients with Down syndrome, spastic paralysis, or brain injury (see section 2, the 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 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.

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

Store below 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 4 weeks after it has been opened for the first time.

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

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of COLIROFTA ATROPINE 5 mg/ml

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

Appearance of the product and contents of the packaging

Colirofta Atropine 5 mg/ml is an eye drop solution; it is a liquid (transparent and colorless solution) presented in a dropper bottle (plastic bottle) of 10 ml with child-resistant cap.

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: May 2020

The detailed information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http://www.aemps.gob.es