Package Insert: Information for the User

COLIROFTA CYCLOPLEGIC 10 mg/ml Eye Drop Solution

ciclopentolato hidrocloruro

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as 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 package insert. See section 4.

It is an eye drop that contains ciclopentolato hydrochloride as its active ingredient, which dilates the pupil (has a mydriatic effect) and paralyzes the ability to focus the eyes (cycloplegic effect).

Colirofta Ciclopléjico is used for the exploration of the back of the eye and for a refraction examination (to measure errors in eye focus and detect refractive defects such as myopia, astigmatism, presbyopia, etc.) and in any condition where a pupil dilation effect (mydriasis) or paralysis of the muscle that produces accommodation (cycloplegia) is desired or when atropine cannot be used (produces a similar effect with a different action) in inflammatory processes of the uveal tract or the intermediate layer of the eye wall.

No use Colirofta Ciclopléjico:

• If you are allergic to ciclopentolato hidrocloruro or any of the other components of this medication (listed in section 6).
• If you have narrow-angle glaucoma (increased eye pressure) or have narrow angles as a form.

Warnings and precautions

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

• Only use this medication in your eye(s).
• You must be very careful if you have previously suffered a severe reaction affecting part of your body to the atropine drug, especially in children.
• Also, if you have a fever or are exposed to high temperatures, especially in children.
• Consult your doctor. The use of this medication may cause:
• • Increased eye pressure. Eye pressure should be controlled before starting treatment, especially in elderly patients.
  • Changes in behavior, especially in children and elderly patients, although these reactions can occur at any age.
  • Sensitivity to light. Protect your eyes (with dark glasses) from intense light.
• If you are being treated with pilocarpine (for glaucoma) this medication may interfere with this drug. Therefore, its use should be avoided at the same time.

Children

• This medication is not recommended for newborns and infants (especially premature infants and low-weight infants) due to the risk of severe adverse reactions. See also sections 3 and 4.
• Use with caution in children in general.
• Use with great caution in: premature infants, newborns, infants, small children, or children with Down syndrome, spastic paralysis (a condition affecting the muscles of the limbs), brain injury, epilepsy, or known epilepsy. These children are very sensitive to suffering from nervous system disorders, digestive disorders, or heart and lung disorders, due to absorption of the active ingredient into the body.
• Children with fair skin and blue eyes may be more prone to adverse effects.
• The use of this medication may cause intolerance to food and necrotizing enterocolitis (ECN) in premature infants.ECN cases have been reported in premature infants after administration.Therefore, do not feed neonates and infantsuntil 4 hours after the examination.
• 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.

Elderly patients

Use with caution in elderly patients as they are more prone to increased eye pressure.

Other medications and Colirofta Ciclopléjico

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:

• Amantadina (used in Parkinson's disease and for the flu)
• Antihistamines (antiallergics)
• Antipsychotics (for mental illnesses)
• Tricyclic antidepressants (for depression)
• Belladonna and alkaloids of this drug, such as atropine and scopolamine (this used before anesthesia or in digestive disorders, such as colic)
• Tiotropio (used by inhalation in respiratory diseases)
• Donepezilo (used in Alzheimer's disease).

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.

Colirofta Ciclopléjico is not recommended during pregnancy.

During breastfeeding, the doctor should decide whether to interrupt breastfeeding or interrupt treatment with this medication, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machinery

You may notice blurred vision and light sensitivity for a prolonged period, such as 24 hours. Do not drive or operate machinery until these effects have disappeared.

COLIROFTA CICLOPLÉJICO contains parahidroxibenzoato de metilo and parahidroxibenzoato de propilo

It may cause allergic reactions (possibly delayed) because it contains parahidroxibenzoato de metilo (E-218) and parahidroxibenzoato de propilo (E-216).

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

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

The recommended dose is:

Ophthalmic route.

Adults

Instill 1 or 2 drops into the eye(s) approximately 40-45 minutes before the refraction examination. If necessary, this dose can be repeated at 5 or 10 minutes.

When seeking a sustained effect in general, 2 drops will be instilled three times a day.

You should exercise caution when using this medication in elderly patients as they are more prone to increased eye pressure.

Use in children

For refraction examination:

• Children under 6 years:instill 1 drop of the solution, 40 or 50 minutes before the examination. If necessary, a second drop can be instilled 5 or 10 minutes later.

In the case of young children, see below.

• Children over 6 years:instill 1 or 2 drops of the solution; a second drop can be applied if necessary 5 minutes later, 40 or 50 minutes before the examination.

After instillation, children should be closely observed for 30 minutes.

You should exercise caution when using this medication in children (see section 2).

This medication is not recommended for newborns and infants (especially premature infants and low-birth-weight infants) due to the risk of severe adverse reactions. See also the "Warnings and precautions" section in section 2, "If you use more Colirofta Ciclopléjico than you should" in section 3, and section 4 "Possible side effects".

The use of this medication in newborns and infants may cause feeding intolerance. Therefore, do not feed them until 4 hours after administration.

Usage recommendations:

• Wash your hands.
• Take the bottle (dropper 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.
• 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).
• 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, surrounding areas, or other surfaces with the dropper. The drops may become contaminated.
• Gently press the base of the bottle with your index finger to allow one drop to fall at a time (figure 2).
• After using this eye drop, press the edge of your eye near the nose with your finger for at least 2 minutes. This helps prevent the eye drop from passing into the rest of your body (figure 3).
• If drops are applied to both eyes, repeat all previous steps for the other eye.
• Close the bottle tightly immediately after using the product.
• Remember to wash your hands after applying the eye drop.

If a drop falls outside the eye, try again.

If you are using other eye medications, wait at least 5 minutes between administering this medication and the other eye medications. Eye ointments should be administered last.

If you use more Colirofta Ciclopléjico than you should

You can remove it by rinsing 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 present with rash in children), blurred vision, rapid and irregular pulse, fever, abdominal swelling in young children, convulsions, hallucinations, or loss of coordination in movements.

Symptomatic treatment should be provided.

The preferred antidote is physostigmine.

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 reactions may occur (especially in children).

If you forgot to use Colirofta Ciclopléjico

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

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 medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been observed:

Unknown frequency side effects (cannot be estimated from available data)

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

• General effects: allergy, hallucination, confusion, disorientation, agitation, restlessness, incoherent speech, recent memory loss, dizziness, headache, drowsiness, vomiting, nausea, dry mouth, skin redness, difficulty walking, fever, and fatigue.

Other side effects:increased eye pressure and glaucoma in patients with a predisposition to acute angle closure, particularly in elderly patients; hyperactivity, tremor, anxiety, sedation, difficulty concentrating, increased heart rate, increased body temperature.

Other side effects in children

Additionally, this medicine may cause in children lack of coordination, seizures, skin rash, behavioral changes, psychiatric disorders, prolonged pupil dilation, abdominal distension in infants, increased heart rate, vasodilation, urinary retention, decreased intestinal motility, decreased salivary and sweat gland secretion, in the throat, bronchi, and nasal passages. Severe reactions are characterized by low blood pressure with progressive and rapid shallow breathing.

In newborns and infants, the use of this medicine may cause feeding intolerance (see section 3). In premature children, this medicine may cause necrotizing enterocolitis. In children, a local allergic reaction to this medicine has been observed, consisting of a skin rash.

The side effects of this medicine occur 20-30 minutes after its application and although they are usually transient, symptoms can last from 12 to 24 hours.

Reporting of side effects

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

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 4 weeks after first opening it.

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. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of COLIROFTA CICLOPLÉJICO

• The active ingredient is cyclopentolate hydrochloride. One milliliter of solution contains 10 mg of cyclopentolate hydrochloride (1%).
• The other components are: methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium chloride, and purified water.

Appearance of the product and content of the container

Colirofta Ciclopléjico is an eye drop solution. It is a transparent and colorless liquid that is presented in a box containing a dropper bottle (plastic bottle with a dispensing dropper) with a cap.

Each container contains 10 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:June 2023

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