Package Leaflet: Information for the User

COLIRCUSÍ FENILEFRINA 100 mg/ml eye drops solution

Fenilefrine hydrochloride

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What COLIRCUSÍ FENILEFRINA is and what it is used for

2.What you need to know before using COLIRCUSÍ FENILEFRINA

3.How to use COLIRCUSÍ FENILEFRINA

4.Possible side effects

5.Storage of COLIRCUSÍ FENILEFRINA

6.Contents of the pack and additional information

It is an eye drop that contains phenylephrine hydrochloride as its active ingredient, which dilates the pupil.

Colircusí Fenilefrina is indicated for: producing pupil dilation (mydriasis), to examine the back of the eye, to facilitate cataract surgery (nuclear cataract) and as part of the treatment of inflammation of the middle layer of the eye (uveitis), particularly, the colored part of the eye (iritis) and inflammation of this and the ciliary body (iridocyclitis).

Do not use Colircusí Fenilefrina:

• If you are allergic to phenylephrine or any of the other components of this medication (listed in section 6).
• In children under 12 years and elderly patients.
• If you have narrow-angle glaucoma (increased eye pressure) or anatomical narrow angle in your eyes (with blockage of drainage channels).
• If you have severe high blood pressure (hypertension).
• If you have a history of severe arteriosclerosis, cardiovascular disease, or cerebrovascular disease, rapid heartbeats (ventricular tachycardia), or heart disease. If you have any aneurysm (enlargement of a blood vessel that may appear as a lump).
• If you have had eye surgery.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Colircusí Fenilefrina.

• Only use this medication in your eye(s).
• Do not use it after eye surgery, in sick or damaged eyes, without tears, or during anesthesia, as the medication may be absorbed in sufficient quantities to produce adverse effects such as increased blood pressure.
• After application, keep your eyes closed while gently pressing with your finger on the lacrimal canal for 2 minutes. See section 3. "How to use COLIRCUSÍ FENILEFRINA".
• Blood pressure should be monitored after application of this medication in susceptible patients and particularly in patients with any autonomic nervous system disease (that controls involuntary actions, such as heartbeats, blood vessels, etc.).
• Be cautious or avoid treatment at the same time as using this medication with medications such as monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, antihypertensive drugs (to lower your blood pressure), atropine, or anesthetics that sensitize the heart to sympathomimetics (see "Other medications and Colircusí Fenilefrina").

• Wash your hands immediately after handling the bottle or after applying this medication.
• This medication should be used with great caution:

• if you have partial heart block (defect in heart conduction),
• if you have slow heartbeats (bradycardia),
• if you have excessive activity of the thyroid gland (hyperthyroidism),
• if you are diabetic and dependent on insulin,
• if you have drops in blood pressure (dizziness, dizziness) related to changes in position (when standing up after being seated for a long time) (orthostatic hypotension).

• Colircusí Fenilefrina should not be used in children under 12 years as children appear to be more sensitive to the risk of severe adverse effects.
• Colircusí Fenilefrina is not recommended for children between 12 and 18 years as there is inadequate clinical experience.

Children

• This medication should not be used in children under 12 years due to the increased risk of systemic toxicity. Children may be especially sensitive to the effects of phenylephrine, with possible severe adverse effects on the heart and circulation.

Elderly patients

• This medication should not be used in elderly patients. In them, the medication has stimulating effects on the central nervous system. Also, these patients experience a greater increase in blood pressure than young people.
• This medication could produce rebound miosis (pupil constriction) the next day. The doctor should monitor this effect.
• In elderly patients, it is more frequent that granular floating pigment in the eyes occurs.

Other medications and Colircusí Fenilefrina

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 or may be exposed to:

• Monoamine oxidase inhibitors (MAOIs). Even if you have taken them in the last 3 weeks (they are medications for treating depression or Parkinson's disease).
• Tricyclic antidepressants.
• Drugs that lower blood pressure, called antihypertensives (guanetidina, reserpine, and non-selective beta-blockers such as propranolol).
• Cycloplegic medications (pupil dilators) of the type of atropine.
• Inhaled anesthetics.
• Methylene blue (used in surgery, among other uses).

Inform your doctor if you are going to undergo surgery with anesthesia.

Use of Colircusí Fenilefrina with food and drinks

- Orange juice: if it contains as an additive some stimulant similar to the active ingredient of this medication, it may produce an increase in stimulating effects.

Pregnancy, lactation, and fertility

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

As a precaution, it is preferable to avoid the use of Colircusí Fenilefrina during pregnancy.

If you are breastfeeding, your doctor should decide whether it is necessary to interrupt breastfeeding or interrupt treatment with this medication, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and operating machines

You may notice blurred vision and other visual disturbances for a prolonged period. Do not drive or operate machines until this effect has disappeared.

Colircusí Fenilefrina contains thimerosal and phosphates

This medication may cause allergic reactions because it contains thimerosal.

This medication contains 1.1 mg of phosphates in each ml.

If you have 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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• To limit the amount of medication that passes into the blood after application of the eye drops

Keep your eyes closed while gently pressing with a finger on the tear duct for at least 2 minutes.

The recommended dose is:

Use in adults

For a fundus examination, it is recommended to apply one drop to each eye. If necessary, the application can be repeated in 1 hour.

When seeking sustained effect, it is recommended to apply one drop 2 or 3 times a day.

Before cataract surgery, the normal dose is one drop to the conjunctiva between 30 and 60 minutes before surgery.

In the treatment of iritis and iridocyclitis, apply one drop. If necessary, it can be repeated the next day. Treatment should not exceed 3-5 consecutive days, if there is no improvement, consult your doctor.

Use in children

This medication is contraindicated in children under 12 years due to the increased risk of systemic toxicity.

Usage recommendations:

12

- Wash your hands.

- Take the bottle.

- Remove the cap by pulling the tab outward and remove the cap.

- Hold the bottle upside down between your fingers.

- Tilt your head back. Gently separate your lower eyelid from your eye with a finger until a pouch forms between your lower eyelid and your eye, where the drop should fall (figure 1).

- Place the tip of the dropper close to your eye. It may be helpful to use a mirror.

- Do not touch your eye, eyelid, nearby areas, or other surfaces with the dropper. The eye drops could become contaminated.

- Press gently the rubber stopper at the top of the bottle while looking up.

- After using this eye drop, press with your finger the edge of your eye near your nose for at least 2 minutes (figure 2). This helps to prevent the medication from passing into the rest of your body.

- If you apply drops to both eyes, repeat all the previous steps with the other eye.

- Close the bottle tightly immediately after using the product.

- It is recommended to wash your hands after handling the bottle or after applying the eye drops.

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 Colircusí Fenilefrina than you should

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

In case of overdose or accidental ingestion, go to a medical center or consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The symptoms of toxicity that may appear are sympathetic stimulation. In case of accidental ingestion, this medication may cause high blood pressure, headache, convulsions, cerebral hemorrhage, abnormal increase in heart palpitations, sensations of tingling, heat, or cold in the skin (paresthesia) or vomiting. Fluid in the lungs (pulmonary edema) and cardiac arrest.

In case of overdose, due to the fact that any severe reaction caused by phenylephrine appears quickly, it is recommended to go to a medical center to receive maintenance treatment.

To treat hypertension as a result of blood vessel constriction (vasoconstriction), it is recommended to avoid the use of beta-blockers and calcium channel blockers.

If you forgot to use Colircusí Fenilefrina

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

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 everyone will experience them.

The following adverse effects have been reported with this medication:

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

• Eye effects:eye pain, eye irritation, eye redness, conjunctivitis, and/or eczema on the eyelid.

• General effects: allergy, dizziness, increased blood pressure, increased heart rate (heartbeats), fluid in the lungs, skin inflammation.

Other adverse effects in children

Fluid or swelling in the lungs: unknown frequency (cannot be estimated from available data).

Other adverse effects that may be caused by this type of medication

In rare cases, some patients with severely damaged transparent layer on the front of the eye (cornea) have experienced cloudy areas in the cornea due to calcium accumulation during treatment.

The following have been reported: headaches, cardiac rhythm disorders (extrasystoles), fainting. The incidence of adverse events with phenylephrine 100mg/ml is higher than with lower concentrations.

This eye drop has caused severe cardiovascular complications, including myocardial infarction on some occasions.

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.

Before the first opening, store in the refrigerator (between 2°C and 8°C).

Once opened, do not store at a temperature above 25°C.

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 on the packaging.

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

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

Composition of COLIRCUSÍ FENILEFRINA

• The active principle is phenylephrine hydrochloride. One ml of solution contains 100mg of phenylephrine hydrochloride (10%).
• The other components are: thimerosal, disodium dodecahydrate hydrogen phosphate, anhydrous sodium sulfiteand purified water.

Appearance of the product and contents of the packaging

Colircusí Fenilefrina is a solution eye drop; it is a transparent and colorless or slightly yellowish liquid.

It is presented in a dropper bottle (opaque glass bottle with rubber dropper), with 10 ml of solution eye drop.

Holder of the marketing authorization

M4 PHARMA, S.L.

Tánger, 86

08018 Barcelona – Spain

Responsible for manufacturing

TUBILUX PHARMA, S.P.A.

Via Costarica 20/22

Pomezia, Rome - I-00071

Italy

Last review date of this leaflet:January 2021

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