Introduction

Patient Information Leaflet

Mirazul 1.25 mg/ml Eye Drops Solution

Fenilephrine Hydrochloride

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this

leaflet or those indicated by your doctor, pharmacist or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or more information, consult your pharmacist.
If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
You should consult a doctor if your condition worsens or does not improve after 5 days.

1. What is Mirazul and what is it used for

Mirazul belongs to the group of medications known as ocular decongestants.

Fenilephrine hydrochloride is a medication that belongs to the group of sympathomimetics used as decongestants, has a vasoconstrictor effect (causes narrowing of blood vessels), producing rapid and prolonged decongestion, relieving eye irritation.

Mirazul is an eye drop solution indicated to relieve eye irritation caused by smoke, air, dust, chlorine from pools, sea water, humid environments, contact lenses, cosmetics, eye fatigue, etc. in adults.

Consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before starting to use Mirazul

Do not use Mirazul:

If you are allergic to phenylephrine hydrochloride or any of the other components of this medication (listed in section 6).
If you have glaucoma (increased pressure within the eye), as the vasoconstrictive action of phenylephrine may lead to a temporary increase in intraocular pressure (pressure of the eye's fluids).
If you are taking any monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants) or have taken it within 21 days of using Mirazul.
If you have any severe thyroid disease (overactive thyroid gland).
If you have dry rhinitis (inflammation of the nasal mucosa).
In children under 12 years old.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Mirazul.

If you have high blood pressure.
If you have advanced arteriosclerosis (advanced hardening of the arteries).
If you have orthostatic hypotension (decreased blood pressure when changing position).
If you have diabetes requiring long-acting insulin.
If you have heart disease, including severe ischemic heart disease (temporary decrease in heart blood circulation).

During administration, be careful not to touch the tip of the dropper with the eye, hands, or any other object. Close it immediately after use.

If no improvement occurs after 5 days of treatment or if symptoms worsen while using the medication, discontinue its use and consult a doctor.

Chronic use of this medication may cause rebound congestion in the eye.

When patients are not yet accustomed to contact lenses, they should not use this medication for more than 5 consecutive days without consulting a doctor, in order to avoid masking possible eye irritation due to incorrect contact lens adjustment.

If eye pain, headache, blurred vision, or changes in vision, eye sensitivity to light, or eye redness occur, consult a doctor.

Children

Mirazul should not be used in children under 12 years old as children appear to be more sensitive to the risk of severe adverse effects.

Mirazul is not recommended for children between 12 and 18 years old as there is inadequate clinical experience.

Use of Mirazul with other medications

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

Tricyclic antidepressants (amitriptyline, doxepin, trimipramine) and MAOIs (isocarboxazid, iproclozid, moclobemide) that are medications for depression treatment may increase the action of this medication.
This medication is incompatible with the local anesthetic butacaine.
The mydriatic response (pupil dilation) of phenylephrine hydrochloride is reduced when the patient is treated simultaneously with levodopa (medication for Parkinson's disease treatment).

Pregnancy and breastfeeding

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

Since the risk to the fetus cannot be excluded, Mirazul is not recommended during pregnancy.

Women breastfeeding should consult their doctor before using this medication, as it is not known with certainty if phenylephrine hydrochloride passes into breast milk.

Driving and operating machinery

Mirazul has a mydriatic effect (abnormal pupil dilation with iris immobility) that increases with dose. This medication may cause visual accommodation disturbances (eye adaptation), and therefore, a decrease in reaction time. Therefore, it is not recommended to drive or operate machinery after administration.

Mirazul contains benzoic acid

This medication may be slightly irritating to the skin, eyes, and mucous membranes because it contains benzoic acid.

Avoid contact with soft contact lenses. Alters the color of soft contact lenses.

Remove contact lenses before application and wait at least 15 minutes before reinserting them.

3. How to use Mirazul

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is 1-2 drops in each eye, as needed, 3 or 4 times a day if necessary.

How to use Mirazul:

Mirazul is used by ocular route

1. Wash your hands before using Mirazul.

2. Take the uncovered container and hold it with one hand, between the thumb and index finger.

3. Using the index finger of the other hand, pull the lower eyelid of the eye downwards.

4. Gently press the container to release one or two drops into the eye.

5. After application, keep the eye closed for a few moments to facilitate the distribution of the liquid over the entire ocular surface.

6. Repeat the previous steps for the other eye.

7. Close the container tightly after each use.

If you use more Mirazul than you should

If you have used more Mirazul than you should, it could lead to symptoms such as elevated blood pressure, acceleration or slowing of heart rate.

In case of overdose or accidental ingestion, go to a medical center indicating the product and the amount ingested or consult the Toxicological Information Service: Tel.: 91.562.04.20.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects may occur, but their frequency has not been defined with precision: allergic conjunctivitis, mydriasis (pupil dilation), visual accommodation disturbances, eye irritation, or contact dermatitis.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an 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:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Mirazul Storage

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

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

Dispose of the product one month after the packaging has been opened and the seal has been broken.

Do not use Mirazul if you observe that the solution changes color or becomes turbid.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Mirazul

The active principle of Mirazul is phenylephrine hydrochloride. Each ml of solution contains 1.25 mg of phenylephrine hydrochloride.
The other components are disodium phosphate, benzoic acid (E-210), ethanol 0.0037% v/v, chlorbutanol, benzyl alcohol, terpineol, methylene blue, sodium chloride, and water for injections.

Appearance of the product and contents of the packaging

Mirazul is an eye drop solution that is presented in a 10 ml bottle.

Holder of the marketing authorization and responsible for manufacturing:

Holder:

Laboratorio de Aplicaciones Farmacodinámicas, S.A.

Grassot, 16 – 08025 Barcelona (Spain)

Date of the last review of this leaflet:June 2021

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