MIRAZUL 1.25 mg/ml EYE DROPS SOLUTION

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 inside the eye), as the vasoconstrictor action of phenylephrine may lead to a transient increase in intraocular pressure (pressure of the eye fluids).
• If you are taking any monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants) or have taken it up to 21 days before 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 of age.

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 (hardening of the arteries).
• If you have orthostatic hypotension (decrease in blood pressure when changing position).
• If you have long-term insulin-dependent diabetes.
• If you have heart disease, including severe ischemic cardiopathy (transient decrease in blood circulation to the heart).

During administration, care should be taken not to touch the dropper tip to the eye, touch it with hands, or with any other object. It should be closed immediately after use.

If there is no improvement after 5 days of treatment or if symptoms worsen when using the medication, its use should be discontinued and a doctor consulted.

Chronic use of this medication can 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 fitting of the lenses.

If eye pain, headache, blurred vision, or changes in vision, sensitivity of the eyes to light, or eye redness occur, a doctor should be consulted.

Children

Mirazul should not be used in children under 12 years of age, as children seem to be more sensitive to the risk of serious side effects.

Mirazul is not recommended in children between 12 and 18 years of age, as there is a lack of adequate clinical experience.

Using Mirazul with Other Medications

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

• Tricyclic antidepressants (amitriptyline, doxepin, trimipramine) and MAOIs (isocarboxazid, iproniazid, moclobemide), which are medications for treating depression, reserpine, and guanethidine (medication for reducing blood pressure), may increase the action of this medication.
• This medication is incompatible with the local anesthetic butacaine.
• The mydriatic response (increase in pupil dilation) of phenylephrine hydrochloride is reduced when the patient is treated simultaneously with levodopa (medication for treating Parkinson's disease).

Pregnancy and Breastfeeding

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.

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

Breastfeeding women should consult their doctor before using this medication, as it is not known with certainty whether phenylephrine hydrochloride passes into breast milk.

Driving and Using Machines

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

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. It changes the color of soft contact lenses.

Remove contact lenses before application and wait at least 15 minutes before putting them back on.

3. How to Use Mirazul

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of 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 via the ocular route

1. Wash your hands before using Mirazul.
2. Take the open container and hold it with one hand, between the thumb and index finger.
3. Using the index finger of the other hand, separate the lower eyelid of the eye downward.
4. Gently press the container, allowing one or two drops to fall into the eye
5. After application, keep the eye closed for a few moments to facilitate the distribution of the liquid over the entire eye surface
6. Repeat the steps above for the other eye.
7. Close the container well after each use.

If You Use More Mirazul Than You Should

If you have used more Mirazul than you should, it could lead to manifestations such as elevated blood pressure, increased or decreased heart rate.

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

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

4. Possible Side Effects

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

The following side effects may occur, whose frequency cannot be defined with precision: allergic conjunctivitis, mydriasis (pupil dilation), alterations in visual accommodation, eye irritation, or contact dermatitis.

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Mirazul

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the container after "EXP". The expiration date is the last day of the month indicated.

Discard the product one month after opening the container.

Do not use Mirazul if you notice that the solution changes color or becomes cloudy.

Medications should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Mirazul Composition

• The active ingredient 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, chlorobutanol, benzyl alcohol, terpineol, methyl blue, sodium chloride, and water for injection.

Product Appearance and Package Contents

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

Marketing Authorization Holder and Manufacturer:

Holder:

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A.

Grassot, 16 – 08025 Barcelona (Spain)

Date of the Last Revision of this Package Leaflet:June 2021

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/, and on the Spanish Agency for Medicines and Health Products (AEMPS) website: http://www.aemps.gob.es/