Leaflet: information for the user

Optialerg 5 mg/ml + 0.25 mg/ml eye drops in solution

Antazolina phosphate, Nafazolina 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 or pharmacist

• 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 or pharmacist, even if they are not listed in this leaflet. See section 4
• You should consult a doctor if you get worse or do not improve after 3 days of treatment

1. What is Optialerg and what it is used for.

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

3. How to use Optialerg.

4. Possible side effects.

5. Storage of Optialerg.

6. Contents of the pack and additional information.

Naphazoline is a sympathomimetic substance that develops a vasoconstrictive action with a rapid decongestant effect on the inflamed mucosa of the conjunctiva.

Antazoline is a substance with antihistaminic activity, normally capable of attenuating the inflammatory processes caused by allergies. The association of these two active substances has been shown to be effective compared to the individual components in the treatment of symptoms caused by allergic eye diseases.

It is indicated for the temporary relief of mild ocular irritation, redness, and congestion of allergic origin in adults and adolescents over 12 years old.

No use Optialerg

-If you are allergic to antazoline, naphazoline, or other adrenergic medications (stimulants of the sympathetic system that, among other actions, can raise blood pressure) or to any of the other components of this medication (listed in section 6).

-If you have narrow-angle glaucoma or a predisposition to it.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Optialerg.

You must be cautious if you are in any of the following cases:

-In the case of being administered certain anesthetics (e.g., halothane, which makes the heart more sensitive to medications like naphazoline).

-If you have bronchial asthma.

-If you have heart or circulation diseases.

-If you have cerebral arteriosclerosis.

-If you have hypertension.

-If you have thyroid disease.

-If you have diabetes.

-If you have any eye disease, infection, or injury.

-If you are taking monoamine oxidase inhibitors (MAOIs) (usually antidepressants) (see "Optialerg use with other medications").

Recommendations for the use of eye drops.

Since it is a sterile preparation, the following instructions are recommended:

-Each patient will use their own container.

-The application of the eye drop should be performed with maximum hygiene: hand washing and avoiding contact of the dropper with any surface (including the eye).

-After each application, keep the container perfectly closed.

-After the established use, the remaining preparation should be discarded, even if it has not been consumed in its entirety.

Do not use the medication for more than 3-5 consecutive days (it may cause rebound congestion). Do not use contact lenses during the use of this medication.

Children

Do not use this medication in children; the safety and efficacy have not been established in children.

Other medications and Optialerg

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

The concurrent administration of Optialerg with monoamine oxidase inhibitors (MAOIs) (usually antidepressants) may lead to the appearance of a hypertensive crisis (blood pressure increase).

If you use any other product by eye drops, it is recommended to leave at least 5 minutes between administrations.

Pregnancy, breastfeeding, and fertility

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

There are no data on the use of this medication by eye drops in pregnant women or breastfeeding women.

Women who are pregnant or breastfeeding should not use Optialerg.

Driving and operating machinery

The influence of Optialerg on the ability to drive or operate machinery is negligible or insignificant.

In rare cases, it may cause blurred vision or dazzle. In this case, do not drive or use hazardous machinery.

Optialerg contains benzalkonium chloride

This medication contains 0.02 mg of benzalkonium chloride per ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of the medication contained in thisleaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctoror pharmacist.

The recommended dose is:

Adults and adolescents 12 years and older: Apply 1 or 2 drops in each eye up to three or four times a day,according to the intensity of the symptoms.

The treatment duration should not exceed 3-5 days.

If symptoms do not resolve or worsen after 3 days of use, you must consult your doctor who will examine the state of your eyes.

Use in children

Optialerg should not be used in children under 12 years old.

How to use Optialerg

This medication is administered via the ocular route.

Before application, wash your hands and dry your eyes.

If you wear contact lenses, remove them before applying the eye drops. You can reinsert them 15 minutes after applying the eye drops.

With your head tilted back, looking up, separate your lower eyelid and let the drops fall into the conjunctival sac (space between the eye and the eyelid). Close your eyes gently and keep them closed for a few seconds.

As this is a sterile preparation, it is recommended to follow the following instructions:

• The packaging should only be used by 1 person.
• The eye drops should be applied with maximum hygiene: hand washing and avoiding contact between the dropper and any surface (including the eye).
• After each application, close the packaging tightly.
• After completing the established use, the remaining preparation should be discarded, even if not fully consumed.
• Discard the packaging after 1 month of opening or earlier if a change in color or turbidity is observed.

If after application, you apply pressure on the nasolacrimal duct or close your eye for 3 minutes, the systemic effects are reduced and local activity is increased.

Before using other eye medications, wait at least 5 minutes.

If you use more Optialerg than you should

Due to the characteristics of this medication, it is not expected to experience intoxication with topical use at the recommended doses.

The symptoms of excessive or very frequent application may be: eye irritation.

In case of accidental ingestion of the contents of a packaging, especially in children, signs of central nervous system (CNS) impairment may appear, such as significant sedation, CNS depression, decreased body temperature, and coma.

With very high doses of naphazoline, cardiovascular effects or circulation may occur, such as palpitations, high blood pressure that may be followed by hypotension (low blood pressure); other adverse effects may be: headache, dizziness, somnolence, and insomnia.

Other symptoms that may appear if the medication is accidentally ingested, especially in children, are: nausea, vomiting, lethargy, respiratory difficulty, etc.

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 ingested.

If you forgot to use Optialerg

Use this medication only if you notice symptoms. If you don't have symptoms, do not use it.

Do not use a double dose to compensate for missed doses.

If necessary, because you notice symptoms again, use it as indicated in the section 3. How to use Optialerg.

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.

It has been observed that it could cause pupil dilation, increased pressure within the eye, and general effects due to absorption.

Possible appearance, with low frequency, of continuous redness and eye irritation.

Unknown frequency: conjunctivitis, eye pain, moderate and transient burning and tearing, changes in vision; with excessive use, blurred vision.

Very rarely: opaque areas in the cornea.

In predisposed patients and with the use of a greater quantity or frequency than recommended, palpitations, headache, tremor, weakness, sweating, and hypertension could be produced.

It could also present an allergic reaction to one of the components.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear 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. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 86°F (30°C).

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 medication 30 days after opening the packaging or sooner if you observe a change in color or clouding.

Medications should not be thrown away through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Optialerg

• The active principles are antazolina phosphate and nafazoline hydrochloride. Each milliliter of eye drop solution contains 5 mg of antazolina phosphate and 0.25 mg of nafazoline hydrochloride.
• The other components (excipients) are: macrogol 8000, polyvinyl alcohol, sodium chloride, disodium edetate, 50% benzalkonium chloride, sodium hydroxide and/or hydrochloric acid, and purified water.

Appearance of the product and contents of the packaging

Optialergis a clear and colorless eye drop solution that is presented in 10 ml low-density polyethylene containers of white color, polyethylene low-density dropper tips, and white high-density polyethylene stoppers.Each container contains a bottle of eye drop solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte (Navarra)-Spain

Responsible for manufacturing

Farmigea S.p.A.

Via G.B. Oliva, 8 56121 Pisa. Italy

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte (Navarra)-Spain

Last review date of this leaflet:October 2021

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