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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Antazoline phosphate, Naphazoline hydrochloride

Read the entire leaflet carefully before you start using this medicine,

because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days of treatment.

Contents of the leaflet

1. What Optialerg is and what it is used for.
2. What you need to know before using Optialerg.
3. How to use Optialerg.
4. Possible side effects.
5. How to store Optialerg.
6. Contents of the pack and other information.

1. What Optialerg is and what it is used for

Naphazoline is a sympathomimetic substance that produces a vasoconstrictor effect, rapidly decongesting the inflamed conjunctival mucosa.

Antazoline is a substance with antihistaminic activity, generally capable of reducing inflammatory processes caused by allergies. The combination of these two active substances has proven to be more effective than the individual components in the treatment of symptoms caused by allergic eye diseases.

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

2. What you need to know before using Optialerg

Do not use Optialerg

• If you are allergic to antazoline, naphazoline, or other adrenergic drugs (sympathetic nervous system stimulants, which among other effects may increase blood pressure), or to any of the other ingredients of this medicine (listed in section 6).
• If you have narrow-angle glaucoma or a predisposition to develop it.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Optialerg.

You should exercise caution if any of the following apply to you:

• If you are receiving certain anesthetics (e.g., halothane), which make the heart more sensitive to drugs like naphazoline.
• If you have bronchial asthma.
• If you have heart or circulatory diseases.
• If you have cerebral arteriosclerosis.
• If you have hypertension.
• If you have thyroid disease.
• If you have diabetes.
• If you have eye diseases, eye infections, or eye injuries.
• If you are taking monoamine oxidase inhibitors (MAOIs), usually antidepressants (see "Use of Optialerg with other medicines").

Recommendations for the use of eye drops

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

• Each patient should use their own container.
• Eye drops should be administered with maximum hygiene: wash hands and avoid contact of the dropper tip with any surface (including the eye).
• After each use, keep the bottle tightly closed.
• Once the treatment course is completed, any remaining solution should be discarded, even if not fully consumed.

Do not use the medicine for more than 3–5 consecutive days (rebound congestion may occur). Do not wear contact lenses during use of this medicine.

Children

Do not use this medicine in children; safety and efficacy have not been established in pediatric patients.

Other medicines and Optialerg

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant use of Optialerg with monoamine oxidase inhibitors (MAOIs)—usually antidepressants—may lead to hypertensive crisis (elevated blood pressure).

If you use any other ophthalmic product, wait at least 5 minutes between administrations.

Pregnancy, breastfeeding, and fertility

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

There are no data available on the ophthalmic use of the combination of active substances in this medicine in pregnant or breastfeeding women.

Pregnant women or women who are breastfeeding should not use Optialerg.

Driving and using machines

The effect of Optialerg on the ability to drive or operate machinery is negligible or none.

However, blurred vision or glare may rarely occur. In such cases, do not drive or operate dangerous machinery.

Optialerg contains benzalkonium chloride

This medicine 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 medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

3. How to use Optialerg

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents aged 12 years and older: Apply 1 or 2 drops into each eye up to three or four times a day, depending on the severity of symptoms.

The duration of treatment should not exceed 3–5 days.

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

Use in children

Optialerg must not be used in children under 12 years of age.

How to use Optialerg

This medicine is administered by ophthalmic (eye) route.

Before application, wash your hands and dry your eyes.

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

Tilt your head backwards and look upwards. Gently pull down the lower eyelid and instill the drops into the conjunctival sac (the space between the eye and the eyelid). Gently close your eyes and keep them closed for a few seconds.

As this is a sterile preparation, the following instructions are recommended:

• The container must be used by only one person.
• The eye drops should be administered with maximum hygiene: wash hands thoroughly and avoid contact of the dropper tip with any surface (including the eye).
• Close the container tightly after each use.
• After the recommended treatment period, discard any remaining solution, even if not completely used.
• Discard the container one month after opening, or earlier if a change in color or cloudiness occurs.

Applying pressure to the nasolacrimal duct or keeping the eye closed for 3 minutes after instillation reduces systemic effects and enhances local activity.

Wait at least 5 minutes before using any other eye medication.

If you use more Optialerg than you should

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

Symptoms of excessive or prolonged dosing may include: eye irritation.

Ingestion of a considerably larger amount of Optialerg than the recommended dose, for example, if Optialerg is accidentally swallowed, may cause serious adverse effects affecting the heart and blood circulation. Symptoms may include: reduced heart rate (bradycardia), acute headache, nausea, vomiting, breathing difficulties, increased heart rate (tachycardia), and chest pain.

In case of accidental ingestion of the contents of a container, especially in children, signs of central nervous system (CNS) involvement may occur, such as marked sedation, CNS depression, decreased body temperature, and coma.

With very high doses of naphazoline, adverse effects on the heart or circulation may occur, such as palpitations, high blood pressure which may be followed by hypotension (low blood pressure); other adverse effects may include: headache, dizziness, drowsiness, and insomnia.

Other symptoms that may occur if the medicine is accidentally ingested, especially by children, include: nausea, vomiting, lethargy, breathing difficulties, etc.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Optialerg

Use this medicine only when you experience symptoms. If you do not have symptoms, do not use it.

Do not use a double dose to make up for a missed dose.

If necessary, due to recurrence of symptoms, use it again as indicated in section 3. How to use Optialerg.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Dilation of the pupil, increased pressure within the eye, and systemic effects due to absorption may occur.

Infrequent occurrence of persistent eye redness and eye irritation is possible.

Frequency not known: conjunctivitis, eye pain, stinging, and mild and transient tearing; changes in vision; with excessive use, blurred vision.

Very rarely: opaque spots on the cornea.

In predisposed patients and with use exceeding the recommended amount or frequency, palpitations, headache, tremor, weakness, sweating, and hypertension may occur.

An allergic reaction to one of the components may also occur.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Optialerg

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Discard the medicine 30 days after unsealing and opening the container, or earlier if you notice a change in colour or cloudiness occurs.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Optialerg

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

Appearance of the product and contents of the pack

Optialerg is a clear, colourless eye drop solution supplied in 10 ml low-density polyethylene bottles, white in colour, with a low-density polyethylene dropper and a white high-density polyethylene cap. Each pack contains one bottle of eye drop solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Manufacturer

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

Date of the most recent revision of this leaflet: July 2025

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

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/81752/P_81752.html

QR code: https://cima.aemps.es/cima/dochtml/p/81752/P_81752.html