ALERGOFTAL 0.25 mg/ml + 5 mg/ml EYE DROPS SOLUTION

2. What you need to know before starting to use Alergoftal eye drops

Do not use Alergoftal:

• If you are allergic to nafazoline or other adrenergic medications (stimulants of the sympathetic system that, among other actions, can raise blood pressure), to antazoline or to any of the other components of this medication (included in section 6).
• If you have narrow-angle glaucoma or are predisposed to having it.

Warnings and Precautions

Consult your doctor before starting to use Alergoftal eye drops.

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

• In case you are being administered certain anesthetics (e.g., halothane, which makes the heart more sensitive to medications of the nafazoline type)
• if you have bronchial asthma
  • if you have heart or circulation diseases
  • if you have arteriosclerosis in the brain
  • if you have hypertension
  • if you have thyroid disease
  • if you have diabetes
  • if you have any eye disease or infection or injury to them
  • if you are taking monoamine oxidase inhibitor (MAOI) medications (generally antidepressants) (see "Other medications and Alergoftal").

Recommendations for the use of eye drops. Since it is a sterile preparation, it is recommended to follow the following instructions:

• Each patient will use their own container.
• The application of the eye drops should be done with maximum hygiene: washing of hands and avoiding any contact of the dropper with any surface (including the eye) as much as possible.
• After each application, keep the bottle perfectly closed.
• After the established use, the remaining preparation should be discarded, even if it has not been fully consumed.

Do not use the medication for more than 3-5 consecutive days (rebound congestion may occur).

Do not wear contact lenses during the use of this medication.

Children

Do not use Alergoftal eye drops in children; safety and efficacy have not been established in children.

Other medications and Alergoftal

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

The concomitant administration of Alergoftal with monoamine oxidase inhibitors (MAOIs) (generally antidepressants) may lead to the appearance of a hypertensive crisis (increase in blood pressure).

If other eye drops are used, wait at least 5 minutes between the instillations of both products.

Pregnancy, breastfeeding, and fertility

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.

There is no data on the ophthalmic use of the combination of the active ingredients of this medication in pregnant or breastfeeding women.

Pregnant or breastfeeding women should not use Alergoftal.

Driving and using machines

The influence of Alergoftal on the ability to drive or use machines is nil or insignificant.

In rare cases, blurred vision or glare may occur. In this case, do not drive or use hazardous machines.

Alergoftal eye drops contain benzalkonium chloride

This medication contains 0.1 mg of benzalkonium chloride per ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove contact lenses before using this medication and wait 15 minutes before putting them back on.

Benzalkonium chloride can 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 any strange sensation, itching, or pain in the eye after using this medication.

3. How to use Alergoftal eye drops

Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Ophthalmic route (administration in the eyes).

The recommended dose is:

• Adults: Instill 1 or 2 drops in the affected eye 3 to 4 times a day, depending on the intensity of the symptoms.

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

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

Use in children

Alergoftal should not be used in children.

Instructions for the correct administration of the medication

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

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

If you use more Alergoftal than you should

Due to the characteristics of this medication, intoxication phenomena are not expected with topical use at the recommended doses.

Taking a considerably larger amount of Alergoftal than the recommended dose, for example, if Alergoftal is accidentally swallowed, may cause serious adverse effects that affect the heart and circulation. Symptoms may include: reduced heart rate (bradycardia), acute headache, nausea, vomiting, respiratory problems, 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 appear, such as significant sedation, CNS depression, decreased body temperature, and coma.

With very high doses of nafazoline, adverse effects on the heart 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, drowsiness, and insomnia.

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

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

If you forget to use Alergoftal

Do not use a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone experiences them.

It has been observed that pupil dilation, increased pressure inside the eye, and general effects due to absorption may occur.

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

With unknown frequency: conjunctivitis, eye pain, itching, and moderate and transient tearing; with excessive use, diffuse haze.

In very rare cases: opaque areas in the cornea.

In predisposed patients and with the use of a greater amount or frequency than recommended, palpitations, headache, tremors, weakness, sweating, and hypertension may occur.

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

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Alergoftal eye drops

Do not store at a temperature above 30°C.

Discard the medication one month after opening the container or earlier if a color change or clouding occurs.

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 CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need at the SIGRE point in the pharmacy. 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

Alergoftal eye drops composition

• The active ingredients are nafazoline hydrochloride and antazoline phosphate. Each ml contains 0.25 mg of nafazoline hydrochloride (0.025%) and 5 mg of antazoline phosphate (0.5%).
• The other components are: benzalkonium chloride, polyethylene glycol (macrogol) 8000, polyvinyl alcohol, sodium chloride, disodium edetate, sodium hydroxide, and/or hydrochloric acid, and purified water.

Appearance of the product and package contents

The medication is an eye drop solution, which is transparent, colorless, or slightly yellowish.

It is presented in a dropper container, which is a polyethylene bottle containing 10 ml of eye drop solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reva Health Europe, S.L.

Pl. Ausiàs March, 1, 4-6

08195 Sant Cugat del Vallès-España

Manufacturer

Tubilux Pharma S.p.A.

Via Costarica 20/22

00071, Pomezia (Roma)

Italy

Date of the last revision of this prospectus:June 2025

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