Prospect: information for user

Alergoftal0.25mg/ml + 5mg/ml Eye Drop Solution

Nafazolina hydrochloride / Antazolina phosphate

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

1. What isAlergoftal eye dropand for what it is used

2. What you need to know before starting to useAlergoftal eye drop

3. How to useAlergoftal eye drop

4. Possible adverse effects

5. Storage ofAlergoftal eye drop

6. Contents of the package and additional information

Contains as active ingredients: nafazoline, with decongestant action (produces vasoconstriction or narrowing of visible blood vessels of the eye) and antazoline, with antiallergic action.

Alergoftal is indicated for: Temporary relief of allergic conjunctivitis, with manifestations such as redness, irritation, itching, burning, and tearing, after contact with the allergen, such as: pollen, dust mites, tobacco smoke, sunlight, other agents.

No use Alergoftal:

• If you are allergic to naphazoline or other adrenergic medications (stimulants of the sympathetic nervous system that, among other actions, may elevate blood pressure), to antazoline or any of the other components of this medication (listed in section 6).
• If you have narrow-angle glaucoma or a predisposition to it.

Advertencias 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 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 "Other medications and Alergoftal").

Recommendations for the use of eye drops. As this 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 performed with maximum hygiene: hand washing and avoiding contact of the dropper with any surface (including the eye).
• After each application, keep the bottle perfectly closed.
• Once the established use is finished, 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 Alergoftal eye drops in children; the safety and efficacy have not been established in children.

Other medications and Alergoftal

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

The concomitant administration of Alergoftal with monoamine oxidase inhibitors (MAOIs) (usually antidepressants) may lead to the appearance of a hypertensive crisis (elevated 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

There are no data related to the use of the active principles of this medication in pregnant women or breastfeeding women.

Do not use Alergoftal in pregnant women or breastfeeding women.

Driving and operating machinery

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

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

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 lenses. 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 part 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 this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Ocular 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, 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 should consult your doctor, who will examine the condition of your eyes.

Use in children

Alergoftal should not be used in children.

Instructions for correct medication administration

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

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

If you use more Alergoftal than you should

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

In case of accidental ingestion of the contents of a container, 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, 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, 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 go to a medical center, or call the Toxicological Information Service, Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Alergoftal

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

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

Like all medications, this medication may produce adverse effects, although not all people may 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 irritation of the eye.

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

In very rare cases: 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 Medicines for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Do not store at a temperature above30ºC.

Discard the medication one month after opening the container or sooner if a change in color or cloudiness occurs.

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

Do not use this medication after the expiration date appearing on the container after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGREpoint at the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Alergoftal eye drops

• The active principles are naphazoline hydrochloride and antazoline phosphate. Each ml contains 0.25 mg of naphazoline 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 contents of the packaging

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Reva Health Europe, S.L.

Pl. Ausiàs March,1, 4-6

08195 Sant Cugat del Vallès-Spain

Responsible for manufacturing

Tubilux Pharma S.p.A.

Via Costarica 20/22

00071, Pomezia (Rome)

Italy

Last review date of this leaflet:June 2016.

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/