Alergoftal 0.25 mg/ml + 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alergoftal 0.25 mg/ml + 5 mg/ml Eye drops solution

Naphazoline hydrochloride / Antazoline phosphate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions of 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 days.

Leaflet contents

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

1. What Alergoftal eye drops is and what it is used for

It contains as active ingredients: naphazoline, with decongestant action (causes vasoconstriction or narrowing of the visible blood vessels in the eye), and antazoline, with antiallergic action.

Alergoftal is indicated for: Temporary relief of allergic conjunctivitis, with symptoms such as redness, irritation, itching, burning, and tearing, following contact with allergens such as pollen, dust mites, tobacco smoke, sunlight glare, and other agents.

2. What you need to know before using Alergoftal eye drops

Do not use Alergoftal:

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

Warnings and precautions

Consult your doctor before using Alergoftal eye drops.

Use with caution if you are in any of the following situations:

• If you are receiving certain anaesthetics (e.g., halothane, which makes 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 any eye disease, infection, or injury
  • If you are taking monoamine oxidase inhibitors (MAOIs) (usually antidepressants) (see "Other medicines and Alergoftal").

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 application, keep the bottle tightly closed.
• After the treatment period, discard any remaining solution, even if not completely used up.

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

Do not wear contact lenses during treatment with this medicine.

Children

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

Other medicines and Alergoftal

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

Concomitant use of Alergoftal with monoamine oxidase inhibitors (MAOIs) (usually antidepressants) may lead to hypertensive crisis (sudden increase in blood pressure).

If other ophthalmic drops are used, wait at least 5 minutes between instillations of each product.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no data on the ophthalmic use of the combination of active substances in this medicine in pregnant or breast-feeding women.

Pregnant or breast-feeding women should not use Alergoftal.

Driving and using machines

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

In rare cases, blurred vision or glare may occur. If this happens, do not drive or operate dangerous machinery.

Alergoftal eye drops contain benzalkonium chloride

This medicine contains 0.1 mg of benzalkonium chloride per ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause ocular 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 pain in the eye after using this medicine.

3. How to use Alergoftal eye drops

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Ophthalmic use (administration into the eyes).

Recommended dose:

• Adults: Instill 1 or 2 drops into the affected eye 3 to 4 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, consult your doctor, who should examine the condition of your eyes.

Use in children

Alergoftal must not be used in children.

Instructions for correct administration of the medicine

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

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

If you use more Alergoftal than you should

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

Ingestion of a considerably larger amount of Alergoftal than the recommended dose, for example, if Alergoftal 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 that 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, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to use Alergoftal

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

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 produce adverse effects, although not everyone will experience them.

Pupil dilation, increased pressure inside the eye, and general systemic effects due to absorption may occur.

Infrequently, prolonged redness and eye irritation may appear.

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

Very rarely: corneal opacities.

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 System of Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alergoftal eye drops

Do not store above 30°C.

Discard the medicine one month after opening the container, or earlier if any change in colour or cloudiness occurs.

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

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alergoftal eye drops

• The active substances 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 medicine and contents of the pack

The medicine is an eye drop solution, which is transparent, colourless or slightly yellowish.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Reva Health Europe, S.L.

Pl. Ausiàs March,1, 4-6

08195 Sant Cugat del Vallès - Spain

Manufacturer

Tubilux Pharma S.p.A.

Via Costarica 20/22

00071, Pomezia (Roma)

Italy

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

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