ANTIHISTAMINE OPHTHALMIC SOLUTION

Patient Information Leaflet: Information for the User

COLLIRIO ALFA Antihistamine 0.8 mg/ml + 1 mg/ml eye drops, solution

Naphazoline nitrate and antazoline hydrochloride
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has advised you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

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

1. What COLLIRIO ALFA Antihistamine Eye Drops is and what it is used for

COLLIRIO ALFA Antihistamine Eye Drops contains the active substances naphazoline nitrate, which belongs to the group of decongestants for inflamed ocular mucosa, and tolpropamine hydrochloride, which belongs to the antiallergic group and relieves ocular inflammation caused by allergies.
COLLIRIO ALFA Antihistamine Eye Drops is therefore useful in cases of allergy and inflammation of the mucous membrane covering the eyeball and the inner surface of the eyelids (conjunctiva), accompanied by photophobia (light sensitivity), tearing, and the sensation of foreign bodies in the eye.

2. What you need to know before using COLLIRIO ALFA Antistaminico

Do not use COLLIRIO ALFA Antistaminico

• if you are allergic to naphazoline nitrate, to cetyramine hydrochloride, or to any of the other ingredients of this medicine (listed in section 6);
• if you have a form of glaucoma called "closed-angle" (an eye disease with increased pressure inside the eye) or other serious eye diseases;
• in children under twelve years of age;
• if you are currently taking antidepressant medicines (monoamine oxidase inhibitors) (see also "Other medicines and COLLIRIO ALFA Antistaminico");
• during pregnancy and breastfeeding. Use only if strictly necessary and under direct medical supervision (see also "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before using COLLIRIO ALFA Antistaminico.
The eye drop solution should be used with caution if you suffer from high blood pressure (hypertension), overactive thyroid (hyperthyroidism), heart problems, bronchial asthma, or high blood sugar (diabetes).
Medical attention is required in case of eye infections, presence of pus, foreign bodies in the eye, or mechanical, chemical, or heat-related injuries.
Keep eye drops out of sight and reach of children, as accidental ingestion may cause central nervous system depression characterized by marked sedation or muscle weakness (hypotonia).

Children and adolescents
Do not use in children under twelve years of age.

Other medicines and COLLIRIO ALFA Antistaminico
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Although the action of COLLIRIO ALFA Antistaminico occurs mainly at the ocular level, it should not be used if you are taking, or have taken within the previous two weeks, antidepressant medicines such as "monoamine oxidase inhibitors", as severe hypertensive crises with a significant rise in blood pressure may occur.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, use only if strictly necessary and under direct medical supervision.

COLLIRIO ALFA Antistaminico (10 ml bottle) contains benzalkonium chloride
COLLIRIO ALFA Antistaminico in the 10 ml bottle contains benzalkonium chloride. Soft contact lenses must not be worn during treatment.
It may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride is known to cause discoloration of soft contact lenses.
Since benzalkonium chloride is not present in the single-dose container, it may be used by contact lens wearers or by individuals who show hypersensitivity to benzalkonium chloride.

3. How to use COLLIRIO ALFA Antihistamine Eye Drops

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
It is forbidden to take this medicine in a different way than that specified in this leaflet, regarding dosage and route of administration.

Dosage
The recommended dose is 1-2 drops instilled into the affected eye, up to 2-3 times daily, as needed.

This product must not be used for longer than 4 consecutive days, unless otherwise prescribed by a doctor, as adverse effects may occur.
If symptoms persist or worsen after a short period of treatment, consult your doctor.

Warning: Do not exceed the recommended doses without medical advice. Strictly adhere to the recommended dosage.
Exceeding the recommended dosage, even for a short period, may lead to serious systemic effects involving the entire organism.

Consult your doctor if symptoms recur frequently or if you notice any changes in your condition.

Method of administration

10 ml bottle
After unscrewing the cap, the bottle is ready for use. Hold it upside down over the eye and gently squeeze with thumb and index finger to release the drops. After use, make sure to screw the cap back on tightly.

Single-dose containers

1. Open the single-dose container by removing the cap (the cap can be used upside down to temporarily close the container).
2. Gently squeeze the body of the single-dose container and let the eye drops drip into the eye, as described above.

COLLIRIO ALFA Antihistamine contained in single-dose containers does not contain preservatives. Therefore, each single-dose container must be discarded immediately after use, even if only partially used.

Use in children and adolescents
Use in children and adolescents under 12 years of age is contraindicated.

If you use more COLLIRIO ALFA Antihistamine than you should
Strictly follow the recommended dosage.
If accidentally ingested or used excessively over a prolonged period, this medicine may cause toxic effects, especially in children.
Accidental ingestion of the medicine may cause, particularly in children, depression of the Central Nervous System (CNS) up to coma. In such cases, consult a doctor immediately.

Significantly exceeding the recommended dose of COLLIRIO ALFA Antihistamine, for example by accidental ingestion, may cause serious adverse effects on the heart and blood circulation. Symptoms may include: reduced heart rate (bradycardia), severe headache, nausea, vomiting, breathing difficulties, increased heart rate (tachycardia), and chest pain.

If adverse effects occur or in case of accidental ingestion of an excessive dose of COLLIRIO ALFA Antihistamine, seek immediate medical advice or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The use of COLLIRIO ALFA Antistaminico may occasionally cause dilation of the pupil, high blood pressure (hypertension), heart disorders, diabetes (hyperglycaemia), increased eye pressure, nausea, headache.
Rarely, hypersensitivity reactions may occur.
If any of the side effects listed above occur, treatment must be discontinued and the doctor should be consulted so that, if necessary, appropriate therapy can be initiated.
If any side effects not described in this leaflet occur, it is advisable to inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store COLLIRIO ALFA Antistaminico

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp." The expiry date refers to the last day of that month for the medicine properly stored.
10 ml bottle
Store in the original packaging.
The bottle has a shelf life of 3 years when the packaging is intact. It must be used within 30 days after first opening the bottle.
Single-dose container
Store in the original packaging and at a temperature not exceeding 30°C.
The eye drops in the single-dose container have a shelf life of 2 years in the original packaging. Please note that it does not contain preservatives; therefore, each single-dose container must be discarded after use, even if only partially used.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What COLLIRIO ALFA Antihistamine Eye Drops contains

• The active substances are: tonzilamine hydrochloride and naphazoline nitrate. 1 ml of solution contains: 1 mg of tonzilamine hydrochloride and 0.8 mg of naphazoline nitrate.
• The other components are: for the 10 ml bottle: sodium chloride, sodium citrate, monobasic sodium citrate, disodium edetate, benzalkonium chloride, levomenthol, ethyl alcohol, water for injections; for the single-dose container: sodium chloride, sodium citrate, monobasic sodium citrate, disodium edetate, levomenthol, ethyl alcohol, water for injections.

Description of the appearance of COLLIRIO ALFA Antihistamine Eye Drops and contents of the package
COLLIRIO ALFA Antihistamine Eye Drops is a solution for ophthalmic use.
Contents of the pack:
10 ml bottle: 10 ml bottle with dropper
Single-dose container: 10 single-dose containers (in 2 strips of 5 containers each); each single-dose container contains 0.3 ml of eye drops.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dompé farmaceutici S.p.A., Via San Martino 12 - 20122 Milan, Italy
Manufacturers
10 ml bottle:
C.O.C. FARMACEUTICI S.R.L. – via Modena, 15 – 40019 Sant’Agata Bolognese (BO), Italy
FAMAR S.A. 63 Ag. Dimitriou str. 174 56 Alimos, Athens, Greece
Single-dose container:
Farmigea S.p.A. – Pharmaceutical Plant of Ospedaletto – via G. B. Oliva, 8 - Pisa, Italy
C.O.C. FARMACEUTICI S.R.L. – via Modena, 15 – 40019 Sant’Agata Bolognese (BO), Italy