Alfa decongestant eye drops

Package leaflet: Information for the user

Alfa Decongestant Eye Drops 0.8 mg/ml eye drops, solution

Naphazoline nitrate
Please read this leaflet carefully before 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 instructed you.

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

Contents of this leaflet:

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

1. What Collirio Alfa decongestionante is and what it is used for

Collirio Alfa decongestionante contains the active substance naphazoline nitrate, which belongs to the group of ocular mucosa decongestants.
Collirio Alfa decongestionante is used for redness, tearing, burning, and itching of the eyes caused by irritative conditions (excessive exposure to dust, smoke, etc.).
Consult your doctor if you do not feel better or if you feel worse after 4 days of treatment.

2. What you need to know before using Alfa decongestant eye drops

Do not use Alfa decongestant eye drops

• If you are allergic to naphazoline nitrate or to any of the other ingredients of this medicine (listed in section 6).
• If you have narrow-angle glaucoma (increased pressure inside the eye) or other serious eye diseases.
• In children under twelve years of age.
• If you are taking monoamine oxidase inhibitor (MAOI) drugs (antidepressants).

Warnings and precautions
Talk to your doctor before using Alfa decongestant eye drops:

• If you have hypertension (high blood pressure), hyperthyroidism (overactive thyroid), heart disorders, bronchial asthma, or hyperglycemia (diabetes).
• In case of eye infections, presence of pus, foreign bodies in the eye, or mechanical, chemical or thermal injuries.

Children and adolescents
Do not use in children under twelve years of age.
Take special care to keep this medicine out of the sight and reach of children, because if accidentally ingested, it may cause central nervous system depression (marked sedation or hypotonia, i.e. muscle weakness).

Other medicines and Alfa decongestant eye drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Even though the action of Alfa decongestant eye drops occurs mainly at the ocular level, do not use it if you are taking monoamine oxidase inhibitor (MAOI) drugs (antidepressants), or within two weeks after stopping such treatment, as severe hypertensive crises (significant increase in blood pressure) may occur.

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

Alfa decongestant eye drops (bottle) contains benzalkonium chloride
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.
Alfa decongestant eye drops (single-dose container) does not contain benzalkonium chloride.
Single-dose containers can be used by contact lens wearers or by individuals who are hypersensitive to benzalkonium chloride.

3. How to use Alfa decongestant eye drops

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Alfa decongestant eye drops are for ophthalmic use (in the eyes).
Any use differing from the recommended dosage regimen or route of administration is prohibited.

Dosage
Instill 1 or 2 drops into the conjunctival sac (inside the lower eyelid) one or two times daily.
Warning: Do not exceed the recommended dose without medical advice.
Consult your doctor if you do not feel better or if you feel worse after a short period/days of treatment.
This product must not be used for more than 4 consecutive days unless otherwise prescribed by a doctor, as adverse effects may occur.
Higher doses of this product, even when administered topically and for a short period, may lead to serious systemic effects.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.

Method of administration
10 ml bottle – Unscrew the cap; the bottle is ready for use. Hold it upside down over the eye: gently squeeze with thumb and index finger to release the drops. After use, screw the cap back on.

Single-dose container
INSTRUCTIONS FOR OPENING THE SINGLE-DOSE CONTAINER

1. Open the single-dose container by removing the cap, which can be used upside down to temporarily close the container.
2. Gently squeeze the body of the single-dose container and instill the eye drops into the eye as described above. Alfa decongestant eye drops in single-dose containers do not contain preservatives; therefore, each single-dose container must be discarded 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 Alfa decongestant eye drops 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.
Significantly exceeding the recommended dose of Alfa decongestant eye drops—for example, in case of accidental ingestion—may cause serious adverse effects on the heart and circulatory system. 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/overdose of Alfa decongestant eye drops, contact your doctor immediately or go to the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The use of this product may occasionally cause pupil dilation, systemic effects due to absorption (hypertension, cardiac disorders, hyperglycaemia), increased intraocular pressure, nausea, headache.
Rarely, hypersensitivity reactions may occur (difficulty in breathing, drop in blood pressure, or appearance of skin rashes). In such cases, discontinue treatment and inform your doctor so that, if necessary, appropriate therapy can be initiated.
Following the instructions provided in this leaflet reduces the risk of side effects.
These side effects are generally temporary. However, if they occur, it is advisable to consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alfa Decongestant Eye Drops

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. This date applies to the product when packaged and stored correctly.
10 ml bottle
Store in the original packaging.
The eye drops in the 10 ml bottle must be used within 30 days of first opening the bottle.
Single-dose container
Store at a temperature not exceeding 30°C, and keep in the original packaging.
The eye drops in the single-dose container do 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 you no longer use. This will help protect the environment.
It is important to always have the medicine information available; therefore, keep both the carton and the package leaflet.

6. Package contents and other information

What Collirio Alfa decongestant contains

• The active substance is naphazoline hydrochloride. 1 ml of solution contains 0.8 mg of naphazoline nitrate.
• The other components are: For Eye Drops (10 ml bottle): Sodium chloride, monobasic potassium phosphate, dibasic sodium phosphate dodecahydrate, benzalkonium chloride, concentrated distilled water of Hamamelis virginiana, ethyl alcohol, camphor, water for injections. For Eye Drops (single-dose container): Sodium chloride, monobasic potassium phosphate, dibasic sodium phosphate dodecahydrate, concentrated distilled water of Hamamelis virginiana, ethyl alcohol, camphor, water for injections.

Description of the appearance of Collirio Alfa decongestant and contents of the pack
Collirio Alfa decongestant is presented as eye drops (for ophthalmic use).
The pack contains either one 10 ml bottle or 10 single-dose containers of 0.3 ml each.

Marketing Authorization Holder and Manufacturer
Dompé farmaceutici S.p.A., Via San Martino 12 - 20122 Milan

Manufacturers
Eye Drops (10 ml bottle)
C.O.C. FARMACEUTICI S.R.L. – Via Modena, 15 – 40019 Sant’Agata Bolognese (BO)
FAMAR S.A. 63 Ag. Dimitriou str. 174 56 Alimos, Athens, Greece
Eye Drops (single-dose container)
Farmigea S.p.A. – Pharmaceutical plant in Ospedaletto (Pisa) – Via G. B. Oliva, 8
C.O.C. FARMACEUTICI S.R.L. – Via Modena, 15 – 40019 Sant’Agata Bolognese (BO)