Package leaflet: Information for the user

Alfaflor eye drops, powder and solvent for solution

Betamethasone sodium phosphate, naphazoline nitrate and tetracycline hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ALFAFLOR is and what it is used for
What you need to know before using ALFAFLOR
How to use ALFAFLOR
Possible side effects
How to store ALFAFLOR
Contents of the pack and other information

1. What ALFAFLOR is and what it is used for

ALFAFLOR is an eye drop formulation containing three active substances: betamethasone, naphazoline, and tetracycline. Betamethasone is a corticosteroid used to treat inflammation (anti-inflammatory), naphazoline acts by constricting blood vessels in the eye and relieving redness (vasoconstrictor), and tetracycline is effective against infections (antibiotic).
This medicinal product is indicated for:

eye inflammations caused by bacteria (subacute and chronic conjunctivitis of bacterial origin);
eye inflammations due to allergy or other causes (non-bacterial conjunctivitis, including allergic forms of any origin);
inflammation and blockage of the tear sac (dacryocystitis and dacryostenosis);
skin inflammations or irritations of the eyelids (blepharoconjunctivitis or eczematous dermatitis of the eyelids);
inflammation of the colored part of the eye (rheumatic iritis);
eye infections caused by bacteria sensitive to tetracycline;
inflammations due to burns or injuries that may become infected.

2. What you need to know before using ALFAFLOR

Do not use ALFAFLOR

if you are allergic to betamethasone sodium phosphate, naphazoline nitrate, tetracycline hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
if you have high pressure inside the eye (endocular hypertension);
if you have acute viral infections of the cornea in the ulcerative phase, such as herpes simplex, unless you are being treated with specific antiviral medicines for herpes virus;
if you have eye inflammation with corneal lesions (conjunctivitis with ulcerative keratitis), even at an early stage (positive fluorescein test);
if you suffer from a disease called ocular tuberculosis;
if you have eye infections caused by fungi (mycoses);
if you have eye or eyelid inflammation with pus discharge (acute purulent ophthalmia, purulent conjunctivitis, and purulent or herpetic blepharitis), because these may be masked or worsened by corticosteroids;
if you have a swollen eyelid caused by infection (sty);
if your thyroid gland produces excessive amounts of thyroid hormones (hyperthyroidism);
if the user is a child under 10 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using ALFAFLOR.
Do not use this medicine for prolonged periods or in excessive doses, as the following may occur:

increased levels of aldosterone (hyperaldosteronism) due to absorption of corticosteroids into the bloodstream;
a disease affecting the optic nerve (glaucoma) and worsening of symptoms in a type of glaucoma known as open-angle glaucoma (see section 4);
corneal perforation, if you suffer from conditions causing corneal thinning.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
This medicine is contraindicated in children under 10 years of age.

Other medicines and ALFAFLOR
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.

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.
If you are pregnant, use this medicine only if clearly needed and under direct medical supervision.

Driving and using machines
This medicine does not impair your ability to drive or operate machinery.

ALFAFLOR contains propyl parahydroxybenzoate
This medicine contains propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

ALFAFLOR contains phosphates
This medicine contains 21 mg of phosphate buffer per 1 ml. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause opaque corneal spots due to calcium deposition during treatment.

3. How to use ALFAFLOR

Use this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 drops applied two or three times a day, as prescribed by your
doctor.
ALFAFLOR consists of two vials, A and B. Prepare the medicine as follows:

transfer the liquid contents of vial A into vial B and shake the resulting solution vigorously;
gently pull down the lower eyelid of the eye to be treated with a finger;
gently squeeze the dropper to instill 1-2 drops into the corner of the eye near the nose, then release the lower eyelid;
repeat the procedure for the other eye if necessary;
close the vial with the closure cap and store in the refrigerator (see section 5).

Follow the recommended dosage instructions carefully. Using higher than recommended doses, even for a short
period of time, may cause serious side effects.
If you use more ALFAFLOR than you should
This medicine, if accidentally ingested or used for prolonged periods at excessive doses,
may cause toxic effects.
In case of accidental ingestion or overdose, contact your doctor or go to the nearest hospital immediately.
If you forget to use ALFAFLOR
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
The following side effects may occur, mainly due to prolonged use:

vision problems due to the development of posterior subcapsular cataract;
increased pressure inside the eye (intraocular pressure), which may occur in 30% of normal patients and in almost all individuals affected by a disease called open-angle glaucoma; in these cases, frequent monitoring of eye pressure is recommended;
hypersensitivity or irritation reactions. In such cases, inform your doctor, who will prescribe appropriate treatment.

Side effects with unknown frequency (frequency cannot be estimated from the available data): blurred vision.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
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 ALFAFLOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
After reconstitution of the solution, store in a refrigerator (2-8°C) and use within 10 days.
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.

6. Package contents and other information

What ALFAFLOR contains
Bottle A

The active substances are betamethasone sodium phosphate and naphazoline nitrate. Each bottle contains 3 mg of betamethasone sodium phosphate and 4.5 mg of naphazoline nitrate.
Other components: hypromellose, polysorbate 80, monosodium phosphate, disodium phosphate, propyl parahydroxybenzoate, purified water.

Bottle B

The active substance is tetracycline hydrochloride. Each bottle contains 30 mg of tetracycline hydrochloride.
Other components: borax, sodium chloride.

Description of the appearance of ALFAFLOR and contents of the pack
Pack containing 2 bottles for the extemporaneous preparation of 3 ml of solution.
Bottle A: 3 ml solution with dropper cap.
Bottle B: 105 mg powder.
Marketing Authorization Holder and Manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera, 26
80026 Casoria (NA)
Italy