Patient Information Leaflet

ANTISETTICO ASTRINGENTE SEDATIVO eye drops, solution

Zinc sulfophenolate, sodium sulfacetamide, naphazoline hydrochloride and lidocaine 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 told you to.

Keep this leaflet. You may need to read it again.
If you need more information or advice, ask your pharmacist.
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Talk to your doctor if you do not notice any improvement or if you notice worsening of symptoms after 7 days.

Contents of this leaflet:

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

1. What ANTISETTICO ASTRINGENTE SEDATIVO is and what it is used for

ANTISETTICO ASTRINGENTE SEDATIVO contains four active substances: zinc sulfophenate,
sulfacetamide sodium, naphazoline hydrochloride, and lidocaine hydrochloride. It belongs to the group of medicines
known as antimicrobials and sulfonamides, which exert antibacterial, ocular decongestant, anti-inflammatory effects, and relieve associated itching and discomfort.
This medicine is indicated for the local treatment of simple conjunctivitis (eye infections).
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using ANTISETTICO ASTRINGENTE SEDATIVO

Do not use ANTISETTICO ASTRINGENTE SEDATIVO

if you are allergic to sulfophenate zinc, sodium sulfacetamide, naphazoline hydrochloride, lidocaine hydrochloride, or to any of the ingredients of this medicine (listed in section 6);
in children under 6 years of age (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before using ANTISETTICO ASTRINGENTE SEDATIVO.
If allergic reactions (sensitization reactions) occur, stop treatment and inform your doctor, who will adopt appropriate therapy.
Children
The use of ANTISETTICO ASTRINGENTE SEDATIVO is contraindicated in children under 6 years of age (See section “Do not use ANTISETTICO ASTRINGENTE SEDATIVO”).
Other medicines and ANTISETTICO ASTRINGENTE SEDATIVO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between ANTISETTICO ASTRINGENTE SEDATIVO and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use ANTISETTICO ASTRINGENTE SEDATIVO during pregnancy and breastfeeding only when strictly necessary and under close medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
ANTISETTICO ASTRINGENTE SEDATIVO contains parahydroxybenzoates and sodium mertiolate
This medicine contains parahydroxybenzoates (p-hydroxybenzoic acid esters) which may cause allergic reactions (including delayed-type reactions).
ANTISETTICO ASTRINGENTE SEDATIVO contains sodium mertiolate which may cause allergic reactions.

3. How to use ANTISETTICO ASTRINGENTE SEDATIVO

Use this medicine exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 drop of eye drops, 2 or more times a day.
Apply the eye drops into the lower part of the eye (lower conjunctival sac), keeping the eye open and gently pressing on the sides of the bottle.
After application, keep the eye closed for a short while.
Do not exceed the recommended doses.
If you exceed the recommended doses, since ANTISETTICO ASTRINGENTE SEDATIVO, even when applied locally to the eyes (topical route) and used for a short period, may cause serious adverse effects affecting the whole body (systemic effects) (See section “Possible side effects”).
Do not use this medicine for more than 7 consecutive days without consulting your doctor.

If you use more ANTISETTICO ASTRINGENTE SEDATIVO than you should
Overdose is very rare, as this medicine is poorly absorbed into the body (low systemic absorption), unless accidentally ingested.
A significantly higher than recommended dose of ANTISETTICO ASTRINGENTE SEDATIVO, 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.
In such cases, your doctor will provide the most appropriate treatment depending on the severity of your symptoms.
If you experience any adverse effects or in case of accidental ingestion/overdose of ANTISETTICO ASTRINGENTE SEDATIVO, seek immediate medical attention.

If you forget to use ANTISETTICO ASTRINGENTE SEDATIVO
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 can cause side effects, although not everybody gets them.
Allergic reactions to the medicine may occur. If this happens, stop treatment and consult your doctor, who will advise you on appropriate therapy.
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 through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store ANTISETTIC ASTRINGENT SEDATIVE

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 that month and to the product in its original, unopened packaging,
correctly stored.
Store below 30 °C.
Use the medicine within 30 days of first opening the container.
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. Contents of the pack and other information

What ANTISETTICO ASTRINGENTE SEDATIVO contains

The active substances are zinc sulfophenate, sodium sulfacetamide, naphazoline hydrochloride and lidocaine hydrochloride. Each 100 ml of eye drops contains 0.500 g of zinc sulfophenate, 3 g of sodium sulfacetamide, 0.005 g of naphazoline hydrochloride and 0.750 g of lidocaine hydrochloride.
The other components are: ammonium chloride, p-hydroxybenzoate esters, sodium mertiolate, purified water.

Description of the appearance of ANTISETTICO ASTRINGENTE SEDATIVO and contents of the pack
10 ml bottle with dropper and screw cap.
Marketing Authorization Holder and Manufacturer
BRUSCHETTINI S.r.l. – Via Isonzo 6 – 16147 Genoa – Italy