Package leaflet: Information for the user

ZINCOMETIL 0.02% + 0.01% eye drops, solution

Zinc sulfate + Benzalkonium chloride
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.
Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What ZINCOMETIL is and what it is used for

ZINCOMETIL eye drops, solution contains two active substances called zinc sulfate and benzalkonium chloride, which belong to the category of ocular disinfectants.
ZINCOMETIL is indicated in adults as a disinfectant solution for the eyes.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using ZINCOMETIL

Do not use ZINCOMETIL

if you are allergic to zinc sulfate or benzalkonium chloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using ZINCOMETIL.
Children and adolescents
In children, this medicine should be administered only under direct medical supervision.
Other medicines and ZINCOMETIL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using other eye drops at the same time, consult your doctor.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
ZINCOMETIL may be used during pregnancy and breastfeeding.
Effects on ability to drive vehicles and use machinery
ZINCOMETIL does not affect the ability to drive vehicles or operate machinery.
ZINCOMETIL contains benzalkonium chloride
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 have a decolorizing effect on soft contact lenses.

3. How to use ZINCOMETIL

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 drops to be instilled into the conjunctival sac 2–4 times a day.
Caution:

Do not exceed the recommended doses without medical advice.
Use only for short-term treatment.

Consult your doctor if the condition recurs or if you notice any recent changes in its characteristics.
If you use more Zincometil than you should
In case of accidental ingestion/overdose of Zincometil, contact your doctor immediately or go to the nearest hospital.
If you forget to use Zincometil
Do not use a double dose to make up for the missed dose.
If you stop using Zincometil
If you have any doubts about using 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.
The side effects that may occur with Zincometil are the following:
Frequency not known (frequency cannot be estimated from the available data)

burning
irritation

These side effects are generally transient. If you experience any of these side effects, consult your doctor or pharmacist.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
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.

How to store ZINCOMETIL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The shelf life after first opening of the bottle is 30 days.
Do not dispose of medicines 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 package and other information

What Zincometil contains

The active substances are Zinc sulfate (0.2 mg in 1 ml) and Benzalkonium chloride (0.1 mg in 1 ml).
The other components are sodium chloride, sodium citrate, citric acid, polysorbate 80, water for injections.

Description of the appearance of Zincometil and contents of the pack
Zincometil is an eye drop solution available in a pack containing 1 bottle with a dropper of 15 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
THEA FARMA S.p.A.
Via Tiziano, 32
20145 Milan
Manufacturer
FARMILA-THEA FARMACEUTICI S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI)