Oculosan

Leaflet attached to the packaging: patient information

Oculosan, (0.2 mg + 0.05 mg)/ml, eye drops, solution
Zinc sulfate+ Naphazoline nitrate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist.
• If after 2 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

• 1. What is Oculosan and what is it used for
• 2. Important information before using Oculosan
• 3. How to use Oculosan
• 4. Possible side effects
• 5. How to store Oculosan
• 6. Package contents and other information

1. What is Oculosan and what is it used for

Oculosan contains two active substances: zinc sulfate and naphazoline nitrate.
It is used for the short-term treatment of redness and non-specific eye irritation.
The medicine should not be used for more than 3 days without medical supervision.

2. Important information before using Oculosan

When not to use Oculosan

• if you are allergic to the active substances or any of the other ingredients of the medicine (listed in section 6);
• if you have dry eye syndrome, especially dry keratoconjunctivitis and Sjögren's syndrome;
• if you have narrow-angle glaucoma;
• in patients taking MAO inhibitors (used in neurology and psychiatry);
• in children;
• in pregnant or breastfeeding women.

Tell your doctor about all concomitant diseases. This will help determine if treatment with Oculosan is possible.

Warnings and precautions

Do not use the medicine while wearing contact lenses. You should not wear contact lenses in case of eye irritation.

• Patient should not use Oculosan for a longer period without a doctor's recommendation. If eye irritation does not improve within 2 days of use, the medicine should be discontinued and a doctor consulted.

Do not use the medicine for a longer period without a doctor's recommendation. If eye irritation does not improve within 2 days of use, the medicine should be discontinued and a doctor consulted.
If you experience eye pain or vision disturbances, stop using the medicine immediately.
Be cautious in patients with a predisposition to glaucoma, hypertension, heart disorders, pheochromocytoma, aneurysm, hyperglycemia, or hyperthyroidism.
After prolonged use, a relapse of hyperemia may occur.

Children

Oculosan should not be used in children.

Oculosan and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In case of concomitant use of other ophthalmic medicines with Oculosan, consult your doctor or pharmacist to determine the optimal administration time for each medicine.
When using other ophthalmic medicines, maintain an interval of at least 5 minutes between administrations.
Patients treated with MAO inhibitors should not use naphazoline-containing medicines until 10 days after the last dose of the MAO inhibitor.
Concomitant use of naphazoline with tricyclic antidepressants may enhance their effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using any medicine.
Using Oculosan in pregnant or breastfeeding women is contraindicated.

Driving and using machines

After using Oculosan, you may rarely experience limited ability to drive or operate machines due to pupil dilation or blurred vision.
Oculosan contains benzalkonium chloride. Do not wear soft contact lenses during administration. Lenses can be reinserted 15 minutes after administration of Oculosan.

3. How to use Oculosan

Always use this medicine exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
The recommended dose of Oculosan for adults is 3 to 4 times a day, 1 drop into the conjunctival sac.

Method of use:

• wash your hands;
• gently pull down the lower eyelid with one hand;
• tilt your head back;
• hold the open bottle with the other hand and direct it towards the eye;
• carefully press the bottle to release 1 drop into the corner of the eye;
• do not touch the dropper tip to the eye or other surfaces, as this may contaminate the solution in the bottle;
• after administration, it is recommended to gently press the tip of your finger on the closed eyelid for 1 to 2 minutes. This may prevent the drops from flowing through the tear ducts into the nose and causing systemic side effects.

Using more than the recommended dose of Oculosan

In case of accidental oral ingestion, the following symptoms may occur: dizziness, headache, nausea, nervousness, weakness, heart rhythm disturbances, pallor, sweating, pupil dilation, increased blood pressure, drowsiness, and decreased body temperature. In infants, bradycardia or even coma may occur.
Seek medical attention immediately.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Oculosan can cause side effects, although not everybody gets them.

Local side effects

Blurred vision.
Very rarely: pupil dilation with a slight increase in intraocular pressure.
Immediately after administration, mild burning may occur, which does not affect the treatment outcome.
Prolonged use may exceptionally cause eye redness (this is a transient effect).
With prolonged use, the following may occur: hyperemia, dryness of the mucous membrane, burning of the eye mucous membrane.

Systemic side effects

In rare cases, systemic circulatory disorders (hypertension, heart disorders) may occur. Some patients have reported fatigue, hyperactivity (palpitations, tremors, weakness, sweating), symptoms similar to angina pectoris, and headache.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Oculosan

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C.
Close the bottle immediately after use.
The medicine retains its potency for 28 days after opening the bottle.
Do not use this medicine after the expiration date stated on the packaging.
Medicines should not be disposed of 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 Oculosan contains

• The active substances of the medicine are zinc sulfate and naphazoline nitrate. 1 ml of solution contains 0.2 mg of zinc sulfate and 0.05 mg of naphazoline nitrate.
• The other ingredients are: benzalkonium chloride (preservative), purified water, Hamamelis virginiana extract, ethanol 95%, orange blossom oil, lavender oil, sodium chloride, sodium hydroxide, water for injections.

What Oculosan looks like and what the package contains

Oculosan is a sterile aqueous solution for use as eye drops.
It is packaged in a transparent polyethylene bottle with a dropper and a cardboard box. The bottle contains 10 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer:
EXCELVISION
27 rue de la Lombardière
ZI la Lombardière
07100 Annonay
France
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
To obtain more detailed information, contact the representative of the marketing authorization holder:
Thea Polska Sp. z o.o.
ul. Cicha 7
00-353 Warsaw
phone: +48 22 642 87 77

Date of last update of the leaflet: