Tears Naturale Ii

Package Leaflet: Information for the User

Tears Naturale II

(3 mg + 1 mg)/ml, eye drops, solution
Hypromellose + Dextran

Read the package 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 package leaflet for the patient 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 the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Tears Naturale II eye drops and what is it used for
• 2. Important information before using Tears Naturale II eye drops
• 3. How to use Tears Naturale II eye drops
• 4. Possible side effects
• 5. How to store Tears Naturale II eye drops
• 6. Contents of the pack and other information

1. What is Tears Naturale II eye drops and what is it used for

Tears Naturale II eye drops are indicated for the treatment of symptoms of dry eye syndrome, including dry keratoconjunctivitis and Sjögren's syndrome.
Additionally, Tears Naturale II eye drops are intended for temporary relief of discomfort associated with mild eye irritation or exposure to sunlight and wind.
If there is no improvement after 3 days or the patient feels worse, they should consult their doctor.

2. Important information before using Tears Naturale II eye drops

When not to use Tears Naturale II eye drops

• If the patient is allergic to hypromellose, dextran (active substances) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Tears Naturale II eye drops should only be used for eye drops (eyes).
• If the patient experiences headaches, eye pain, vision disturbances, eye irritation, persistent redness, or if the symptoms of the disease worsen, they should stop using the medicine and consult a doctor. Before starting to use Tears Naturale II eye drops, the patient should discuss this with their doctor or pharmacist.

Tears Naturale II eye drops and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
However, it is unlikely that the medicine will interact with other medicines.
If the patient is using more than one eye medicine, they should wait 5 minutes between each administration. Eye ointments should be administered last.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Tears Naturale II eye drops may be used during pregnancy and breastfeeding.

Driving and using machines

During the use of Tears Naturale II eye drops, temporary vision disturbances may occur. The patient should not drive or operate machinery until their vision has returned to normal.

3. How to use Tears Naturale II eye drops

The medicine is intended for use in the eyes only.
This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Recommended dose
Usually, 1 or 2 drops of Tears Naturale II eye drops are instilled into the affected eye or both eyes as needed.
There is no data on the use of the medicine in children and adolescents, as well as in patients with liver or kidney function disorders.
Method of administration
The drops should not be used if the solution changes color or becomes cloudy.
After each use, the bottle should be tightly closed.

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• 1. Prepare the medicine bottle and a mirror.
• 2. Wash your hands thoroughly.
• 3. Remove the cap. If the protective collar is loose after removing the cap, it should be discarded before using the medicine.
• 4. Hold the bottle upside down between the thumb and middle finger (figure 1).
• 5. Tilt your head back. Gently pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye. The medicine should be instilled into this pocket (figure 2).
• 6. Bring the dropper tip close to the eye. You can use a mirror.
• 7. Do not touch the eye or eyelid, surrounding tissues, or any surfaces with the dropper tip.This could cause infection of the drops.
• 8. Gently pressing the index finger on the bottle, instill one drop of the medicine (figure 3).
• 9. After using the medicine, remove the finger that held the lower eyelid. Close your eye and gently press the corner of your eye near your nose (figure 4). This will help reduce the amount of medicine that enters the entire body.

• 10. If the medicine is to be used in both eyes, repeat steps 4 to 9 for the second eye.
• 11. Tighten the cap on the bottle immediately after using the medicine.
• 12. Only one bottle of medicine should be used at a time.

If the drop does not get into the eye, try again.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using more than the recommended dose of Tears Naturale II eye drops

In case of using more than the recommended dose, Tears Naturale II eye drops should be rinsed from the eye with lukewarm water. Do not instill more drops until the next scheduled dose.

Missing a dose of Tears Naturale II eye drops

Take the next dose at the scheduled time. However, if the time for the next dose is near, skip the missed dose and continue with the planned dosing schedule.
Do not take a double dose to make up for a missed dose.
If the patient is using more than one eye medicine, they should wait 5 minutes between each administration. Eye ointments should be administered last.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In connection with the use of Tears Naturale II eye drops, the following side effects have been observed:
Very common (may affect more than 1 in 10 people)

• Eye disorders: blurred vision Common (may affect up to 1 in 10 people)
• Eye disorders: dry eye, eyelid disorders, abnormal sensations or feeling of a foreign body in the eye, eye discomfort Uncommon (may affect up to 1 in 100 people)
• Eye disorders: eye itching, irritation, or redness
• General disorders: headache Frequency not known (cannot be estimated from the available data)
• Eye disorders: eyelid redness, eye pain or swelling, eye discharge, crusts on the eyelid margins, increased tear production
• General disorders: hypersensitivity (allergy), headache.

If any side effect gets worse or if side effects not listed in this leaflet occur, the patient should consult their doctor or pharmacist.

Reporting side effects

If side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Tears Naturale II eye drops

To avoid infection of the drops, the bottle should be discarded one month after first opening. The date of first opening of the bottle should be written in the space provided below.
Date of first opening:

• The medicine should be kept out of the sight and reach of children.
• Store in a temperature below 25°C.
• Do not store in the refrigerator.
• Keep the container tightly closed.
• Do not use the medicine if the solution changes color or becomes cloudy.
• Do not use if the seal on the packaging is broken before the first use.

Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the month.
In case of questions or doubts, consult a doctor.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tears Naturale II eye drops contain

• The active substances of the medicine are hypromellose and dextran 70. 1 ml of solution contains 3 mg of hypromellose and 1 mg of dextran.
• The other ingredients (excipients) are: polyidronium chloride, borax, sodium chloride, potassium chloride, sodium hydroxide, and/or hydrochloric acid to adjust the pH, purified water.

What Tears Naturale II eye drops look like and contents of the pack

Tears Naturale II eye drops are a clear, colorless solution. The medicine is available in bottles of 15 ml.

Marketing authorization holder

Alcon Polska Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
phone: (+48) 22 820 34 50

Manufacturer/Importer responsible for batch release

Alcon Laboratories Belgium
Lichterveld 3
2870 Puurs-Sint-Amands
Belgium
Siegfried El Masnou, S.A.
Camil Fabra 58 08320 El
Masnou, Barcelona
Spain
Date of last revision of the leaflet:09/2024