Tears naturale ii

Patient Information Leaflet: Information for the User

Tears Naturale II
(3 mg + 1 mg)/ml, eye drops, solution
Hypromellose + Dextran
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as
advised by your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Table of Contents

1. What Tears Naturale II eye drops are and what they are 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 Tears Naturale II eye drops are and what they are 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 sun and wind.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. 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 be used only for instillation into the eye(s).
• If the patient experiences headache, eye pain, vision disturbances, eye irritation, persistent redness, or if symptoms worsen, the use of the medicine should be discontinued and medical advice should be sought. The patient should discuss this with a doctor or pharmacist before starting treatment with Tears Naturale II eye drops.

Tears Naturale II eye drops and other medicines
The patient should inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
However, it is unlikely that this medicine will cause interactions with other medicines.
If the patient uses more than one eye medication, a 5-minute interval should be maintained between the administration of each medicine. Ocular ointments should be administered last.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Tears Naturale II eye drops may be used during pregnancy and breastfeeding.

Driving and operating machinery
Transient disturbances in vision may occur during the use of Tears Naturale II eye drops. The patient should not drive or operate machinery until normal visual acuity is restored.

3. How to use Tears Naturale II eye drops

This medicine is intended for ocular use only.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Usually, 1 or 2 drops of Tears Naturale II eye drops should be instilled into the affected eye or both eyes as needed.
There is no data available regarding use in children and adolescents or in patients with hepatic or renal impairment.
Method of administration
Do not use the drops if the solution has changed colour or become cloudy.
After each instillation, the bottle must be tightly closed.

1 2 3 4

1. Prepare the medicine bottle and a mirror.
2. Wash hands thoroughly.
3. Unscrew the cap. If the safety collar is loose after removing the cap, discard it before using the medicine.
4. Hold the bottle upside down between the thumb and middle finger (Figure 1).
5. Tilt the head backward. Gently pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye. Instill the medicine into this space (Figure 2).
6. Bring the dropper tip close to the eye. You may use a mirror.
7. Do not touch the eye, eyelid, surrounding tissues, or any surface with the dropper tip. This could contaminate the drops and lead to infection.
8. Gently press with the index finger on the bottle to instill one drop of the medicine (Figure 3).
9. After applying the medicine, remove the finger holding the lower eyelid. Close the eye and gently press with a finger on the inner corner of the eye near the nose (Figure 4). This helps reduce the amount of medicine absorbed into the systemic circulation.
10. If the medicine is to be used in both eyes, repeat steps 4 to 9 for the second eye.
11. Carefully screw the cap back onto the bottle immediately after use.
12. Only one bottle of the medicine should be used at a time.

If the drop misses the eye, repeat the instillation attempt.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Tears Naturale II eye drops
If more than the recommended dose is used, rinse the eye with lukewarm water. Do not instill further drops until the next scheduled dose is due.
Missed dose of Tears Naturale II eye drops
Take the next dose at the scheduled time. However, if the next dose is due shortly, skip the missed dose and return to the regular dosing schedule.
Do not use a double dose to make up for a missed dose.
If more than one eye medicine is being used, wait 5 minutes between each medicine. Ointments should be administered last.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed with the use of Tears Naturale II eye drops:

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 a foreign body sensation in the eye, eye discomfort

Uncommon (may affect up to 1 in 100 people)

• Eye disorders: eye itching, eye 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 (allergic reaction), headache

If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, consult your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tears Naturale II eye drops

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

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

Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
If you have any questions or doubts, consult your doctor.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging and other information

What Tears Naturale II eye drops contain

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

What Tears Naturale II eye drops look like and contents of the pack
Tears Naturale II eye drops is a clear, colourless solution. The medicine is available in 15 ml bottles.
Marketing Authorisation Holder
Alcon Polska Sp. z o.o.
ul. Marynarska 15
02-674 Warszawa
tel.: (+48) 22 820 34 50
Manufacturer/Importer responsible for batch release
Alcon Laboratories Belgium
Lichterveld 3
2870 Puurs-Sint-Amands
Belgium