1 mg/ml + 3 mg/ml eye drops, solution
dextran 70/hypromellose
What Tears Naturale is and what it is used for
Tears Naturale contains the active substances dextran 70 and hypromellose.
Tears Naturale is an artificial tear fluid that helps the natural tear film and lubricates unpleasant dry spots in the eye.
Tears Naturale is used to treat the eyes in connection with mild eye irritation or dry eyes in adults, the elderly, and young people over 12 years of age.
Dextran 70 and hypromellose found in Tears Naturale may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Tears Naturale
Do not use Tears Naturale
- if you are allergic to dextran 70, hypromellose, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Tears Naturale.
If you experience headache, pain in the eye, vision changes, persistent eye redness or irritation, or if the eye does not improve, stop using the medicine and consult a doctor.
If the solution changes color or becomes cloudy, do not use the eye drops.
Other medicines and Tears Naturale
The effect of simultaneous use of other drugs has not been studied.
When contacting a doctor or other healthcare professional, remember to mention that you are using or have recently used Tears Naturale.
Pregnancy, breastfeeding, and fertility
Tears Naturale can be used during pregnancy and breastfeeding and is not expected to have any effect on fertility.
Driving ability and use of machinery
If blurred vision or other visual disturbances occur after using Tears Naturale, you should wait to drive or operate machinery until your vision clears again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to use Tears Naturale
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
Adults, the elderly, and young people over 12 years of age
1–2 drops in the affected eye 3–4 times daily unless otherwise prescribed by a doctor.
Not recommended for children under 12 years of age.
Use Tears Naturale only for eye drops.
How to use Tears Naturale correctly
Once the cap is removed, the safety ring should be removed (if loose) before using the drops.
- Take out the bottle of Tears Naturale.
- Wash your hands and sit in front of a mirror.
- Unscrew the lid.
- Hold the bottle upside down between your thumb and middle finger (picture 1).
- Tilt your head back. Pull down the lower eyelid with a clean finger so that a “pocket” is formed between the eyelid and the eye. The drop should end up here.
- Hold the tip of the bottle close to the eye. Use a mirror if that helps.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the dropper tip. It can contaminate the eye drops in the bottle.
- Do not squeeze the bottle: it is designed so that only light pressure is needed on the bottom (picture 2).
- Lightly press the bottom of the bottle to drip one drop of Tears Naturale at a time (picture 3).
- If you are using Tears Naturale in both eyes, repeat steps 4 to 9 for the other eye.
- Screw the lid on tightly immediately after use.
If a drop misses the eye, try again.
If you use other eye drops or eye ointments, wait at least 5 minutes between each medication. Eye ointments should be used last.
If you have used too much Tears Naturale
An overdose of Tears Naturale can be flushed out of the eye with lukewarm tap water.
If you have ingested too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Tears Naturale
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been seen with Tears Naturale:
Very common (may affect more than 1 in 10 users):
Effects in the eyes: blurred vision.
Common (may affect up to 1 in 10 users):
Effects in the eyes: dry eyes, eyelid disorder, abnormal sensation in the eye, the sensation of having something in the eye, discomfort in the eyes.
Uncommon (may affect up to 1 in 100 users):
Effects in the eyes: itching in the eye, eye irritation, red eyes.
General side effects: headache.
Has been reported (occurring in an unknown number of users):
Effects in the eyes: erythema ( redness ) of the eyelid, eye pain, swollen eyes, discharge from the eye, crusting of the eyelids, and increased tear flow.
General side effects: allergy (hypersensitivity).
How to store Tears Naturale
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after “Expiry Date”. The expiration date is the last day of the specified month.
Discard the bottle 4 weeks after opening.
Store at a maximum of 25 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are dextran 70 and hypromellose. 1 ml of solution contains 1 mg of dextran 70 and 3 mg of hypromellose.
- Other ingredients are polonium chloride (preservative), sodium chloride, borax, potassium chloride, sodium hydroxide, and/or hydrochloric acid (for pH adjustment), and purified water.
Appearance and package sizes of the medicine
Tears Naturale is a clear, colorless solution supplied in a 10 ml plastic bottle (DROPTAINER) with a screw cap.
Marketing Authorisation Holder
Alcon Nordic A/S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Manufacturer
Alcon Laboratories Belgium
Lichterveld 3
2870 Puurs-Sint-Amands
Belgium
Or
SA Alcon-Couvreur NV
Rijksweg 14
2870 Puurs
Belgium
Or
Siegfried El Masnou, SA
Camille Fabra 58
08320 El Masnou
Barcelona
Spain