Patient Information Leaflet

Hidrathea 9 mg/ml Eye Drops Solution

Sodium Chloride

Hidrathea is a solution that moistens, lubricates, and hydrates the surface of the eyes.

Hidrathea is indicated to relieve symptoms of irritation and dryness in the eyes.

The absence of preservative in the product allows its use with contact lenses in place.

Do not use Hidrathea

• if you are allergic to sodium chloride oranyof the components of this medication (listed in section 6).

Consult your doctor or pharmacist if you are unsure.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hidrathea.

Hidrathea is presented in the form of eye drops and must be used topically. Do not inject or ingest.

If irritation, pain, redness, or changes in vision occur, or if you consider your condition to be worsening, stop using this medication and consult your doctor or pharmacist.

Children

No specific studies have been conducted in children. Consult your doctor before using this medication in children.

Use of Hidrathea with other medications

The efficacy of the eye drops may be altered when used simultaneously with another eye drop. In this case, wait 10 minutes between the first and second instillation.

There is incompatibility between Hidrathea and silver salts.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Hidrathea has no restrictions for use during pregnancy.

Breastfeeding

Hidrathea has no restrictions for use during breastfeeding.

Driving and operating machines

No effects ofHidratheaon driving and operating machines have been described.

As with other eye drops, your vision may be blurred immediately after application. Do not drive or operate machines until your vision returns to normal.

Hidrathea contains phosphates

This medication contains 37.3 mg of phosphates in each drop, equivalent to 1.25 mg/ml.

If you suffer from severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is one drop of the solution in the lower inner corner of the affected eye, 3 to 4 times a day and, up to 8 times a day if necessary, due to eye discomfort caused by tear deficiency.

The application should be performed at regular intervals throughout the day, according to the patient's needs.

The Hidrathea packaging incorporates a new technology, called the ABAK® system, for the sterile supply of the product without preservatives.

As a general precaution in all eye drop containers, the application of the eye drop should be performed with maximum cleanliness, avoiding any contact of the dropper with the fingers and the surface of the eye or any other, in order to prevent microbial contamination of the eye.

Wash your hands carefully before proceeding with the application.

Verify that the packaging seal is intact.

Open the packaging by unscrewing the cap.

Instill one drop in the eye looking upwards and pulling the eyelid downwards. The drop appearance time is longer than that of a classic eye drop container.

Close the bottle after each use.

If no improvement is observed or symptoms persist, consult your doctor or pharmacist.

If you use more Hidrathea than you should

Due to the characteristics of this preparation, intended to be administered by the ocular route, no intoxication phenomena are expected.

In case of accidental ingestion in large quantities, consult your doctor or pharmacist immediately or the Toxicological Information Service. Phone 915620420.

If you forgot to use Hidrathea

Do not use a double dose to compensate for the missed doses. Use a normal dose and apply the next one according to the established schedule.

If you interrupt the treatment with Hidrathea

If you interrupt the treatment prematurely, inform your doctor or pharmacist.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The only adverse effect observed is the appearance of a mild itching sensation that is usually transient.

If you consider the itching you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https//: notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use Hidrathea after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Hidrathea after 8 weeks of the first opening of the packaging.

Medicines should not be thrown down the drain or in the trash.Dispose of the packaging and medicines that you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Hidrathea

• The active principle is sodium chloride. Each ml of solution contains 9 mg of sodium chloride.

• The other components are: sodium dodecahydrate phosphate, dihydrogen phosphate of sodium, and water for injectable preparations.

Appearance of the product and contents of the packaging

Hidratheais presented in a container containing 10 ml of preservative-free eye drops.

Each container contains 10 ml and has a dropper for the product dosage, provided with a 0.2 micra filter membrane.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Laboratorios Thea S.A.,

C/ Enric Granados, nº 86-88, 2nd floor,

08008 - Barcelona

Responsible for manufacturing

EXCELVISION, Rue de la Lombardière, BP 131 - 07100 Annonay - France

Last review date of this prospectus:July 2020

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/