HIDRATHEA 9 mg/ml EYE DROPS SOLUTION

Introduction

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Hidrathea 9 mg/ml eye drops in solution

Sodium chloride

Read the entire leaflet carefully because it contains important information for you, as it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the leaflet

1. What is Hidrathea and what is it used for
2. What you need to know before starting to use Hidrathea
3. How to use Hidrathea
4. Possible side effects
5. Storage of Hidrathea
6. Package contents and additional information

1. What is Hidrathea and what is it used for

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

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

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

2. What you need to know before starting to use Hidrathea

Do not use Hidrathea

• if you are allergic to sodium chloride or any of the components of this medicine (included in section 6).

In case of doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Hidrathea.

Hidrathea is presented in the form of eye drops and should be used via the ocular route. Do not inject or ingest.

If irritation, pain, redness, or changes in vision occur, or if you consider that your situation worsens, stop using this medicine and consult your doctor or pharmacist.

Children

No specific studies have been carried out in children. Consult your doctor before using this medicine in children.

Using Hidrathea with other medicines

The efficacy of the eye drops may be altered when using another eye drop simultaneously. 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 recently used, or may need to use any other medicine.

Pregnancy and breastfeeding

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

Pregnancy

Hidrathea has no restrictions on use in case of pregnancy.

Breastfeeding

Hidrathea has no restrictions on use in case of natural breastfeeding.

Driving and using machines

No effects of Hidratheaon driving and using machines have been described.

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

Hidrathea contains phosphates

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

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

3. How to use Hidrathea

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

The recommended dose is one drop of the solution in the lower eyelid 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 lack of tears.

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

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

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

Wash your hands carefully before proceeding to apply.

Check that the package seal is intact.

Open the package by unscrewing the cap.

Instill one drop in the eye, looking up and pulling the eyelid down. The time of appearance of the drop is superior to that of a classic eye drop package.

Recap the bottle after each use.

If you do not observe an improvement or if the 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 via the ocular route, intoxication phenomena are not expected.

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

If you forget to use Hidrathea

Do not use a double dose to make up for forgotten doses. Use a normal dose and apply the next one according to the schedule you have established.

If you interrupt treatment with Hidrathea

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The only side effect observed is the appearance of mild itching, which is usually transient.

If you consider that the itching you suffer is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https//: notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Hidrathea

Keep out of sight and reach of children.

Do not use Hidrathea after the expiration date that appears on the package 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 package.

Medicines should not be thrown away through wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Hidrathea

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

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

Appearance of the product and package contents

Hidrathea is presented in a package containing 10 ml of preservative-free eye drops.

Each package contains 10 ml and has a dropper for the dosing of the product, provided with a 0.2-micron filter membrane.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Thea S.A.,

C/ Enric Granados, nº 86-88, 2ª planta ,

08008 - Barcelona

Manufacturer

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

Date of the last revision of this leaflet:July 2020

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.es/