Label: Information for the User

Solution for Physiological Use Respitol 8.5 mg/ml Nasal Drops

Sodium Chloride

Read this label carefully before using this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.
• You should consult a doctor if your condition worsens or does not improve after 3 days of treatment.

1. What is Solution for Physiological Use Respitol and how it is used

2. What you should know before starting to use Solution for Physiological Use Respitol

3. How to use Solution for Physiological Use Respitol

4. Possible adverse effects

5. Storage of Solution for Physiological Use Respitol

6. Contents of the container and additional information

physiological solution respitolis a nasal spray solution that contains sodium chloride.

It acts by humidifying the nasal mucosa and facilitating the elimination of mucus by contributing to its fluidity.

This medication is indicated for symptomatic relief of nasal congestion, dryness, and mucosa cleaning.

Consult a doctor if symptoms worsen or do not improve after 3 days of treatment.

Do not use respitol physiological solution

– If you are allergic to sodium chloride, or to any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take respitol physiological solution.

– It should be used by nasal route. Do not ingest.

– Once opened, discard the container after 7 days.

– The contents of the bottle should not be used by more than one person, it may lead to contagion.

– If the solution is not colorless or becomes turbid, discard the product.

Use of respitol physiological solution with other medications

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

No interactions with other medications have been described.

Use of respitol physiological solution with food and beverages

Foods or beverages do not affect the efficacy of the medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

This medication does not affect the ability to drive and operate machines.

Respitol physiological solution contains methyl parahydroxybenzoate (E-218).

It may produce allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking) because it contains methyl parahydroxybenzoate (E-218).

Follow exactly the administration instructions forRespitol Physiological Solutionprescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

1 to 3 drops (as needed) in each nostril, as often as necessary.

You should consult a doctor if symptoms worsen or persist after 3 days of treatment.

If you use more Respitol Physiological Solution than you should

Due to the type of medication and its use, there are no known cases of overdose.

In case of overdose or accidental ingestion, go to a medical center and/or call the Toxicological Information Service (Phone: 91 562 04 20), indicating the name of the medication and the amount ingested.

Like all medications,physiological respirotol solutionmay cause adverse effects, although not all people will experience them.

If the inside of the nose is very dry and irritated, it may cause a burning sensation. It may lead to itching, sneezing, increased nasal discharge, and a salty taste.

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

Keep out of reach and sight of children.

Keep the container perfectly closed. Store protected from light. Do not store at a temperature above 30°C.

Once opened, store in a cool place and discard after 7 days.

Do not useRespiratory Physiological Solutionafter the expiration date that appears on the container after “CAD”. The expiration date is the last day of the month indicated.

Do not useRespiratory Physiological Solutionif you observe signs of deterioration in the contents of the container (change in coloration, density, aroma).

Medicines should not be thrown away through drains or in the trash. Dispose of containers and medicines that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of physiological solution respitol

• The active principle is sodium chloride. Each 1 ml of solution contains 8.5 mg of sodium chloride.
• The other components are: disodium dodecahydrate hydrogen phosphate, phosphoric acid, methyl parahydroxybenzoate (E-218) and purified water.

Appearance of the product and contents of the packaging

Physiological solution respitolis presented in a cylindrical bottle of 30 or 50 ml with a dropper.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 - Industrial Estate Areta.

31620 Huarte - Pamplona (Navarra)-Spain

This leaflet was approved in June 2013.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)www.aemps.gob.es/