PHYSIOLOGICAL SOLUTION RESPITOL 8.5 mg/ml NASAL DROPS

Introduction

Package Leaflet: Information for the User

physiological solution respitol 8.5 mg/ml nasal drops

Sodium chloride

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 not listed in this package leaflet.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

Contents of the Package Leaflet:

1. What is physiological solution respitol and what is it used for
2. What you need to know before starting to use physiological solution respitol
3. How to use physiological solution respitol
4. Possible side effects
5. Storage of physiological solution respitol
6. Package Contents and Additional Information

1. What is physiological solution respitol and what is it used for

Physiological solution respitolis a nasal 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 the symptomatic relief of congestion, dryness, and cleansing of the nasal mucosa.

You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

2. What you need to know before starting to use physiological solution respitol

Do not use physiological solution respitol

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

Warnings and Precautions

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

• It should be used nasally. 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, as it may lead to contagion.
• If the solution is not colorless or becomes cloudy, discard the product.

Using physiological solution respitol with other medications

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

No interactions with other medications have been reported.

Using physiological solution respitol with food and beverages

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

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

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

Physiological solution respitol contains methylparahydroxybenzoate (E-218).

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden feeling of suffocation) because it contains methylparahydroxybenzoate (E-218).

3. How to use physiological solution respitol

Follow the administration instructions for physiological solution respitolexactly as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

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

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

If you use more physiological solution respitol than you should

Due to the type of medication and its form of use, cases of overdose are not known.

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

4. Possible Side Effects

Like all medications, physiological solution respitolmay cause side effects, although not everyone will experience them.

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

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of physiological solution respitol

Keep out of the reach and sight of children.

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

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

Do not use physiological solution respitolafter the expiration date stated on the container after "EXP". The expiration date is the last day of the month indicated.

Do not use physiological solution respitolif you observe signs of deterioration in the container contents (change in color, density, aroma).

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of physiological solution respitol

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

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

31620 Huarte - Pamplona (Navarra)-Spain

This package leaflet was approved in June 2013.

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es/