Physiological solution Respitol 8.5 mg/ml nasal drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

solución fisiológica respitol 8.5 mg/ml nasal drops

Sodium chloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor or pharmacist.

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

Contents of the leaflet:

1. What solución fisiológica respitol is and what it is used for
2. What you need to know before using solución fisiológica respitol
3. How to use solución fisiológica respitol
4. Possible adverse effects
5. How to store solución fisiológica respitol
6. Contents of the pack and other information

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

Respitol physiological solution is a nasal solution containing sodium chloride.

It works by moisturizing the nasal mucosa and facilitating mucus clearance by helping to liquefy it.

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

You should consult your doctor if your condition worsens or does not improve after 3 days of treatment.

2. What you need to know before using Respitol physiological solution

Do not use Respitol physiological solution

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Respitol physiological solution.

• Must be used by nasal route. Do not ingest.
• Once opened, discard the container after 7 days.
• The contents of the bottle must not be shared between more than one person, as this may lead to transmission of infections.
• If the solution is not colourless or becomes cloudy, discard the product.

Using Respitol physiological solution with other medicines

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

No interactions with other medicines have been reported.

Using Respitol physiological solution with food and drink

Food or drink do not affect the effectiveness of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

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

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

3. How to use respitol physiological solution

Follow exactly the administration instructions for respitol physiological solution provided by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

1 to 3 drops (according to need) into each nostril, as often as necessary.

Consult your doctor if your condition worsens or symptoms persist after 3 days of treatment.

If you use more respitol physiological solution than you should

Due to the type of medication and its method 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 medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, solución fisiológica respitol may produce adverse effects, although not everyone will experience them.

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Respitol physiological solution

Keep out of the reach and sight of children.

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

After opening, keep in a cool place and discard after 7 days.

Do not use Respitol physiological solution after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Do not use Respitol physiological solution if you notice any signs of deterioration in the contents of the container (change in colour, consistency, or odour).

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Respitol physiological solution

• The active substance 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, methyl parahydroxybenzoate (E-218) and purified water.

Appearance of the product and contents of the container

Respitol physiological solution is supplied in a cylindrical bottle of 30 ml or 50 ml with a dropper pipette.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

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

31620 Huarte - Pamplona (Navarra) - Spain

This patient information leaflet was approved in June 2013.

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