RADIO SALIL SPRAY CUTANEOUS SPRAY SOLUTION

Introduction

Leaflet: information for the user

Radio salil spray cutaneous spray solution

Diethylamine salicylate

Menthol

Camphor

Read the entire 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 leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed 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 radio salil spray is and what it is used for
2. What you need to know before starting to use radio salil spray
3. How to use radio salil spray
4. Possible side effects
5. Storage of radio salil spray

Contents of the package and additional information

1. What radio salil spray is and what it is used for

It is a solution for cutaneous spray.

It is indicated for individuals over 12 years old for the local symptomatic relief of muscle and joint pain such as: lumbago, torticollis, minor sports injuries and overexertion such as mild sprains, bruises, mild twists and muscle cramps.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before starting to use radio salil spray

Do not use radio salil spray

• If you are allergic to diethylamine salicylate, menthol, camphor, or any of the other components of this medication (listed in section 6).
• If you are allergic to salicylates.
• Do not use radio salil spray in children under 12 years old.
• If you have allergic asthma: in asthmatic patients with any type of allergy that may increase with the use of an aerosol.

Warnings and precautions

Consult your doctor or pharmacist before starting to use radio salil spray.

Do not apply to irritated or damaged skin. Avoid contact with the eyes. In case of contact with the eyes, wash immediately and abundantly with water and consult a doctor. Do not ingest.

Do not apply to large areas of the skin and avoid sun exposure (even if cloudy) or to ultraviolet (UVA) lamps in the treated area after applying the medication.

Do not apply this medication with occlusive dressings or apply heat to the area where it is used. If you cover the area where you have used radio salil spray, do so in a way that the garment covering the treated area remains slightly loose.

Do not exceed the recommended dose of 3-4 applications per day.

If the discomfort persists, does not improve, or worsens after 7 days of treatment, you should consult a doctor.

Children

Children under 12 years old cannot use this medication.

Children are especially sensitive to some components of this medication. Application to the skin can cause a drop in blood pressure, choking, bluish discoloration of the skin, and convulsions.

Use of radio salil spray with other medications

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

If you are being treated with warfarin (a medication used to prevent blood clot formation), avoid chronic or high-dose use of radio salil spray, as this medication contains diethylamine salicylate, which may increase the risk of bleeding caused by warfarin.

It is not recommended to use this medication simultaneously with others that also contain analgesics for cutaneous use or with medications that, when used on the skin, cause redness and a sensation of heat in the application area (rubefacient medications), as the adverse effects of both medications may be potentiated.

Pregnancy and lactation

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

The use of this medication is not recommended in pregnant or breastfeeding women, unless your doctor prescribes it because no safer alternative has been found.

Driving and using machines

The use of this medication does not affect the ability to drive and operate machines.

3. How to use radio salil spray

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

The recommended dose is:

1 or 2 sprays, as needed to treat the affected area, up to a maximum of 3-4 times a day if necessary.

This medication is for cutaneous use only, exclusively on intact skin. Do not ingest.

Apply directly to the area to be treated without rubbing.

Press the valve, keeping the container in a vertical position.

If necessary, wash your hands after application.

Do not apply this medication with occlusive dressings or apply heat to the area where it is used. If you cover the area where you have used radio salil spray, do so in a way that the garment covering the treated area remains slightly loose.

When using the medication, keep it away from a flame or any other heat source (see section 5).

If the symptoms persist after 7 days of treatment, or if irritation or worsening occurs, you should consult a doctor.

Use in children

It is contraindicated in children under 12 years old.

If you use more radio salil spray than you should

Skin problems may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

Intoxication should be treated by medical personnel, and treatment should be suspended. Do not induce vomiting in case of accidental ingestion.

In the event of accidental ingestion of the medication, consult your doctor or pharmacist immediately. The following symptoms may occur due to camphor: nausea, vomiting, colic, headache, dizziness, sensation of heat, delirium, nervousness, epileptic-type convulsions, central nervous system depression, and coma.

Breathing is difficult and the breath has a characteristic odor.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the period of use of this medication, the following side effects have occurred, whose frequency could not be established with precision.

Disorder of the skin and subcutaneous tissue: This medication has a certain rubefacient action, so that the presence of heat and redness is part of its medicinal activity. However, in some sensitive skin, it may cause: irritation, erythema, allergic skin sensitization, or allergic skin reactions in the application area, which remit when treatment is interrupted.

Reporting side effects

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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use website: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of radio salil spray

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the container after CAD. The expiration date is the last day of the month indicated.

Pressurized container: may burst if heated.

Do not puncture or burn, even after use.

Protect from sunlight. Do not expose to temperatures above 50 °C / 122 °F.

Do not spray near an open flame or other ignition source.

Keep away from heat, hot surfaces, sparks, open flames, and any ignition source. Do not smoke.

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Contents of the package and additional information

Composition of radio salil spray

The active ingredients are: Each ml contains:

• Diethylamine salicylate 100 mg
• Menthol 25 mg
• Camphor 10 mg

The other components (excipients) are: isopropyl myristate and 96% ethanol.

As a propellant gas, carbon dioxide.

Appearance of the product and contents of the container

Cutaneous spray solution, which is presented in pressurized containers containing 130 ml of solution. It is a transparent, colorless, or very slightly yellowish liquid with a mentholated camphor odor.

Marketing authorization holder

LABORATORIOS VIÑAS, S.A. - Provenza, 386 – 08025-Barcelona

Manufacturer

RECIPHARM PARETS, S.L.U. – Ramón y Cajal, 2 – 08150-Parets del Vallès (Barcelona)

Date of the last revision of this leaflet:April 2018

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