Label: information for the user

Radio Salil Spray Solution for Cutaneous Spraying

Dietilamine Salicylate

Menthol

Camphor

Read this label carefully before starting to use this medication, as it contains important information for you.

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

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

Label Content

1. What is Radio Salil Spray 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 adverse effects
5. Storage of Radio Salil Spray

Contents of the package and additional information

A topical spray solution.

Indicated in individuals 12 years of age and older for the local symptomatic relief of muscle and joint pain, including: lower back pain, neck stiffness, minor sports injuries, and overexertion such as mild sprains, bruises, mild strains, and muscle cramps.

Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

Do not use radio salil spray

- If you are allergic to salicylate of diethylamine, 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 a spray.

Warnings and precautions

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

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

Do not apply on large areas of the skin and avoid exposure to the sun (even on cloudy days) or to 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 it in such a way that the garment covering the treated area is slightly loose.

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

If the discomfort persists, does not improve or increases after 7 days of treatment, consult your doctor.

Children

Children under 12 years old cannot use this medication.

Children are especially sensitive to some components of this medication. Application on the skin may cause hypotension, choking, blue discoloration of the skin and convulsions.

Use of radio salil spray with other medications

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

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

It is not recommended to use this medication simultaneously with other medications that also contain topical analgesics 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 breastfeeding

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

This medication is not recommended for use in pregnant women or those breastfeeding, unless your doctor prescribes it as there is no safer alternative.

Driving and operating machinery

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

Follow exactly the administration instructions of the medication contained in this leaflet or those 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 topical use, exclusively on intact skin. Do not ingest.

Apply directly to the area to be treated and do not rub.

Pump 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 is slightly loose.

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

If symptoms persist after 7 days of treatment, irritation occurs, or symptoms worsen, 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 Toxicological Information Service, phone 915620420, indicating the medication and the amount used.

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

In the case of accidental ingestion ofthe 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 seizures, depression of the central nervous system, and coma.

Respiration is difficult, and the breath has a characteristic odor.

Like all medications,this medicationmay cause adverse effects, although not everyone will experience them.

During the period of use of this medication, the following adverse effects have occurred, but their frequency has not been established with precision.

Dermatological and subcutaneous tissue disorders: This medication has a certain rubefacient action, so the presence of heat and redness is part of its medicinal activity. However, in sensitive skin, it may cause: irritation, erythema, cutaneous allergic sensitization, or cutaneous allergic reactions in the application area, which resolve upon discontinuing treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use website:www.notificaram.es.

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

Keep this medication out of the sight and reach of children.

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

Pressurized container: it may burst if heated.

Do not pierce or burn, even after use.

Protect from sunlight. Do not expose to temperatures above50 °C/122 °F.

Do not spray onto 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 disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of radio salil spray

The active principles are:Each ml contains:

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

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

As a propellant, carbon dioxide.

Appearance of the product and content of the container

A skin spray solution, presented in pressure containers containing 130ml of solution. It is a transparent, colorless or very pale yellow liquid, with a menthol camphor odor.

Holder of the marketing authorization

Laboratorios Viñas, S.A. - Provenza, 386 – 08025-Barcelona

Responsible for manufacturing

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

Date of the last review of this leaflet:April 2018

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