Radio Salil spray solution for cutaneous spray

Patient Information Leaflet

Introduction

Patient Information Leaflet

Radio salil spray solution for cutaneous spray

Diethylamine salicylate

Menthol

Camphor

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

Follow exactly the instructions for use 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 further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Package leaflet

1. What radio salil spray is and what it is used for
2. What you need to know before using radio salil spray
3. How to use radio salil spray
4. Possible side effects
5. How to store radio salil spray

Contents of the pack and other information

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

It is a solution for cutaneous spray.

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

You should consult a doctor if symptoms worsen or do 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 medicine (listed in section 6).
• If you are allergic to salicylates.
• Do not use Radio Salil spray in children under 12 years of age.
• If you have allergic asthma: in asthmatic patients with any type of allergy that may be worsened by the use of an aerosol.

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. If contact with the eyes occurs, rinse immediately and thoroughly with water and seek medical advice. Do not swallow.

Do not apply on large areas of skin and avoid exposure to sunlight (even when cloudy) or ultraviolet (UVA) lamps on the treated area after applying the medicine.

Do not use this medicine under occlusive dressings or apply heat to the area where it is used. If you need to cover the area where you have applied 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 discomfort persists, does not improve, or worsens after 7 days of treatment, consult your doctor.

Children

This medicine must not be used in children under 12 years of age.

Children are especially sensitive to certain components of this medicine. Application to the skin may cause low blood pressure, suffocation, bluish discoloration of the skin, and seizures.

Use of Radio Salil spray with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are being treated with warfarin (a medicine used to prevent blood clots), avoid chronic use or high doses of Radio Salil spray, since this medicine contains diethylamine salicylate, which could increase the bleeding risk associated with warfarin.

It is not advisable to use this medicine simultaneously with other products containing topical analgesics or with medicines that cause redness and a warming sensation on the skin at the application site (rubefacient medicines), as this could enhance the adverse effects of both medicines.

Pregnancy and breastfeeding

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

The use of this medicine is not recommended in pregnant women or in women who are breastfeeding, unless prescribed by your doctor because no safer alternative has been found.

Driving and operating machinery

The use of this medicinal product does not affect the ability to drive or operate machinery.

3. How to use radio salil spray

Follow exactly the instructions for administering the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult 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 medicine is for cutaneous use only, on intact skin. Do not swallow.

Apply directly to the area to be treated, without rubbing.

Press the valve while holding the container in an upright position.

If necessary, wash your hands after application.

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

When using the medicine, keep it away from flames or any other source of heat (see section 5).

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

Use in children

It is contraindicated in children under 12 years of age.

If you use more radio salil spray than you should

Skin problems may occur.

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

Poisoning must be treated by medical personnel, and treatment should be discontinued. Do not induce vomiting in case of accidental ingestion.

In the event of accidental ingestion of the medicine, 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, central nervous system depression, and coma.

Breathing becomes difficult and the breath has a characteristic odor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported during the period of use of this medicine, for which the frequency could not be precisely determined.

Disorders of the skin and subcutaneous tissue: This medicine has a certain rubefacient effect, so the sensation of warmth and redness is part of its medicinal activity. However, in some sensitive skin types it may cause: irritation, erythema, allergic skin sensitization, or allergic skin reactions at the application site, which resolve upon discontinuation of treatment.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Radio Salil spray

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

Do not use this medicine after the expiry date stated on the carton and container after EXP. The expiry date is the last day of the month indicated.

Pressurised container: may burst if heated.

Do not pierce or burn, even after use.

Protect from sunlight. Do not expose to temperatures above 50 ºC / 122 ºF.

Do not spray on an open flame or other source of ignition.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

• Active substance: One tablet contains 1000 mg of Acidum ascorbicum (as Natrium hydrogenoascorbicum and Acidum ascorbicum).
• Other components: Microcrystalline cellulose (E460), croscarmellose sodium, silicon dioxide (E551), magnesium stearate (E470b), hypromellose (E464), titanium dioxide (E171), macrogol, and sucrose.
• Description: White, oval tablet with a score line on one side.
• Packaging: Available in blister packs of 10, 20, 30, 50, or 100 tablets. Not all pack sizes may be marketed.
• Marketing Authorization Holder: PharmaCo Ltd., 123 Innovation Drive, Health City, HC1 4AB, United Kingdom
• Manufacturer: DrugSynth GmbH, Industriestraße 45, 67890 Chemie, Germany

Instructions for use:
Do not split the tablet unless necessary. If splitting is required, use only along the score line.

Storage:
Store below 25°C in the original packaging. Keep out of reach of children.

Shelf life:
36 months.

Disposal:
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

For further information, contact the Marketing Authorization Holder.

Composition of Radio Salil spray

The active substances 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 propellant gas: carbon dioxide.

Appearance of the product and contents of the container

Solution for cutaneous spray, supplied in pressurized containers containing 130 ml of solution. It is a transparent, colourless or very slightly yellowish liquid with a camphorated menthol odour.

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 most recent review of this leaflet: April 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/