Leaflet: information for the user

Radio Salil anti-inflammatory cream

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• For advice on any matter relating to this medicine, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You must consult a doctor if your symptoms worsen or do not improve after 7 days.

1. What is Radio Salil anti-inflammatory and for what it is used

2. What you need to know before starting to use Radio Salil anti-inflammatory

3. How to use Radio Salil anti-inflammatory

4. Possible side effects

5. Storage of Radio Salil anti-inflammatory

6. Contents of the pack and additional information

It is a topical cream with analgesic, anti-inflammatory action, and when used on the skin, it reddens the area and produces a sensation of heat at the application site (rubefacient action).

It is indicated for local symptomatic relief of muscle and joint pain such as: back pain, torticollis, minor sports injuries and overexertion such as mild sprains, bruises, mild twists, and muscle cramps.

Consult a doctor if it worsens or does not improve after 7 days of treatment.

No use radio salil antiinflamatorio

- If you are allergic to methyl salicylate, menthol, salicylic acid, camphor, methyl nicotinate, or any of the other components of this medication (listed in section 6).

- If you are allergic to salicylates.

- Do not use radio salil antiinflamatorio in children under 12 years old.

Warnings and precautions

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

Do not apply this medication on eyes, mucous membranes, wounds, or on skin that is eroded or burned; apply only on intact skin. Do not ingest.

Do not apply on large areas of the skin and avoid exposure to sunlight (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 antiinflamatorio, do it in such a way that the clothing covering the treated area is slightly loose.

Do not exceed the recommended dose of 2-3 applications per day.

If the discomfort persists, does not improve or worsens 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. Applying it on the skin may cause hypotension, choking, blue discoloration of the skin, and convulsions

Using radio salil antiinflamatorio 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 antiinflamatorio, as this medication contains methyl salicylate and salicylic acid, which may increase the risk of bleeding caused by warfarin.

It is not recommended to use this medication simultaneously with other 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.

radio salil antiinflamatorio contains propylenglycol and cetyl alcohol.

This medication may cause skin irritation due to propylenglycol.

This medication may cause local skin reactions (such as contact dermatitis) due to cetyl alcohol.

Follow exactly the administration instructions 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:

A small amount of salicylic acid anti-inflammatory cream on the skin area to be treated. Its action is facilitated by a gentle massage or friction, avoiding contact with the eyes and mucous membranes. If necessary, it can be repeated up to a maximum of 2-3 times a day.

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

Wash your hands after each 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 salicylic acid anti-inflammatory cream,do it in such a way that the garment covering the treated area is slightly loose.

If symptoms persist after 7 days of treatment, or worsen, you should consult a doctor.

In the case of accidental ingestion of salicylic acid anti-inflammatory cream in children, consult your doctor immediately to provide the necessary treatment. Do not attempt to induce vomiting.

Use in children

It is contraindicated in children under 12 years old.

If you use more salicylic acid anti-inflammatory cream than you should

Skin problems may occur.

If you have ingested salicylic acid anti-inflammatory cream, 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.

The poisoning should be treated by qualified personnel, and treatment should be suspended. Do not induce vomiting.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of this medication, the following adverse reactions have occurred, whose frequency has not been established with exactness.

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 some sensitive skins it may cause: irritation, erythema, cutaneous allergic sensitization or cutaneous allergic reactions in the application area, which resolve upon interrupting treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear 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.

No special storage conditions are required.

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

Do not use this medication after 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.

Do not use this medication if you observe changes in the appearance of the cream.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at 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 radiosalil anti-inflammatory

The active principles are:Each gram of cream contains:

• Methyl salicylate ……………………….. 100 mg
• Menthol ……..……………………………. 50 mg
• Salicylic acid …………………………… 20 mg
• Camphor …………………………………... 20 mg
• Methyl nicotinate ……………………… 10 mg

The other components (excipients) are: stearic acid, propylene glycol, white vaseline, polisorbate 20, white beeswax, cetyl alcohol, monomyristate of glycerin, triethanolamine, diethanolamine cetyl phosphate and purified water.

Appearance of the product and content of the packaging

It is presented in the form of a white cream, in aluminum tubes of 30 and 60 grams.

Holder of the marketing authorization

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

Responsible for manufacturing

Laboratorios Viñas, S.A.

Torrente Vidalet, 29 Barcelona 08012 España

Date of the last review of this prospectus: December 2013

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