RADIO SALIL ANTI-INFLAMMATORY CREAM

Introduction

Package Leaflet: Information for the User

radio salil anti-inflammatory cream

Read the entire package 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 package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What radio salil anti-inflammatory is and what it is used for
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. Package Contents and Additional Information

1. What radio salil anti-inflammatory is and what it is used for

It is a cream for cutaneous use with analgesic, anti-inflammatory, and rubefacient action (causing redness and a sensation of heat in the area of application).

It is indicated 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 anti-inflammatory

Do not use radio salil anti-inflammatory

• 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 anti-inflammatory in children under 12 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use radio salil anti-inflammatory.

Do not apply this medication to the eyes, mucous membranes, wounds, or eroded or burned skin; apply only to intact skin. Do not ingest.

Do not apply to large areas of the skin and avoid sun exposure (even if cloudy) or 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 anti-inflammatory, do so in a way that the garment 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, you should consult a doctor.

Children

Children under 12 years of age 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.

Using radio salil anti-inflammatory 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 clots), avoid chronic or high-dose use of radio salil anti-inflammatory, as it 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 medications that also contain topical analgesics or medications that cause redness and a sensation of heat in the area of application (rubefacient medications), as the adverse effects of both medications may be potentiated.

Pregnancy and Breastfeeding

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 machinery.

radio salil anti-inflammatory contains propylene glycol and cetyl alcohol.

This medication may cause skin irritation because it contains propylene glycol.

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

3. How to use radio salil anti-inflammatory

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

The recommended dose is:

A small amount of radio salil anti-inflammatory on the area of the skin to be treated. Its action is facilitated by 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 cutaneous use only, 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 radio salil anti-inflammatory, do so in a way that the garment covering the treated area is slightly loose.

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

In case of accidental ingestion of radio salil anti-inflammatory in children, consult your doctor immediately for the necessary treatment. Do not attempt to induce vomiting.

Use in Children

It is contraindicated in children under 12 years of age.

If you use more radio salil anti-inflammatory than you should

Skin problems may occur.

If you have swallowed radio salil anti-inflammatory, 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 convulsions, central nervous system depression, and coma.

Breathing is difficult and the breath has a characteristic odor.

Intoxication should be treated by medical personnel, and treatment should be discontinued. Do not induce vomiting.

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.

4. Possible Side Effects

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

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

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

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 package 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 anti-inflammatory

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown 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 notice changes in the appearance of the cream.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of radio salil anti-inflammatory

The active ingredients 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 petroleum jelly, polysorbate 20, white beeswax, cetyl alcohol, glycerin monomyristate, triethanolamine, cetylphosphate diethanolamine, and purified water.

Appearance of the Product and Package Contents

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

Marketing Authorization Holder

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

Manufacturer

LABORATORIOS VIÑAS, S.A.

Torrente Vidalet, 29 Barcelona 08012 Spain

Date of the Last Revision of this Package Leaflet: December 2013

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/