Radio Salil anti-inflammatory cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

radio salil antiinflammatory cream

Read the entire leaflet carefully before you start using this medicine, because 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 more 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 if you do not improve after 7 days.

Contents of the leaflet

1. What radio salil antiinflammatory is and what it is used for
2. What you need to know before using radio salil antiinflammatory
3. How to use radio salil antiinflammatory
4. Possible adverse effects
5. How to store radio salil antiinflammatory
6. Contents of the pack and other information

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

It is a topical cream with analgesic and anti-inflammatory action that, when applied to the skin, causes redness and produces a sensation of warmth at the site of application (rubefacient action).

It is indicated for the local symptomatic relief of muscular and joint pain, such as: lumbago, torticollis, minor sports injuries and overexertion, including mild sprains, bruises, 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 using radio salil antiinflamatorio

Do not 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 medicine (listed in section 6).
• If you are allergic to salicylates.
• Do not use radio salil antiinflamatorio in children under 12 years of age.

Warnings and precautions

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

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

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

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

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

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

Children

Children under 12 years of age must not use this medicine.

Children are especially sensitive to some 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 antiinflamatorio with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 antiinflamatorio, as this medicine contains methyl salicylate and salicylic acid, which could increase the bleeding risk associated with warfarin.

It is not advisable to use this medicine simultaneously with other topical analgesics or with medicines that cause skin redness and a warming sensation upon application (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 or breastfeeding women, unless prescribed by your doctor due to lack of a safer alternative.

Driving and operating machinery

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

radio salil antiinflamatorio contains propylene glycol and cetyl alcohol.

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

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

3. How to use radio salil antiinflammatory

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

A small amount of radio salil antiinflammatory applied to the affected skin area. Enhance its action by gently massaging or rubbing, avoiding contact with eyes and mucous membranes. If necessary, the application may be repeated up to a maximum of 2–3 times daily.

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

Wash hands after each application.

Do not apply this medicine under occlusive dressings or apply heat to the area where it is used. If covering the area where radio salil antiinflammatory has been applied, do so in such a way that the garment covering the treated area remains slightly loose.

If symptoms persist for more than 7 days of treatment, or worsen, consult a doctor.

In the event of accidental ingestion of radio salil antiinflammatory by a child, consult your doctor immediately for appropriate 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 antiinflammatory than you should

Skin problems may occur.

If you have swallowed radio salil antiinflammatory, 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 breath has a characteristic odor.

Poisoning must 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 at telephone number 91 562 04 20, indicating the medicine and the quantity used.

4. Possible adverse effects

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

The following adverse reactions have been reported during the period of use of this medicine, although their frequency cannot be accurately determined.

Skin and subcutaneous tissue disorders: This medicine has a certain rubefacient effect, so the sensation of warmth and redness is part of its medicinal action. However, in some sensitive skin types it may cause: irritation, erythema, allergic skin sensitization, or allergic skin reactions at the site of application, 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 Medicines 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 anti-inflammatory

No special storage conditions are required.

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 refers to the last day of the month indicated.

Do not use this medicine if you notice any changes in the appearance of the cream.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of radio salil anti-inflammatory cream

The active substances 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, polysorbate 20, white beeswax, cetyl alcohol, glyceryl monomyristate, triethanolamine, diethanolamine cetyl phosphate, and purified water.

Appearance of the product and contents of the container

It is presented as a white cream in aluminum tubes of 30 and 60 grams.

Marketing Authorization Holder

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

Manufacturer responsible

LABORATORIOS VIÑAS, S.A.
Torrente Vidalet, 29 Barcelona 08012 Spain

Date of the most recent review of this leaflet: December 2013

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/