CAPSIDOL 0.25mg/g CREAM

Introduction

Patient Information Leaflet: Information for the User

Capsidol 0.25 mg/g Cream

Capsicum Oleoresin

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

Follow the administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Leaflet

1. What is Capsidol and what is it used for
2. What you need to know before starting to use Capsidol
3. How to use Capsidol
4. Possible side effects
5. Storage of Capsidol
6. Package contents and additional information

1. What is Capsidol and what is it used for

Capsidol is a local analgesic medicine.

It contains capsicum oleoresin, which is obtained from the fruits of the spicy varieties of capsicum or chili pepper. Its topical application produces a transient burning sensation (rubefacient action), followed by a progressive decrease in localized pain in the skin and underlying tissues at the site of application.

It is indicated for the symptomatic relief of localized muscle or joint pain.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before starting to use Capsidol

This medicine is for external use only, and its application should be avoided on irritated, burned, or wounded skin, as well as on eyes and mucous membranes. Do not use Capsidol

• If you are allergic to the active ingredient or any of the other components of this medicine (listed in section 6).
• Do not apply to open wounds, inflamed, infected, or eczematous areas.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Capsidol.

• This medicine is exclusively for cutaneous use.
• Avoid contact with eyes and mucous membranes.
• It is recommended not to scratch the application area to avoid skin lesions.
• Do not apply external heat sources or tight bandages.
• In case the medicine comes into contact with eyes and membranes, wash the area with plenty of cold water.
• Do not use for prolonged periods or on extensive areas.

Children and adolescents

Do not administer this medicine to children under 12 years of age.

Other medicines and Capsidol

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

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

No effects of this medicine have been described that alter the ability to drive vehicles or use machines.

Capsidolcontains propylene glycol, cetyl alcohol, benzyl alcohol, methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate (E-216)

This medicine contains 70 mg of propylene glycol per gram of cream.

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

This medicine contains 12 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions and moderate local irritation. It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate (E-216).

3. How to use Capsidol

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Capsidol is a cream for exclusive local use on the skin.

The recommended dose is:

Adults and children over 12 years: apply a thin layer of product 3 or 4 times a day to the affected area, spreading it gently.

It is advisable to wash your hands immediately with cold water and soap after each application, as well as avoid contact of the product with eyes and mucous membranes.

If the pain persists, does not improve, or worsens, or if irritation or redness occurs after 7 days of treatment, you should consult a doctor.

If you use more Capsidol than you should

Acute intoxication is practically impossible with proper use of the medicine.

In case of overdose, accidental ingestion, or contact with eyes, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Capsidol

Do not make a double application to compensate for forgotten doses. Continue with the recommended treatment regimen.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The main side effect described is the initial burning sensation that occurs after applying the product. This reaction usually decreases over time as treatment continues at the recommended dose.

In some people, it may cause allergic reactions (irritation, redness, itching). In this case, stop treatment.

The side effects listed below are classified according to their frequency and the classification by organ and system. The frequency categories are defined by the following convention: very common (affects more than 1 in 10 people); common (affects up to 1 in 100 people); uncommon (affects up to 1 in 1000 people); rare (affects between 1 and 10 in 10,000 people); very rare (affects less than 1 in 10,000 people); frequency not known (cannot be estimated from available data).

Very common:

Sensation of burning or stinging on the skin, skin irritation or dryness at the application site.

Common:

Sneezing or coughing, tearing.

Common adverse reactions occur as a consequence of inhaling dry cream residues. Therefore, it is essential to apply the minimum amount of cream necessary and avoid leaving residues on the skin, as well as washing hands with cold water and soap after use.

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 leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Capsidol

No special storage conditions are required.

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Capsidol composition

• The active ingredient is capsicum oleoresin. Each gram of cream contains 0.25 mg of capsicum oleoresin (expressed as capsaicin).
• The other ingredients (excipients) are: isopropyl myristate, stearic acid, propylene glycol, glycerin monomyristate, cetyl phosphate diethanolamine, cetyl alcohol, benzyl alcohol, diazolidinyl urea, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate (E-216), and purified water.

Appearance of the product and package contents

Capsidol is presented in the form of a cream for cutaneous use, ivory to salmon-colored, in 30-gram and 60-gram tubes.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona - Spain

Manufacturer

Laboratorios Viñas, S.A.

Torrente Vidalet, 29

08012 Barcelona - Spain

Date of the last revision of this leaflet:October 2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/