Package Insert: Information for the User

Capsidol 0.25 mg/g Cream

Capsaicin Oil

Read this entire package insert carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, 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 not listed in this package insert. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

Capsidol is a local anesthetic medication.

It contains capsaicin resin, which is obtained from the fruits of the pungent varieties of Capsicum or chili pepper. Its topical application produces a transient sensation of burning (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 symptomatic relief of localized muscle or joint pain.

Consult a doctor if symptoms worsen or do not improve after 7 days.

This medication 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 medication (listed in section 6).
• Do not apply on open wounds, inflamed, infected, or eczematous areas.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Capsidol.

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

Children and adolescents

Do not administer this medication to children under 12 years old.

Other medications and Capsidol

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

Pregnancy and lactation and fertility

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

Driving and operating machines

No effects on the ability to drive vehicles and operate machines have been described for this medication.

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

This medication contains 70 mg of propylene glycol in each gram of cream.

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

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

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

Capsidol is a cream forexclusive 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 on the affected area, spreading it smoothly.

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 irritation or redness occurs after 7 days of treatment, you should consult your doctor.

If you use more Capsidol than you should

Acute poisoning is practically impossible with the proper use of the medication.

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

If you forgot to use Capsidol

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

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

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

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

The adverse effects listed below are classified according to their frequency and 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 fewer than 1 in 10,000 people); frequency not known (cannot be estimated from available data).

Very common:

Burning or stinging sensation on the skin, skin irritation or dryness in the application area.

Common:

Runny nose or cough, tearing.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. www.notificaram.es.

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

This product does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Capsidol

• The active principle is capsaicin oil. Each gram of cream contains 0.25 mg of capsaicin oil (expressed as capsaicin).
• The other components (excipients) are: isopropyl myristate, stearic acid, propylene glycol, monomiristate of glycerin, cetil phosphate of dietanolamine, cetyl alcohol, benzyl alcohol, diazolidinyl urea, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate (E-216) and purified water.

Appearance of the product and contents of the packaging

Capsidol is presented in the form of a topical cream, off-white to salmon-colored, in tubes of 30 grams and 60 grams.

Holder of the marketing authorization andresponsible for the manufacture

Holder of the marketing authorization

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona - Spain

Responsible for the manufacture

Laboratorios Viñas, S.A.

Torrente Vidalet, 29

08012 Barcelona - Spain

Date of the last review of this prospectus:October 2013

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