Product Information for the User

Capsicin 0.75 mg/g Cream

Capsaicin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Capsicin is a topical cream medication whose active ingredient, capsaicin, is a local analgesic active ingredient.

This medication is indicated for the relief of moderate to severe pain in diabetic painful neuropathy that interferes with daily activities and has not responded to other treatment.

No use Capsicin

If you are allergic to capsaicin or any of the other components of this medication (listed in section 6).

Warnings and PrecautionsConsult your doctor or pharmacist before starting to use Capsicin

• This treatment must be initiated and supervised by the specialist treating the diabetic patient.
• This medication is only for external use on the skin. Avoid contact with the eyes and mucous membranes.
• Do not use Capsicin on damaged skin or open wounds.
• Contact with the eyes or other mucous membranes may cause a burning sensation. In case of occurrence, the area will be rinsed with plenty of cold water.
• If the pain persists or worsens after the first 2 weeks of treatment or disappears and reappears a few days later, or excessive irritation appears, interrupt treatment and consult the doctor.
• Do not apply heat or tight bandages to the area. Do not use for a prolonged period or in extensive areas.

Other Medications and Capsicin

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

The possible interactions of Capsicin with other topical medications are unknown.

As it is a topical product, no interactions with other systemic medications are expected.

Pregnancy and Breastfeeding

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

If you are pregnant, your doctor will determine whether it is advisable to start this treatment.

Similarly, if you are breastfeeding, it will also be your doctor who determines whether it is advisable to start treatment with this medication.

Driving and Operating Machines

Capsicin does not affect the ability to drive or use machines.

Capsicin 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.

It may cause 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 cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219) and propyl parahydroxybenzoate (E-216).

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Capsicin is a medication for exclusive external use on the skin. It will be applied to the painful skin areas.

Adults and elderly

• Apply the minimum amount of cream necessary to cover the affected skin area.
• Spread the cream with a gentle massage until it is fully absorbed, avoiding any residue.
• Always wash your hands thoroughly with cold water and soap immediately after each application, and unless your doctor explicitly indicates otherwise, avoid applying the cream near the eyes or mucous membranes (for example, the mouth).
• If the treated area is your hands, do not wash them for at least 30 minutes after application. During this time, do not touch your eyes, mouth, or other sensitive areas.
• It is essential to make 3 or 4 applications daily. The treatment duration will be 8 weeks, after which your doctor will determine whether to suspend or continue treatment.
• Your doctor will inform you of the duration of your Capsicin treatment.

Use in children

Not recommended.

If you use more Capsicin than you shouldyou should

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

In case of overdose or accidental ingestion, or eye contact, 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 Capsicin

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

If you interrupt treatment with Capsicin

In case of interrupting treatment, consult your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

During the first few days of treatment, a burning or stinging sensation on the skin at the application site may occur in approximately 50% of cases. This reaction, known as such, is a consequence of the pharmacological action of capsaicin, which releases substance P from peripheral nerve endings and accumulates in the synapse, and usually disappears or decreases over time as the treatment continues at the recommended dose, without the need to interrupt it. Its duration and intensity are variable but may be prolonged if Capsicin is applied less than 3 or 4 times a day. Hot water, excessive sweating, or occlusion may intensify this sensation. Other possible adverse effects on the skin may be irritative erythema and dry skin at the application site.

During treatment, other possible adverse effects, such as sneezing, tearing, or coughing (less than 2%), may also occur as a result of inhaling dry cream residues. 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:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This product does not require special conditions for preservation.

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.

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 packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Capsicin

• The active principle is capsaicin. Each gram of cream contains 0.75 mg of capsaicin.
• The other components (excipients) are: isopropyl myristate, stearic acid, propylene glycol, monomyristate of glycerin, potassium hexadecyl hydrogen phosphate, cetyl alcohol, benzyl alcohol, diazolidinyl urea, methyl parahydroxybenzoate, sodium salt (E219), propyl parahydroxybenzoate (E216), and purified water.

Appearance of the product and contents of the packaging

Capsicin is presented in a pharmaceutical form of cream for cutaneous use, white in color, in aluminum tubes of 30 and 50 grams.

Holder of the marketing authorization:

Holder of the marketing authorization:

Laboratorios Viñas, S.A.

Provenza, 386

08025 – Barcelona

Spain

Responsible for manufacturing:

Laboratorios Viñas, S.A.

Torrent d’en Vidalet, 29

08012 - Barcelona

Spain

Last review date of this prospectus: November 2020

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