CAPSICIN 0.75 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Capsicin 0.75 mg/g cream

Capsaicin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Capsicin and what it is used for
2. What you need to know before you use Capsicin
3. How to use Capsicin
4. Possible side effects
5. Storage of Capsicin
6. Contents of the pack and further information

1. What is Capsicin and what it is used for

Capsicin is a medicine in the form of a cream for cutaneous use, whose active principle, capsaicin, is a local analgesic active principle.

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

2. What you need to know before you use Capsicin

Do not use Capsicin

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

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

• This treatment should be initiated and supervised by the specialist who treats the diabetic patient.
• This medicine is for external cutaneous use only. 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 can cause a burning sensation. If this occurs, the area should be washed with plenty of cold water.
• If the pain persists or worsens after the first 2 weeks of treatment or disappears and reappears after a few days, or excessive irritation appears, discontinue treatment and consult your doctor.
• Do not apply heat or tight bandages to the area. Do not use for prolonged periods or on extensive areas.

Other medicines and Capsicin

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Possible interactions of Capsicin with other topical medicines are not known.

As it is a topical product, interactions with other systemic medicines are not expected

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

If you are pregnant, your doctor will decide whether to start this treatment.

Similarly, if you are breastfeeding, your doctor will decide whether to start treatment with this medicine.

Driving and using 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 medicine contains 70 mg of propylene glycol per gram of cream.

It 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 Capsicin

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Capsicin is a medicine for external cutaneous use only. It should be applied to the painful areas of the skin.

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 leaving any residue.
• Always wash your hands well with cold water and soap immediately after each application, and unless your doctor indicates otherwise, avoid applying the cream near the eyes or on mucous membranes (e.g., the mouth).
• When the treated area is the 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 important to make 3 or 4 applications daily. The duration of the treatment will be 8 weeks, after which your doctor will determine whether to suspend or continue it.
• Your doctor will indicate the duration of your treatment with Capsicin.

Use in children

Not recommended.

If you use more Capsicin than you should

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

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

If you forget to use Capsicin

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

If you stop using Capsicin

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the first days of treatment, a burning or itching sensation may appear in the application area in approximately 50% of cases. This reaction, which is known, is a consequence of the pharmacological action of capsaicin, releasing substance P from peripheral nerve endings and accumulating in the synapse, and usually disappears or decreases over time as 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 side effects at the cutaneous level may be irritative erythema and dryness of the skin at the application site.

During treatment, estornudos, lacrimation, or cough (less than 2%) may also appear, as a consequence of inhaling dry cream residues. Therefore, it is important to apply the minimum amount of cream necessary and avoid leaving residues on the skin, as well as washing your hands with cold water and soap after use.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Capsicin

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 which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the packaging and any unused medicine, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

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, glycerin monomyristate, 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 pack

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

Marketing authorization holder:

Marketing authorization holder:

Laboratorios Viñas, S.A.

Provenza, 386

08025 – Barcelona

Spain

Manufacturer:

Laboratorios Viñas, S.A.

Torrent d’en Vidalet, 29

08012 - Barcelona

Spain

Date of last revision of this leaflet: November 2020

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