Capsidol 0.25 mg/g cream
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Capsidol 0,25 mg/g cream
Capsaicin oleoresin
Read this 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.
Leaflet Contents
- What Capsidol is and what it is used for
- What you need to know before using Capsidol
- How to use Capsidol
- Possible adverse effects
- How to store Capsidol
- Contents of the pack and other information
1. What Capsidol is and what it is used for
Capsidol is a locally acting analgesic medicine.
It contains capsicum oleoresin, obtained from the fruits of the hot varieties of capsicum or chili pepper. Its topical application produces a transient burning sensation (rubefacient effect), followed by a progressive reduction in localized pain in the skin and underlying tissues at the site of application.
It is indicated for the symptomatic relief of localized muscular or joint pain.
You should consult your doctor if your condition worsens or does not improve after 7 days.
2. What you need to know before using Capsidol
This medicine is for external use only. Avoid applying it to irritated, burned, or wounded skin, as well as to eyes and mucous membranes. Do not use Capsidol
- If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
- Do not apply on open wounds, inflamed or infected areas, or areas with eczema.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Capsidol.
- This medicine is for cutaneous use only.
- Avoid contact with eyes and mucous membranes.
- Scratching the treated area is not recommended, in order to prevent skin damage.
- Do not use external heat sources or tight bandages.
- If the medicine comes into contact with eyes or mucous membranes, wash the area thoroughly with plenty of cold water.
- Do not use for prolonged periods or over large areas of skin.
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 might need to use any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported with this medicine.
Capsidol contains propylene glycol, cetyl alcohol, benzyl alcohol, methylparaben sodium (E-219), and propylparaben (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 methylparaben sodium (E-219) and propylparaben (E-216).
3. How to use Capsidol
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.
Capsidol is a cream for external use only, on the skin.
The recommended dose is:
Adults and children over 12 years: apply a thin layer of the product 3 or 4 times daily to the affected area, spreading it gently.
It is advisable to wash your hands immediately with cold water and soap after each application, and to avoid contact of the product with eyes and mucous membranes.
If pain persists, does not improve or worsens, or if irritation or redness occurs after 7 days of treatment, consult your 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 the eyes, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount used.
If you forget to use Capsidol
Do not apply a double amount to make up for a missed dose. Continue the treatment with the recommended dosage.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The main adverse effect described is an initial burning sensation occurring after application of the product. This reaction usually decreases over time as treatment continues at the recommended dose.
In some individuals, allergic reactions (irritation, redness, itching) may occur. In such cases, discontinue treatment.
The adverse effects listed below are classified according to frequency and by organ system. 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 1,000 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 of the skin, irritation or dryness of the skin at the site of application.
Common:
Sneezing or coughing, tearing.
Common adverse reactions occur as a consequence of inhaling dried cream residue. Therefore, it is important to apply the smallest necessary amount of cream, avoid leaving any residue on the skin, and wash hands with cold water and soap after use.
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 through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.
By reporting adverse effects, you can help provide 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 expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Capsidol
- The active substance is capsicum oleoresin. Each gram of cream contains 0.25 mg of capsicum oleoresin (expressed as capsaicin).
- The other components (excipients) are: isopropyl myristate, stearic acid, propylene glycol, glyceryl monomyristate, cetyl phosphate diethanolamine, cetyl alcohol, benzyl alcohol, diazolidinyl urea, methylparaben, sodium salt (E-219), propylparaben (E-216), and purified water.
Appearance of the product and contents of the pack
Capsidol is presented as a cream for topical use, ivory to salmon-colored, in tubes of 30 grams and 60 grams.
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 most recent revision of this package leaflet: October 2013
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/