Picasum 0.075% cream
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Picasum 0.075% cream
Oleoresin of Capsicum annuum L. (capsaicin)
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Picasum is and what it is used for
- What you need to know before using Picasum
- How to use Picasum
- Possible adverse effects
- How to store Picasum
- Contents of the pack and other information
1. What Picasum is and what it is used for
Picasum contains oleoresin of Capsicum annuum L., which is a local-acting anesthetic active substance.
It 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 in adults.
2. What you need to know before using Picasum
Do not use Picasum
If you are allergic to oleoresin from Capsicum annuum L. or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Picasum.
This treatment should be initiated and supervised by the specialist managing the diabetic patient. This medicine is for external (cutaneous) use only. Do not apply on irritated skin or wounds. The product is highly irritating. Avoid contact with eyes and mucous membranes. For this reason, it is recommended to always wash hands thoroughly with cold water and soap immediately after each application. Unless specifically instructed by a doctor, avoid applying the cream near the eyes or on mucous membranes (e.g. mouth). Contact with eyes or other mucous membranes may cause a burning sensation. If this occurs, rinse the affected area thoroughly with copious amounts of cold water.
When treating the hands, patients should not wash them for at least 30 minutes after application. During this time, care must be taken to avoid accidental contact with sensitive areas.
If pain persists or worsens after the first 2 weeks of treatment, or if pain disappears and reappears after a few days, or if excessive irritation occurs, discontinue treatment and consult your doctor.
Do not apply heat or tight bandages to the treated area. Do not use for prolonged periods or over large areas of skin.
Children and adolescents
Not recommended.
Other medicines and Picasum
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Possible interactions between this medicine and other topical medicines are not known.
As this 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 become pregnant, consult your doctor or pharmacist before using this medicine.
If you are pregnant, your doctor will determine whether it is appropriate to start this treatment.
Likewise, if you are breastfeeding, your doctor will decide whether it is appropriate to start treatment with this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Picasum contains cetyl alcohol, methylparaben sodium salt (E-219), propylparaben sodium salt (E-217), and propylene glycol (E-1520)
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.
This medicine may cause allergic reactions (possibly delayed) because it contains methylparaben sodium salt (E-219) and propylparaben sodium salt (E-217).
This medicine contains 50 mg of propylene glycol in each gram of cream.
3. How to use Picasum
Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
Picasum is a cutaneous medicine intended for external use only. It should be applied to the painful areas of the skin.
Use in adults and elderly patients
The recommended dose is three or four applications per day for 8 weeks, after which your doctor will determine whether to discontinue or continue treatment.
Use in children and adolescents
Not recommended.
Instructions for correct administration
The tube must be pierced before first use. Pierce the tube and apply as per the following instructions:
Follow these instructions unless your doctor has given you different directions.
Apply the minimum amount of cream necessary to cover the affected area of skin.
Spread the cream with a gentle massage until completely absorbed, avoiding any residue, as shown in graph 6 of section 3.
It is important to perform the applications daily.
The duration of treatment will be 8 weeks, after which your doctor will determine whether to discontinue or continue treatment.
Your doctor will indicate the duration of your treatment with Picasum.
If you use more Picasum than you should
Acute intoxication is practically impossible with proper use of this 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 at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Picasum
Do not apply a double dose to make up for missed doses.
Continue your treatment with the recommended dosage.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
During the first days of treatment, a sensation of burning or stinging on the skin at the application site may occur in approximately 50% of cases. This known reaction is due to the pharmacological action of capsaicin, which releases substance P from peripheral nerve endings and causes its accumulation at the synapse. This sensation usually diminishes or disappears over time as treatment continues at the recommended dose, without the need to interrupt therapy. Its duration and intensity are variable but may be prolonged if Picasum is applied less than 3 or 4 times a day. Hot water, excessive sweating, or occlusion may intensify this sensation. Other possible cutaneous adverse effects may include irritant erythema and dryness of the skin at the application site.
During treatment, sneezing, tearing, or coughing (less than 2%) may also occur, but much less frequently, as a result of inhaling dried cream residues. Therefore, it is important to apply the smallest necessary amount of cream, avoid leaving 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Picasum
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Return unused or expired containers and medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Picasum
- The active substance is oleoresin of Capsicum annuum L. Each 100 grams of Picasum 0.075% cream contains 312 - 625 mg of oleoresin of Capsicum annuum L., equivalent to 75 mg of capsaicin.
- The other components (excipients) are: stearic acid; cetostearyl alcohol; oleyl alcohol; isopropyl myristate; glycerol monostearate; polyethylene glycol monostearate; methylparaben sodium salt (E-219); propylparaben sodium salt (E-217); propylene glycol (E-1520); purified water.
Appearance of the product and contents of the pack
Picasum is a yellowish-white cream.
This medicine is available in 30-gram and 50-gram packs.
Marketing Authorization Holder and Manufacturer
Especialidades Farmacéuticas Centrum, S.A.
C/Sagitario, 14
03006 Alicante (Spain)
Grupo Asacpharma
Date of the most recent review of this leaflet: March 2022
Other sources of information
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/