PICASUM 0.075% CREAM

Introduction

Package Leaflet: Information for the User

Picasum 0.075% Cream

Oleoresin of Capsicum annuumL. (capsaicin)

Read the package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the Package Leaflet

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

1. What Picasum is and what it is used for

Picasum contains oleoresin of Capsicum annuumL., which is a local anesthetic active ingredient.

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 taking Picasum

Do not use Picasum

If you are allergic to oleoresin of Capsicum annuumL. or to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Picasum.

This treatment should be initiated and supervised by the specialist who treats the diabetic patient. This medication is for external use only. Do not apply to irritated skin or wounds. The product is highly irritating. Avoid contact with eyes and mucous membranes. To do this, it is recommended to wash your hands thoroughly with cold water and soap immediately after each application, and unless indicated by your doctor, you should avoid applying the cream near the eyes or on mucous membranes (e.g., the mouth). Contact with the eyes or other mucous membranes can cause a burning sensation. If this occurs, rinse the area with plenty of cold water.

When the treated area is the hands, patients should not wash their hands for at least 30 minutes after application. During this time, accidental contact with sensitive areas should be monitored.

If the pain persists or worsens after the first 2 weeks of treatment, or disappears and returns 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 large areas.

Children and adolescents

Not recommended.

Other medications and Picasum

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

Possible interactions of this medication with other topical medications are not known.

As this is a topical product, interactions with other systemic medications are not expected.

Pregnancy and breastfeeding

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

If you are pregnant, your doctor will determine the suitability of starting this treatment.

Similarly, if you are breastfeeding, your doctor will determine the suitability of starting treatment with this medication.

Driving and using machines

Using this medication does not affect your ability to drive or use machines.

Picasumcontains cetyl alcohol, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), and propylene glycol (E-1520)

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

This medication may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate, sodium salt (E-217).

This medication contains 50 mg of propylene glycol per gram of cream.

3. How to use Picasum

Follow your doctor's instructions for administering this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

Picasum is a topical medication 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 suspend or continue treatment.

Use in children and adolescents

Not recommended.

Instructions for correct administration

The tube must be pierced before its first application. Pierce the tube and apply following these instructions:

Follow these instructions unless your doctor has given you different instructions.

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 remaining residue, as indicated in graph 6 of section 3.

It is essential to make daily applications.

The duration of treatment will be 8 weeks, after which your doctor will determine whether to suspend 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 the proper use of this medication.

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

If you forget to use Picasum

Do not make a double application to compensate for forgotten doses.

Continue with the treatment as recommended.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the first few days of treatment, a burning or itching sensation may occur on the skin in the application area in approximately 50% of cases. This known reaction 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 needing to interrupt it. The 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 can intensify this sensation. Other possible side effects at the skin level may be irritative erythema and dryness of the skin at the application site.

During treatment, estornudos, lagrimeo, or tos (less than 2%) may also appear, as a consequence of inhaling dry cream residues. Therefore, it is essential 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Picasum

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. By doing so, you will help protect the environment.

6. Contents of the pack and further information

Composition of Picasum

• The active ingredient is oleoresin of Capsicum annuumL. Each 100 grams of Picasum 0.075% cream contains 312 - 625 mg of oleoresin of Capsicum annuumL., equivalent to 75 mg of capsaicin.
• The other ingredients (excipients) are: stearic acid; cetyl alcohol; oleic acid; isopropyl myristate; glycerol monostearate; polyethylene glycol monostearate; methyl parahydroxybenzoate, sodium salt (E-219); propyl parahydroxybenzoate, sodium salt (E-217); propylene glycol (E-1520); purified water.

Appearance and packaging of the product

Picasum is a white-yellowish cream.

This medication is available in 30 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 last revision of this package leaflet:March 2022

Other sources of information

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