Leaflet: information for the user

Alacapsin 0.075% Cream

Oleoresin ofCapsicum annuumL (equivalent to capsaicin 0.075%)

Read this 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 you, 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.

1. What isAlacapsin creamand what it is used for

2. What you need to know before starting to useAlacapsin cream

3. How to useAlacapsin cream

4. Possible side effects

5. Storage ofAlacapsin cream

6. Contents of the pack and additional information

Alacapsin creamcontains capsaicin resinfrom Capsicum annuum, which is a local anesthetic active principle.

It 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.

Do not use Alacapsin cream

If you are allergic to the oleoresin ofCapsicum annuum Lor to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Alacapsin.

This treatment should be initiated and supervised by the specialist treating the diabetic patient. This preparation is for exclusive external use. Do not apply it to irritated skin or wounds. The product is highly irritating. Avoid contact with the 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 your doctor indicates otherwise, avoid applying the cream near the eyes or in mucous membranes (such as the mouth). Contact with the eyes or other mucous membranes may cause a burning sensation. In case of occurrence, the area should be washed with plenty of cold water.

If the treated area is the hands, patients should not wash them 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 if it disappears and returns a few days later, or if excessive irritation appears, discontinue treatment and consult your doctor.

Do not apply heat or tight bandages to the area. Do not use for an extended period or in extensive areas.

Other medications and Alacapsin cream

The possible interactions of this specialty with other topical medications are unknown.

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or if you 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 machinery

The influence ofAlacapsin creamon the ability to drive and operate machinery is zero.

Alacapsin cream contains cetomacrogol, methyl p-hydroxybenzoate sodium (E-219), propyl p-hydroxybenzoate sodium (E-217) and propylene glycol (E-1520)

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetomacrogol. It may also cause allergic reactions (possibly delayed) because it contains methyl p-hydroxybenzoate sodium (E-219) and propyl p-hydroxybenzoate sodium (E-217).

This medication contains 5 mg of propylene glycol in each 100 mg.

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

Alacapsin cream is a topical medication for external use only. It will be applied to the painful skin areas.

Adults and elderly

The usual 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

Not recommended.

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 residue.

It is essential to make daily applications.

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 treatment with Alacapsin cream.

If you use more Alacapsin than you should

Acute poisoning is almost impossible with the proper use of this specialty.

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 ingested.

If you forgot to use Alacapsin cream

Do not make a double application to compensate for the missed doses.

Continue treatment with the recommended dosage.

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 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 treatment continues at the recommended dose, without the need to interrupt it. Its duration and intensity are variable but may be prolonged if Alacapsin cream 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 adverse effects, such as sneezing, tearing, or coughing (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 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:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for preservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and the

medicines that you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. In this way, you will help protect the environment.

Composition of Alacapsin cream

- The active principle is the oleoresin ofCapsicum annuumL. Each 100 grams of cream contains Oleoresin ofCapsicum annuumL (312-625) mg equivalent to 75 mg of capsaicin.

- The other components (excipients) are: monoestearate of polyethylene glycol, monoestearate of glyceryl, isopropyl myristate, propylene glycol (E-1520), oleic alcohol, stearic acid, cetilic alcohol, p-hydroxybenzoate sodium methyl (E-219), p-hydroxybenzoate sodium propyl (E-217), purified water.

Appearance of the product and content of the packaging

Alacapsin creamis a cream of white yellowish color. The content of the packaging is 30 and 50 grams.

Holder of the marketing authorization

Alfasigma España, S.L.

Avda. Diagonal, 490,4º, 2º

08006 Barcelona

Responsible for manufacturing

Especialidades Farmaceuticas Centrum, S.A.

C/ Sagitario, 14

03006 – Alicante - Spain

Date of the last review of this leaflet: April 2021

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/