ALACAPSIN 0.075% CREAM

Introduction

Package Leaflet: Information for the User

Alacapsin 0.075% Cream

Oleoresin ofCapsicum annuumL (equivalent to capsaicin 0.075%)

Read the entire 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, consult 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 side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Alacapsin cream is and what it is used for
2. What you need to know before using Alacapsin cream
3. How to use Alacapsin cream
4. Possible side effects
5. Storage of Alacapsin cream
6. Package contents and additional information

1. What Alacapsin cream is and what it is used for

Alacapsin cream contains oleoresin of Capsicum annuum, which is a local anesthetic active ingredient.

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

2. What you need to know before using Alacapsin cream

Do not use Alacapsin cream

If you are allergic to oleoresin of Capsicum 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 who treats the diabetic patient. This preparation is for external use only. 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 always wash your hands well with cold water and soap immediately after each application, and unless the doctor explicitly indicates otherwise, 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, wash the area with plenty of cold water.

When 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 reappears after a few days, 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 prolonged periods or on extensive areas.

Other Medications and Alacapsin Cream

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

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

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

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 advisability of starting this treatment.

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

Driving and Using Machines

The influence of Alacapsin cream on the ability to drive and use machines is nil.

Alacapsin cream contains cetyl alcohol, methylparaben (E-219), propylparaben (E-217), and propylene glycol (E-1520)

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol. It may also cause allergic reactions (possibly delayed) because it contains methylparaben (E-219) and propylparaben (E-217).

This medication contains 5 mg of propylene glycol per 100 mg.

3. How to Use Alacapsin Cream

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

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

Adults and Elderly

The normal dose is three or four applications per day for 8 weeks, after which the 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 leaving any residue.

It is essential to make daily applications.

The duration of treatment will be 8 weeks, after which the doctor will determine whether to suspend or continue treatment.

Your doctor will indicate the duration of your treatment with Alacapsin cream.

If You Use More Alacapsin Than You Should

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

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 Alacapsin Cream

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

Continue with the treatment as recommended.

If you have any other questions about the use of 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 appear on the skin 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. The duration and intensity are variable, but they can be prolonged if Alacapsin cream 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Monitoring System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Alacapsin Cream

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

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

This medication does not require special storage conditions.

Medications should not be thrown away through the sewage system or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Angileptol Mint Flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other components (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and mint flavor

Appearance of the Product and Package Contents

Angileptol is a sucking tablet, white, round, and with the Greek letter σ on one of the faces.

It is presented in packages containing 15 and 30 sucking tablets.

Other Presentations

Angileptol Mint-Eucalyptus Flavor

Angileptol Honey-Lemon Flavor

Marketing Authorization Holder

Alfasigma España S.L.

C/ Aribau 195, 4º

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of the Last Revision of this Package Leaflet:September 2021

Other Sources of Information

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