BLASTOESTIMULINA 20 mg/g CUTANEOUS POWDER

Introduction

Package Leaflet: Information for the User

Blastoestimulina 20 mg/g Cutaneous Powder

Extract of Centella asiatica

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

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet

1. What is Blastoestimulina and what is it used for
2. What you need to know before using Blastoestimulina
3. How to use Blastoestimulina
4. Possible side effects
5. Storage of Blastoestimulina
6. Package Contents and Additional Information

1. What is Blastoestimulina and what is it used for

Blastoestimulina 20 mg/g cutaneous powder is a medication for cutaneous use with wound-healing action.

This medication is indicated for wound healing, fissures, ulcers, sores, bedsores, and other skin erosions (or cracks).

It is also indicated for the healing of minor burns and post-operative wounds, especially in cases where good aeration and rapid drying of the process to be treated are desired.

2. What you need to know before using Blastoestimulina

Do not use Blastoestimulina

• if you are allergic to Centella asiatica extract or any of the other components of this medication (listed in section 6).
• if you have eczema (skin rash).
• if the burns or ulcers to be treated are severe or affect large areas of the skin, unless your doctor indicates otherwise.
• in the eyes.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Blastoestimulina.

Do not ingest. For cutaneous use.

This medication should not be used for extended periods or on infected wounds. If you do not observe clinical improvement after 5 days of treatment, you should consult your doctor, who will review the convenience of the treatment.

Children

This medication is not recommended for children due to the lack of safety and efficacy data in this population.

Other Medications and Blastoestimulina

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

To date, no interactions are known.

Pregnancy, Breastfeeding, and Fertility

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.

There are no data on the use of this medication during pregnancy or breastfeeding, so the use of Blastoestimulina is not recommended during pregnancy and breastfeeding.

Driving and Using Machines

The use of Blastoestimulina does not produce adverse effects on driving ability or machine operation.

3. How to use Blastoestimulina

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor or pharmacist.

For cutaneous use. Do not ingest.

The recommended dose in adults is: administer the powder 1 to 3 times a day, applying a small amount of it to the area to be treated. It is recommended to clean the affected area before starting treatment.

If you use more Blastoestimulina than you should

Due to its cutaneous use, it is unlikely that intoxication cases will occur, unless it is accidentally used on large areas of the skin and at doses much higher than recommended.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 915 620 420, or consult your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

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

The application of this product may cause itching, burning, skin irritation, and contact dermatitis (red rash on the skin, with itching, due to contact with a substance).

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Blastoestimulina

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

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Blastoestimulina

• The active ingredient of Blastoestimulina 20 mg/g cutaneous powder is Centella asiatica extract. Each gram of powder contains 20 mg of purified dry extract of the aerial parts of Centella asiatica.

• The other components are: magnesium stearate, anhydrous colloidal silica, and talc.

Appearance of the Product and Package Contents

Blastoestimulina 20 mg/g cutaneous powder is a fine white powder presented in 5-gram bottles.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A.

General Mitre, 151

08022 Barcelona (Spain)

Manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II, Venus 72

08228 Terrassa (Spain)

or

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 - Sant Andreu de la Barca (Spain)

Date of the Last Revision of this Package Leaflet:May 2022

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/)