Blastoestimulina 20 mg/g cutaneous powder

Spain
Brand name Blastoestimulina 20 mg/g cutaneous powder
Form powder, cutaneous
Active substance / Dosage
Prescription type Over The Counter
Registration number 35908
Manufacturer Almirall S.A.
Blastoestimulina 20 mg/g cutaneous powder powder, cutaneous

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Blastoestimulina 20 mg/g cutaneous powder

Centella asiatica extract

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, pharmacist, or nurse.

  • Keep this leaflet, as you may need to read it again.

  • If you need advice or further information, consult your pharmacist.

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

  • You should consult a doctor if your condition worsens or if you do not improve after 5 days.

Contents of this leaflet

  1. What Blastoestimulina is and what it is used for
  2. What you need to know before using Blastoestimulina
  3. How to use Blastoestimulina
  4. Possible adverse effects
  5. How to store Blastoestimulina
  6. Contents of the pack and other information

1. What Blastoestimulina is and what it is used for

Blastoestimulina 20 mg/g cutaneous powder is a topical medication with healing properties.

This medication is indicated for the healing of wounds, fissures, ulcers, sores, pressure ulcers, and other skin erosions (or cracks).

It is also indicated for the healing of mild burns and postoperative wounds, especially in cases where good aeration and rapid drying of the affected area are desired.

2. What you need to know before using Blastoestimulina

Do not use Blastoestimulina

  • if you are allergic to Centella asiática extract or to any of the other components of this medicine (listed in section 6).
  • if you have skin eczema (rash).
  • if the burns or ulcers being treated are severe or affect extensive areas of skin, unless otherwise directed by your doctor.
  • in the eyes.

Warnings and precautions

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

Do not ingest. For cutaneous use only.

This medicine should not be used for prolonged periods or on infected wounds. If no clinical improvement is observed after 5 days of treatment, you should consult your doctor, who will assess whether continuing treatment is appropriate.

Children

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

Other medicines and Blastoestimulina

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions have been reported to date.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no data available regarding the use of this medicine during pregnancy or breastfeeding; therefore, the use of Blastoestimulina is not recommended during pregnancy or breastfeeding.

Driving and operating machinery

The use of Blastoestimulina does not produce adverse effects on the ability to drive or operate machinery.

3. How to use Blastoestimulina

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist.

For topical use only. Do not ingest.

The recommended dose in adults is: apply the powder 1 to 3 times daily, using a small amount directly onto the affected area. It is recommended to clean the affected area before starting treatment.

If you use more Blastoestimulina than you should

Due to its topical use, poisoning is unlikely, unless accidentally used over large areas of skin and at doses much higher than recommended.

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everybody will experience them.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Blastoestimulina

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Blastoestimulina

  • The active substance in Blastoestimulina 20 mg/g cutaneous powder is extract of Centella asiática. Each gram of powder contains 20 mg of purified dry extract from the aerial parts of Centella asiática.

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

Appearance of the product and contents of the pack

Blastoestimulina 20 mg/g cutaneous powder is a fine white powder supplied 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 most recent revision of this summary: May 2022

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