BLASTOESTIMULINA 10 mg/g OINTMENT

Introduction

Leaflet: information for the user

Blastoestimulina 10 mg/g ointment

extract of Centella asiatica

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

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

• Keep this 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 leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the leaflet

1. What is Blastoestimulina and what is it used for
2. What you need to know before starting to use 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 contains as an active ingredient extract of Centella asiatica, with wound-healing action.

Blastoestimulina 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.

2. What you need to know before starting to use Blastoestimulina

Do not useBlastoestimulina

• if you are allergic to extract of Centella asiatica or to any of the other components of this medicine (listed in section 6).
• in eczema (skin rash).
• in severe burns or ulcers that affect large areas of 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 external use only (on the skin).

Do not use this medicine for extended periods or on infected wounds.

If you do not observe clinical improvement after 7 days of treatment, you should consult your doctor, who will review the suitability of the treatment.

Children and adolescents

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

Other medicines and Blastoestimulina

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

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 medicine.

There are no data on the use of this medicine 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 the ability to drive or use machines.

Blastoestimulina contains propylene glycol (E-1520), diethylene glycol palmitostearate, and fragrances that contain allergens

This medicine contains 291 mg of propylene glycol and 171 mg of diethylene glycol palmitostearate per gram of ointment.

Propylene glycol and diethylene glycol palmitostearate may cause skin irritation. Do not use on open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

This medicine contains fragrances with allergens, such as geranium essence with: citronellol, geraniol, linalool, citral, and d-limonene; and lavender essence with: linalool, d-limonene, coumarin, geraniol, citronellol, benzyl alcohol, benzyl cinnamate, anisic alcohol, amylcinnamaldehyde, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, and citral.

Allergens may cause allergic reactions.

3. How to use Blastoestimulina

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

For external use only. Do not ingest.

The recommended dose in adults is: apply the ointment 1 to 3 times a day, in sufficient quantity to obtain a thin layer on the area to be treated. It is recommended to clean the affected area before starting treatment, removing any organic residue.

If you use more Blastoestimulina than you should

Due to its external use, it is unlikely that cases of intoxication will occur, unless it is accidentally used on large areas of 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 medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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 of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Blastoestimulina

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

Store below 30°C.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated. Once the packaging is opened, discard after 3 months.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Blastoestimulina 10 mg/g ointment

• The active ingredient is extract of Centella asiatica. Each gram of ointment contains 10 mg of extract of Centella asiatica (1%).

• The other ingredients are: propylene glycol (E-1520), diethylene glycol palmitostearate, corn germ oil, geranium essence (citronellol, geraniol, linalool, citral, and d-limonene), lavender essence (linalool, d-limonene, coumarin, geraniol, citronellol, benzyl alcohol, benzyl cinnamate, anisic alcohol, amylcinnamaldehyde, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, and citral), meglumine, and purified water.

Appearance of the product and package contents

Blastoestimulina is a white to creamy white ointment.

It is presented in polyethylene tubes of 30g or 60g of ointment.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca – Barcelona (Spain)

Almirall Hermal GmbH

Scholtzstrasse 3

21465 Reinbek

Germany

Date of the last revision of this leaflet:December 2021.

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