Prospect: information for the user

Blastoestimulina 10 mg/g ointment

Centella asiatica extract

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

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor, pharmacist, or nurse.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

1. What isBlastoestimulinaand for what it is used

2. What you need to know before starting to useBlastoestimulina

3. How to useBlastoestimulina

4. Possible adverse effects

5. Conservation ofBlastoestimulina

6. Contents of the package and additional information

Blastoestimulina contains Centella asiática extract as its active ingredient,with ahealing action.

Blastoestimulina is indicated for wound healing, fissures, ulcers, sores, scabs, and other skin erosions (or cracks). It is also indicated for the healing of minor burns and post-operative wounds.

Do not useBlastoestimulina

• if you are allergic to Centella asiatica extract or any of the other components of this medication (listed in section 6).
• in eczema (skin eruption).
• in severe burns or ulcers that affect extensive areas of the skin, except if your doctor advises you to do so.
• in the eyes.

Warnings and precautions

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

Do not ingest. Use exclusively on the skin.

Do not use this medication for prolonged periods or on infected wounds.

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

Children and adolescents

Thismedication is not recommended for children and adolescentsdue 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 used recently, or may have to use any other medication.

As of now, there are no known interactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend 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 operating machines

The use of Blastoestimulina does not produce adverse effects on driving or operating machines.

Blastoestimulina contains propylene glycol (E-1520), diethylhexyl phthalate, and fragrances that contain allergens

This medication contains 291 mg of propylene glycol and 171 mg of diethylhexyl phthalate in each gram of ointment.

Propylene glycol and diethylhexyl phthalate 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 medication contains fragrances with allergens,such as geranium essential oilwith: citronellol, geraniol, linalool, citral, and d-limonene; and lavender essential oil with: linalool, d-limonene, coumarin, geraniol, citronellol, benzyl alcohol, benzyl cinnamate, anisaldehyde, amyl cinnamaldehyde, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, and citral.

The allergensmay cause allergic reactions.

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

Topical use. 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 over 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 topical use, it is unlikely that cases of intoxication will occur, except in cases where it is accidentally used on large skin surfaces and at doses much higher than those recommended.

In case of overdose or accidental ingestion, consult the Toxicological 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.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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.

Store below 30°C.

Do not use this medication 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 disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Blastoestimulina 10 mg/g ointment

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

• The other components are: propylene glycol (E-1520), dietilenglicol palmitoestearate, corn germ oil, geranium essence(citronelol, geraniol, linalol, citral and d‑limoneno), lavender essence(linalol, d‑limoneno, coumarin, geraniol, citronelol, benzyl alcohol, benzyl cinnamate, anisic alcohol, amyl cinnamaldehyde, 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 content of the container

Blastoestimulina is a white to creamy white ointment.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 Barcelona (Spain)

Responsible for manufacturing

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

Last review date of this leaflet:December 2021.

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)