Leaflet: information for the user

Blastoestimulina 20 mg/g topical powder

Centella asiatica extract

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

Followexactly the administration instructions for the medicine contained in this leaflet or those 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.

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

• You should consult a doctor if you get worse or do not improveafter 5 days.

1. What is Blastoestimulina and what it is 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. Contents of the pack and additional information

Blastoestimulina 20 mg/g topical powder is a topical medication with a wound-healing action.

This medication is indicated for the healing of wounds, fissures, ulcers, sores, scabs, 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 treated area are of interest.

Do not use Blastoestimulina

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

Warnings and precautions

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

Do not ingest. Use topical only.

Do not use this medication for prolonged periods or on infected wounds. If you do not observe clinical improvement after 5 days of treatment, you must consult your doctor who will review the appropriateness of the treatment.

Children

This medication is not recommended for childrendue 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 need 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 related to 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 the ability to drive or operate machines.

Follow exactly the administration instructions of the medication 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: administer the powder 1 to 3 times a day, applying a small amount of the same to 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, 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, pharmacist, or nurse even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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.

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

Composition of Blastoestimulina

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

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

Appearance of the product and contents of the packaging

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

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

Kern Pharma, S.L.

Polígono Ind. Colón II, Venus 72

08228 Terrassa (Spain)

or

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 - Sant Andreu de la Barca (Spain)

Last review date of this leaflet:May 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)