Blastoestimulina 10 mg/g ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Blastoestimulina 10 mg/g ointment

Centella asiática extract

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

Follow exactly the instructions for use of 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.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

Leaflet contents

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 contains as its active ingredient extract of Centella asiática, which has wound-healing properties.

Blastoestimulina is indicated for the healing of wounds, fissures, ulcers, sores, pressure ulcers, and other erosions (or cracks) of the skin. It is also indicated for the healing of mild burns and post-surgical wounds.

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 ingredients of this medicine (listed in section 6).
• in cases of eczema (skin rash).
• in severe burns or ulcers, or those affecting large areas of skin, except if specifically indicated 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 (on the skin).

This medicine should not be used 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 assess whether continuing the treatment is appropriate.

Children and adolescents

This medicine is not recommended for use in children and adolescents 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 using machines

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

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

This medicine contains 291 mg of propylene glycol and 171 mg of diethylene glycol palmitostearate in each 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 first consulting your doctor or pharmacist.

This medicine contains fragrances with allergens, including geranium essence containing: citronellol, geraniol, linalool, citral, and d-limonene; and lavender essence containing: linalool, d-limonene, coumarin, geraniol, citronellol, benzyl alcohol, benzyl cinnamate, anisyl alcohol, amyl cinnamaldehyde, 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 exactly the dosage instructions for the medicine provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor or pharmacist.

For topical 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 over the affected area. 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, cases of poisoning are unlikely, except if accidentally used over large skin surfaces or 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 cause adverse effects, although not everyone will experience them.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible 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.

Store below 30°C.

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. After opening the container, discard the contents after 3 months.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Blastoestimulina 10 mg/g ointment

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

• The other components are: propylene glycol (E-1520), diethylene glycol palmitostearate, corn germ oil, geranium fragrance (citronellol, geraniol, linalool, citral and d‑limonene), lavender fragrance (linalool, d‑limonene, coumarin, geraniol, citronellol, benzyl alcohol, benzyl cinnamate, anisyl 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 medicinal product and contents of the package

Blastoestimulina is a white to creamy white ointment.

It is available in polyethylene tubes containing 30 g or 60 g 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 most recent revision of this leaflet: December 2021.

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