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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use FILSUVEZ GEL

Contents of the leaflet

  1. Introduction
  2. What is Filsuvez and what is it used for
  3. What you need to know before you use Filsuvez
  4. How to use Filsuvez
  5. Possible side effects
  6. Storage of Filsuvez
  7. Contents of the pack and other information

Introduction

Package Leaflet: Information for the Patient

Filsuvez Gel

Birch Bark Extract

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

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Filsuvez and what is it used for

Filsuvez gel is a herbal medicine that contains dry extract of birch bark.

It is used for the treatment of wounds in adults and children (from 6 months of age) who suffer from a type of disease called "epidermolysis bullosa" (EB), specifically "dystrophic" (DEB) or "junctural" (JEB). This is a condition where the outer layer of the skin separates from the inner layer, making the skin very fragile and causing wounds to appear.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use Filsuvez

Do not use Filsuvez

  • if you are allergic to birch bark or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Filsuvez.

If you have an allergic reaction, stop using Filsuvez immediatelyand go to your doctor or nurse. Signs of an allergic reaction include:

  • itching, swelling, and redness of the skin that is more severe in the area where the medicine has been applied.

Wound infection is a serious complicationthat can occur during the healing process. Possible signs of wound infection are:

  • yellow or greenish liquid (pus) coming out of the wound,
  • red, hot, swollen, or increasingly painful skin around the wound.

If you have a wound infection, you may need to stop using Filsuvezand another treatment may be necessary. Your doctor or nurse will tell you if Filsuvez treatment can be restarted once the infection has cleared up.

People with EB are more likely to develop a type of skin cancer called "squamous cell carcinoma" (SCC). If you are diagnosed with skin cancer while using Filsuvez, you should talk to your doctor or nurse and stop using Filsuvezon that part of the skin.

Filsuvez does notcontain birch pollen, so it can be used in people with a birch pollen allergy.

Avoid getting Filsuvez in your eyes. If this happens, rinse your eyes well with clean water. Contact your doctor or nurse if the discomfort continues.

Children

Do not give this medicine to children under 6 months of age.

Other medicines and Filsuvez

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

There is no information on how Filsuvez might interact with other medicines applied to the skin, taken by mouth, or injected. Do not apply other products to the wound area at the same time as applying Filsuvez. If you need to use more than one product, talk to your doctor or nurse.

Pregnancy, breastfeeding, and fertility

No studies have been done on the effects of Filsuvez in pregnant women, but since the absorption of this medicine into the body is extremely low, the risk to the fetus is negligible. Filsuvez can be used during pregnancy.

It is not known if Filsuvez passes into breast milk, but since the absorption of this medicine into the body is extremely low, the risk to the fetus is negligible. Filsuvez can be used during breastfeeding, unless the breast area is being treated.

Since the absorption of this medicine into the body is extremely low, it is not expected to affect your fertility.

Driving and using machines

Your ability to drive and use machines will not be affected by this medicine.

3. How to use Filsuvez

Follow the instructions for administration of this medicine exactly as told by your doctor, pharmacist, or nurse. If you are unsure, talk to your doctor, pharmacist, or nurse again.

Methods of administration

  • Clean the wound before applying Filsuvez.
  • You can apply Filsuvez in two ways:
  1. Apply directly to the wound
    • Apply a thick layer (about 1 mm thick) of Filsuvez to the wound (step 1).
    • Spread the gel generously and cover the entire wound area with a clean hand or glove (step 2). Do notrub the gel.
    • Cover with a non-adhesive sterile dressing (step 3).

Step 1: Apply

Step 2: Spread

Step 3: Cover

Tube squeezing cream onto a white and black intravaginal applicator

Hand applying pressure on a rectangular adhesive dressing placed on the skin

Gauze strips with a grid texture, one partially unfolded showing its length and pattern

Or

  1. Apply to a non-adhesive sterile dressing
    • Apply a thick layer (about 1 mm thick) of Filsuvez to the wound dressing (step 1).
    • Spread generous amounts of gel to the area that will be in direct contact with the wound with a clean hand or glove (step 2).
      • Cover the wound with the dressing (step 3).

Step 1: Apply

Step 2: Spread

Step 3: Cover

Hand applying cream or ointment to a grid-textured surface with white lines and dark background

Hand applying a rectangular medicinal patch to the arm skin with firm pressure

Hand slowly peeling off the protective transparent cover of a medicinal adhesive patch on a grid background

  • Reapply the gel every time the dressing is changed, until the wound is healed.
  • Filsuvez is not intendedfor internal use. Avoid contact with the eyes, mouth, or nostrils. In case of accidental contact, rinse immediately with clean water.
  • This tube of sterile gel is intended for single use. Once opened, the gel must be used immediately and the tube must be discarded, even if some gel remains. A new tube should be used for each dressing change.

Duration of treatment

Your doctor, pharmacist, or nurse will tell you how long you should use the gel. If your symptoms continue or worsen after use, or if complications occur in the wound, talk to your doctor, pharmacist, or nurse.

If you use more Filsuvez than you should

Filsuvez is applied to the skin and absorption into the body is extremely low. This makes overdose very unlikely, even if applied to large areas of skin and for a long period of time.

If you forget to use Filsuvez

Apply Filsuvez at the next scheduled dressing change, continuing with your usual routine.

If you stop using Filsuvez

Filsuvez should be used as directed by your doctor, pharmacist, or nurse. Do not stop using itwithout talking to your doctor, pharmacist, or nurse.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor, pharmacist, or nurse immediately if you notice any of the following side effects, including those listed below.

Very common(may affect more than 1 in 10 people)

  • wound complications (e.g., increased wound size, wound reopening, and pain in the wound)

Common(may affect up to 1 in 10 people)

  • wound infection
  • allergic reaction (hypersensitivity)
  • itching of the skin
  • pain and itching at the application site
  • wound healing complications

Uncommon(may affect up to 1 in 100 people)

  • wound secretion
  • skin irritation (dermatitis)
  • itchy rash
  • purple-colored rash
  • pain

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Filsuvez

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

Do not use this medicine after the expiry date which is stated on the carton and tube after "EXP". The expiry date is the last day of the month shown.

Store below 30°C.

This tube of sterile gel is intended for single use. Once opened, the gel must be used immediately and the tube must be discarded, even if some gel remains. A new tube should be used for each dressing change.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Filsuvez

The active substance is dry extract of birch bark.

1 g of gel contains: 100 mg of extract (as refined dry extract) from Betula pendulaRoth, Betula pubescensEhrh., as well as hybrids of both species, bark (equivalent to 0.5-1.0 g of birch bark), including 84-95 mg of triterpenes calculated as the sum of betulin, betulinic acid, erythrodiol, lupeol, and oleanolic acid. Extraction solvent: n-heptane.

The other ingredient is refined sunflower oil.

Appearance of the product and pack contents

Filsuvez is a colorless to slightly yellowish, opalescent, and non-aqueous gel.

Filsuvez gel is available in white, foldable aluminum tubes. The tubes are closed with a tamper-evident aluminum membrane and are equipped with a white polypropylene screw cap.

The tube is packaged in a cardboard box.

Pack sizes:

1 tube, 10 tubes, and 30 tubes of 23.4 g gel.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturer

Amryt GmbH

Streiflingsweg 11

75223 Niefern-Öschelbronn

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

België/Belgique/Belgien

Chiesi sa/nv

Tel: + 32 (0)2 788 42 00

Lietuva

ExCEEd Orphan s.r.o.

Bucharova 2657/12, Prague 5, 158 00

Czech Republic

Tel.: +370 661 663 99

[email protected]

Text with contact information of a Bulgarian company ExCEEd Orphan sro, address in Prague, and phone and email data

Luxembourg/Luxemburg

Chiesi sa/nv

Tel: + 32 (0)2 788 42 00

Ceská republika

ExCEEd Orphan s.r.o.

Bucharova 2657/12, Prague 5, 158 00

Czech Republic

Tel: +420 724 321 774

[email protected]

Magyarország

ExCEEd Orphan s.r.o.

Bucharova 2657/12, Prague 5, 158 00

Czech Republic

Tel.: +36 20 399 4269

[email protected]

Danmark

Chiesi Pharma AB

Tlf: + 46 8 753 35 20

Malta

Amryt Pharmaceuticals DAC

Tel: +44 1604 549952

[email protected]

Deutschland

Chiesi GmbH

Tel: + 49 40 89724-0

Nederland

Chiesi Pharmaceuticals B.V.

Tel: + 31 88 501 64 00

Eesti

ExCEEd Orphan s.r.o.

Bucharova 2657/12, Prague 5, 158 00

Czech Republic

Tel.: +370 661 663 99

[email protected]

Norge

Chiesi Pharma AB

Tlf: + 46 8 753 35 20

Ελλάδα

Amryt Pharmaceuticals DAC

Τηλ: +800 44 474447

Τηλ: +44 1604 549952

[email protected]

Österreich

Chiesi Pharmaceuticals GmbH

Tel: + 43 1 4073919

España

Chiesi España, S.A.U.

Tel: + 34 93 494 8000

Polska

ExCEEd Orphan s.r.o.

Bucharova 2657/12, Prague 5, 158 00

Czech Republic

Tel: +48 502 188 023

[email protected]

France

Chiesi S.A.S.

Tél: + 33 1 47688899

Portugal

Chiesi Farmaceutici S.p.A.

Tel: + 39 0521 2791

Hrvatska

ExCEEd Orphan Distribution d.o.o.

Savska cesta 32, Zagreb, 100 00

Croatia

Tel: +385 99 320 0330

[email protected]

România

ExCEEd Orphan s.r.o.

Bucharova 2657/12, Prague 5, 158 00

Czech Republic

Tel: +40 744 366 015

[email protected]

Ireland

Chiesi Farmaceutici S.p.A.

Tel: + 39 0521 2791

Slovenija

ExCEEd Orphan s.r.o.

Bucharova 2657/12, Prague 5, 158 00

Czech Republic

Tel: +386 30 210 050

[email protected]

Ísland

Chiesi Pharma AB

Sími: +46 8 753 35 20

Slovenská republika

ExCEEd Orphan s.r.o.

Bucharova 2657/12, Prague 5, 158 00

Czech Republic

Tel: +420 608 076 274

[email protected]

Italia

Chiesi Italia S.p.A.

Tel: + 39 0521 2791

Suomi/Finland

Chiesi Pharma AB

Puh/Tel: +46 8 753 35 20

Κύπρος

Amryt Pharmaceuticals DAC

Τηλ: +800 44 474447

Τηλ: +44 1604 549952

[email protected]

Sverige

Chiesi Pharma AB

Tel: +46 8 753 35 20

Latvija

ExCEEd Orphan s.r.o.

Bucharova 2657/12, Prague 5, 158 00

Czech Republic

Tel.: +370 661 663 99

[email protected]

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/). There are also links to other websites about rare diseases and orphan medicines.

Online doctors for FILSUVEZ GEL

Discuss questions about FILSUVEZ GEL, including use, safety considerations and whether a prescription is appropriate, subject to medical assessment and local regulations.

Doctor
5.0(6)

Jorge Correa Bellido

General medicine7 years of experience
Licence no. 464626297

Dr. Jorge Correa Bellido is a Spanish physician who offers online consultations in Spanish and English. He graduated from the University of La Laguna and has a solid background in clinical practice and international research.

Throughout his career, he has participated in various medical and academic projects, including a research fellowship in Spain, where he contributed to evidence-based studies in the field of family medicine. This experience allowed him to broaden his global perspective on healthcare and comprehensive patient care.

Dr. Correa Bellido has worked with several healthcare providers in Spain, focusing particularly on patient-centered care and public health initiatives aimed at communities with limited access to healthcare services.

In addition, he actively participates in international medical conferences and workshops, which allows him to stay up to date with the latest medical advances and collaborate with healthcare professionals from different countries.

Dr. Correa Bellido provides comprehensive care for a wide variety of medical conditions, including:

  • respiratory infections
  • gastrointestinal disorders
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  • as well as mental health conditions such as anxiety and depression.

He also treats infectious and allergic diseases, general health concerns, and provides guidance on prevention and healthy lifestyle habits.

His services include virtual consultations, diagnosis and management of acute and chronic diseases, prescription renewals, and personalized medical advice.

With a patient-centered approach and a strong commitment to continuous learning, Dr. Correa Bellido provides accessible and high-quality healthcare to patients both in Spain and around the world.

Book a video appointment
€86
Doctor

Chikeluo Okeke

General medicine4 years of experience

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

Common reasons for consultation:

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Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

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€66
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5.0(21)

Nuno Tavares Lopes

General medicine18 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies

  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management

  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses

  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment

  • Weight management and wellness: personalised weight loss programmes, lifestyle guidance

  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis

  • Pain management: acute and chronic pain, post-surgical care

  • Public health: prevention, health screenings, long-term monitoring

  • Sick leave (Baixa médica) connected to Segurança Social in Portugal

  • IMT medical certificates for driving licence exchange

Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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€70
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5.0(3)

Lina Travkina

General medicine13 years of experience

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.Areas of medical care include:

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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.

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Additional care areas:

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  • Structured support for undiagnosed complaints.

  • Second opinion on diagnoses and treatment plans.

  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.

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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

Book a video appointment
€75
Doctor
4.7(11)

Anastasiia Shalko

General medicine13 years of experience
Licence no. 52891

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

  • acute respiratory symptoms (cough, sore throat, runny nose, fever)
  • viral illnesses such as colds and seasonal infections
  • gastrointestinal complaints (nausea, diarrhoea, abdominal pain, gastroenteritis)
  • sudden changes in how a child or adult feels
  • questions about existing treatment and whether adjustments are needed
  • renewal of prescriptions when clinically appropriate

Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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€56
Doctor
5.0(1)

Tomasz Grzelewski

DermatologyAllergology21 years of experience

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
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  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

Book a video appointment
€106

Frequently Asked Questions

FILSUVEZ GEL requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.

The active ingredient in FILSUVEZ GEL is Betulae cortex. This information helps identify medicines with the same composition but different brand names.

FILSUVEZ GEL is manufactured by Chiesi Farmaceutici S.P.A.. Pharmacy brands and packaging may differ depending on the distributor.

Doctors such as Family doctors, Dermatologists, Allergists, General medicine doctors, Intensive care physicians may assess whether FILSUVEZ GEL is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.

The prescription is issued by a doctor after assessing your health. In Spain, FILSUVEZ GEL is then dispensed in pharmacies with that prescription. An online consultation does not guarantee that a prescription will be issued: the decision always rests with the doctor.

To request an assessment, you can use Oladoctor:

Other medicines with the same active substance (Betulae cortex) include BLASTOESTIMULINA 10 mg/g OINTMENT, BLASTOESTIMULINA 20 mg/g CUTANEOUS POWDER, LINITUL CICATRIZANTE POMADA - Healing Liniment Ointment. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.

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