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FILSUVEZ GEL

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About the medicine

How to use FILSUVEZ GEL

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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 prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Tomasz Grzelewski

Dermatology 21 years exp.

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:

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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.
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Lina Travkina

Family medicine 13 years exp.

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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  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

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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.

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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
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Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
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  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Frequently Asked Questions

Is a prescription required for FILSUVEZ GEL?
FILSUVEZ GEL requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in FILSUVEZ GEL?
The active ingredient in FILSUVEZ GEL is Betulae cortex. This information helps identify medicines with the same composition but different brand names.
Who manufactures FILSUVEZ GEL?
FILSUVEZ GEL is manufactured by Chiesi Farmaceutici S.P.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of FILSUVEZ GEL online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists 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.
What are the alternatives to FILSUVEZ GEL?
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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