Інструкція із застосування FILSUVETS
Зміст інструкції
Filsuvez gel
birch bark extract
Read this leaflet carefully before using this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 1. What Filsuvez is and what it is used for
- 2. What you need to know before you use Filsuvez
- 3. How to use Filsuvez
- 4. Possible side effects
- 5. How to store Filsuvez
- 6. Contents of the pack and other information
1. What Filsuvez is and what it is used for
Filsuvez gel is a medicine of plant origin 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 “bullous epidermolysis” (EB, defined as “dystrophic” (DEB) or
“junctional” (JEB). In this disease, the outer layer of the skin separates from the inner layer; this
makes the skin very fragile and causes the formation of wounds.
2. What you need to know before using Filsuvez
Do not use Filsuvez
- if you are allergic to birch triterpenes (extracted from birch bark) or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Filsuvez.
If you develop an allergic reaction, immediately stop using Filsuvezand consult your
doctor or nurse. The signs of an allergic reaction include:
- itching, swelling and redness of the skin, more pronounced in the area where the medicine has been applied.
A serious complicationthat can occur during the healing process is infection of the
wound. Possible signs of a wound infection are:
- discharge of yellow or greenish (pus) fluid from the wound;
- redness, heat, swelling or increased pain in the skin around the wound. If a wound infection occurs, you will likely need to stop using Filsuvezand start another therapy. Your doctor or nurse will tell you when you can resume treatment with Filsuvez once the infection has resolved.
People affected by EB are more likely to develop a type of skin cancer
called “squamous cell carcinoma”. If you have been diagnosed with skin cancer during
the use of Filsuvez, consult your doctor or nurse and stop using Filsuvezon the area of the
tumor.
Filsuvez does notcontain birch pollen, so it can be used by people who are allergic to
birch pollen.
Avoid contact of Filsuvez with the eyes. If this should happen, rinse your eyes thoroughly with
clean water. See your doctor or nurse if you continue to experience discomfort.
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 taking, have recently taken or might take
any other medicines.
There is no information available on how Filsuvez may interact with other medicines applied to the
skin, taken by mouth or by injection. 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
Studies on the effects of Filsuvez in pregnant women have not been conducted; however, since
the absorption of this medicine into the body is extremely low, the risk to the unborn child is
negligible. Filsuvez can be used during pregnancy.
It is not known whether Filsuvez passes into breast milk; however, since the absorption of this medicine
into the body is extremely low, the risk to the baby is negligible. Filsuvez can be
used during breastfeeding, provided that the area to be treated is not the chest area.
Because the absorption of this medicine into the body is extremely low, it is not expected to
have effects on fertility.
Driving and using machines
This medicine does not impair the ability to drive vehicles and use machines.
3. How to use Filsuvez
Use this medicine following the instructions of your doctor, pharmacist or nurse exactly. If you have any doubts, consult your doctor, pharmacist or nurse.
Methods of administration
- Clean the wound before applying Filsuvez.
- Filsuvez can be applied in 2 ways:
- 1. Direct application to the wound or Apply a thick layer (approximately 1 mm) of Filsuvez to the wound (Phase 1). or With a clean hand or wearing a glove, spread an abundant amount of gel so as to completely cover the wound area (Phase 2). The gel must notbe rubbed into the wound. or Cover the wound with a non-adhesive dressing (Phase 3).
Phase 1 - ApplyPhase 2 - SpreadPhase 3 - Cover



OR
- 2. Application of the gel to a sterile, non-adhesive dressing or Apply a thick layer (approximately 1 mm) of Filsuvez to the wound dressing (Phase 1). or With a clean hand or wearing a glove, spread an abundant amount of gel onto the part that will come into direct contact with the wound (Phase 2). or Cover the wound with the dressing (Phase 3).
Phase 1 - ApplyPhase 2 - SpreadPhase 3 - Cover



- Reapply the gel with each dressing change, until the wound is healed.
- Filsuvez is not for internal use. Avoid contact with eyes, mouth or nostrils. If accidental contact occurs, immediately wash the affected area with clean water.
- This tube of sterile gel is for single use only. Once opened, the gel must be used immediately and the tube must be discarded, even if it still contains some gel. A new tube must be used with each dressing change.
Duration of use
Your doctor, pharmacist or nurse will tell you how long you should use the gel. If symptoms
persist or worsen after use, or if complications occur, consult 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. For this
reason, an overdose is very unlikely, even if the medicine is applied to large
areas of skin and for a prolonged period of time.
If you forget to use Filsuvez
Apply Filsuvez at the next scheduled dressing change, continuing treatment
normally.
If you stop using Filsuvez
Filsuvez must be used according to the instructions of your doctor, pharmacist or nurse. Do not
interrupt treatmentwithout first consulting your doctor, pharmacist or nurse.
If you have any doubts about using this medicine, consult your doctor, pharmacist or
nurse.
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
side effect, including those listed below.
Very common(may affect more than 1 in 10 people)
- wound complications (e.g. increased wound extension, wound reopening, pain at the wound site)
Common(may affect up to 1 in 10 people)
- wound infection
- allergic reaction (hypersensitivity)
- skin itching
- pain and itching in the area where the medicine is applied
- complications of the wound healing process
Uncommon(may affect up to 1 in 100 people)
- wound secretion
- skin irritation (dermatitis)
- itchy rash
- purple rash
- pain
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help to provide more information on the safety of this medicine.
5. How to store 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 pack and the tube after
‘Expiry’. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
This tube of sterile gel is for single use only. Once opened, the gel must be used
immediately and the tube must be discarded, even if it still contains some gel. A new tube must be used
with each dressing change.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Filsuvez contains
The active ingredient is a dry extract of birch bark.
1 g of gel contains: 100 mg of extract (as refined dry extract) of Betula pendula
Roth , Betula pubescensEhrh. and hybrids of both species (equivalent to 0.5-1.0 g of birch bark), of which 84-95 mg of triterpenes calculated as the sum of betulin, betulinic acid,
erythrodiole, lupeol and oleanolic acid. Extraction solvent: n-heptane.
The other component is refined sunflower seed oil.
Description of the appearance of Filsuvez and contents of the pack
Filsuvez is a gel from colourless to slightly yellowish, opalescent, non-aqueous.
Filsuvez gel is packaged in white aluminium collapsible tubes. The tubes are sealed with an aluminium
tamper-evident membrane and 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
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy
Manufacturer
Amryt GmbH
Streiflingsweg 11
75223 Niefern-Öschelbronn
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
Lietuva
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +370 661 663 99
[email protected]
България
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Teл.: +359 888 918 090
[email protected]
België/Belgique/Belgien
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00
Luxembourg/Luxemburg
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00
Česká 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
Tηλ: + 800 44 474447
Tηλ: + 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
Tηλ: + 800 44 474447
Tηλ: + 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]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu. Furthermore, links to other websites on rare diseases and related therapeutic treatments are provided.

- Країна реєстрації
- Лікарська формаGel, 1 g
- Код АТХD03AX13
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до FILSUVETSЛікарська форма: Cream, 0.2%Діюча речовина: Гиалуроновая кислотаВиробник: FIDIA FARMACEUTICI S.P.A.Рецепт не потрібенЛікарська форма: Ointment, 1% + 60 IUДіюча речовина: collagenase, combinationsВиробник: SMITH & NEPHEW GMBHПотрібен рецептЛікарська форма: Gel, 2 GДіюча речовина: bromelainsВиробник: MEDIWOUND GERMANY GMBHПотрібен рецепт
Аналоги FILSUVETS в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог FILSUVETS у Іспанія
Аналог FILSUVETS у Польща
Аналог FILSUVETS у Україна
Лікарі онлайн щодо FILSUVETS
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на FILSUVETS онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
FILSUVETS потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у FILSUVETS — Betulae cortex. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
FILSUVETS виробляється компанією CHIESI FARMACEUTICI S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування FILSUVETS з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати FILSUVETS у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Betulae cortex) включають KONNETTIVINA, IRUXOL, NEXOBRID. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















