FilsuveZ

Patient Information Leaflet

Filsuvez gel

birch bark extract
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 using 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 herbal medicinal product containing dry extract of birch bark.
It is used for the treatment of wounds in adults and children (from the age of 6 months) who
suffer from a type of disease called “epidermolysis bullosa” (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 leads to 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, stop using Filsuvez immediately and consult your doctor or nurse. Signs of an allergic reaction include:

• itching, swelling, and redness of the skin, particularly in the area where the medicine has been applied.

A serious complication that may occur during the healing process is wound infection. Possible signs of wound infection include:

• discharge of yellow or greenish fluid (pus) from the wound;
• redness, warmth, swelling, or increased tenderness of the skin around the wound.
  If a wound infection occurs, you will likely need to stop using Filsuvez and start another treatment. Your doctor or nurse will advise you when you can resume treatment with Filsuvez once the infection has resolved.

People with EB have an increased risk of developing a type of skin cancer called "squamous cell carcinoma". If you are diagnosed with skin cancer while using Filsuvez, consult your doctor or nurse and stop using Filsuvez on the area of the tumour.
Filsuvez does not contain birch pollen and therefore can be used by people who are allergic to birch pollen.
Avoid contact of Filsuvez with the eyes. If this occurs, rinse the eyes thoroughly with clean water. Consult your doctor or nurse if irritation persists.

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

Other medicines and Filsuvez
Inform your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.
There is no information available on how Filsuvez may interact with other medicines applied to the skin, taken by mouth, or administered by injection. Do not apply other products to the wound area at the same time as Filsuvez. If you need to use more than one product, discuss this with your doctor or nurse.

Pregnancy, breastfeeding, and fertility
Studies on the effects of Filsuvez in pregnant women have not been conducted; however, since absorption of this medicine into the body is extremely low, the risk to the unborn child is negligible. Filsuvez may be used during pregnancy.
It is not known whether Filsuvez passes into breast milk; however, due to the extremely low systemic absorption of this medicine, the risk to the breastfed infant is negligible. Filsuvez may be used during breastfeeding, provided the area to be treated is not on the chest.
Because systemic absorption of this medicine is extremely low, it is not expected to have any effect on fertility.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How to use Filsuvez

Use this medicine exactly as instructed by your doctor, pharmacist, or
nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Methods of application

• 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 (Step 1). or With a clean hand or while wearing a glove, spread a generous amount of gel to completely cover the wound area (Step 2). The gel must not be rubbed into the wound. o Cover the wound with a non-adherent dressing (Step 3).

Step 1 - Apply Step 2 - Spread Step 3 - Cover

OR

2. Application of the gel onto a sterile, non-adherent dressing or Apply a thick layer (approximately 1 mm) of Filsuvez to the wound dressing (Step 1). or With a clean hand or while wearing a glove, spread a generous amount of gel on the side that will be in direct contact with the wound (Step 2). o Cover the wound with the dressing (Step 3).

Step 1 - Apply Step 2 - Spread Step 3 - Cover

• Reapply the gel at each dressing change, until the wound has healed.
• Filsuvez is not for oral use. Avoid contact with the eyes, mouth, or nostrils. In case of accidental contact, immediately rinse the affected area with clean water.
• This tube contains sterile gel for single use only. Once opened, the gel should be used immediately and the tube must be discarded, even if some gel remains. A new tube must be used for each dressing change.

Duration of use
Your doctor, pharmacist, or nurse will advise you on how long you should use the gel. If symptoms
persist or worsen after using the product, 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, overdose is very unlikely, even if the medicine is applied to large areas of
skin and for prolonged periods of time.
If you forget to use Filsuvez
Apply Filsuvez at the next scheduled dressing change, continuing treatment as usual.
If you stop using Filsuvez
Filsuvez should be used according to the instructions provided by your doctor, pharmacist, or nurse. Do not
stop treatment without first consulting your doctor, pharmacist, or nurse.
If you have any doubts about how to use 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.
If you experience any side effect, including those listed below, inform your doctor, pharmacist or nurse immediately.

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

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

Common (may affect up to 1 in 10 people)

• wound infection
• allergic reaction (hypersensitivity)
• skin itching
• pain and itching at the site where the medicine is applied
• complications in the wound healing process

Uncommon (may affect up to 1 in 100 people)

• wound discharge
• skin irritation (dermatitis)
• itchy rash
• purple-coloured rash
• pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help 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 stated on the carton and on the tube after 'Exp'. The expiry date refers to the last day of that month.
Store 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 some gel remains. A new tube must be used at each dressing change.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Filsuvez contains
The active substance is a dry extract of birch bark.
1 g of gel contains: 100 mg of extract (as refined dry extract) from the bark of Betula pendula Roth*, Betula pubescens Ehrh., and hybrids of both species (equivalent to 0.5–1.0 g of birch bark), containing 84–95 mg of triterpenes calculated as the sum of betulin, betulinic acid, erythrodiol, lupeol, and oleanolic acid. Extraction solvent: n-heptane.
The other component is refined sunflower seed oil.

Description of the appearance of Filsuvez and the pack contents
Filsuvez is a non-aqueous, opalescent gel ranging from colourless to slightly yellowish.
Filsuvez gel is packed in white, collapsible aluminium tubes. The tubes are sealed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap.
The tube is packaged in a cardboard carton.
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 about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Chiesi sa/nv ExCEEd Orphan s.r.o.
Tél/Tel: + 32 (0)2 788 42 00 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]

Luxembourg/Luxemburg
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00

Česká republika Magyarország
ExCEEd Orphan s.r.o. ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00 Bucharova 2657/12, Prague 5, 158 00
Czech Republic Czech Republic
Tel: +420 724 321 774 Tel.: +36 20 399 4269
[email protected] [email protected]

Danmark Malta
Chiesi Pharma AB Amryt Pharmaceuticals DAC
Tlf.: +46 8 753 35 20 Tel: +44 1604 549952
[email protected]

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: +49 40 89724-0 Tel: +31 88 501 64 00

Eesti Norge
ExCEEd Orphan s.r.o. Chiesi Pharma AB
Bucharova 2657/12, Prague 5, 158 00 Tlf: +46 8 753 35 20
Czech Republic
Tel.: +370 661 663 99
[email protected]

Ελλάδα Österreich
Amryt Pharmaceuticals DAC Chiesi Pharmaceuticals GmbH
Tηλ: +800 44 474447 Tel: +43 1 4073919
Tηλ: +44 1604 549952
[email protected]

España Polska
Chiesi España, S.A.U. ExCEEd Orphan s.r.o.
Tel: +34 93 494 8000 Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Tel.: +48 502 188 023
[email protected]

France Portugal
Chiesi S.A.S. Chiesi Farmaceutici S.p.A.
Tél: +33 1 47688899 Tel: +39 0521 2791

Hrvatska România
ExCEEd Orphan Distribution d.o.o. ExCEEd Orphan s.r.o.
Savska cesta 32, Zagreb, 100 00 Bucharova 2657/12, Prague 5, 158 00
Croatia Czech Republic
Tel: +385 99 320 0330 Tel: +40 744 366 015
[email protected] [email protected]

Ireland Slovenija
Chiesi Farmaceutici S.p.A. ExCEEd Orphan s.r.o.
Tel: +39 0521 2791 Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Tel: +386 30 210 050
[email protected]

Ísland Slovenská republika
Chiesi Pharma AB ExCEEd Orphan s.r.o.
Sími: +46 8 753 35 20 Bucharova 2657/12, Prague 5, 158 00
Czech Republic
Tel: +420 608 076 274
[email protected]

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: +39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
Amryt Pharmaceuticals DAC Chiesi Pharma AB
Tηλ: +800 44 474447 Tel: +46 8 753 35 20
Tηλ: +44 1604 549952
[email protected]

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. Links to other websites on rare diseases and related therapeutic treatments are also provided.