Filsuvez gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Filsuvez gel

birch bark extract

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

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• 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.

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 birch extract derived from the bark.

It is used for the treatment of wounds in adults and children (from 6 months of age) who have a type of disease called "epidermolysis bullosa" (EB), specifically "dystrophic" (DEB) or "junctional" (JEB) forms. This is a condition in which the outer layer of the skin separates from the inner layer, resulting in very fragile skin and the development of wounds.

2. What you need to know before using Filsuvez

Do not use Filsuvez

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Filsuvez.

If you have an allergic reaction, stop using Filsuvez immediately and contact your doctor or nurse. Signs of an allergic reaction include:

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

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

• yellow or green fluid (pus) draining from the wound,
• skin around the wound becoming red, warm, swollen, or increasingly painful.

If you develop a wound infection, you may need to stop using Filsuvez, and additional treatment may be required. Your doctor or nurse will advise you whether treatment with Filsuvez can be resumed once the infection has cleared.

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 speak with your doctor or nurse and stop using Filsuvez on that area of skin.

Filsuvez does not contain birch pollen, so it can be used in people who are allergic to birch pollen.

Avoid getting Filsuvez in your eyes. If this happens, rinse your eyes thoroughly with clean water. Contact your doctor or nurse if irritation persists.

Children

Do not administer 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 available on how Filsuvez might interact with other medicines applied to the skin, taken orally, 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, speak 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 fetus is negligible. Filsuvez may be used during pregnancy.

It is not known whether Filsuvez passes into breast milk, but since systemic absorption of this medicine is extremely low, the risk to the infant is negligible. Filsuvez may be used during breastfeeding, unless the breast area is the site being treated.

Because systemic absorption of this medicine is extremely low, it is not expected to affect fertility.

Driving and using machines

Your ability to drive and operate machinery will not be affected by this medicine.

3. How to use Filsuvez

Follow exactly the instructions for administration of this medicine given to you by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Methods of administration

• Clean the wound before applying Filsuvez.

• Filsuvez can be applied in two ways:

1. Apply directly to the wound
   • Apply a thick layer (approximately 1 mm thick) of Filsuvez onto the wound (step 1).
   • Generously spread the gel and cover the entire wound area with a clean hand or glove (step 2). Do not rub the gel.
   • Cover with a sterile, non-adherent dressing (step 3).

O

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

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

Duration of treatment

Your doctor, pharmacist, or nurse will advise you how long to use the gel. If symptoms persist or worsen after use, or if complications arise in the wound, consult your doctor, pharmacist, or nurse.

If you use more Filsuvez than you should

Filsuvez is applied to the skin and systemic absorption is extremely low. This makes overdose very unlikely, even if applied over large areas of skin and for prolonged periods.

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 it without consulting your doctor, pharmacist, or nurse.

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 can cause adverse effects, although not everyone experiences them. Immediately inform your doctor, pharmacist, or nurse if you notice any side effects, including those listed below.

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

• wound complications (e.g., wound enlargement, wound reopening, and pain at the wound site)

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• wound discharge
• skin irritation (dermatitis)
• itchy rash
• purplish rash
• pain

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the tube and carton after "EXP". The expiry date refers to the last day of the month indicated.

Store below 30 °C.

This sterile gel tube is intended for single use only. After opening, the gel should 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 unused medicines and their packaging. This helps 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: 0.1 g of extract (as refined dry extract) derived from Betula pendula Roth*, Betula pubescens Ehrh., 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 component is refined sunflower oil.

Appearance of the product and contents of the container

Filsuvez is a gel ranging from colourless to slightly yellowish, opalescent and non-aqueous.

Filsuvez gel is supplied 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 box.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer

Amryt GmbH
Streiflingsweg 11
75223 Niefern-Öschelbronn
Germany

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.euopa.eu, and on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)}. There are also links to other websites about rare diseases and orphan medicinal products.