Prospect: information for the patient

Filsuvez gel

extract of birch bark

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.

people, even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor, pharmacist, or nurse,

even if the adverse effects are not listed in this prospect. See section 4.

1. What Filsuvez is and for what it is used

2. What you need to know before starting to use Filsuvez

3. How to use Filsuvez

4. Possible adverse effects

5. Storage of Filsuvez

6. Contents of the package and additional information

Filsuvez gel is a plant-based medication containing dry extract of birch bark.

It is used for the treatment of wounds in adults and children (aged 6 months and above) suffering from a type of disease called "epidermólisis bullosa" (EB) known as "distrófica" (EBD) or "juntural" (EBJ). This is a condition in which the outer layer of the skin separates from the inner layer, making the skin very fragile and causing the appearance of wounds.

No use Filsuvez

-if you are allergic to birch bark or any of the other components of this medication (listed in section6).

Warnings and Precautions

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

If you have an allergic reaction,stop using Filsuvez immediatelyand consult your doctor or nurse. Symptoms of an allergic reaction include:

• itching, swelling, and redness of the skin that is more severe in the area where the medication was applied.

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

• yellow or greenish liquid (pus) oozing from the wound,
• red, warm, swollen, or increasingly painful skin around the wound.

If you have a wound infection, you may need tostop using Filsuvezandanother treatment may be necessary.Your doctor or nurse will inform you if treatment with Filsuvez can be resumed once the infection has cleared up.

People with EB are more prone to developing 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 andstop using Filsuvezon that area of skin.

Filsuvezdoes notcontain birch pollen, so it can be used in people with birch pollen allergy.

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

Children

Do not administer this medication to children under 6 months of age.

Other Medications andFilsuvez

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may use any other medication.

There is no information on how Filsuvez may interact with other medications 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

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

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

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

Driving and Operating Machinery

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

Follow exactly the administration instructions of thismedicationas indicated by your doctor, pharmacist or nurse. In case of doubt, consult again with your doctor, pharmacist or nurse.

Administration Forms

• Clean the wound before applyingFilsuvez.

• Filsuvez can be applied in two ways:

1. Apply directly on the wound

• Apply a thick layer (approximately 1mm in thickness) of Filsuvezon the wound (step1).
• Spread the gel abundantly and cover the entire wound areawith a clean hand or with a glove (step2).Do notrub the gel.
• Cover with a sterile non-adhesive dressing (step3).

Or

2. Apply on a sterile non-adhesive dressing

• Apply a thick layer (approximately 1mm in thickness) of Filsuvez on the dressing of the wound (step1).
• Spread abundant gel on the area that will have direct contact with the woundwith a clean hand or with a glove(step2).
• • Cover the wound with the dressing (step3).

• Reapply the gel every time the dressing is changed, until the wound is healed.
• Filsuvezis not intendedfor internal use. Avoid contact with the eyes, mouth or nostrils. In case of accidental contact, wash immediately with clean water.
• This sterile gel tube 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 must be used for each dressing change.

Treatment Duration

Your doctor, pharmacist or nurse will indicate for how long you should use the gel. If symptoms persist or worsen after use, or if complications occur in the wound, consult your doctor, pharmacist or nurse.

If you use more Filsuvez than you should

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

If you forgot to use Filsuvez

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

If you interrupt treatment with Filsuvez

Filsuvezmust be used according to the indications of your doctor, pharmacist or nurse.Do not stop using itwithout consulting your doctor, pharmacist or nurse.

If you have any other questions about the use of this medication, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.Inform your doctor, pharmacist, or nurse immediately if you notice any side effects, including those listed below.

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

• wound complications (for example, increased wound size, wound reopening, and pain at the same site)

Common(may affect up to 1 in 10 people)

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

Rare(may affect up to 1 in 100 people)

• exudate from the wound
• skin irritation (dermatitis)
• pruritic rash
• purple rash
• pain

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possibleside effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the tube after "CAD". The expiration date is the last day of the month indicated.

Store below 30°C.

This sterile gel tube is intended for a single application. 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.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition ofFilsuvez

The active principle is dry extract of birch bark.

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

The other component is refined sunflower oil.

Appearance of theproduct and contents of the packaging

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

Filsuvez gel is presented in collapsible aluminum tubes of white color. The tubes are closed with an aluminum membrane resistant to manipulations and are equipped with a white polypropylene screw cap.

The tube is packaged in a cardboard box.

Packaging sizes:

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

ChiesiPharmaceuticals S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturer

Amryt GmbH

Streiflingsweg 11

75223 Niefern‑Öschelbronn

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: August 2024

For detailed information about this medicine, please visit the website of the European Medicines Agency:https://www.ema.europa.eu,and 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 medicines.