Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Filsuvez Gel
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Betula pendula roth, betula pubescens ehrh. (as dry extract, refined) may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Filsuvez gel is a herbal medicinal product which contains dry extract from birch bark. It is used to treat wounds in adults and children (age 6 months and older) who have a type of the condition "epidermolysis bullosa" (EB) called "dystrophic" (DEB) or "junctional" (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. 2.
What you need to know before you take it
e 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 using Filsuvez. If you get an allergic reaction, stop using Filsuvez immediately and see your doctor or nurse. Signs of an allergic reaction include: • itching, swelling and redness of the skin that is more severe on the area where the medicine has been applied. Wound infection is a serious complication that can occur during the healing process. Possible signs of a wound infection are: • yellow or greenish fluid (pus) draining from the wound, • red, warm, swollen, or increasingly painful skin around the wound. If you have a wound infection, you may need to stop using Filsuvez and another treatment may be required. Your doctor or nurse will let you know if treatment with Filsuvez can be restarted once the infection has gone.
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People with EB are more likely to develop a type of skin cancer called "squamous cell carcinoma" (SCC). If you are diagnosed with a skin cancer while using Filsuvez you should talk with your doctor or nurse and stop using Filsuvez on that part of your skin. Filsuvez does not contain birch pollen, so it may be used by people with a birch pollen allergy. Avoid getting Filsuvez in your eyes. If this does happen, rinse your eyes well with clean water. Contact your doctor or nurse if any discomfort continues. Children Do not give this medicine to children below 6 months. 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 could react 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, breast-feeding and fertility No studies have been done on the effects of Filsuvez on pregnant women, but since the absorption of this medicine into the body is extremely low, the risk to the unborn baby is negligible. Filsuvez can be used during pregnancy. It is not known whether Filsuvez passes into human breast milk, but since the absorption of this medicine into the body is extremely low, the risk to the baby is negligible. Filsuvez can be used during breast-feeding, unless the chest area is being treated. Since the absorption of this medicine into the body is extremely low, it is not expected to affect fertility. Driving and using machines Your ability to drive and use machines will not be affected by this medicine. 3.
How to take it
Filsuvez
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Methods of administration • Clean the wound before applying Filsuvez. • You can apply Filsuvez in 2 ways: 1. Apply directly to the wound o Apply a thick layer (approximately 1 mm thick) of Filsuvez to the wound (Step 1). o Spread plenty of gel and cover the whole area of the wound with a clean or gloved hand (Step 2). Do not rub in the gel. o Cover with a sterile non-adhesive wound dressing (Step 3).
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Step 1 – Apply
Step 2 – Spread
Step 3 – Cover
OR 2. Apply onto a sterile non-adhesive dressing o Apply a thick layer (approximately 1 mm thick) of Filsuvez to the wound dressing (Step 1). o Spread plenty of gel on the area that will have direct contact with the wound with a clean or gloved hand (Step 2). o Cover the wound with the dressing (Step 3). Step 1 – Apply
• • •
Step 2 – Spread
Step 3 – Cover
Re-apply the gel each time your dressing is changed, until the wound is healed. Filsuvez is not for internal use. Avoid contact with the eyes, mouth or nostrils. If accidental contact does occur, immediately wash with clean water. This tube of sterile gel is for a single application. Once opened, the gel should be used immediately and the tube thrown away, even if there is some gel left. A new tube should be used at each dressing change.
Duration of use Your doctor, pharmacist or nurse will tell you for how long you should use the gel. If symptoms continue or worsen after use, or if wound complications occur, speak to your doctor, pharmacist or nurse. If you use more Filsuvez than you should Filsuvez is applied to the skin and the absorption into the body is extremely low. This makes overdose very unlikely, even if applied to large skin areas and for a long period of time. If you forget to use Filsuvez Apply Filsuvez at the next planned change of wound dressing, continuing with your normal routine. If you stop using Filsuvez Filsuvez should be used as advised by your doctor, pharmacist or nurse. Do not stop using it without consulting your doctor, pharmacist or nurse. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor, pharmacist or nurse straight away if you notice any side effects including those listed below. Very common (may affect more than 1 in 10 people) • wound complication (e.g. increase in wound size, wound re-opening, wound pain) Common (may affect up to 1 in 10 people) • wound infection • allergic reaction (hypersensitivity) • itchy skin • pain and itching where the medicine is applied • complications of wound healing Uncommon (may affect up to 1 in 100 people) • wound secretion • skin irritation (dermatitis) • itchy rash • purple coloured rash • pain Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.
How to store it
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 refers to the last day of that month. Store below 30°C. This tube of sterile gel is for a single application. Once opened, the gel should be used immediately and the tube thrown away, even if there is some gel left. A new tube should be used at each dressing change. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Filsuvez contains The active substance is a dry extract from birch bark. 1 g gel contains: 100 mg extract (as a refined dry extract) from Betula pendula Roth, Betula pubescens Ehrh.as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), including 84-95 mg 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. 5
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What Filsuvez looks like and contents of the pack Filsuvez is a colourless to slightly yellowish, opalescent non-aqueous gel. Filsuvez gel is packed in white collapsible aluminium tubes. The tubes are closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap. The tube is packed in a carton. Pack sizes: 1, 10 and 30 tubes of 23.4 g gel. Not all pack sizes may be marketed. Marketing Authorisation Holder Chiesi Limited 333 Styal Road Manchester Tel: 0161 488 5555 Manufacturer Amryt GmbH Streiflingsweg 11 75223 Niefern-Öschelbronn Germany This leaflet was last revised in August 2024 Detailed information on this medicine is available on the Medicines and Healthcare products Regulatory Agency (MHRA) web site: http://www.mhra.gov.uk
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Frequently asked questions about Filsuvez Gel
How do I take Filsuvez Gel?
Filsuvez Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Filsuvez Gel?
The active substance in Filsuvez Gel is betula pendula roth, betula pubescens ehrh. (as dry extract, refined).
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Filsuvez Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Filsuvez Gel without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: betula pendula roth, betula pubescens ehrh. (as dry extract, refined)
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.
4.2. Posology and method of administration
Posology
The gel should be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile non adhesive wound dressing or applied to the dressing so that the gel is in direct contact with the wound. The gel should not be applied sparingly. It should not be rubbed in. The gel should be reapplied at each wound dressing change. The maximum total wound area treated in clinical studies was 5,300 cm2 with a median total wound area of 735 cm2. If symptoms persist or worsen after use, or if wound complications occur, the patient's condition should be fully clinically assessed prior to continuation of treatment, and regularly re evaluated thereafter.
Special populations
Renal or hepatic impairment
No studies have been conducted with Filsuvez in patients with renal or hepatic impairment. No dose adjustment or special considerations are anticipated for patients with renal or hepatic impairment (see section 5.2).
Elderly
No dose adjustment is required.
Paediatric population
The posology in paediatric patients (6 months and older) is the same as in adults. The safety and efficacy of Filsuvez in children aged less than 6 months have not been established. No data are available.
Method of administration
For cutaneous application only.
Filsuvez should be applied to cleansed wounds. This medicinal product is not for ophthalmic use and should not be applied to mucous membranes.
Each tube is for single use only. The tube should be discarded after use.
4.3. Contraindications
Hypersensitivity to the active substance or to the excipient listed in section 6.1.
4.4. Special warnings and precautions for use
Hypersensitivity
Hypersensitivity has occurred in patients treated with Filsuvez (see section 4.8). If signs and symptoms of local or systemic hypersensitivity occur, Filsuvez should be discontinued immediately and appropriate therapy should be initiated.
Wound infection
The gel is sterile. However, wound infection is an important and serious complication that can occur during wound healing. In the case of infection, it is recommended to interrupt treatment. Additional standard treatment may be required (see section 4.5). Treatment may be re‑initiated once the infection has resolved.
Squamous cell carcinoma and other skin malignancies
Patients with dystrophic EB (DEB) and junctional EB (JEB) may be at increased risk of development of squamous cell carcinoma. While there has been no increased risk of skin malignancies associated with Filsuvez to date, a theoretical increased risk of skin malignancies associated with use of Filsuvez cannot be ruled out. In the case of diagnosis of squamous cell carcinoma or other skin malignancies, treatment to the affected area should be discontinued.
Use in dominant dystrophic EB (DDEB) and junctional EB (JEB)
The quantity of clinical data from use of Filsuvez in patients with DDEB and JEB is limited (see section 5.1). The patient's condition should be regularly evaluated to assess the benefit of continued treatment.
Birch pollen allergy
Filsuvez is safe to use for people who are allergic to birch pollen, as these allergens are not present in this medicinal product.
Accidental eye exposure
In the case of exposure to eyes product should be removed by eye irrigation.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Since the systemic exposure of the main component betulin following cutaneous application is negligible no interaction with systemic treatments is expected. Interactions with topical products have not been investigated in clinical trials. Other topical products should not be concomitantly used together with Filsuvez but rather sequentially or alternatively depending on the clinical need.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of Filsuvez in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). No effects during pregnancy are anticipated, since systemic exposure to Filsuvez is negligible. Filsuvez can be used during pregnancy.
Breast‑feeding
It is unknown whether birch bark extract/metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to Filsuvez is negligible. Filsuvez can be used during breast‑feeding, unless the chest area is subject to treatment.
Fertility
No adverse effects on fertility were observed in male and female rats administered birch bark extract. No effects on human fertility are anticipated, since the systemic exposure is negligible
4.7. Effects on ability to drive and use machines
Filsuvez has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most frequently observed adverse reactions were wound complication (in 11.6% of EB patients and 2.9% of patients with other partial thickness wounds (PTW)), application site reaction (in 5.8% of EB patients), wound infections (in 4.0% of EB patients), pruritus (in 3.1% of EB patients and 1.3% of patients with other PTW), pain of skin (in 2.5% of patients with other PTW) and hypersensitivity reactions (in 1.3% of EB patients). There were no clinically relevant differences in the reactions reported in EB patients compared to patients with other PTW.
Tabulated list of adverse reactions
In the following table, adverse reactions are listed by MedDRA system organ class and preferred term. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Table 1 lists all adverse reactions reported across clinical studies.
Table 1: Adverse reactions
System organ class
Very common
Common
Uncommon
Infections and infestations
Wound infections
Immune system disorders
Hypersensitivity reactions*
Skin and subcutaneous tissue disorders
Wound complication*
Pruritis
Dermatitisa
Rash pruritica
Purpuraa
General disorders and administration site conditions
Application site reactions* (e.g. application site pain and application site pruritis)
Paina
Injury, poisoning and procedural complications
Wound complication*a
Wound secretion
* see Description of selected adverse reactions
a adverse reactions observed in studies of patients with grade 2a burn wounds or split‑thickness skin grafts
Description of selected adverse reactions
Hypersensitivity
Common cases of hypersensitivity‑like reactions have been observed during clinical trials in EB patients. These reactions include rash, urticaria and eczema which were mild in 1.3% of patients and severe in 0.4% of patients. For specific recommendations, see section 4.4.
Application site reactions
Mild or moderate application site reactions are common and include application site pain and application site pruritis.
Wound complication
In studies with EB patients, wound complication comprised different kinds of local complications such as increase in wound size, wound re‑opening, wound pain and wound haemorrhage.
In studies in patients with burn wounds or split‑thickness skin grafts, wound complications comprised different kinds of local complications such as post‑procedural complications, wound necrosis, wound secretion, impaired healing, or inflammation of wound.
Paediatric population
70% (n=156) of patients randomised in the pivotal study (see section 5.1) were under the age of 18 with a median age of 12 years. 8% (n=17) of patients were below 4 years of age and 2 patients were under 1 year of age. The adverse reactions observed in the overall population were similar to those observed in the paediatric population.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdosing with Filsuvez is unlikely. No case of overdose has been reported when a maximum amount of 69 g was used on a daily basis for more than 90 days.
No data have been generated to establish the effect of accidental ingestion of Filsuvez. Further management should be as clinically indicated.
💬 Ask about this leaflet
Ask anything about Filsuvez Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.