Betula pendula Roth, Betula pubescens Ehrh. (as dry extract, refined) at a glance
Medicine type
Herbal preparation for treating wounds and ulcers.
Licensed use
Partial-thickness wounds associated with dystrophic or junctional epidermolysis bullosa.
Who can use it
Adults and children aged 6 months and older.
Route
Applied to cleansed wounds or a sterile non-adhesive dressing; for skin use only.
What is Betula pendula Roth, Betula pubescens Ehrh. (as dry extract, refined) used for?
Filsuvez is licensed for:
Partial-thickness wounds associated with dystrophic epidermolysis bullosa.
Partial-thickness wounds associated with junctional epidermolysis bullosa.
Patients aged 6 months and older.
How does Betula pendula Roth, Betula pubescens Ehrh. (as dry extract, refined) work?
The extract contains triterpenes, including betulin. Laboratory studies suggest it affects inflammatory signals and pathways involved in skin-cell movement and maturation needed for wound closure. Its precise mechanism remains uncertain.
How to take Betula pendula Roth, Betula pubescens Ehrh. (as dry extract, refined)
For skin use only. Clean the wound, then spread the gel over it or onto the part of a sterile non-adhesive dressing that will touch it. Do not rub it in. Avoid the eyes, mouth and nostrils. Each sterile tube is for one application and must be discarded immediately after use.
Use a clean or gloved hand to spread the gel.
Cover the treated wound with a sterile non-adhesive dressing.
If gel enters an eye, rinse thoroughly with clean water and seek advice if discomfort continues.
Betula pendula Roth, Betula pubescens Ehrh. (as dry extract, refined) side effects
Common or expected effects
- Wound complications, including increased wound size, reopening, pain or bleeding.
- Pain or itching where the gel is applied.
- Wound infection.
- Itching.
- Hypersensitivity reactions, including rash, hives or eczema.
Get urgent medical advice
- Stop treatment and seek urgent assessment for local or systemic hypersensitivity.
- Seek prompt assessment for pus, spreading redness, warmth, swelling or increasing wound pain.
- Report persistent worsening, wound reopening or other significant wound complications to the treating team.
Betula pendula Roth, Betula pubescens Ehrh. (as dry extract, refined) in pregnancy
There are no clinical pregnancy data, but systemic exposure after skin application is negligible and animal studies did not indicate reproductive harm. The UK product information states that Filsuvez can be used during pregnancy; discuss treatment with the specialist team.
Betula pendula Roth, Betula pubescens Ehrh. (as dry extract, refined) while breastfeeding
It is unknown whether birch-bark extract or its metabolites enter breast milk. Effects on the breastfed child are not anticipated because maternal systemic exposure is negligible. Filsuvez can be used while breastfeeding, except when the chest area is being treated.
Betula pendula Roth, Betula pubescens Ehrh. (as dry extract, refined) interactions
Formal interaction studies have not been performed. Systemic interactions are not expected because absorption is minimal, but simultaneous use of other products on the same wound has not been studied.
Other topical wound or skin products
Do not apply another topical product to the wound at the same time. Where clinically necessary, use products sequentially or alternatively under clinical guidance.
Medicines taken by mouth or injection
A clinically significant interaction is not expected because systemic exposure to betulin is negligible.
Common questions about Betula pendula Roth, Betula pubescens Ehrh. (as dry extract, refined)
Answers are fully visible for fast scanning and source review.
Can someone with birch-pollen allergy use Filsuvez?
Yes. It does not contain the birch-pollen allergens responsible for pollen allergy. It must not be used by someone allergic to birch-bark extract itself or refined sunflower oil.
Can Filsuvez be used in babies?
It is licensed from 6 months of age. Safety and effectiveness have not been established in younger infants.
Can Filsuvez be applied inside the mouth or nose?
No. It is for skin use only and must not be applied to mucous membranes.
Can another cream or gel be applied with Filsuvez?
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.