Filsuvez

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w)

Available from:

Amryt Pharmaceuticals DAC

ATC code:

D03AX13

INN (International Name):

birch bark extract

Therapeutic group:

Preparations for treatment of wounds and ulcers

Therapeutic area:

Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional

Therapeutic indications:

Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.

Product summary:

Revision: 2

Authorization status:

Authorised

Authorization date:

2022-06-21

Patient Information leaflet

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FILSUVEZ GEL
birch bark extract
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 further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Filsuvez is and what it is used for
2.
What you need to know before you use 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 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 USE 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)

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Filsuvez gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains 100 mg of extract (as dry extract, refined) from
_Betula pendula_
Roth,
_Betula _
_pubescens_
Ehrh. as well as hybrids of both species, cortex (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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel
Colourless to slightly yellowish, opalescent, non-aqueous gel.
4.
CLINICAL PARTICULARS
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 cm
2
with a median total wound area of 735 cm
2
. 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 bee