Patient leaflet - FILSUVEZ GEL
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) 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.
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.
Step 1 - Apply
Manufacturer
Amryt GmbH
Streiflingsweg 11
75223 Niefern-Öschelbronn Germany
Text continues overleaf Step 2 - Spread Step 3 - Cover
Step 1 - Apply Step 2 - Spread Step 3 - Cover
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XXXX-XX CP0083/1 Driving and using machines
Your ability to drive and use machines will not be affected by this medicine.
3. How to use 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).
- 1.
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).
- • 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.
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 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.
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
M22 5LG
Tel: 0161 488 5555
This leaflet was last revised in September 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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Chiesi No.: 7661-00-MU1
Chiesi Ltd.
Chiesi Ltd. - Version 2 - May 2024