Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - filsuvez

Document Subject

Generated Narrative: MedicinalProductDefinition mp5c0fb39b14c2c2f1d40da5ef86f1b627

identifier: http://ema.europa.eu/identifier/EU/1/22/1652/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Filsuvez gel

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5c0fb39b14c2c2f1d40da5ef86f1b627

identifier: http://ema.europa.eu/identifier/EU/1/22/1652/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - filsuvez

Attesters

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

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.

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.

Driving and using machines Your ability to drive and use machines will not be affected by this medicine.

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 * Apply a thick layer (approximately 1 mm thick) of Filsuvez to the wound (Step 1). * 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. * Cover with a sterile non-adhesive wound dressing (Step 3).

Step 1 - Apply Step 2 - Spread Step 3 - Cover

OR

2. Apply onto a sterile non-adhesive dressing * Apply a thick layer (approximately 1 mm thick) of Filsuvez to the wound dressing (Step 1). * Spread plenty of gel on the area that will have direct contact with the wound with a clean or gloved hand (Step 2). * 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.

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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.

What Filsuvez contains
The active substance is a dry extract from birch bark. 1 g of gel contains: 100 mg extract (as a refined dry extract) 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.

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 and 30 tubes of 9.4 g or
1, 10 and 30 tubes of 23.4 g gel.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Amryt Pharmaceuticals DAC 45 Mespil Road Dublin 4 Ireland tel: 00 800 4447 4447 (toll free) tel: +44 1604 549 e-mail: medinfo@amrytpharma.com

Manufacturer Amryt GmbH Streiflingsweg 75223 Niefern- schelbronn Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Chiesi sa/nv
T l/Tel: + 32 (0)2 788 42 Lietuva ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +370 661 663 pv.global@exceedorphan.com

ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Te .: +359 888 918 pv.global@exceedorphan.com

Luxembourg/Luxemburg Chiesi sa/nv
T l/Tel: + 32 (0)2 788 42 esk republika ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel: +420 724 321 pv.global@exceedorphan.com

Magyarorsz g ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +36 20 399 4pv.global@exceedorphan.com Danmark Chiesi Pharma AB
Tlf: + 46 8 753 35 Malta Amryt Pharmaceuticals DAC Tel: +44 1604 549medinfo@amrytpharma.com

Deutschland Chiesi GmbH
Tel: + 49 40 89724-0

Nederland Chiesi Pharmaceuticals B.V.
Tel: + 31 88 501 64 Eesti ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +370 661 663 pv.global@exceedorphan.com

Norge Chiesi Pharma AB
Tlf: + 46 8 753 35
Amryt Pharmaceuticals DAC T : +800 44 474T : +44 1604 549medinfo@amrytpharma.com

sterreich Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073Espa a Chiesi Espa a, S.A.U.
Tel: + 34 93 494 8Polska ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +48 502 188 pv.global@exceedorphan.com

France Chiesi S.A.S.
T l: + 33 1 47688Portugal Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2Hrvatska ExCEEd Orphan Distribution d.o.o. Savska cesta 32, Zagreb, 100 Croatia
Tel: +385 99 320 0pv.global@exceedorphan.com

Rom nia ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel: +40 744 366 pv.global@exceedorphan.com

Ireland Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2Slovenija ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel: +386 30 210 pv.global@exceedorphan.com

sland Chiesi Pharma AB
S mi: +46 8 753 35 Slovensk republika ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel: +420 608 076 pv.global@exceedorphan.com

Italia Chiesi Italia S.p.A.
Tel: + 39 0521 2Suomi/Finland Chiesi Pharma AB
Puh/Tel: +46 8 753 35
Amryt Pharmaceuticals DAC T : +800 44 474T : +44 1604 549medinfo@amrytpharma.com

Sverige Chiesi Pharma AB
Tel: +46 8 753 35 Latvija ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 Czech republic Tel.: +370 661 663 pv.global@exceedorphan.com

United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: