Patient leaflet - Episalvan
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Episalvan gel birch bark extract
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or nurse.
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– 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Episalvan is and what it is used for
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2. What you need to know before you use Episalvan
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3. How to use Episalvan
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4. Possible side effects
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5. How to store Episalvan
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6. Contents of the pack and other information
1. What Episalvan is and what it is used for
Episalvan gel is a herbal medicinal product which contains dry extract from birch bark.
It is used in adults for the treatment of skin wounds, resulting for example from grade 2a burn wounds or from surgical skin graft transplantation. There is no experience of the use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers or venous leg ulcers.
2. What you need to know before you use Episalvan
Do not use Episalvan
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– 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 or nurse before using Episalvan.
Episalvan does not contain birch pollen, so it may be used by people with birch pollen allergy.
Wound infection is a serious complication that can occur during the healing process.
Possible signs of a wound infection are that the wound begins to drain yellow or greenish fluid (pus), or that the skin around the wound becomes red, warm, swollen, or increasingly painful.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age because there is insufficient experience of the use of Episalvan in these patients.
Other medicines and Episalvan
If you have an infection in the wound additional treatment may be required.
Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
No studies have been performed to establish whether Episalvan will interact with other medicines. However, since the amount of Episalvan absorbed into the body is extremely low it is not expected that Episalvan will interact with other medicines.
No data are available on possible interaction between Episalvan and other medicines applied to the skin. Do not apply other products to the skin wound area at the same time of applying Episalvan.
Pregnancy, breast-feeding and fertility
No studies have been done on the effects of Episalvan on pregnant women, but since the absorption of this medicine into the body is extremely low, the risk to the unborn baby is negligible. Episalvan can be used during pregnancy.
It is not known whether Episalvan passes into human breast milk, but since the absorption of this medicine into the body is minimal, the risk to the baby is negligible. Episalvan can be used during breast-feeding, unless the chest area is being treated.
The effect of Episalvan on fertility has not been studied, but since the absorption of this medicine into the body is extremely low, it is not expected to have an effect on your fertility.
Driving and using machines
Your ability to drive and use machines will not be affected by this medicine.
3. How to use Episalvan
Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor or nurse if you are not sure.
Method of administration
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– If necessary, wounds should be cleansed using a suitable antiseptic solution prior to application of Episalvan
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– Episalvan should be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile wound dressing.
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– Re-apply the gel each time the dressing is changed, until the wound is healed.
Duration of use
Your doctor or nurse will tell you for how long you should use the gel. Episalvan should be used until the wound is healed or up to 4 weeks.
There is no experience from long-term use of Episalvan for more than 4 weeks.
If you use more Episalvan than you should
Episalvan is applied to the skin and the absorption into the body is minimal. This makes overdose very unlikely, even if applied to large skin areas and for a long period of time.
If you forget to use Episalvan
Do not use a double dose to make up for a forgotten dose. Apply Episalvan at the next planned change of the wound dressing, continuing with your normal routine.
If you stop using Episalvan
Episalvan should be used as advised by your doctor or nurse. Do not stop using it without consulting your doctor or nurse. If your wound shows no signs of improvement over time, talk to your doctor or nurse.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any side effects including those listed below.
The most frequently reported side effects are:
Common side effects (may affect up to 1 in 10 people)
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– complications in the wound healing process
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– painful skin
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– itching
Other side effects include:
Uncommon side effects (may affect up to 1 in 100 people)
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– wound infection
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– allergic reaction (hypersensitivity)
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– skin irritation (dermatitis)
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– itchy rash
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– purple coloured rash
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– pain
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Episalvan
Keep this medicine out of the sight and reach of children.
Store below 30°C.
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.
This product is for single use only and once opened, the product should be used immediately. Discard the tube after first use.
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 Episalvan contains
The active substance is a dry extract from birch bark.
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1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula pendula , Betula pubescens as well as hybrids of both species (equivalent to 0.5–1.0 g birch bark), corresponding to 72–88 mg betulin.
What Episalvan looks like and contents of the pack
Episalvan is a colourless to slightly yellowish, opalescent gel.
Episalvan 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 cardboard box.
Pack size:1 tube of 23.4 g gel.
Marketing Authorisation Holder and Manufacturer
Amryt GmbH
Streiflingsweg 11
75223 Niefern-Oschelbronn
Germany
tel +49 (0) 7233 9749 – 0
fax+49 (0) 7233 9749 – 210
Email:
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
ANNEX IV
GROUNDS FOR ONE ADDITIONAL RENEWAL
Grounds for one additional renewal
Based upon the data that have become available since the granting of the initial Marketing authorisation, the CHMP considers that the benefit-risk balance of Episalvan remains positive, but considers that its safety profile is limited for the following reasons:
For Episalvan limited safety information is available because of limited exposure due to limited marketing of the medicinal product. As of the DLP, Episalvan has been placed on the market in only one EU country.
Episalvan has not yet been commercially launched or placed on the market in any other EU country and thus, no post-authorisation data are currently available. Furthermore, no data on post-authorisation use in special populations were reported as no non-interventional studies, including market research and registries, have been conducted with Episalvan since the granting of the marketing authorisation.
Therefore, based upon the limited safety profile of Episalvan, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
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