Versatis

Package Leaflet: Information for the Patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Versatis, 700 mg, medicinal patch

Lidocaine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Versatis and what is it used for
• 2. Important information before using Versatis
• 3. How to use Versatis
• 4. Possible side effects
• 5. How to store Versatis
• 6. Contents of the pack and other information

1. What is Versatis and what is it used for

Versatis contains lidocaine, a locally acting analgesic that reduces the intensity of skin pain.
Versatis is used to treat painful skin disease - postherpetic neuralgia, whose main symptoms are local burning, piercing, or stabbing pain.

2. Important information before using Versatis

When not to use Versatis

• if you are allergic to lidocaine or any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction to other similar substances to lidocaine, such as: bupivacaine, etidocaine, mepivacaine, or prilocaine;
• on damaged skin and open wounds.

Warnings and precautions

Before starting to use Versatis, discuss it with your doctor, pharmacist, or nurse.
If you suffer from severe liver disease, if you have serious heart or kidney problems, before starting to use Versatis, you should consult your doctor.
Versatis can be used on skin areas after the healing of postherpetic lesions. It should not be used on the eyes and nose or in their vicinity.
Lidocaine is metabolized in the liver to several chemical compounds. One of these compounds is 2,6-xylidine. It has been shown that when administered to rats throughout their lives in high doses, it causes tumors. The significance of these observations for humans is unknown.
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Children and adolescents

Versatis has not been studied in patients under 18 years of age. For this reason, it is not recommended to use the medicine in this age group of patients.

Versatis and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Versatis should not be used during pregnancy, unless it is absolutely necessary.
The use of the patch in breastfeeding women has not been studied. During the use of Versatis, very small amounts of the active substance - lidocaine - appear in the blood of breastfeeding women.
It is unlikely that they will affect the breastfed child.

Driving and using machines

It is unlikely that Versatis will affect your ability to drive or use machines. Therefore, during the use of Versatis, you can drive and use machines.

Versatis contains propylene glycol (E 1520), methyl parahydroxybenzoate (E 218), and propyl parahydroxybenzoate (E 216)

The patch contains propylene glycol (E 1520), which may cause skin irritation. Additionally, the patch contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions. Allergic reactions may sometimes occur after some time from the first application of the patch.

3. How to use Versatis

This medicine should always be used as directed by your doctor or pharmacist.
If you are unsure, ask your doctor or pharmacist.
Usually, the recommended daily dose of the medicine is one to three patches, depending on the size of the painful skin area. Versatis can be cut into smaller pieces to fit the diseased skin areas. Do not use more than 3 patches at the same time.
Patches should be removed after 12 hours of use, so as to maintain a 12-hour patch-free period. The Versatis patch can be applied during the day or at night.
Usually, a reduction in pain intensity occurs already on the first day of using the patch, but the full analgesic effect of Versatis may occur only after 2-4 weeks. If after this time the patient still experiences severe pain, they should consult their doctor, as in such a situation, the benefits and potential risks associated with the treatment should be considered (see section 2 "Warnings and precautions").
Your doctor will check the effectiveness of Versatis at regular intervals.

Before applying Versatis to the affected area

• If the painful area on the skin is hairy, the hair can be cut with scissors. Do not shave.
• The skin should be clean and dry.

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• During the period when the patch is not attached, creams and liquids can be applied to the affected skin.
• After bathing and showering, wait before applying the patch until the skin temperature drops.

Applying the patch

Step 1: Open the sachet and remove one or more patches

• puncture or cut the sachet along the broken line
• when using scissors, be careful not to damage the patches
• remove one or more patches, depending on the size of the painful skin area

Step 2: Close the sachet

• after use, close the sachet tightly
• the patch contains water and will dry out if the sachet is not properly closed

Step 3: If necessary, cut the patch

• if necessary, before removing the protective layer, cut the patch to obtain a patch of a size adapted to the painful skin area

Step 4: Remove the protective layer

• remove the transparent protective layer from the patch

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• try not to touch the adhesive part of the patch

Step 5: Apply the patch and press it firmly to the skin

• apply a maximum of three patches to the painful skin area
• press the patch to the skin
• press for at least 10 seconds to ensure the patch adheres tightly to the skin
• make sure the entire patch, including the edges, is attached to the skin

Leave the patch on the skin for up to 12 hours

It is important that Versatis is in contact with the skin for only up to 12 hours. If the strongest pain occurs, for example, at night, you can apply the patch at 7:00 pm and remove it at 7:00 am.
If the strongest pain occurs during the day, you can apply the Versatis patch at 7:00 am and remove it at 7:00 pm.

Bathing, showering, and swimming

As much as possible, during the use of Versatis, avoid contact with water. You can bathe, shower, and swim when you do not have the patch attached. After bathing and showering, wait before applying the patch until the skin temperature drops.

If the patch falls off

Rarely, the patch may fall off or come loose. In this case, try to reattach it to the same place. If this does not work, remove it and apply a new patch to the same place.

How to remove the Versatis patch

When changing the patch, slowly peel off the old patch. If the patch does not come off, you can soak it in warm water for a few minutes before peeling.

If you forget to remove the patch after 12 hours

Remove the patch immediately after remembering. A new patch can be applied after 12 hours from the removal of the old one.

Using more patches than recommended

Using more patches than recommended or leaving them on the skin for too long may increase the risk of side effects.

Missing a patch application

If, after 12 hours without a patch, you forget to apply a new patch, you can apply a new patch as soon as you remember.
If you have any doubts about using the medicine, ask your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects or symptoms to look out for and what to do if they occur:

If irritation or burning occurs during the use of the patch, remove the patch.
Do not apply a patch to the irritated area; wait until the irritation has resolved.

Other side effects that may occur:

Very common (may affect more than 1 in 10 people):

skin changes at the patch application site and around it, such as: redness, rash, itching, burning, skin inflammation, and small blisters.

Uncommon (may affect up to 1 in 100 people):

skin damage and skin wounds.

Rare (may affect up to 1 in 10,000 people):

open wounds, severe allergic reactions, and hypersensitivity.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Versatis

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store in the refrigerator or freeze.
After opening, store the sachet tightly closed to protect it from light.
Shelf life after first opening: 14 days.
Do not use Versatis if the sachet is damaged. If the sachet is damaged, the patches may dry out and their adhesiveness may be reduced.

How to dispose of Versatis

The used patch still contains the active substance and may be harmful to others.
After removing the patch, roll it up with the adhesive side inwards and then dispose of it in a place inaccessible to children.
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Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Versatis contains

• The active substance of Versatis is lidocaine. Each patch of 10 cm x 14 cm contains 700 mg (5% w/w) of lidocaine.
• The other ingredients of the medicine are: glycerol, liquid sorbitol, sodium carmellose, propylene glycol (E 1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminum glycinate, disodium edetate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), polyacrylic acid, sodium polyacrylate, purified water. Backing layer and protective film: poly(ethylene terephthalate) (PET).

What Versatis looks like and contents of the pack

The medicinal patch is 14 cm long and 10 cm wide. It is white and made of a fabric marked with the inscription "LIDOCAINE 5%". The patches are packed in a sachet (with the possibility of re-closing). Each sachet contains 5 patches.
The outer packaging - a cardboard box may contain 1, 2, 4, 5, or 6 sachets, which corresponds to 5, 10, 20, 25, or 30 patches.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Slovakia, the country of export:

Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany

Manufacturer:

Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Slovakia, the country of export: 01/0054/10-S

Parallel import authorization number: 378/24

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden: Versatis
Portugal: Vessatis

Date of revision of the leaflet: 29.10.2024

[Information about the trademark]
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