Versatis
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How to use Versatis
Leaflet included in the packaging: patient information
Versatis, 700 mg, medicinal patch
Lidocaine
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.
- You should keep this leaflet, so that you can read it again if necessary. If you have any questions, you should consult a 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, you should 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 packaging 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 substances similar to lidocaine, such as bupivacaine, etidocaine, mepivacaine, or prilocaine;
- on damaged skin and open wounds;
Warnings and precautions
Before starting to use Versatis, you should discuss it with your doctor, pharmacist, or nurse.
If you have severe liver disease, serious heart problems, or kidney problems, you should consult your doctor before starting to use Versatis.
Versatis can be used on areas of skin after the healing of postherpetic lesions. It should not be used on the eyes, nose, or their surroundings.
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.
Children and adolescents
Versatis has not been tested 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
You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about 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, you should consult your doctor or pharmacist 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, only 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 vehicles and operate machines.
Versatis contains propylene glycol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate
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 after the first application of the patch.
3. How to use Versatis
This medicine should always be used exactly as advised by your doctor or pharmacist.
If you are not sure, you should consult 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. You should not use more than three patches at the same time.
The patches should be removed after 12 hours of use, so that a 12-hour patch-free period is maintained. The Versatis patch can be applied during the day or at night.
Usually, a reduction in pain intensity occurs within the first day of using the patch, but the full analgesic effect of Versatis may only occur 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 using scissors. They should not be shaved.
- The skin should be clean and dry.
- During the period when the patch is not attached, creams and liquids can be applied to the affected skin.
- After bathing and showering, you should wait before applying the patch until the skin temperature has dropped.
Applying the patch
Step 1: Open the sachet and take out one or more patches
cut the sachet along the broken line
if using scissors, be careful not to damage the patches
take out 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
Step 4: Remove the protective layer
remove the transparent protective layer from the patch
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 that the patch adheres well to the skin
make sure that the entire patch, including the edges, is attached to the skin
Leave the patch on the skin for up to 12 hours
It is essential that Versatis is in contact with the skin for only up to 12 hours. If the most severe pain occurs, for example, at night, you can apply the patch at 7:00 pm and remove it at 7:00 am.
If the most severe 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, you should avoid contact with water. You can bathe, shower, and swim when you do not have the patch attached. After bathing and showering, you should wait before applying the patch until the skin temperature has dropped.
If the patch falls off
Rarely, the patch may fall off or come loose. In such a case, you should try to stick it back in the same place. If this does not work, you should remove it and apply a new patch to the same place.
How to remove the Versatis patch
When changing the patch, the old patch should be slowly peeled off. If the patch does not come off, you can soak it in warm water for a few minutes before peeling it off.
If you forget to remove the patch after 12 hours
You should 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 the 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 the use of the medicine, you should consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects or symptoms to watch out for and what to do when they occur:
If, during the use of the patch, irritation or burning occurs, the patch should be removed.
Do not apply the 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions 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
e-mail: [email protected].
Reporting side effects will help to gather more information on the safety of this medicine.
5. How to store Versatis
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton. The expiry date refers to the last day of that 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, you should fold it in half with the adhesive side inwards and then throw it away in a place inaccessible to children.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
6. Contents of the packaging 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, acetic acid, gelatin, polyvinyl alcohol, aluminum glycinate, disodium edetate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), polyacrylic acid, sodium polyacrylate, purified water. The backing and protective film: poly(ethylene terephthalate) (PET).
- The backing and protective film: poly(ethylene terephthalate) (PET).
What Versatis looks like and contents of the pack
The patch with the medicine 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 packaged in a sachet (with the possibility of re-closing). Each sachet contains 5 patches.
The outer packaging - a carton - may contain 1, 2, 4, 5, or 6 sachets, which corresponds to 5, 10, 20, 25, or 30 patches. Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer:
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany
This medicinal product 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, United Kingdom: Versatis
Portugal: Vessatis
Date of last revision of the leaflet: 01.02.2018.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterGruenenthal GmbH
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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