What Versatis is and what it is used for
Versatis contains lidocaine, a local pain reliever that works by relieving pain in the skin.
You have been given Versatis to treat a painful skin condition called postherpetic neuralgia (pain caused by previous shingles infection). This condition is characterized by local symptoms such as burning, throbbing, or stabbing pain.
What you need to know before using Versatis
Do not 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 products similar to lidocaine, such as bupivacaine, etidocaine, mepivacaine, or prilocaine.
- on damaged skin or in open wounds.
Warnings and precautions
Talk to your doctor or pharmacist before using Versatis.
If you have serious liver, heart, or kidney disease, you should talk to your doctor before using Versatis.
Versatis should only be used on the skin after the shingles have healed. It should not be used on or near the eyes or mouth.
Lidocaine is broken down in the liver into several different substances. One of these is 2,6 xylidine, which has been shown to cause tumors in rats when given throughout the rats’ lifetimes in very high doses. The significance of this discovery to humans is not known.
Children and young people
Versatis has not been studied in patients under 18 years of age. Use in these patients is therefore not recommended.
Other medicines and Versatis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Versatis should be used during pregnancy, only when necessary.
There are no studies on the use of the patch in breastfeeding women. When using Versatis, there are probably only very small amounts of the active substance, lidocaine, in the blood. An effect on breastfed children is unlikely.
Driving ability and use of machinery
The influence of Versatis on the ability to drive and use machines is unlikely. You can therefore drive vehicles and operate machinery while using Versatis.
Versatis contains propylene glycol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate
The patches contain propylene glycol (E1520), which can cause skin irritation. In addition, the patch contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which can cause allergic reactions. Allergic reactions can sometimes occur after you have used the patches for some time.
How to use Versatis
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended daily dose is the use of between 1 and 3 patches of the same size as the painful skin area. Versatis can be cut into smaller pieces to fit the painful skin area. You should not use more than 3 patches at the same time.
The patches should be removed after 12 hours of use, so you get a 12-hour patch-free period. You can choose to put the patch on during the day or the night.
You usually feel some pain relief the first day you use the patches, but it can take up to 2-4 weeks before you get the full pain relief effect of Versatis. If after that time you are still in a lot of pain, you should talk to your doctor as the benefits of the treatment must be weighed against any possible risks (see section 2, under “Warnings and precautions”).
The doctor will check how well Versatis is working at regular intervals.
Before putting Versatis on the painful area
- If the painful skin surface is hairy, cut the hair with scissors. Do not shave them off.
- The skin must be dry and clean.
- Creams and lotions can be used on the affected skin area during the period you do not have a patch.
- If you have just bathed or showered, you should wait until the skin has cooled down before applying the patch.
Application of plasters
Step 1: Open the bag and take out one or more patches
- tear or cut open the bag along the dotted line
- if you use scissors, you must be careful not to damage the patches
- remove one or more plasters depending on how large the painful skin surface is
Step 2: Close the bag
- close the bag carefully
- the patches contain water and will dry out if the bag is not sealed properly
Step 3: Cut as needed to the patch
| before removing the protective film, if necessary, the patch can be cut to the desired size to fit the painful area. |
Step 4: Remove the protective film
Step 5: Apply the patch and press it against the skin
Leave the patch on the skin for a maximum of 12 hours
Versatis mustn’t be in contact with the skin for longer than 12 hours. For example, if you have the most pain at night, you can put the patch on at 7:00 p.m. and take it off at 7:00 in the morning.
If you have more pain during the day than at night, you can put Versatis on at 7 am and take it off at 7 pm.
Bathing, showering, and swimming
If possible, you should avoid contact with water while using Versatis. Bathing, showering, and swimming can be postponed to the period when you are not wearing a patch. If you have just bathed or showered, you should wait until the skin has cooled down before applying the patch.
If the patch falls off
In very rare cases, the patch may fall off or become detached. If this happens, try to push it back to the same place. If it doesn’t stick, remove it and apply a new patch in the same place.
Removing Versatis
When changing the patch, pull off the old patch slowly. If it is difficult to remove, you can soak it in warm water for a few minutes before pulling off the patch.
If you forget to remove the patch after 12 hours
Remove the patch as soon as you remember. A new patch can be used again after 12 hours.
If you have used too much Versatis
If you use more patches than necessary or leave them on for too long, this can increase the risk of side effects.
If you have used too much medicine or if, for example, a child has used or ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Versatis
If you forget to put on a new patch after the 12-hour patch-free period, you should put on a new patch as soon as you remember.
If you have further questions about this medicine, contact your doctor or pharmacist.
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 measures to take if you are affected:
If you feel irritation or burning while using the patch, you should take it off. The irritated area should be free of plasters until the irritation has passed.
Other side effects that may occur:
Very common (may affect more than 1 in 10 users):
Skin conditions on or around the patch application site which may include redness, rash, itching, burning, skin inflammation, and small blisters.
Uncommon (may affect up to 1 in 100 users):
Skin damage and skin ulcers.
Very rare (may affect up to 1 in 10,000 users):
Open wound, severe allergic reaction, and allergy.
How to store Versatis
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the bag and carton. The expiration date is the last day of the specified month.
Store protected from cold. Do not freeze.
After opening the bag, it must be kept tightly closed. Light sensitive.
Shelf life after opening the bag: 14 days.
Do not use this medicine if you notice that the bag is damaged, as the patches may dry out and become less sticky.
Destruction of Versatis
Used patches still contain the active ingredient, which may be harmful to others. Fold the used patch in half with the sticky sides facing each other and dispose of it out of the reach of children.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is lidocaine.
- Each 10 cm x 14 cm patch contains 700 mg ( equivalent to 5% v/v) of lidocaine.
- Other ingredients in the patch (excipients) are glycerol, liquid sorbitol, carmellose sodium, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminum glycinate, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polyacrylic acid, sodium polyacrylate, purified water.
Support fabric and protective film: polyethylene terephthalate (PET)
Appearance and package sizes of the medicine
The medical patch is 14 cm long and 10 cm wide. It is white and made of fleece textile marked with “lidocaine 5%”. The patches are packed in resealable bags, each containing 5 patches.
Each box contains 5, 10, 20, 25, or 30 patches packed in 1, 2, 4, 5, or 6 bags respectively. Not all pack sizes may be marketed.
Grünenthal GmbH
Zieglerstr. 6
52078 Aachen
Germany
This medicine is approved in the European Economic Area under the names:
Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom, Hungary, Austria: Versatis
Portugal: Vessatis