Versatis
Italy
Table of Contents
Patient Information Leaflet
Versatis 700 mg medicated patch
Lidocaine
Please read this leaflet carefully before using this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).
Contents of this leaflet
- What Versatis is and what it is used for
- What you need to know before using Versatis
- How to use Versatis
- Possible side effects
- How to store Versatis
- Contents of the pack and other information
1) What is VERSATIS and what is it used for?
Versatis contains lidocaine, a local analgesic that works by reducing pain at the skin level.
It has been prescribed to treat pain caused by post-herpetic neuralgia. This condition is typically characterized by localized symptoms such as burning, stabbing, or shooting pain.
2) What you need to know before using Versatis
Do not use Versatis
- if you are allergic to lidocaine or to 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 open wounds.
Warnings and precautions
Talk to your doctor or pharmacist before using Versatis
If you suffer from severe liver disease or have serious heart or kidney problems, you should discuss this with your doctor before using Versatis.
Versatis should be applied to the skin after the herpes zoster lesions have healed. It must not be applied to or near the eyes or mouth.
Lidocaine is metabolized into several compounds in the liver. One of these compounds is 2,6-xylidine, which has been shown to cause tumors in rats when administered continuously at very high doses. The relevance of these findings in humans is unknown.
Children and adolescents
Versatis has not been studied in patients under 18 years of age. Therefore, its use in these patients is not recommended.
Other medicines and Versatis
Inform 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, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Versatis should not be used during pregnancy unless strictly necessary.
There are no studies on the use of the patch during breastfeeding. When using Versatis, only a small amount of the active ingredient, lidocaine, may be present in the blood. It is unlikely to have an effect on breastfed infants.
Driving and using machines
It is unlikely that Versatis will affect your ability to drive or use machinery. Therefore, it is generally safe to drive or operate machinery while using Versatis.
Versatis contains propylene glycol, methyl 4-hydroxybenzoate, and propyl 4-hydroxybenzoate.
The patches contain propylene glycol (E1520), which may cause skin irritation. In addition, they contain methyl 4-hydroxybenzoate (E218) and propyl 4-hydroxybenzoate (E216), which may cause allergic reactions. Sometimes allergic reactions may appear after using the patches for some time.
3) How to use Versatis
Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual daily dose is one to three patches, sized to cover the painful skin area. Versatis may be cut into smaller pieces to cover the affected area. Do not use more than three patches at the same time.
The patches should be removed after 12 hours of application, leaving a 12-hour period without the patch. You may choose whether to apply Versatis during the day or at night.
You may feel some pain relief as early as the first day of use, but it may take 2 to 4 weeks before the full analgesic effect of Versatis is achieved. If the pain remains severe after this time, inform your doctor, as the benefits of treatment should be weighed against potential risks (see “Warnings and precautions”).
Your doctor will regularly check whether Versatis is working for you.
Before applying Versatis to the affected area
- If the painful skin area is covered with hair, trim it with scissors. Do not shave.
- The skin must be clean and dry.
- Creams or lotions may be applied to the treated skin only during the time when the patch is not in place.
- If you have just taken a bath or shower, wait until the skin has cooled before applying the patch.
Applying the patch
Step 1: Open the pouch and remove one or more patches
- Tear or cut the pouch along the dotted line
- If using scissors, take care not to damage the patches
- Take one or more patches, depending on the size of the painful skin area
Step 2: Close the pouch
- Close the pouch tightly after use
- The patch contains water and may dry out if the pouch is not properly sealed
Step 3: Cut the patch, if necessary
- If needed, cut the patch to the required size before removing the protective film, to cover the painful skin area.
Step 4: Remove the protective film
- Remove the transparent protective film from the patch
- Try not to touch the adhesive side of the patch
Step 5: Apply the patch and press firmly onto the skin
- Apply up to three patches to the painful skin area
- Press the patch onto the skin
- Hold the patch in place for at least 10 seconds to ensure good adhesion
- Make sure the entire patch, including the edges, adheres to the skin.
Leave the patch applied for only 12 hours
It is important that Versatis remains applied to the skin for only 12 hours. For example, if you experience more pain at night, you may apply the patch at 7 PM and remove it at 7 AM. If you have more pain during the day, you may apply Versatis at 7 AM and remove it at 7 PM.
Bathing, showering, and swimming
Since contact of Versatis with water should be avoided, bathing, showering, or swimming should be done only during the time when the patch is not applied. After bathing or showering, wait until the skin has cooled before reapplying the patch.
If the patch comes off
Very rarely, the patch may come off or not adhere properly. In this case, try to reattach it to the same area. If it does not stay in place, remove it completely and apply a new patch to the same area.
How to remove Versatis
To change the patch, remove the old patch slowly. If it does not come off easily, moisten it with warm water for a few minutes before removal.
If you forget to remove the patch after 12 hours
Remove the patch as soon as you remember. The new patch can be applied after 12 hours.
If you use more patches than you should
If you use more patches than recommended or leave them on for too long, your risk of side effects may increase.
If you forget to apply Versatis
If you forget to apply a new patch after the 12-hour interval without the previous patch, apply the new patch as soon as you remember.
If you have any doubts about using this medicine, 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 for and what to do if they occur:
If you experience irritation or a burning sensation during patch application, remove the patch. Do not apply another patch to that area until the irritation has healed.
Other possible side effects include:
Very common (may affect more than 1 in 10 people)
Skin changes in the area where the patch is applied or nearby, including redness, rash, itching, burning, dermatitis, and blisters.
Uncommon (may affect up to 1 in 100 people)
Skin changes and skin injuries
Very rare (may affect up to 1 in 10,000 people)
Open wounds, severe allergic reactions, and allergy.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects, you can help provide more information on the safety of this medicine.
5) How to store Versatis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pouch and carton after EXP. The expiry date refers to the last day of that month.
Do not store in a refrigerator or freezer.
Reseal the pouch carefully after first opening to protect the patches from light.
Shelf life after first opening of the pouch: 14 days.
Do not use this medicine if you notice that the pouch is damaged. In this case, the patch may have dried out and may not adhere properly.
How to dispose of Versatis
Used patches still contain active ingredient, which could be harmful to others. Fold the used patches in half with the adhesive side inside and dispose of them safely, out of children's reach.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6) Contents of the pack and other information
What Versatis contains
- The active substance is lidocaine
- Each 10 cm x 14 cm patch contains 700 mg (5% w/w) of lidocaine
- The other ingredients in the patch (excipients) are: glycerol, liquid sorbitol, sodium carmellose, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminium glycinate, disodium edetate, methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), polycrylic acid, sodium polycrylate, purified water. Support and adhesive layers: polyethylene terephthalate (PET).
Description of the appearance of Versatis and contents of the pack
The medicated patches are 14 cm long and 10 cm wide. They are white, made of soft material, and marked with “lidocaine 5%”. The patches are packed in resealable pouches, each containing 5 patches. Each pack contains 5, 10, 20, 25, or 30 patches, packed in 1, 2, 4, 5, or 6 pouches, respectively. Not all pack sizes may be commercially available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GRÜNENTHAL ITALIA S.r.l., via Carlo Bo 11, 20143 Milan, Italy
Manufacturer:
Grünenthal GmbH – Zieglerstrasse 6 – 52078 Aachen (Germany)
This medicine is authorized in the European Economic Area countries under the following names:
Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, France, Germany, Greece, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland, Czech Republic, Slovakia, United Kingdom, Romania, Slovenia, Spain, Sweden, Hungary: Versatis
Portugal: Vessatis