Versatis 700 mg medicated plaster
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Versatis 700 mg medicated adhesive patch
Lidocaine
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Versatis is and what it is used for
- What you need to know before using Versatis
- How to use Versatis
- Possible adverse effects
- How to store Versatis
- Contents of the pack and other information
1. What Versatis is and what it is used for
Versatis contains lidocaine, a local anaesthetic, which works by reducing pain in the skin.
You have been given Versatis to treat a painful skin condition called postherpetic neuralgia. This condition is generally characterised by localized symptoms such as burning pain, stabbing pain, or sharp, jabbing 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 medicines similar to lidocaine, such as bupivacaine, etidocaine, mepivacaine, or prilocaíne,
- on damaged skin or open wounds.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Versatis.
If you have severe liver disease, severe heart problems, or severe kidney problems, you should speak with your doctor before using Versatis.
Versatis should only be applied to areas of skin where the skin has completely healed. It must not be used on or near the eyes or mouth.
Lidocaine is broken down in the liver into several compounds. One of these compounds is 2,6-xylidine, which has been shown to cause tumours in rats when administered life-long at very high doses. The relevance of these findings to humans is unknown.
Children and adolescents
Versatis has not been studied in patients under 18 years of age. Therefore, its use is not recommended in this patient population.
Using Versatis with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Versatis should not be used during pregnancy unless clearly necessary.
No studies have been conducted with the adhesive patch in breastfeeding women. When using Versatis, only very small amounts 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 operate machinery. Therefore, you may drive or operate machinery while using Versatis.
Versatis contains propylene glycol, methylparahydroxybenzoate, and propylparahydroxybenzoate
The patches contain propylene glycol (E1520), a substance which may cause skin irritation. They also contain methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216), substances which may cause allergic reactions. Sometimes, allergic reactions may occur after having used the patch for some time.
3. How to use Versatis
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended daily dose consists of covering the painful areas of skin using between one and three patches. Versatis may be cut into smaller pieces to fit the affected area. You must not use more than 3 patches at the same time.
The patches should be removed after 12 hours of use, followed by a 12-hour period without a patch.
You may choose to apply Versatis during the day or during the night.
You will usually experience some pain relief on the first day of using the patch, but it may take up to 2–4 weeks before the full effect of Versatis on pain relief is achieved. If you still have significant pain after this time, speak with your doctor, as the benefits of treatment should be weighed against the potential risks (see section 2 “Warnings and precautions”).
Your doctor will check at regular intervals whether Versatis is working effectively.
Before applying Versatis to the affected area
- If the painful area of skin is hairy, you may trim the hair using scissors. Do not shave it.
- The skin must be clean and dry.
- Creams and lotions may be used on the affected skin during the time when you are not wearing the patch.
- If you have recently taken a bath or shower, you should wait until the skin has cooled before applying the patch.
Applying the patch
Step 1: Open the pouch and remove one or more patches
? Open the pouch by tearing or cutting along the dotted line
? When using scissors, take care not to damage the patches
? Remove one or more patches depending on the size of the painful area of skin
Step 2: Close the pouch
- Seal the pouch tightly after use
- The patch contains water and will dry out if the pouch is not closed properly
Step 3: Cut the patch, if necessary
- If needed, cut the patch to adjust its size to the painful area of skin before removing the protective liner
Step 4: Remove the protective liner
- Remove the transparent protective liner from the adhesive patch
- Try not to touch the adhesive surface of the patch
Step 5: Apply the patch and press firmly onto the skin
- Apply up to three patches to the painful area of skin
- Press the patch onto the skin
- Press for at least 10 seconds to ensure the patch adheres firmly
- Make sure the entire patch adheres to the skin, including the edges
Leave the adhesive patch on for only 12 hours
It is important that Versatis remains in contact with the skin for only 12 hours. For example, if you have more pain at night, you may wish to apply the patch at 7 p.m. and remove it at 7 a.m.
If you have more pain during the day than at night, you may wish to apply Versatis at 7 a.m. and remove it at 7 p.m.
Bathing, showering and swimming
If possible, contact with water should be avoided while using Versatis. You may bathe, shower, or swim during the time when you are not wearing the patch. If you have recently bathed or showered, wait until the skin has cooled before applying the patch.
If the patch becomes detached
Very rarely, the patch may fall off or become detached. If this happens, try to reapply it to the same area. If it does not stay in place, remove it and apply a new patch to the same area.
How to remove Versatis
When changing the patch, slowly remove the old patch. If it does not peel off easily, you may soak it in lukewarm water for a few minutes before removal.
If you forget to remove the patch after 12 hours
As soon as you remember, remove the old patch. You may apply a new patch again after 12 hours.
If you use more patches than you should
If you use more patches than needed or wear them for too long, this may increase the risk of experiencing adverse effects.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20.
If you forget to use Versatis
After the 12-hour period without a patch, if you forget to apply a new patch, apply a new one as soon as you remember.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Important adverse effects or symptoms to be aware of and what to do if affected:
If irritation or a burning sensation occurs while using the adhesive patch, the patch should be removed. The irritated area should remain without a patch until the irritation stops.
Other possible adverse effects:
Very common (may affect more than 1 in 10 people): Skin problems at or around the site of application of the adhesive patch, which may include redness, rash, itching, burning, dermatitis, and small blisters.
Uncommon (may affect up to 1 in 100 people): Skin lesions and skin wounds.
Very rare (may affect up to 1 in 10,000 people): Open wound, severe allergic reaction, and allergy.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 the carton after "EXP". The expiry date refers to the last day of the month indicated.
Do not refrigerate or freeze.
After first opening: Keep the pouch tightly closed to protect it from light.
Period of validity after first opening of the pouch: 14 days.
Do not use this medicine if you notice that the pouch has been damaged. If this has occurred, the patches may dry out and fail to adhere properly.
Disposal of Versatis
Used patches still contain active substance, which may be harmful to other people. Fold used patches in half with the adhesive sides together and dispose of them in a way that keeps them out of the reach of children.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Versatis
- The active substance is lidocaine.
- Each 14 cm x 10 cm adhesive patch contains 700 mg (equivalent to 5% w/w) of lidocaine.
- The other components of the patch (excipients) are glycerol, liquid sorbitol, sodium carmellose, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminium glycinate, disodium edetate, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), polycrylic acid, sodium polycrylate, purified water.
Backing material and release liner: polyethylene terephthalate (PET)
Nature of the product and pack contents
The medicated patch measures 14 cm in length and 10 cm in width. It is white in colour and made of non-woven textile material, marked with “Lidocaine 5%”. The adhesive patches are packed in sealed pouches, each containing 5 patches.
Each carton contains 5, 10, 20, 25 or 30 patches, packed in 1, 2, 4, 5 or 6 pouches respectively. Some pack sizes may not be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Grünenthal Pharma, S.A.
Doctor Zamenhof, 36 – 28027 Madrid, Spain
Manufacturer:
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen, Germany
This medicinal product is authorised in the European Economic Area member states under the following names:
Germany, Austria, Belgium, Bulgaria, Cyprus, Denmark, Slovenia, Spain, Estonia, France, Greece, Netherlands, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, United Kingdom, Czech Republic, Slovakia, Romania, Sweden: Versatis
Portugal: Vessatis
Date of the most recent revision of this leaflet: May 2018.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/