Leaflet: information for the user

Versatis 700 mg adhesive medicated plaster

Lidocaína

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Versatis and what it is used for

2. What you need to know before you start using Versatis

3. How to use Versatis

4. Possible side effects

5. Storage of Versatis

6. Contents of the pack and additional information

Versatis contains lidocaine, a local anesthetic, which acts by reducing pain in the skin.

Versatis has been given to treat a painful skin condition called postherpetic neuralgia.This condition is generally characterized by localized symptoms such as burning pain, stabbing pain or stabbing pain.

Do not use Versatis

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Versatis.

If you have a severe liver disease, or serious heart problems, or serious kidney problems, you should talk to your doctor before using Versatis.

Versatis should only be used on areas of skin that have fully healed.It should 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 produce tumors in rats when administered over a long period 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 is not recommended in this patient population.

Use of Versatis with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 the infant.

Driving and operating machines

It is unlikely that Versatis will affect your ability to drive and use machines.Therefore, you may drive or operate machines while using Versatis.

Versatis contains propylene glycol, methyl parahydroxybenzoate and propyl parahydroxybenzoate

The patches contain propylene glycol (E1520), a substance that may cause skin irritation.It also contains methyl parahydroxybenzoate (E218)and propyl parahydroxybenzoate(E216), substancesthat may cause allergic reactions.Allergic reactions may occur after using the patch for some time.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The recommended daily dose consists of covering painful skin areas using one to three patches.Versatis can be cut into smaller pieces to fit the affected area.Do not use more than 3 patches at the same time.

The patches should be removed after 12 hours of use, and a 12-hour period without a patch should follow.

You can choose to apply Versatis during the day or at night.

Usually, you will experience some pain relief on the first day you use the patch, but it may take 2-4 weeks to see the full effect of Versatis in pain relief.If after that time you still have a lot of pain, talk to your doctor, because the benefits of treatment must be weighed against the possible risks (see section 2 "Warnings and precautions").

Your doctor will check regularly if Versatis is working well.

Before sticking Versatis on the affected area

• If the painful skin area has hair, you can cut the hair using scissors.Do not shave.
• The skin must be clean and dry.
• Crems and lotions can be used on the affected skin during the time the patch is not in use.
• If a bath or shower has been taken recently, wait until the skin has cooled down before using the patch.

Applying the patch

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

?Open the package by tearing or cutting along the dotted 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 package

• Close the package hermetically after use
• The patch contains water and will dry out if the package is not closed properly

Step 3: Cut the patch, if necessary

• If necessary, cut the patch to adjust its size to the painful skin area before removing the protective liner

Step 4: Remove the protective liner

• Remove the transparent liner from the adhesive patch
• Try not to touch the adhesive part of the patch

Step 5: Apply the patch and press firmly on the skin

• Apply up to three patches to the painful skin area
• 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 essential that Versatis is in contact with the skin for only 12 hours.For example, if you have more pain at night, you may want to apply the patch at 7 pm and remove it at 7 am.

If you have more pain during the day than at night, you may want to apply Versatis at 7 am and remove it at 7 pm.

Baths, showers, and swimming

Try to avoid contact with water while using Versatis.You can bathe, shower, or swim during the time the patch is not in use.If a bath or shower has been taken recently, wait until the skin has cooled down before using the patch.

If the patch falls off

Very rarely, the patch may fall off or detach.If it does, try to reattach 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 patches, remove the old patch slowly.If it does not come off easily, you can soak it in warm water for a few minutes before removing it.

If you forget to remove the patch after 12 hours

As soon as you remember, remove the old patch.You can use a new patch again after 12 hours.

If you use more patches than you should

If you use more patches than necessary or leave them on for too long, this may increase the risk of adverse effects.

For accidental ingestion or overdose, contact the Toxicology Information Service, phone 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 patch as soon as you remember.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may 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 dressing, the dressing should be removed.The irritated area should remain without dressing until the irritation stops.

Otheradverse effects that may occur:

Very common (may affect more than 1 in 10 people):Dermatological problems at or around the site of the adhesive dressing application, which may include redness, rash, itching, burning, dermatitis, and small blisters.

Uncommon (may affect up to 1 in 100 people):Cutaneous lesions and skin wounds.

Muy rare (may affect up to 1 in 10,000 people):Open wound, severe allergic reaction, and allergy.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the box after "CAD".The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

After the first opening: Keep the packaging hermetically closed to protect it from light.

Validity period after the first opening of the packaging: 14 days.

Do not use this medication if you observe that the packaging has been damaged. If this has occurred, the patches may dry out and not adhere properly.

Disposal of Versatis

The used patches still contain active ingredient, which can be harmful to others.Double the used patches in half, joining the adhesive sides and dispose of them in a way that they are out of the reach of children.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Versatis

• The active ingredient is lidocaine.
• Each adhesive patch of 14 cm x 10 cm contains 700 mg (equivalent to 5% w/w) of lidocaine.
• The other components of the patch (excipients) are glycerol, liquid sorbitol, sodium caramel, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminum glycinate, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), acrylic acid, sodium acrylate, purified water.

Support tissue and release film:polyethylene terephthalate (PET)

Appearance of the product and content of the container

The medicated patch measures 14 cm in length and 10 cm in width.It is white in color and made of non-woven fabric, marked with “Lidocaine 5%”.The adhesive patches are packaged in sealed pouches, each containing 5 patches.

Each box contains 5, 10, 20, 25 or 30 patches packaged in 1, 2, 4, 5 or 6 pouches, respectively.Some packaging sizes may not be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid

Responsible manufacturer:

Grünenthal GmbH

Zieglerstrasse 6

52078 Aachen

Germany

This medicine is authorized in the member states of the European Economic Area with 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, Slovak Republic, Romania, Sweden: Versatis

Portugal: Vessatis

Last review date of this leaflet: May 2018.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/