• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Versatis is and what it is used for
2. What you need to know before you use Versatis
3. How to use Versatis
4. Possible side effects
5. How to store Versatis
6. Contents of the pack and other information

• 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 which are similar to lidocaine, such as bupivacaine, etidocaine, mepivacaine or prilocaine.
• on injured skin or open wounds

Talk to your doctor or pharmacist before using Versatis.

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

Versatis should only be used on the areas of skin after the shingles has healed. It should not be used on or near the eyes or mouth.

Lidocaine is broken down in your liver to several compounds. One of these compounds is 2,6 xylidine which has been shown to cause tumours in rats when given lifelong in very high doses. The significance of these findings in humans is not known.

Versatis has not been studied in patients under 18 years of age. Therefore it is not recommended for use in this patient population.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Versatis should not be used in pregnancy unless clearly necessary.

There are no studies of the plaster in breast-feeding women. When using Versatis, only very small amounts of the active substance lidocaine may be present in the blood stream. An effect on breast-fed infants is unlikely.

An effect of Versatis on the ability to drive and use machines is unlikely. Therefore you may drive or operate machinery whilst using Versatis.

The plasters contain propylene glycol (E1520) which may cause skin irritation. In addition it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions. The allergic reactions may sometimes occur after you have been using the plaster for some time.

• If the painful area of skin has hairs on it, you can cut the hairs off using scissors. Do not shave them off.
• The skin should be clean and dry.
• Creams and lotions may be used on the affected skin during the period when you are not wearing the plaster.
• If you have had a recent bath or shower, you should wait until your skin cools before using the plaster.

Step 1: open the sachet and remove one or more plasters

• tear open or cut the sachet along the dotted line
• when using scissors, be careful not to damage the plasters
• take out one or more plasters depending on the size of the painful area on your skin

Step 2: close the sachet

• close the sachet tightly after use
• the plaster contains water, and will dry out if the sachet is not closed properly.

Step 3: cut the plaster, if necessary

• if required, cut the plaster to the required size to fit the painful area of skin before removing the liner.

Step 4: remove the liner

• remove the transparent liner from the plaster
• try not to touch the sticky part of the plaster

Step 5: apply the plaster and press it firmly onto the skin

• apply up to three plasters to the painful area of skin
• press the plaster onto your skin
• press for at least 10 seconds to make sure the plaster sticks firmly
• make sure that all of it sticks to your skin, including the edges

Leave the plaster on for 12 hours only

It is important that Versatis is in contact with your skin for only 12 hours. For example, if you have more pain at night you might want to apply the plaster at 7pm in the evening and remove it at 7am in the morning.

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

If at all possible contact with water should be avoided whilst using Versatis. Bathing, showering or swimming can be done in the time period when you are not wearing the plaster. If you have had a recent bath or shower, you should wait until your skin cools before using the plaster.

Very rarely the plaster might fall off, or come unstuck. If it does, try sticking it back on the same area. If it does not stay on, remove it and put a new plaster on the same area.

When changing the plaster, remove the old plaster slowly. If it does not come off easily, you can soak it in warm water for a few minutes before removing the plaster.

As soon as you remember, remove the old plaster. A new plaster can be used again after 12 hours.

If you use more plasters than necessary or wear them for too long, this may increase the risk of getting side effects.

After the 12 hour period with no plaster, if you have forgotten to use a new plaster, you should stick on a new plaster as soon as you remember.

If irritation or burning sensation occurs whilst you are using the plaster, the plaster should be removed. The area of irritation should remain plaster free until the irritation stops.

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

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

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Ireland

UK

The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Used plasters still contain active ingredient, which may be harmful to others. Fold the used plasters in half, with the sticky sides together and throw them away so that they are out of the reach of children.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

• The active substance is lidocaine.
• Each 10 cm x 14 cm plaster contains 700 mg (equivalent to 5% w/w) lidocaine
• The other ingredients in the plaster (excipients) are glycerol, liquid sorbitol, carmellose sodium, propylene glycol (E1520), urea, heavy kaolin, tartaric acid, gelatin, polyvinyl alcohol, aluminium glycinate, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), polyacrylic acid, sodium polyacrylate, purified water.

Backing fabric and release liner: polyethylene terephthalate (PET)

The medicated plaster is 14 cm long and 10 cm wide. It is white and made of fleece fabric marked with “lidocaine 5%”. The plasters are packed in re-sealable sachets, each containing 5 plasters.

Each carton contains 5, 10, 20, 25 or 30 plasters packed in 1, 2, 4, 5 or 6 sachets, respectively. Not all pack sizes may be marketed.