Prospecto:Information for the User

Actilogic 700 mg Adhesive Medicamentous Patch

Lidocaína

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect,as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you,and you must not give it to other peoplealthough they may have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Actilogic and for what it is used

2.What you need to know before starting touse Actilogic

3.How to use Actilogic

4.Possible adverse effects

5.Storage of Actilogic

6.Contents of the package andadditional information

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

Actilogic 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.

No use Actilogic

-if you are allergic to lidocaine or any of the other components of this medication (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

Consult your doctor or pharmacist before starting to use Actilogic.

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

Actilogic should only be used on areas of the skin after the skin has completely 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 at very high doses over a long period of time.The relevance of these findings in humans is unknown.

Children and adolescents

Actilogic has not been studied in patients under 18 years of age.Therefore, its use is not recommended in this patient population.

Use of Actilogic with other medications

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Actilogic should not be used during pregnancy, unless clearly necessary.

No studies have been conducted with the adhesive patch in breastfeeding women.When using Actilogic, 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 machinery

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

Actilogic 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 between one and three patches.Actilogic can be cut into smaller pieces to adjust to 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 Actilogic during the day or at night.

Usually, you will experience some relief from pain on the first day you use the patch, but it may take up to 2-4 weeks to see the full effect of Actilogic 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 at regular intervals if Actilogic is working well.

Before applying Actilogic to 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 film

Step 4: Remove the protective film

• Remove the transparent film from the adhesive patch
• Try not to touch the adhesive part 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
• Press for at least 10 seconds to

ensure the patch adheres firmly

• Ensure the entire patch adheres to the skin,

including the edges

Leave the adhesive patch on for only 12 hours

It is essential that Actilogic 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 Actilogic at 7 am and remove it at 7 pm.

Baths, showers, and swimming

Try to avoid contact with water while using Actilogic.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 attached, remove it and apply a new patch to the same area.

How to remove Actilogic

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.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forgot to use Actilogic

After the 12-hour period without a patch, if you forgot to use a new patch, apply a new patch as soon as you remember.

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

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

Other adverse effects that may occur:

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

Rare(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 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.

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 dressings may dry out and not adhere properly.

Disposal of Actilogic

The used dressings still contain active ingredient, which can be harmful to other people.Double the used dressings 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 thrown away through the drains or in the trash.Deposit the packaging and medications that you do not need in the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help to protect the environment.

Composition of Actilogic

• The active principle is lidocaine.
• Each adhesive dressing of 14 cm x 10 cm contains 700 mg (equivalent to 5% w/w) of lidocaine.
• The other components of the dressing (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 packaging

The medicated dressing 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 dressings are packaged in sealed pouches, each containing 5 dressings.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid

Responsible for manufacturing:

Grünenthal GmbH

Zieglerstrasse 6

52078 Aachen

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: September 2021

The 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/