ActiLogic 700 mg medicated patch
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Actilogic 700 mg medicated adhesive patch
Lidocaine
Read the 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, 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 these are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Actilogic is and what it is used for
- What you need to know before using Actilogic
- How to use Actilogic
- Possible side effects
- How to store Actilogic
- Contents of the pack and other information
1. What Actilogic is and what it is used for
Actilogic contains lidocaine, a local anaesthetic that works by reducing pain in the skin.
You have been given Actilogic to treat a painful skin condition called postherpetic neuralgia. This condition is generally characterized by localized symptoms such as burning pain, stabbing pain, or sharp, jabbing pain.
2. What you need to know before using Actilogic
Do not use Actilogic
- 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 prilocaine,
- on damaged skin or open wounds.
Warnings and precautions
Talk to your doctor or pharmacist before using Actilogic.
If you have severe liver disease, severe heart problems, or severe kidney problems, you should speak with your doctor before using Actilogic.
Actilogic should only be used on areas of skin where 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 cause tumours in rats when administered for a lifetime at very high doses. The relevance of these findings to 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.
Using Actilogic with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
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 breastfed infants.
Driving and using machines
It is unlikely that Actilogic will affect your ability to drive or 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. They also contain methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), substances which may cause allergic reactions. Sometimes, allergic reactions may occur after having used the patch for some time.
3. How to use Actilogic
Follow exactly the administration instructions for this medicine 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 one to three patches. Actilogic may be cut into smaller parts to fit the affected area. You must not use more than 3 patches at the same time.
Patches must be removed after 12 hours of use, followed by a 12-hour patch-free period.
You may choose to apply Actilogic 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 Actilogic on pain relief is seen. If you still have significant pain after this time, speak with your doctor, as the benefits of treatment should be weighed against the possible risks (see section 2 “Warnings and precautions”).
Your doctor will check at regular intervals whether Actilogic is working properly.
Before applying Actilogic to the affected area
- If the painful area of skin is hairy, you may trim the hair with 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 had a bath or shower, you must 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
- Close the pouch tightly after use.
- The patch contains water and will dry out if the pouch is not properly sealed.
Step 3: Cut the patch, if necessary
- If necessary, 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 in place for 12 hours only
It is important that Actilogic 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 Actilogic 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 Actilogic. You may bathe, shower or swim during the time when you are not wearing the patch. If you have recently had a bath or shower, you must 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 Actilogic
When changing patches, remove the old patch slowly. If it does not peel off easily, you may soak it with 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 necessary or wear them for too long, this may increase the risk of 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 Actilogic
After the 12-hour patch-free period, if you forget to apply a new patch, apply a new patch 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 experiences them.
Important adverse effects or symptoms to watch for and what to do if affected:
If irritation or a burning sensation occurs while using the medicated 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 medicated 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 injuries.
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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Actilogic
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and 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 sachet tightly closed.
Shelf life after first opening of the sachet: 14 days.
Do not use this medicine if you notice that the sachet has been damaged. If this has occurred, the patches may dry out and fail to adhere properly.
Disposal of Actilogic
Used patches still contain active substance, which could be harmful to other people. Fold used patches in half, bringing the adhesive sides together, and dispose of them so they are out of the reach of children.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Actilogic
- 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, aluminum glycinate, disodium edetate, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), polycrylic acid, sodium polycrylate, purified water.
Backing material and release liner: polyethylene terephthalate (PET)
Presentation of the medicinal product and pack contents
The medicated patch measures 14 cm in length and 10 cm in width. It is white in color 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 Authorization Holder and Manufacturer
Marketing Authorization Holder:
Grünenthal Pharma, S.A.
Doctor Zamenhof, 36 – 28027 Madrid
Manufacturer:
Grünenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany
This medicinal product is authorized in the European Economic Area member states under the following names:
Germany | Actilogic |
Spain | Actilogic |
Date of the last revision of this leaflet: September 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/