Rapidan

Leaflet attached to the packaging: information for the user

Rapydan, 70 mg + 70 mg, medicinal patch

Lidocaine + Tetracaine

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects get worse or if you notice any not listed in the leaflet, you should tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Rapydan and what is it used for
• 2. Important information before using Rapydan
• 3. How to use Rapydan
• 4. Possible side effects
• 5. How to store Rapydan
• 6. Contents of the packaging and other information

1. What is Rapydan and what is it used for

Rapydan contains two local anesthetics - lidocaine and tetracaine. These medicines are used to anesthetize small areas of skin before a potentially painful procedure, such as an injection or a minor surgical procedure.

2. Important information before using Rapydan

When not to use the Rapydan medicinal patch

• if you are allergic (hypersensitive) to lidocaine, tetracaine, sodium borate, or any of the other ingredients of the Rapydan patch (see section 6);
• if you are allergic (hypersensitive) to other local anesthetics;
• if you are allergic (hypersensitive) to para-aminobenzoic acid - a compound that is formed by the breakdown of tetracaine in the body.

The Rapydan patch should not be used on damaged skin or on mucous membranes, e.g. inside the mouth or nose.

When to exercise special caution when using the Rapydan medicinal patch

You should inform your doctor or pharmacist:

• if you have liver, kidney, or heart problems,
• if you are in poor general health, as you may be more sensitive to the effects of lidocaine and tetracaine.

Rapydan should be used with caution near the eyes. If Rapydan comes into contact with the eye, it should be rinsed immediately with water or a saline solution and protected until sensation returns.
Rapydan contains a heat-generating component, CHADD, which may reach a maximum temperature of 40°C at an average temperature of 26°C to 34°C.

Using other medicines

You should tell your doctor or pharmacist about all the medicines you have taken recently, including those that are available without a prescription.
The risk of side effects increases when Rapydan is used at the same time as certain other medicines, such as:

• certain medicines used to treat heart conditions, such as quinidine, disopyramide, tocainide, mexiletine, and amiodarone,
• other medicines containing lidocaine and/or tetracaine.

Pregnancy and breastfeeding

The use of the Rapydan patch can be considered during pregnancy and breastfeeding, after consulting a doctor.
Before using any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Rapydan does not affect the ability to drive or use machines.

Important information about some of the ingredients of the Rapydan medicinal patch

Rapydan contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) - substances that may cause allergic reactions (possible delayed reactions).

3. How to use Rapydan

Rapydan should always be used according to the doctor's recommendations. If you are unsure, you should consult a doctor or pharmacist.
Rapydan should be applied to clean, dry skin for 30 minutes. Detailed instructions can be found in the "How to use the Rapydan medicinal patch" section below.
Rapydan should be used immediately after opening the sachet. Rapydan is intended for single use.
Rapydan also contains a heat-generating layer, CHADD (controlled release of the medicine with heat generation), which slightly raises the skin temperature (see section 2 "Important information before using Rapydan"). The heat-generating component requires the presence of oxygen to work and is therefore packaged in a sealed sachet. This means that as soon as the sachet is opened, the patch should be used immediately, as it starts to heat up slightly. You should make sure to open the sachet when the patient is ready to apply the patch.
Rapydan should not be used under occlusive dressings due to the heat generated by the patch.

Adults

1 or a maximum of 4 patches at the same time. Do not use more than 4 patches in 24 hours.

Children and adolescents (over 3 years old)

1 or a maximum of 2 patches at the same time. In children, do not use more than 2 patches in 24 hours.
Do not use in children under 3 years old.

HOW TO USE RAPYDAN

• 1. The skin must be clean and dry.
• 2. Open the thermally sealed sachet and remove the patch.
• 3. Remove the plastic tab from the patch. Do not touch the white, round insert containing the medicines.

• 4. Apply the patch so that the white, round insert containing the medicines covers the area to be anesthetized.
• 5. Press the edges of the medicinal patch to ensure it adheres properly to the skin.
• 6. Gently press the center of the patch to ensure the medicines come into contact with the skin.
• 7. Note the time of application. Rapydan should be applied 30 minutes before the procedure. Be careful not to let the medicinal patch come off the skin during this time.
• 8. Remove the patch and thoroughly clean the skin area before starting the procedure. If the patch is applied by a doctor, they should also remove it, unless the doctor gives other instructions.

After removing Rapydan

Rapydan causes numbness of the treated skin area, reducing sensation. To avoid accidental physical injury, you should be careful not to scratch or rub the anesthetized area, or touch very hot or cold surfaces until full sensation returns.

Using more Rapydan than recommended

If the patch stays on the skin for longer than recommended or if more patches are used than recommended, the risk of serious side effects increases.
Overdose of Rapydan is unlikely if the patches are used correctly. However, if too much of the active substance is absorbed or if the active substance is accidentally absorbed by a child, you should contact a doctor or the emergency department of the nearest hospital for assistance.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rapydan can cause side effects, although not everybody gets them.
The patch may cause allergic reactions (anaphylactoid reactions), such as skin rash, swelling, and breathing difficulties. If you experience any of these symptoms, you should
immediately remove the patch and contact a doctor.
Most side effects are local and occur at the site where the patch is applied. The symptoms are usually mild, short-lived, and resolve after the treatment is finished.

If any of the following side effects become troublesome, you should inform your doctor or pharmacist.

Very common side effects (occurring in more than 1 in 10 treated patients):

• redness at the application site
• pallor
• swelling

Common side effects (occurring in less than 1 in 10 treated patients):

• rash

Uncommon side effects (occurring in less than 1 in 100 treated patients):

• blistering rash
• itching

Rare side effects (occurring in less than 1 in 1000 patients):

• urticaria or rash with spots
• skin discoloration
• pain
• taste disturbances

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw. Tel.: + 48 22 49 21 301. Fax: + 48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine.

• 309. Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rapydan

Store out of sight and reach of children.
Do not use the medicine after the expiry date stated on the sachet and carton after the letters "EXP", which state the expiry date.
Do not store above 25°C.
Do not use Rapydan if the packaging is damaged in any way.
Used patches should be folded with the adhesive side inwards and disposed of safely to prevent children from coming into contact with the patch. Any unused product or waste material should be disposed of in accordance with local regulations. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Rapydan contains

• Each medicinal patch contains as active substances: 70 mg of lidocaine and 70 mg of tetracaine.
• The patch contains: polyvinyl alcohol sorbitol monopalmitate purified water methyl parahydroxybenzoate (E 218) propyl parahydroxybenzoate (E 216) a layer of synthetic fiber coated with sodium borate

impermeable separating layer applied thermally: laminate (polyethylene and aluminum) coated with an acrylic adhesive layer
adhesive layer: polyethylene and acrylic adhesive layer
heat-generating layer CHADD: iron powder; activated carbon, sodium chloride, and wood powder
placed in filter paper
outer protective layer: polyethylene layer coated with an acrylic adhesive layer on one side

What Rapydan looks like and what the packaging contains

Oval, light brown medicinal patch (approximately 8.5 cm x 6.0 cm) with a removable non-transparent plastic tab.
The patches are packaged individually in protective sachets (polyester/Aluminum/polyethylene laminate).
Pack sizes: 1, 2, 5, or 25 patches.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 09/2024.