Rapydan 70 mg / 70 mg Lidocaine/Tetracaine Medical Patch
What Is Rapydan, And What Is Rapydan Used For?
Rapydan contains two local anesthetics – lidocaine and tetracaine. They are used to numb a small area of the skin before a procedure that may hurt, such as needle sticks or simple surgical procedures.
Before Using Rapydan
Do Not Use:
- If you are allergic (hypersensitive) to lidocaine or tetracaine, sodium borate, or any of the other ingredients of it (see section 6).
- If you are allergic (hypersensitive) to other local anesthetics.
- If you are allergic (hypersensitive) to para-aminobenzoic acid, your body breaks tetracaine into this substance.
- Do not use it on irritated or damaged skin or mucous membranes, e.g., inside the mouth or nose.
Take Special Care With Rapydan:
Consult a physician or pharmacist
- If you have impaired liver, kidney, or heart function.
- If you are acutely ill or have a reduced general condition, you may be more sensitive to the effects of lidocaine and tetracaine.
Rapydan should be used with caution near the eyes. If Rapydan comes in contact with the eyes, immediately rinse the eyes with water or sodium chloride solution and protect the eyes until the sensation returns.
This medicine contains a heat-releasing component that can reach a maximum temperature of up to 40 ° C, with an average temperature of 26–30 ° C.
Use Of Other Medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The risk of side effects is increased if Rapydan is used at the same time as certain other medicines, e.g.
- Certain drugs for the treatment of heart diseases, such as quinidine, disopyramide, tocainide, mexiletine, and amiodarone
- Other medicines containing lidocaine and tetracaine
Pregnancy And Breastfeeding:
Your doctor will decide if you can use it during pregnancy and breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving And Using Machines:
This medicine does not affect the ability to drive and use machines.
Important Information About Some Of The Ingredients Of Rapydan:
Rapydan patch contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed).
How To Use Rapydan?
- Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- This medicine is applied to clean and dry skin for 30 minutes. See this leaflet’s “Instructions for Use” below for detailed instructions.
- Rapydan should be used immediately after opening the bag. Rapydan is for single use only.
- This medicine also contains a heating component (CHADD heat capsule) that raises the skin temperature slightly (see section 2, Before using this medicine). The heating component needs oxygen, so the patch is packed in an airtight bag. This means the patch must be used immediately when the bag is opened as it slowly starts to heat up. You mustn’t open the bag until you have finished using the medical patch.
- Rapydan should not be used under occlusive dressings due to the heat-dissipating properties of the patch.
Adults:
- 1 or at most 4 patches at a time. Do not use more than 4 patches per day.
- Children and adolescents (older than 3 years):
- 1 or at most 2 patches at a time. Do not use more than 2 patches for one child per day.
- Do not use it for children under 3 years.
INSTRUCTIONS FOR USE:
- Make sure the skin is clean and dry.
- Open the bag of heat-sealed film and remove the patch.
- Remove the plastic tray from the patch. Do not touch the round white bar containing the active substances.
- Apply the patch so that the round white field with the active substance covers the area to be treated.
- Press the patch around the edges and ensure it closes tightly to the skin.
- Gently press on the center of the patch to ensure that the drugs come in contact with the skin.
- Take time to apply. Rapydan must be kept on for 30 minutes before any treatment. Care should be taken so that the medical patch does not fall off during this time.
- Remove the patch and clean the area thoroughly before the procedure. If the patch is applied before a procedure that a doctor should do, have the doctor remove the patch unless you have been instructed otherwise.
When Rapydan was removed:
Rapydan numbs the treated skin area so that the feeling is reduced. To avoid accidental damage, avoid scratching or rubbing the anesthetized area or touching hot or cold surfaces until the sensation has fully returned.
If You Use More Rapydan Than You Should:
If the patch is allowed to remain on the skin longer than recommended, or if more patches are used than recommended, the risk of serious side effects increases. Overdose with the normal use of the Rapydan patch is unlikely.
If you have still ingested too much active substance or if, e.g., a child ingested the active substances by mistake, contact a doctor or hospital for risk assessment and advice. Ask your doctor or pharmacist for further questions about using this product.
Possible Rapydan Side Effects:
Rapydan can cause side effects like all medicines, although not everybody gets them. The patch may cause allergic (anaphylactoid) reactions, e.g.:
- Skin rash
- Swelling
- Difficulty breathing
If you get any of the above side effects, you must remove the patch immediately and consult a doctor. Most side effects are local and occur in the area where the patch has been applied. They are generally mild and transient and cease after treatment.
Tell your doctor or pharmacist if you have any of the following side effects.
Very common side effects (affects more than 1 patient in 10)
- Redness where the patch has been applied
- The pallor of the skin
- Swelling
Common side effects (affects less than 1 patient in 10)
- Rash
Uncommon side effects (affects less than 1 patient in 100)
- Skin rash with blisters
- Itching
Rare side effects (affects less than 1 user in 1,000)
- Hives or rashes with spots
- Discoloration of the skin
- Pain
- Change of taste
How To Store Rapydan?
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the sachet and carton after EXP.
- Do not store above 25 ° C.
- Do not use this medicine if you can see that the packaging is damaged in any way.
- Used patches should be folded with the sticky side inwards and discarded safely so children cannot access the patch. Local requirements should dispose of any unused product or waste material. Unused medicines should not be disposed of via wastewater or household waste. Ask at the pharmacy how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Other Information:
Content Declaration
- The active substances in each medical patch are 70 mg lidocaine and 70 mg tetracaine.
- The patch consists of the following:
- Backing: polyethylene film, covered on one side with acrylate adhesive
- CHADD (Controlled Heat Assisted Drug Delivery) heat capsule: iron powder, activated carbon, sodium chloride, and wood flour encapsulated in a filter paper bag.
- Adhesive film: polyethylene and acrylate adhesive
- Heat-sealable foil: laminate of polyethylene and aluminum, covered with polyester urethane adhesive
- Drug layer: polyvinyl alcohol, sorbitan monopalmitate, purified water, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium borate covered nonwoven fabric
- Plastic tray (polyethylene), which is removed before using the patch
What Does The Medicine Look Like And The Contents Of The Pack?
- Oval, light brown medical patch (approximate size: 8.5 cm x 6.0 cm) with a removable opaque plastic tray.
- The patches are packed in a protective bag (polyester/aluminum/polyethylene laminate).
- Pack sizes: 1, 2, 5, 10, 25, or 50 patches.
- Not all pack sizes may be marketed.
Marketing Authorization Holder aAd Manufacturer:
Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands
This medicinal product is authorized under the European Economic Area under the names:
| Name of Member State | The name of the drug |
| Belgium / Luxembourg | Rapydan® 70 mg / 70 mg prescription drugsRapydan® 70 mg / 70 mg medicated patchRapydan® 70 mg / 70 mg active ingredient plaster |
| Denmark | Ralydan 70 mg / 70 mg medical patch |
| Greece / Cyprus | Rapydan 70mg / 70mg Pharmaceutical Pharmacy |
| Ireland / Great Britain | Rapydan 70/70 mg medicated plaster |
| Italy | Ralydan 70 mg / 70 mg cerotto medicato |
| Netherlands | Rapydan 70 mg / 70 mg medicated patch |
| Norway | Rapydan 70 mg / 70 mg medicated patch |
| Austria / Germany | Rapydan 70 mg / 70 mg active ingredient plaster |
| Poland | Rapydan: 70 mg + 70 mg plastic leczniczy |
| Portugal | Rapydan 70mg / 70mg, emplastro medicamentoso |
| Sweden | Rapydan 70mg / 70mg medical patch |
| Hungary | Velocaine 70 mg / 70 mg gyógyszeres tapasz |