Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Rapydan 70mg/70mg medicated plaster

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Tetracaine, Lidocaine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Tetracaine, Lidocaine
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Rapydan contains two local anaesthetics – lidocaine and tetracaine. These medicines are used to numb a small area of skin before a procedure that might be painful, such as an injection or a minor surgical procedure. 2.

Before you use Rapydan

Do not use Rapydan if you are allergic (hypersensitive) to lidocaine, tetracaine or sodium borate or any of the other ingredients of Rapydan (see section 6). if you are allergic (hypersensitive) to other local anaesthetics. if you are allergic (hypersensitive) to para-aminobenzoic acid, a compound that is formed when your body breaks down tetracaine. Do not use Rapydan on broken or damaged skin or on mucous membranes, e.g. inside the mouth or nose. Take special care with Rapydan Tell your doctor or pharmacist if you have problems with your liver, kidney or heart. if you are very unwell or in poor physical condition, because you may be more sensitive to the effects of lidocaine and tetracaine. Rapydan should be used with caution close to the eyes. If Rapydan comes into contact with your eye, immediately rinse your eye with water or salt solution and protect it until feeling returns. Rapydan contains a heat-releasing component that may reach a maximum temperature of up to 40°C, with an average temperature of 26-34°C. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 15 October 2024

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The risk of side effects increases if Rapydan is used at the same time as some other medicines, e.g. some medicines for treatment of heart conditions such as quinidine, disopyramide, tocainide, mexiletine and amiodarone. other medicines containing lidocaine and/or tetracaine. Pregnancy and breast-feeding The use of Rapydan may be considered during pregnancy and lactation, as advised by your doctor. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Rapydan has no influence on the ability to drive and use machines. Important information about some of the ingredients of Rapydan Rapydan contains methyl parahydroxybenzoate (E 218) and propyl parahydoxybenzoate (E 216), which may cause allergic reactions (possibly delayed). 3.

How to take it

Rapydan

Always use Rapydan according to the doctor's instructions. Ask a doctor or pharmacist if you are unsure of anything. Rapydan is applied to clean dry skin for 30 minutes. For detailed instructions, see "Instructions for use" below. Rapydan should be used immediately once the sachet has been opened. Rapydan can only be used once. Rapydan also contains a heating component (CHADD heating pod) which raises the skin temperature slightly (see section 2 Before You Use Rapydan). The heating component needs oxygen to make it work so the plaster is packaged in an air-tight pouch. This means as soon as the pouch is opened the plaster should be used immediately because it will start to gently heat up. It is important that the pouch is opened only when you are ready to use the medicated plaster. Rapydan should not be used under occlusive dressings due to the heat-releasing nature of the plaster. Adults 1 or at most 4 plasters at the same time. Do not use more than 4 plasters in a day (24 hours). Children and adolescents (older than 3 years of age) 1 or at most 2 plasters at the same time. Do not use more than 2 plasters on a child in a day (24 hours). Do not use on children under 3 years of age. INSTRUCTIONS FOR USE 1. Make sure the skin is clean and dry. 2. Open the heat-sealed film sachet and remove the plaster. 3. Remove the plastic tray from the plaster. Do not touch the white round pad that contains the medicines. 4. Apply the plaster so that the white, round pad containing the medicines covers the area to be treated. 5. Press firmly only around the edges of the medicated plaster to ensure that the medicated plaster sticks well to the skin. 6. Press gently on the centre of the plaster to ensure that the medicines come into contact with the skin. 7. Take note of the time of application. Rapydan must be applied for 30 minutes before any procedures are carried out. Care should be taken that the medicated plaster does not fall off during this time. 8. Remove the plaster and clean the area thoroughly before the procedure. If applying the plaster before a procedure to be performed by a doctor, let the doctor remove the plaster, unless instructed otherwise. 15 October 2024

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After Rapydan has been removed Rapydan numbs the area of skin treated so that feeling is reduced. To avoid any accidental damage, take care not to scratch or rub the numbed area or touch very hot or cold surfaces until complete sensation has returned. If you use more Rapydan than you should If the plaster is left on the skin for longer than recommended, or if more than the recommended number of plasters are used, the risk of serious side effects increases. Overdose of Rapydan is unlikely with normal use. However, if you absorb too much of the active substances, or if for example, a child absorbs the active substances by mistake, contact your doctor or local Accident and Emergency department for help. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4.

Possible side effects

Like all medicines, Rapydan can have side effects, although not everybody gets them. The plaster may cause allergic (anaphylactoid) reactions such as skin rash, swelling and breathing difficulties. If you experience any of the above side effects you must remove the plaster immediately and contact a doctor. Most side effects are local and occur at the site where the plaster has been placed. They are generally mild, only last for a short time and usually go away after the end of treatment. Tell your doctor or pharmacist if any of the following side effects become troublesome. Very common side effects (affecting more than 1 in 10 treated patients): • redness where the plaster has been applied • pallor of the skin • swelling Common side effects (affecting fewer than 1 in 10 treated patients): • rash Uncommon side effects (affecting fewer than 1 in 100 treated patients): • rash with blisters • itching Rare side effects (affecting fewer than 1 in 1000 treated patients): • nettle rash or rash with spots • discoloration of the skin • pain • change in taste sensation Reporting of side effects 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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

15 October 2024

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5.

How to store it

Rapydan

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the sachet and carton after "EXP". Do not store above 25°C. Do not use Rapydan if you can see that the packaging is damaged in any way. Used plasters should be folded together with the sticky side inwards, and disposed of safely so that children cannot get at the plaster. Any unused product or waste material should be disposed of in accordance with local requirements. Unused medicine should not be flushed down the toilet or thrown into household waste. Ask at the pharmacy what you should do with medicine that is no longer used. These measures are to protect the environment. 6.

Further information

What Rapydan contains The active substances in each medicated plaster are 70 mg lidocaine and 70 mg tetracaine. Plaster consists of: • Backing layer: polyethene film, covered on one side with acrylate adhesive • Controlled Heat Assisted Drug Delivery (CHADD) heating pod: iron powder, activated carbon, sodium chloride, and wood flour, encapsulated in a filter paper pouch • Adhesive film: polyethene and acrylate adhesive • Heat sealable foil: polyethene and aluminium laminate, covered with polyester urethane adhesive • Drug layer: polyvinyl alcohol, sorbitan monopalmitate, purified water, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium borate-covered fibre coating • Plastic (polyethylene) tray, which is removed before using the plaster What Rapydan looks like and contents of the pack Oval, light brown medicated plaster (approximate dimensions: 8.5 cm x 6.0 cm), with a removable opaque plastic tray. The plasters are packed individually in protective sachets (polyester/aluminium/polythene laminate). Pack sizes: 1, 2, 5, 10, 25 or 50 plasters. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, Netherlands

This leaflet was last revised in 07/2024.

15 October 2024

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Frequently asked questions about Rapydan 70mg/70mg medicated plaster

What is the active substance in Rapydan 70mg/70mg medicated plaster?

The active substance in Rapydan 70mg/70mg medicated plaster is tetracaine, lidocaine.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Rapydan 70mg/70mg medicated plaster, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Rapydan 70mg/70mg medicated plaster without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Lidocaine (11 medicines), Tetracaine (3 medicines), Tetracaine, lidocaine (1 medicine)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Surface anaesthesia of the skin in connection with needle puncture and in cases of superficial surgical procedures (such as excision of various skin lesions and punch biopsies) on normal intact skin in adults.

Surface anaesthesia of the skin in connection with needle puncture on normal intact skin in children from 3 years of age.

4.2. Posology and method of administration

Adults (including elderly): 1 or at most 4 plasters simultaneously. Maximum 4 plasters per 24 hours.

Children from 3 years of age: 1 or at most 2 plasters simultaneously. Maximum 2 plasters per 24 hours.

Application time: 30 minutes. The plaster should be applied for the duration of 30 minutes before needle puncture or a superficial surgical procedure is conducted as a shorter duration may result in a decreased efficacy.

Please note that the medicated patch contains a heat-releasing component that may reach a maximum temperature of 40°C, with a mean temperature of 26-34°C.

If considered necessary, hairs in the affected area can be cut off (not shaved) before the plaster is applied to ensure that there is adequate contact between the skin and the plaster.

Rapydan medicated plasters are for single use only, and should be used immediately once the sachet has been opened.

Used plasters should be discarded carefully in accordance with instructions given in section 6.6.

Children under 3 years of age:

Use of Rapydan is strongly discouraged for children under the age of 3 years due to insufficient clinical experience (see section 4.4).

Patients with hepatic, renal and cardiac impairment:

Rapydan should be used with caution in patients with severe hepatic, renal and cardiac impairment (see section 4.4).

4.3. Contraindications

Hypersensitivity to the active substances, to sodium borate or to any of the other excipients.

Hypersensitivity to local anaesthetics of the amide or ester type or to para-aminobenzoic acid (by-product in tetracaine metabolism).

Rapydan should not be used on mucous membranes or on areas with a compromised skin barrier.

4.4. Special warnings and precautions for use

A prolonged application time or application of more plasters than recommended can lead to increased absorption of lidocaine and tetracaine into the systemic circulation with accompanying serious systemic effects.

The plaster should be used with caution in patients with hepatic, renal or cardiac impairment, and in subjects with increased sensitivity to systemic circulatory effects of lidocaine and tetracaine, such as the acutely ill or debilitated.

Allergic or anaphylactoid reactions associated with lidocaine, tetracaine or other ingredients in Rapydan can occur. Tetracaine may be associated with a higher incidence of such reactions than lidocaine.

Caregivers are recommended to avoid direct contact with the patch or the skin exposed to the patch, in order to avoid contact dermatitis.

Rapydan contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

Rapydan should be used with caution in the proximity of the eyes, as severe corneal irritation was observed in animal studies with similar products. If Rapydan comes into contact with the eye, the eye should be rinsed immediately with water or sodium chloride solution and the eye protected until feeling returns.

Lidocaine has bactericidal and antiviral properties in concentrations above 0.5-2%. Therefore the result of intradermal injections of live vaccine (e.g. BCG) should be closely monitored.

Rapydan contains a heat-releasing component that may reach a maximum temperature of up to 40°C, with a mean temperature of 26-34°C.

Rapydan should not be used under occlusive dressings due to the heat-releasing nature of the plaster.

Use in children below 3 years of age is strongly discouraged based on limited clinical experience. The available pharmacokinetic data suggest that lidocaine exposure (AUC and Cmax) is inversely correlated with age. In the single paediatric study which included children under 3 years, the maximum peak lidocaine concentration seen in a single child under 3 years was 331 ng/ml compared to 63.3 ng/ml and 12.3 ng/ml for children aged 3-6 and 7-12 years, respectively. Variability is seen in the exposure levels obtained with Rapydan, and as a concentration of approximately 1000 ng/ml is known to have anti arrhythmic activity, it is possible that children under 3 could be exposed to concentrations of lidocaine associated with this activity (see section 5.2). Plasma levels of tetracaine in this age group were so low after application of one or two plasters that there was no discernable effect of age or dose.

Care should be taken when using the medicated plaster with children to ensure that the medicated plaster remains in position on the skin, in order to decrease the risk of ingestion or contact with the eyes, which could occur with handling of the plaster by a child.

Used plasters

For environmental and safety reasons, used plasters should be disposed of in accordance with the instructions given in section 6.6.

4.5. Interaction with other medicinal products and other forms of interaction

The risk of additional systemic toxicity should be considered when Rapydan medicated plasters are applied to patients receiving Class I antiarrhythmic medicinal products (such as quinidine, disopyramide, tocainide and mexiletine) and class III antiarrhythmic medicinal products (e.g. amiodarone) or other products containing local anaesthetic agents.

Should Rapydan be used concomitantly with other products containing lidocaine and/or tetracaine, cumulative doses from all formulations must be considered.

4.6. Pregnancy and lactation

Pregnancy

Data on a limited number of exposed pregnancies indicate no adverse effects of lidocaine and tetracaine on pregnancy or on health of the fetus/newborn child. Animal studies are insufficient with respect to the effects of lidocaine on pregnancy, embryonal/fetal development, parturition or postnatal development (see section 5.3). Animal studies do not indicate direct or indirect harmful effects of tetracaine with respect to pregnancy, embryonal/fetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant women.

Lactation

Lidocaine and probably tetracaine are excreted in human milk (the plasma/milk ratio of lidocaine is 0.4 and has not been determined for tetracaine) but the risk of affecting the child appears low when using recommended doses. Breast-feeding may therefore continue during Rapydan therapy.

4.7. Effects on ability to drive and use machines

Rapydan has no influence on the ability to drive and use machines.

4.8. Undesirable effects

The most commonly reported adverse drug reactions are erythema, oedema and blanching, occurring in 71%, 12% and 12% of patients respectively (see below). These reactions were generally mild and transient, and disappeared after discontinuation of treatment.

Undesirable effects seen in clinical trials are reported below according to the MedDRA convention on frequency and organ system classification.

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to ≤ 1/1,000); very rare (≤ 1/10,000).

Nervous system disorders

Rare:

Pain, taste perversion

Skin and subcutaneous tissue disorders

Very common:

Common:

Uncommon:

Rare:

Erythema, blanching

Rash

Vesiculobullous rash, pruritus, contact dermatitis

Urticaria, maculopapular rash, skin discolouration

General disorders and administration site conditions

Very common:

Uncommon:

Oedema

Application site reaction

Allergic or anaphylactoid reactions associated with lidocaine, tetracaine or other ingredients in Rapydan may occur. Tetracaine may be associated with a higher incidence of such reactions than lidocaine.

Systemic adverse reactions following appropriate use of Rapydan are unlikely, due to the small dose absorbed (see section 5.2).

4.9. Overdose

Systemic toxicity is very unlikely with normal use of Rapydan. In the event of any toxicity the symptoms are expected to be similar to those seen after other local anaesthetic treatment, i.e. excitatory CNS symptoms and in severe cases CNS depression and myocardial depression.

Severe neurological symptoms (seizures, CNS depression) require symptomatic treatment such as assisted ventilation and spasmolytic agents. Due to slow systemic absorption, a patient with symptoms of toxicity should be observed for several hours following any treatment of these symptoms.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Tetracaine, Lidocaine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

  • VERSATIS 700 mg prescription partial — not the same combinationLIDOCAINUM · skin / topical
  • INSTILLIDO 20 mg/ml prescription partial — not the same combinationLIDOCAINUM · skin / topical

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

  • PliaglisLidocainum + Tetracainum

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Rapydan 70mg/70mg medicated plaster. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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