RAPYDAN

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. 6. 4). 4).

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: Erythema, blanching Common: Rash Uncommon: Vesiculobullous rash, pruritus, contact dermatitis Rare: Urticaria, maculopapular rash, skin discolouration General disorders and administration site conditions Very common: Oedema Uncommon: 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. 2).

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. 5-2%. 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.

3 ng/ml for children aged 3-6 and 7-12 years, respectively. 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.

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.