CRED NPM

Precautions before handling:

Do not apply to broken or irritated skin.

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• Avoid contact with mucous membranes, eyes, and nose.

4.3 Contraindications

Silentio is contraindicated in patients with:

• Known hypersensitivity to silentinine, insonol, or any excipients listed in section 6.1.

• Extremely large ears (e.g., macrotia) where topical application may lead to excessive systemic absorption.

• Musicians actively performing, due to potential interference with auditory perception.

Pregnancy (see section 4.6).

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• Untreated bacterial, fungal, or viral infections of the skin, particularly around the ears.

• Open or ulcerated skin lesions near the application area.

4.4 Special warnings and precautions for use

Silentio is for cutaneous use only. Avoid contact with eyes, mucous membranes, or ingestion. In the event of accidental contact with eyes, rinse thoroughly with lukewarm water.

If signs of irritation or an allergic reaction occur, discontinue use immediately and consult a healthcare professional.

Use with caution in patients with compromised skin barriers (e.g., eczema or dermatitis).

Silentio should not replace noise protective equipment (e.g., earplugs or earmuffs) when such protective measures are recommended or required. The use of Silentio does not eliminate the need for proper hearing protection in environments with high noise exposure.

4.5 Interaction with other medicinal products and other forms of interaction

Caffeine: Concomitant use of caffeine may reduce the efficacy of Silentio in reducing auditory sensitivity.

Local anesthetics: The combined use of local anesthetics (e.g., lidocaine) may increase the absorption of the active ingredients in Silentio, leading to potential side effects.

4.6 Fertility, pregnancy and lactation

Pregnancy : Silentio is contraindicated in pregnancy due to a lack of sufficient safety data and potential risks to fetal auditory development. Breast-feeding : It is unknown whether the active ingredients of Silentio are excreted in human breast milk. Use caution when administering to nursing mothers. Avoid application on or near the breast.

Fertility : There are no data on the effects of Silentio on fertility.

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