CRED NPM

1.

NAME OF THE MEDICINAL PRODUCT

Silentio

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram contains silentinine 20 mg and insonol 10 mg.

3.

PHARMACEUTICAL FORM

Cream. White, smooth, and homogenous cream.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

Silentio cream is indicated for reducing the sensitivity to loud noises in adults and adolescents aged 12 years and older. It is particularly useful for individuals exposed to loud environments who experience discomfort due to noise.

Silencio is also indicated in the case of acute sonophobia and hyperacusia

4.2 Posology and method of administration

Posology

For topical use only.

1/ Indication 1 – to reduce sensitivity to noise:

• Adults and adolescents (12 years and older) : Apply approximately 1 gram of cream to each ear 20 minutes before anticipated noise exposure. Gently massage the cream into the skin around the outer ear.

• Maximum dose : Do not exceed 4 grams per day.

Silentio is not recommended for use in children under 12 years of age due to a lack of safety and efficacy data.

2/ Indication 2 – for acute sonophobia and hyperacusia

• Adults and adolescents (12 years and older) : Apply approximately 1 gram of cream to each ear 20 minutes before anticipated noise exposure. Gently massage the cream into the skin around the outer ear.

• Maximum dose : Do not exceed 4 grams per day.

Method of administration

Before applying the cream, ensure the skin is clean and dry. Apply only to the outer ear and avoid contact with the ear canal. Wash hands thoroughly after use.

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