CRED NPM

4.7 Effects on ability to drive and use machines

Silentio has minor influence on the ability to drive and use machines however given it will affect hearing it could lead to not hearing emergency vehicules and therefore is not advised in case of driving

4.8 Undesirable effects

Adverse reactions are listed by frequency and system organ class. The frequency of adverse reactions is defined as follows:

Very Common (≥1/10)

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Common (≥1/100 to <1/10)

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Uncommon (≥1/1,000 to <1/100)

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Rare (≥1/10,000 to <1/1,000)

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Very Rare (<1/10,000)

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The most frequently reported adverse reactions include the following:

Common (≥1/100 to <1/10)

• Localized irritation, erythema, or pruritus at the application site

• Contact dermatitis in individuals sensitive to excipients

Uncommon (≥1/1,000 to <1/100)

• Temporary hearing changes, such as mild distortion or decreased clarity, typically resolving upon cessation of treatment

Rare (≥1/10,000 to <1/1,000)

Temporary full hearing loss

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Excessive hair growth on the ears

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Earlobe growth

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Discoloration of ears

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• Increased inclination to listen to Mariah Carey's "All I Want for Christmas"

Paediatric population : The safety profile in adolescents (12 years and older) is similar to that observed in adults.

Reporting of suspected adverse reactions : Healthcare professionals are encouraged to report any suspected adverse reactions via the national reporting system listed in Appendix V.

4.9 Overdose

Silentio may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse the features of chronic hypoacusia may occur.

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