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This medicinal product is subject to additional monitoring. Healthcare professionals are asked to report any suspected adverse reactions. See section 4. Isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements. Roaccutane should not be used for the treatment of prepubertal acne and is not recommended in children less than 12 years of age due to a lack of data on efficacy and safety.

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Isotretinoin will harm an unborn baby. It is very important that women taking isotretinoin do not get pregnant.

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Comments:

This is due to the need for a dermatologist referral and blood tests prior to being prescribed Accutane, which can take months. This retinoid is derived from Vitamin A and occurs in small quantities naturally in the body.

   
7.4

Rainer (taken for 1 to 6 years) 26.09.2017

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Acne is a common inflammatory disorder of the face, back, and chest that is characterised by the presence of blackheads, pustules, and potentially cysts and scars. Isotretinoin is an oral treatment for severe types of acne.

   
7.3

Flora (taken for 1 to 7 years) 07.06.2016

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The figure is up from five fatalities the year before and is the highest since records began in However, the MHRA noted that the reaction may not have occurred that year but only been reported then.

   
8.2

Arnold (taken for 1 to 7 years) 09.01.2019

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