Beacon Pharmaceuticals Ltd


ISOTRETINOIN
Pregnancy Prevention Programme




ISOTRETINOIN CAPSULES AND THE
PREGNANCY PREVENTION PROGRAMME

Isotretinoin is regarded as a highly effective product for the treatment of severe forms of acne resistant to standard therapy, but like all medications it can sometimes cause unwanted effects.
Of particular concern is the extremely high risk that exposure of an unborn child to Isotretinoin will result in life threatening abnormality to the baby.

The Regulatory Agency in the UK, the Medicines and Healthcare Regulatory Agency (MHRA), have approved a “Pregnancy Prevention Programme”.

This Pregnancy Prevention Programme (PPP) has been implemented in order to protect female patients and Beacon provides the appropriate approved information and materials for use by doctors, pharmacists and patients.

Beacon Pharmaceuticals were the first UK company to provide a “Pregnancy Prevention Programme” that had been approved by the MHRA. The Beacon Isotretinoin packs contain specific warnings relating the risk of exposure to the unborn child on the product carton, pack insert and the blister pack.

A number of documents related to Beacons Isotretinoin and the Pregnancy Prevention Programme are available for viewing by downloading as detailed below. These materials from the Beacon Isotretinoin Pregnancy Prevention Programme are available for information purposes only. If they are downloaded for use then it is the responsibility of the user to check with Beacon Pharmaceuticals that they are still using the most current version of the documentation before use.

Beacon Pharmaceuticals make every effort to ensure that the latest versions of these leaflets are available on the website, but we cannot guarantee that this is the case, so if these documents are downloaded for use we strongly recommend that you check by telephone or e-mail to confirm suitability.


Downloads Available.
Files are in Adobe Acrobat PDF format.


Patient Information Brochure

This patient brochure provides useful information for the patient

Brochure on Contraception

This brochure is useful for informing patients of the range of contraceptive options that are available.

Patient Information Leaflet

This is a copy of the leaflet found in the packs of Beacon’s isotretinoin capsules.

Summary of Product Characteristics

A full copy of the approved prescribing information for Beacon’s Isotretinoin capsules.

Acknowledgement Form

The acknowledgement form should be signed by the patient and/or parent/guardian to confirm that they understand the need to comply with the PPP.

For more information please Click Here to contact us.