3. Medicine to be supplied under this Patient Group Direction 3.1 Levonorgestrel 1500microgram tablet Name, strength (Levonelle® 1500) and form of medicine(s) 3.2 POM Legal Status 3.3 NO triangle Black triangle drugs (see BNF) are newly licensed medicines that are closely monitored by the MHRA. All suspected reactions should be reported using yellow cards (see below Adverse Drug Reactions) 3.4 Levonorgestrel 1500microgram is not licensed for women under 16 years of age. PGD covering use outside The use of 2 x Levonorgestrel 1500microgram tablets if the patient is taking terms of drugs (see Section 2.3 above) is an unlicensed indication. However, this is Summary of the recommendation in the current BNF. Product Characteristics (SPC)? Use between 72 and 96 hours after UPSI EHC with Levonorgestrel 1500mcg may be considered for use between 72 and 96 hours after UPSI, but women should be informed of the limited evidence of efficacy and that such use falls outside the licence of the product. If >72 hours but <less 120 hours from UPSI, advise that the option of an insertion of an IUD is the recommended first line treatment but that EHC is supported by – evidence from a World Health Organisation trial. Use of EHC does NOT stop a woman from having the IUD fitted as well but may ensure some protection whilst more effective protection is sought. Provision of Ulipristal acetate (which is licensed for up to 120 hrs) could be another alternative which would require referral to a medical practitioner to consider Use more than once in a cycle The product SPC advises against this because of the possibility of disturbance of the However, use more than once is supported by guidance from the Faculty of Sexual and Reproductive Healthcare. But, if a second act of UPSI has occurred within 12 hours of taking Levonorgestrel 1500mcg an additional dose is not necessary If Ulipristal has been used in this cycle then hormonal contraception will be affected. See SPC. Women seeking EHC in these circumstances should be advised to see a medical practitioner as an IUD would be the recommended first line treatment. If they
3. Medicine to be supplied under this Patient Group Direction 3.1 Name, strength and form of medicine(s) Levonorgestrel 1500microgram tablet (Levonelle® 1500) 3.2 Legal Status POM 3.3 triangle NO Black triangle drugs (see BNF) are newly licensed medicines that are closely monitored by the MHRA. All suspected reactions should be reported using yellow cards (see below Adverse Drug Reactions) 3.4 PGD covering use outside terms of Summary of Product Characteristics (SPC)? Levonorgestrel 1500microgram is not licensed for women under 16 years of age. The use of 2 x Levonorgestrel 1500microgram tablets if the patient is taking drugs (see Section 2.3 above) is an unlicensed indication. However, this is the recommendation in the current BNF. Use between 72 and 96 hours after UPSI EHC with Levonorgestrel 1500mcg may be considered for use between 72 and 96 hours after UPSI, but women should be informed of the limited evidence of efficacy and that such use falls outside the licence of the product. If >72 hours but <less 120 hours from UPSI, advise that the option of an insertion of an IUD is the recommended first – line treatment but that EHC is supported by evidence from a World Health Organisation trial. Use of EHC does NOT stop a woman from having the IUD fitted as well but may ensure some protection whilst more effective protection is sought. Provision of Ulipristal acetate (which is licensed for up to 120 hrs) could be another alternative which would require referral to a medical practitioner to consider Use more than once in a cycle The product SPC advises against this because of the possibility of disturbance of the However, use more than once is supported by guidance from the Faculty of Sexual and Reproductive Healthcare. But, if a second act of UPSI has occurred within 12 hours of taking Levonorgestrel 1500mcg an additional dose is not necessary If Ulipristal has been used in this cycle then hormonal contraception will be affected. See SPC. Women seeking EHC in these circumstances should be advised to see a medical practitioner as an IUD would be the recommended first line treatment. If they
Ratification-Pboro-use-of-PGD-v2-Signed-LR.docx