Ramonna 1500 microgram Tablet

Changes to section 5.1 - Pharmacodynamic properties. The follwoing changes have been made under subheading 'Clinical efficacy and safety':

Clinical efficacy and safety

Results from a the randomised, double-blind clinical studystudies conducted in 1998, 2001(Lancet 2002; 360: 1803-1810) and 2010 showed that a 1500  microgram single dose of levonorgestrel (taken within 72  hours of unprotected sex) prevented 85%, 84%, 97% of expected pregnancies (compared , respectively.

The pregnancy rate (number of observed pregnancies in women taking EC/total number of women taking EC) was 1.1%, 1.34%, and 0.32%, respectively. Prevented fraction appeared to decrease and pregnancy rates appeared to increase with 79%time of start of treatment after unprotected intercourse, highest efficacy is reached when  two 750 microgram tablets wereEC is taken 12within 24 hours apart). after intercourse. Efficacy appears to decrease with increasing time from unprotected intercourse.

Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010) showed that the pregnancy rate of levonorgestrel is 1.01% (59/5 863) (compared to an expected pregnancy rate of about 8% in the absence of emergency contraception) see Table 1.

Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010)

*CI: confidence interval (compared to an expected pregnancy rate of about 8% in the absence of emergency contraception)

There is limited and inconclusive data on the effect of high body weight/high BMI on the contraceptive efficacy. In three WHO studies no trend for a reduced efficacy with increasing body weight/BMI was observed (Table 12), whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table 23). Both meta-analyses excluded intake later than 72 hours after unprotected intercourse (i.e. off-label use of levonorgestrel) and women who had further acts of unprotected intercourse (For pharmacokinetic studies in obese women see section 5.2).

Table 2: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010)

Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010)

Table 23: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010

At the recommended regimen, levonorgestrel is not expected to induce significant modification of blood clotting factors, and lipid and carbohydrate metabolism.

Change to section 10 - Date of revision of the text

January, 2020 September 2021

Levonorgestrel-containing emergency hormonal contraception: advice for users of hepatic-enzyme inducers.

Levonorgestrel emergency contraception - Important information for women taking other medicines.