Deletion of:

“Hypersensitivity to levonorgestrel or any of the excipients”

Addition of:

“Hypersensitivity to the active substance or to any of the excipients listed in section 6.1”.

SECTION 4.4: SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Removal of the below text from the text box:

“Limited and inconclusive data suggest that there may be reduced efficacy of Norlevo with increasing body weight or body mass index (BMI) (see section 5.1). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman’s body weight or BMI”.

Addition of the above, as a new paragraph (paragraph 2).

Change of:

“Norlevo” to “NorLevo”

SECTION 4.5: INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Deletion of:

“anticonvulsant, phenobarbital”

Addition of:

“mainly CYP3A4 enzyme inducers. Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%”

to the following sentence: “The metabolism of levonorgestrel is enhanced by concomitant use of liver enzyme inducers…”

Addition of:

“Drugs suspected of having similar capacity to reduce plasma levels of levonorgestrel include barbiturates (including primidone)”

Deletion of:

“primidone, rifabutin; rifampicin; griseofulvin; ritonavir;”

Addition of:

“herbal medicines containing”

Deletion of:

“The efficacy of Norlevo 1.5 mg may be decreased”

Addition of:

“, rifampicin, ritonavir, rifabutin, and griseofulvin”

Addition of:

“For women who have used enzyme-inducing drugs”

Deletion of:

“case of”

Addition of:

“the past 4 weeks and need emergency contraception, the use of non-hormonal emergency contraception (i.e. a Cu-IUD) should be considered. Taking a double dose of levonorgestrel (i.e. 3000 mcg within 72 hours after the unprotected intercourse) is an option for women who are unable or unwilling to use a Cu-IUD, although this specific combination (a double dose of levonorgestrel during”

Deletion of:

“intake of these active substances”

Addition of:

“use of an enzyme inducer) has not been studied”.

Addition of:

“Medicines containing levonorgestrel may increase the risk of cyclosporin toxicity due to possible inhibition of cyclosporin metabolism”.

SECTION 4.6: FERTILITY, PREGNANCY AND LACTATION

Change of:

“Breastfeeding” to “Breast-feeding”

Change of:

“Norlevo” to “NorLevo”

SECTION 4.7: EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Change of:

“Norlevo” to “NorLevo”

SECTION 4.8: UNDESIRABLE EFFECTS

Change of:

“Delay in menses³” to “Delay in menses⁴” (change in reference)

Change of:

“Norlevo” to “NorLevo”

Addition of:

“Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V”.

SECTION 5.1: PHARMACODYNAMIC PROPERTIES

Addition of:

“ATC Code” in “Pharmacotherapeutic group: EMERGENCY CONTRACEPTIVES”

Addition of:

“Mechanism of action” as a title before paragraph 1

Addition of:

“Clinical efficacy and safety” as a title before paragraph 2

Addition of:

“Paediatric population

A prospective observational study showed that out of 305 treatments with levonorgestrel emergency contraceptive tablets, seven women became pregnant resulting in an overall failure rate of 2.3%. The failure rate in women under 18 years (2.6% or 4/153) was comparable to the failure rate in women 18 years and over (2.0% or 3/152)”.

SECTION 5.2:  PHARMACOKINETIC PROPERTIES

Removal of:

 “Bioavailability of oral levonorgestrel is approximately 100 percent. In the plasma, it is strongly bound to SHBG. Levonorgestrel is eliminated via kidney (60-80%) and liver (40-50%)”.

Addition of:

“Absorption” as a title before paragraph 1

Addition of:

“Distribution/Biotransformation” as a title before paragraph 2

Addition of:

“Elimination” as a title before paragraph 3

Removal then replaced as paragraph 3:

“Bioavailability of oral levonorgestrel is approximately 100 percent. In the plasma, it is strongly bound to SHBG. Levonorgestrel is eliminated via kidney (60-80%) and liver (40-50%)”.

SECTION 5.3: PRECLINICAL SAFETY DATA

Change of:

“Nonclinical” to “Non-clinical”

Addition of:

“based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential”

Change of:

“SPC” to “SmPC”