Lornestin 1,50 mg Tablet

Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.

Posology
The tablet should be taken, no later than 72 hours after unprotected intercourse. If the patient vomits within three to four hours of taking the tablet, another tablet should be taken immediately. Lornestin can be used at any time during the menstrual cycle unless menstrual bleeding is overdue. After using emergency contraception, it is recommended to use a local barrier method (e.g., condom) until the next menstrual period starts. The use of Lornestin does not contraindicate the continuation of regular hormonal contraception.
Paediatric population
Lornestin is not recommended in children. Very limited data are available in women under 16 years of age.
Method of administration
For oral administration.

Lornestin is contraindicated in:
u2022 hypersensitivity to levonorgestrel or to any of the excipients listed in section 6.1;
u2022 severe hepatic insufficiency;
u2022 pregnancy or suspected pregnancy (see section 4.6);
u2022 depression not well controlled with treatment;
u2022 a history of depression with the use of hormonal contraceptives.

Emergency contraception is an occasional method to be used in an u201cemergency situationu201d only. It should in no instance replace a regular contraceptive method. Lornestin does not prevent a pregnancy in every instance. If there is uncertainty about the timing of the unprotected intercourse or if the woman has had unprotected intercourse more than 72 hours earlier in the same menstrual cycle, conception may have occurred. Treatment with Lornestin following the second act of intercourse may therefore be ineffective in preventing pregnancy. If menstrual periods are delayed by more than 5 days or abnormal bleeding occurs at the expected date of menstrual periods or pregnancy is suspected for any other reason, pregnancy should be excluded. If pregnancy occurs after treatment with Lornestin, the possibility of an ectopic pregnancy should be considered, especially in those women who present with abdominal/pelvic pain or collapse and those with a history of ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease. The absolute risk of ectopic pregnancy is likely to be low, as Lornestin prevents ovulation and fertilization. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding. Therefore, Lornestin is not recommended for patients who are at risk of ectopic pregnancy (previous history of salpingitis or of ectopic pregnancy). Lornestin is not recommended in patients with severe hepatic dysfunction (see section 4.3). Severe malabsorption syndromes, such as Crohn's disease, might impair the efficacy of Lornestin. After Lornestin intake, menstrual periods are usually normal and occur at the expected date. They can sometimes occur earlier or later than expected by a few days. It is recommended to make a medical appointment to initiate or adopt a method of regular contraception. In case no menstrual period occurs in the next pill-free period following the use of Lornestin after regular hormonal contraception, pregnancy should be ruled out. Repeated administration within a menstrual cycle is not advisable because of the possibility of disturbance of the cycle. Limited and inconclusive data suggest that there may be reduced efficacy of Lornestin with increasing body weight or body mass index (BMI). In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI. Lornestin is not as effective as a conventional regular method of contraception and is suitable only as an emergency measure. Women who present for repeated courses of emergency contraception should be advised to consider long-term methods of contraception. Use of emergency contraception does not replace the necessary precautions against sexually transmitted diseases. Mood changes and depression are side effects reported with the use of hormonal contraceptives including Lornestin. There is some evidence that hormonal contraceptive use may be associated with severe depression and a higher risk of suicidal thoughts/behaviour (e.g., talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes) and suicide. Prescribers should inform their patients to contact their doctor for advice if they experience mood changes and depression whilst on treatment with Lornestin.

The metabolism of Lornestin is enhanced by concomitant use of liver enzyme inducers, mainly CYP3A4 enzyme inducers. Concomitant administration of efavirenz has been found to reduce plasma levels of levonorgestrel (AUC) by around 50%. Medicines suspected of having the capacity to reduce the efficacy of levonorgestrel containing medication include barbiturates (including primidone), phenytoin, carbamazepine, herbal medicines containing Hypericum perforatum (St. Johnu2019s Wort), rifampicin, ritonavir, rifabutin, griseofulvin, ampicillin and other antibiotics, including medicines used to treat tuberculosis, ciclosporin (see below). For women who have used enzyme-inducing medicines in 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., 3,00 mg 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 concomitant use of an enzyme inducer) has not been studied. The requirement for oral antidiabetics and insulin can change as a result of an effect on glucose tolerance. Medicines containing levonorgestrel as in Lornestin may increase the risk of ciclosporin toxicity due to possible inhibition of ciclosporin metabolism.

Pregnancy
Lornestin should not be given to pregnant women and will not interrupt the pregnancy. In case of failure of this emergency contraception with developing pregnancy, epidemiological studies indicate no adverse effects of progestogens on the foetus. In case of unprotected coitus more than 72 hours earlier, the patient may be pregnant. In these cases, pregnancy should be excluded.
Breastfeeding
About 0,1 % of the maternal Lornestin dose can be transferred via milk to the nursed infant. Potential exposure of an infant to Lornestin can be reduced if the breastfeeding woman takes the tablet immediately after feeding and avoids nursing at least 8 hours following Lornestin administration.
Fertility
Levonorgestrel increases the possibility of cycle disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however, there are no fertility data in the long term.

No studies on the effects on the ability to drive and use machines have been performed.

a. Summary of the safety profile
The most frequently reported side effect is nausea.
b. Tabulated summary of adverse reactions

The following side effects have been reported with the post marketing use of hormonal contraceptives:
System Organ Class
Frequency
Undesirable effect
Psychiatric disorders
Frequency unknown
Severe depression with a higher risk of suicidal thoughts/behaviour and suicide.
Gastrointestinal disorders
Less frequent
Abdominal pain.
Skin and subcutaneous tissue disorders
Less frequent
Rash, urticaria, pruritus.
Reproductive system and breast disorders
Less frequent
Pelvic pain, dysmenorrhoea.
General disorders and administration site conditions
Less frequent
Face oedema.

Serious undesirable effects have not been reported following acute ingestion of large doses of oral contraceptives. Overdose may cause nausea, and withdrawal bleeding may occur. There are no specific antidotes and treatment should be symptomatic and supportive.