ESCAPELLE Tablet Ref.[50444] Active ingredients: Levonorgestrel

Emergency contraception is an occasional method to be used in an “emergency situation” only. It should in no instance replace a regular contraceptive method. ESCAPELLE 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 ESCAPELLE 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 with treatment with ESCAPELLE, 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. ESCAPELLE is not recommended in patients with severe hepatic dysfunction.

Severe malabsorption syndromes, such as Crohn’s disease, might impair the efficacy of ESCAPELLE. After ESCAPELLE 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 adapt a method of regular contraception.

In case no menstrual period occurs in the next pill-free period following the use of ESCAPELLE 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.

ESCAPELLE 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 Escapelle. 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 Escapelle.

Contains lactose. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take Escapelle.

The metabolism of ESCAPELLE is enhanced by concomitant use of liver enzyme inducers. 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. John’s Wort), rifampicin, ritonavir, rifabutin, griseofulvin, ampicillin and other antibiotics, including medicines used to treat tuberculosis, cyclosporine (see below).

For women who have used enzyme-inducing drugs 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. 3000 micrograms 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 ESCAPELLE may increase the risk of cyclosporine toxicity due to possible inhibition of cyclosporine metabolism.

Pregnancy

ESCAPELLE 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.

Lactation

About 0,1% of the maternal ESCAPELLE dose can be transferred via milk to the nursed infant. Potential exposure of an infant to ESCAPELLE can be reduced if the breast-feeding woman takes the tablet immediately after feeding and avoids nursing following ESCAPELLE 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.

Nervous system disorders

Very common (>1/10): Headache

Common (>1/100 ≤1/10): Dizziness

Gastrointestinal disorders

Very common (>1/10): Nausea, lower abdominal pain

Common (>1/100 ≤1/10): Diarrhoea, vomiting

Reproductive system and breast disorders

Very common (>1/10): Bleeding not related to menses

Common (>1/100 ≤1/10): Breast tenderness, delay of menses more than 7 days, menstruation irregular

Bleeding patterns may be temporarily disturbed. 78% of women will have their next menstrual period within 5 days of expected time.

If the next menstrual period is more than 5 days overdue pregnancy should be excluded.

General disorders

Very common (>1/10): Fatigue

The following side effects have been reported with the post marketing use of hormonal contraceptives:

• Severe depression with a higher risk of suicidal thoughts/behaviour and suicide.
• Gastrointestinal disorders: Very rare (<1/10,000): abdominal pain
• Skin and subcutaneous tissue disorders: Very rare (<1/10,000): rash, urticaria, pruritus,
• Reproductive system and breast disorders: Very rare (<1/10,000): pelvic pain, dysmenorrhoea
• General disorders and administration site conditions: Very rare (<1/10,000): face oedema

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Not applicable.