Escapel, 1.5 mg tablets

Interaction

Concomitant use with drugs inducers of microsomal liver enzymes (mainly inducers of CYP3A4 isoenzyme) accelerates the metabolism of levonorgestrel.

The concomitant use of efavirenz decreases plasma concentrations of levonorgestrel by approximately 50%.

The following liver enzyme-inducing drugs may decrease the effectiveness of levonorgestrel: barbiturates (including primidone), phenytoin and carbamazepine, preparations containing Hypericum perforatum, and rifampicin, ritonavir, rifabutin and griseofulvin.

The drugs containing levonorgestrel may increase the risk of cyclosporine toxicity by inhibiting its metabolism.

Levonorgestrel may decrease the efficacy of ulipristal acetate through competitive effects on the progesterone receptor, and therefore concomitant use is not recommended.

Special Instructions

Emergency contraception is a method that can be used occasionally. It should not replace routine contraception.

Emergency contraception does not prevent pregnancy in all cases.

If there are doubts concerning the time of unprotected sexual intercourse, or if unprotected intercourse took place more than 72 hours during the same menstrual cycle, there is a possibility that conception has already occurred. In this connection the use of Escapel® at the second sexual intercourse can be ineffective with respect to prevention of pregnancy. If menstrual bleeding is delayed for more than 5-7 days and its character has changed (scarce or abundant bloody discharge) it is necessary to exclude pregnancy.

If pregnancy occurs after the use of the drug Escapel® it is necessary to consider the possibility of ectopic pregnancy. The appearance of pain in the lower abdomen, fainting may indicate an ectopic pregnancy. The absolute risk of ectopic pregnancy seems to be low, since levonorgestrel prevents ovulation and fertilization. Ectopic pregnancy may develop despite the occurrence of uterine bleeding. In this regard, the use of the drug Escapel® is not recommended in women with the risk of developing
ectopic pregnancy (salpingitis or ectopic pregnancy in the anamnesis).

The use of the drug Escapel® is not recommended in patients with severe hepatic impairment.

Severe malabsorption syndromes, such as Crohn’s disease, may reduce the effectiveness of the levonorgestrel.

After taking Escapel® the menstrual cycle is usually unchanged and menstrual bleeding occurs on time. Sometimes menstrual bleeding may start a few days earlier or later. Women should be advised to see a doctor to choose and start using one of the methods of planned contraception. If Escapel® was taken against a background of regular hormonal contraception, but
the expected bleeding “cancellation” in the next 7-day period “without the pill” has not occurred, pregnancy should be excluded.

Repeated use of the drug during one menstrual cycle is not recommended due to the possibility of cycle disorders.

There is limited data requiring further confirmation that the contraceptive efficacy of Escapel® may decrease with increasing body weight or BMI. In all women, regardless of body weight and BMI, emergency contraception should be taken as soon as possible after unprotected intercourse.

Escapel® is ineffective as a permanent method of contraception and can only be used as an emergency measure. Levonorgestrel in a dose of 1.5 mg should be used only for emergency contraception!

Women who seek repeated courses of emergency contraception should be recommended to use methods of planned contraception.

Use of the drug in adolescent girls under 16 years is possible only in exceptional cases (including rape) and only after consulting a gynecologist. After emergency contraception, consultation with a gynecologist is recommended.

Fertility
Levonorgestrel increases the risk of menstrual irregularities, which in some cases may lead to earlier or later ovulation. These changes may affect fertility, but there are no data on the effects of levonorgestrel on fertility with long-term use.

The use of emergency contraception does not replace necessary precautions related to protection against sexually transmitted diseases.

Influence on driving and operating machinery

The effect of the drug on driving and operating machinery has not been studied.

Synopsis

Flat round tablets, white or almost white, beveled and engraved “G00” on one side.

Contraindications

– Hypersensitivity to levonorgestrel and/or to any of the excipients in the drug.
– Age under 16 years (due to the limited data on safety and efficacy of levonorgestrel in this age group).
– Severe hepatic failure.
– Known or suspected pregnancy.
– Breast-feeding for at least 8 hours after taking the drug.
– Lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

With caution
Liver disease (mild to moderate severity) or biliary tract; jaundice (including anamnesis); severe malabsorption syndromes, such as Crohn’s disease; presence of hereditary or acquired predisposition to thrombosis.

Side effects

The most common adverse reaction (AR) with levonorgestrel was nausea.

HDs are presented by systemic organ class according to the MedDRA classification and with frequency of occurrence: very common (≥1/10), common (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000), very rare (< 1/10000), including individual reports. Within each group, HPs are distributed in decreasing order of importance.

Nervous system disorders

Very common: headache.

Often: dizziness.

Gastrointestinal tract disorders

Very common: nausea, pain in the lower abdomen.

Often: diarrhea, vomiting.

Genital and mammary disorders

Very common: bleeding not associated with menstruation.

Often: menstrual delays of more than 7 days, irregular menstrual bleeding, breast engorgement.

General disorders and disorders at the site of administration

Very common: increased fatigue.

The nature of menstrual bleeding may change slightly, but in most women the next menstruation begins within 5 days of the expected due date.

If your next period is more than 5 days late, pregnancy should be ruled out.

The following adverse events have been observed in clinical practice during the post-registration period:

Gastrointestinal disorders

Very rare: abdominal pain.

Skin and subcutaneous tissue disorders

Very rare: skin rash, urticaria, itching.

Gender and mammary gland disorders

Very rare: pelvic pain, dysmenorrhea.

General disorders and disorders at the site of administration

Very rare: facial swelling.

Overdose

No serious adverse reactions have been reported in acute overdose with high doses of oral contraceptives.

Symptoms: nausea and bleeding “withdrawal”.

Treatment: symptomatic. There is no specific antidote.

Pregnancy use

Pregnancy
Administration of the drug during known or suspected pregnancy is contraindicated. Based on available data, no adverse effects on the fetus have been identified in the case of continued pregnancy with levonorgestrel-containing emergency contraception.

Breastfeeding
Levonorgestrel penetrates into breast milk. The potential effects of levonorgestrel on the baby can be reduced if the woman takes the drug immediately after breastfeeding. After taking the drug, breastfeeding should be stopped for at least 8 hours.

Similarities

Postinor