Expiration date: 10/2028

Structure and Composition:

Tablets. 1 tablet contains levonorgestrel 1.5 mg

Excipients: potato starch Colloidal anhydrous silica Magnesium stearate, talc, corn starch, lactose monohydrate

in blister 1 pc. In the paper cartons 1 blister.

Description pharmaceutical form:

Flat round tablets white or nearly white, with beveled and engraved with «GOO» on one side.

Characteristic:

Contraceptives - progestogen.

Pharmacokinetics:

When oral levonorgestrel is rapidly and completely absorbed from the gastrointestinal tract. Cmax in plasma observed after 2 hours and 18.5 ng / ml.

Gastrointestinal diseases occurring with malabsorption, reduce the absorption of the drug, which may affect its effectiveness.

Levonorgestrel binds to albumin and globulin, sex hormone binding (SHBG). 1.5% of the total plasma in the form of free steroid 65% of specifically bound to SHBG.

The absolute bioavailability of 100% of the dose.

0.1% of the dose ingested by the infant with breast milk.

It is hydroxylated in the liver and levonorgestrel as glucuronide conjugates excreted. Levonorgestrel pharmacologically active metabolites are unknown.

After reaching Cmax levonorgestrel concentration in blood decreases, T1 / 2 -. 7.2 hours, 60% of the drug appears in the form of metabolites in the urine and 40% - in the faeces.

Description of the pharmacological actions:

The recommended doses of levonorgestrel is inhibition of ovulation, if the sexual intercourse took place in the preovulatory phase of the menstrual cycle, ie in the period of greatest probability of fertilization. In addition, the drug caused regression of endometrial proliferation prevents implantation of a fertilized egg. When held implanting the drug ineffective.

Contraceptive Effectiveness decreases as the time elapsed between sexual intercourse and drug intake. Under the recommended dosing regimen of levonorgestrel has no significant effect on blood clotting factors, fat and carbohydrate metabolism.

The risk of pregnancy is 1.1% on average.

Testimony:

Emergency (postcoital) contraception.

Contraindications:

• hypersensitivity to any component of the drug
  
• diseases of the liver or bile ducts
  
• jaundice (including history)
  
• pregnancy
  
• puberty.
  

Application of pregnancy and breastfeeding:

Contraindicated during pregnancy.

Breastfeeding after taking the drug should be discontinued for 36 hours.

Side effect:

Rarely - nausea, vomiting, diarrhea, fatigue, abdominal pain, headache, dizziness, tension of the mammary glands, menstrual disorders.

Possible time delay of menstruation (usually not exceeding 5-7 days).

Drug Interactions:

With simultaneous application of drugs - inducers of microsomal liver enzymes oxidation metabolism of levonorgestrel is enhanced. The efficacy of levonorgestrel can reduce medicinal preparations containing active ingredients listed below: barbiturates, primidone, phenytoin, carbamazepine, rifampicin, ampicillin, tetracycline, ritonavir, rifabutin, griseofulvin, and preparations hypericum (Hypericum perforatum).

Levonorgestrel can enhance the toxicity of cyclosporine by inhibiting its metabolism.

Dosage and administration:

Inside. It is used in the first 96 hours after intercourse.

Overdose:

Symptoms: nausea, menstrual disorders.

Treatment: symptomatic therapy. No specific antidote.

Special instructions:

This product is intended for emergencies, in any case, not a substitute for regular contraception.

Levonorgestrel is not in all cases prevent fertilization. In the case where the sexual intercourse is not known, or when after intercourse more than 96 hours have passed without contraception, high probability of fertilization. In such cases, a pill Escapelle after the second sexual act will not bring the desired result. If menstruation delayed more than 7 days, and when the timely onset of menstruation unusual occurs, or there is a suspicion of a pregnancy for any other reason, there should be a gynecological examination to exclude pregnancy.

If within 3 hours after administration of the tablet occurred vomiting Escapelle efficiency decreases.

Escapelle The tablet can be taken any day of the menstrual cycle, provided that the previous menstruation was normal.

After application of the tool to be applied barrier contraceptives, such as condoms, until the next period. The use of tablets Escapelle is not a contraindication for the continuation of the previously started receiving oral hormonal contraceptive.

Avoid re-use tablet Escapelle during the same menstrual cycle in order to avoid its violations.

In women with abdominal / pelvic pain, or there is a history of ectopic pregnancy, surgery on the fallopian tubes, inflammatory diseases of the pelvic organs, the use of levonorgestrel may serve as an additional risk factor for ectopic pregnancy. If there is pain in the lower abdomen, the appearance of syncope, have a history of ectopic pregnancy, surgery on the pelvic organs or their inflammation to exclude ectopic pregnancy.

Use of the drug, generally does not break the regularity and nature of normal menses. In the case, when the drug was used Escapelle because of an error in a regular hormonal contraception, and the subsequent 7-day break is absent menstruation, pregnancy should be excluded.

Do not use the drug as a means for regular and continuous contraception, as This leads to lower efficacy and frequent adverse reactions. With regular sex life is recommended to use other methods of contraception.

Emergency contraception does not protect against sexually transmitted diseases by.