Escapel - instructions for use, dose, side effects, contraindications

Active substanceLevonorgestrelLevonorgestrel

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Escapel®

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Dosage form: & nbsppills

Composition:

Each tablet contains:

Active ingredient: levonorgestrel 1.50 mg.

Auxiliary substances: potato starch: silicon colloidal dioxide: magnesium stearate; talc; corn starch; lactose monohydrate.

Description:

Flat round tablets of white or almost white color, with a bevel and with an engraving "G00" on one side.

Pharmacotherapeutic group:Gestagen

ATX: & nbsp

G.03.A.D Preparations for emergency contraception

G.03.A.D.01 Levonorgestrel

Pharmacodynamics:

Levonorgestrel is a synthetic gestagen with a contraceptive effect, expressed by gestagenic and antiestrogenic properties. With the recommended dosing regimen, levonorgestrel suppresses ovulation and fertilization, if sexual intercourse has occurred in the preovulatory phase, when the possibility of fertilization is greatest. It can also cause changes in the endometrium, which prevent implantation.The drug is not effective if the implantation has already occurred.

Efficiency: reception of Escapel® it is recommended to start as soon as possible (but not later than 72 hours) after sexual intercourse, if no protective measures have been applied. The more time passed between intercourse and taking the drug, the lower its effectiveness (95% during the first 24 hours, 85% - from 24 to 48 h, and 58% - from 48 to 72 hours). In the recommended dose levonorgestrel does not significantly affect the clotting factors of blood, the exchange of fats and carbohydrates.

Pharmacokinetics:

When taken orally levonorgestrel quickly and almost completely absorbed. After taking one tablet of Escapel®, the maximum serum concentration in the serum is 18.5 ng / ml achieved after 2 hours. After reaching the maximum level of concentration, the content of levonorgestrel is reduced, and the half-life is about 26 hours.

Levonorgestrel is excreted approximately equally by the kidneys and through the intestine exclusively in the form of metabolites. Biotransformation of levonorgestrel corresponds to the metabolism of steroids. Levonorgestrel It is hydroxylated in the liver and metabolites are excreted in the form of conjugated glucuronides.Pharmacologically active metabolites of levonorgestrel are unknown.

Levonorgestrel binds with serum albumin and with globulin binding sex hormones (SHBG). Only 1.5% of the total dose is in free form, and 65% is related to SHBG. Absolute bioavailability is 100% of the dose.

Indications:

Emergency (postcoital) contraception (after unprotected sex or unreliability of the contraceptive method used).

Contraindications:

Hypersensitivity to any component of the drug, use in adolescents under 16 years, severe hepatic impairment, pregnancy.

Patients with rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully:

Diseases of the liver or biliary tract, jaundice (including, in the anamnesis), Crohn's disease, lactation.

Pregnancy and lactation:

Escapel ® can not be used during pregnancy. If the pregnancy occurred when using an emergency method of contraception, then based on the available data, the adverse effect of the drug on the fetus is not revealed.

Levonorgestrel penetrates into the mother's milk.After taking the drug, breast-feeding should be stopped for 24 hours.

Dosing and Administration:

The drug is administered orally. One tablet should be taken as soon as possible, but no later than 72 hours after unprotected intercourse. If within three hours after taking the tablet Escapel ® there was vomiting, you should take another tablet of Eskapel ®.

Eskapel® can be used at any time of the menstrual cycle. In the case of an irregular menstrual cycle, pregnancy should be excluded.

After taking an emergency contraceptive before the next menstrual period, local barrier contraceptive methods (eg, a condom) should be used. The use of the drug with repeated unprotected intercourse during one menstrual cycle is not recommended because of the increased frequency of acyclic bleeding / bleeding.

Side effects:

Allergic reactions are possible: hives, rash, itching, edema of the linden.

Transient side effects that occur at different frequencies (often: ≥ 1/100, <1/10, very often: ≥ 1/10) and do not require medication.

Often: vomiting, diarrhea, dizziness, headache, breast tenderness, delay in menstruation (no more than 5-7 days), if menstruation is delayed for a longer period, pregnancy should be excluded.

Very often: nausea, fatigue, pain in the lower abdomen, acyclic spotting (bleeding).

Overdose:

Increased severity of side effects. There is no specific antidote. Treatment is symptomatic.

Interaction:

At simultaneous reception of drugs-inducers of liver enzymes, the metabolism of levonorgestrel is accelerated.

The following drugs may reduce the effectiveness of levonorgestrel: amprekavil, lansoprazole, nevirapine, oxcarbazepine, tacrolimus, topiramate, tretinoin, barbiturates, including primidon, phenytoin and carbamazepine, preparations containing St. John's wort (Hypericum perforatum), and rifampicin, ritonavir, ampicillin, tetracycline, rifabutin, griseofulvin. Reduces the effectiveness of hypoglycemic and anticoagulant (coumarin derivatives, fenindion) of medicinal products. Increases plasma concentrations of glucocorticosteroids.Women who take these drugs should consult a doctor. Preparations containing levonorgestrel, can increase the risk of toxicity of cyclosporine, due to the suppression of its metabolism.

Special instructions:

Escapel ® should be used exclusively for emergency contraception! Repeated use of the drug Escapel ® during one menstrual cycle is not recommended! Eskapel® be taken as soon as possible but not later than 72 hours after the unprotected coitus. The effectiveness of emergency contraception with delayed use of the drug is significantly reduced.

The drug does not replace the use of permanent methods of contraception. In most cases, Escapel ® does not affect the nature of the menstrual cycle. However, acyclic bleeding may occur and menstruation may be delayed for several days. If you delay menstruation for more than 5-7 days and change its nature (scanty or abundant discharge), you must exclude pregnancy. The appearance of pain in the lower abdomen, fainting can indicate ectopic (ectopic) pregnancy.

Adolescents under the age of 16 in exceptional cases (including rape) need a consultation with the gynecologist to confirm the pregnancy.

After emergency contraception, a gynecologist is recommended to choose the most suitable method for permanent contraception.

Emergency contraception does not protect against sexually transmitted diseases.

In case of violations of the function of the gastrointestinal tract (for example, with Crohn's disease) the effectiveness of the drug may decrease.

Effect on the ability to drive transp. cf. and fur:

The effect of the drug on the ability to drive a car and other machines has not been investigated.

Form release / dosage:Tablets of 1.5 mg.

Packaging:

1 tablet of 1.50 mg in blister AL/ PVC. 1 blister in a cardboard box with the attached instruction for use.

Storage conditions:

List B. At a temperature of 15 to 25 ° C. Keep out of the reach of children!

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015924 / 01

Date of registration:08.09.2009

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER, Ltd. Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp31.05.2016

Illustrated instructions

Instructions

Escapel® (Escapelle®)