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Escapelle® (Levonorgestrel) 1.5 mg, 1 tablet

$19.40

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Description

The instruction for medical use

of medicine

ESCAPELLE

the Trade name

Escapelle

the International unlicensed

name Levonorgestrel Dosage Form

of the Tablet of 1.5 mg

Structure

One tablet contains

active agent – levonorgestrel of 1.5 mg

excipients: talc, silicon dioxide colloidal anhydrous, lactoses monohydrate, starch corn, potato starch, magnesium stearate.

The description

Flat tablets of white or almost white color, with a facet, and with an engraving of G00 on one party.

Pharmacotherapeutic group

Sex hormones and modulators of function of genitals, progestogens.

The code of automatic telephone exchange

the Pharmacological

Pharmacokinetics At properties oral administration levonorgestrel is quickly and almost completely soaked up by G03A C03. In 2 hours after reception of the tablet Cmax Escapelle = 18.5 ng/ml. The average size AUC (0 – ∞) = 310182.56 pg. h/ml. After achievement of the maximum concentration the levonorgestrel level in blood decreases, average elimination half-life ≈ 26 h.

It is removed in the form of metabolites with urine and a stake in equal ratios. Biotransformation of levonorgestrel is carried out on the metabolic way characteristic of steroids. In a liver levonorgestrel is hydroxylated and in the form of glyukuronidny conjugates is removed from an organism. Pharmacological active metabolites of levonorgestrel are unknown.

Levonorgestrel takes up with albumine and the globulin, connecting sex hormones (G,CSH). 1.5% of total in blood plasma are in a form of free steroid, 65% are specifically connected with GSPG.

After reception of one tablet of Escapelle average concentration of GSPG in blood ≈ the 40th nmol/l. Within 24 hours the concentration of GSPG in blood remains invariable or increases a little, then begins to decrease and in 192 hours makes ≈ the 30th nmol/l.

The absolute bioavailability is 100% of the accepted dose.

0.1% of the accepted dose of drug get to the baby’s organism together with breast milk.

A pharmacodynamics

Levonorgestrel – active ingredient of the drug Escapelle. The exact mechanism of effect of drug is unknown. In the recommended doses levonorgestrel has effect on an ovulation and fertilization if sexual intercourse takes place in a preovulatory phase of a menstrual cycle, i.e. at the time of the largest probability of fertilization. Besides, the endometrium changes caused by drug interfere with oospore implantation. At the begun implantation, drug is inefficient.

Prevents pregnancy in 84% of cases. The recommended doses of levonorgestrel have no significant effect on blood clotting factors, exchange of fats and carbohydrates.

Indications

– urgent oral contraception in the first 72 hours after sexual intercourse during which any methods of contraception it was not applied or the applied method of contraception was not rather reliable.

The route of administration and doses

Is applied orally in the first 72 hours after sexual intercourse.

If within three hours after reception of a tablet there was vomiting, it is necessary to take one more pill.

The pill Escapelle can be taken in any day of a menstrual cycle provided that the previous periods proceeded normally.

After use of the emergency means it is necessary to apply local barrier contraceptives, for example condom to prevention of conception, up to the following periods. Use of the tablet Escapelle is not a contraindication for continuation of regular intake of oral hormonal contraceptive.

Side effects

– a headache, dizziness, fatigue

– tension of mammary glands

– nausea, vomiting, a diarrhea

– pains in the bottom of a stomach, disturbances of a menstrual cycle, a delay of periods more than 7 days

Perhaps temporary change of nature of periods. At 78% of women the shifts of terms of periods are in limits of 5 days. At a periods delay for more than 5-day term it is necessary to exclude pregnancy existence.

Contraindications

– hypersensitivity to active ingredients or to any of drug excipients

– children’s age up to 16 years

– heavy degree of a hepatic unsufficiency

– pregnancy

Medicinal interactions

At simultaneous use of drugs inductors of metabolism of a liver the metabolism of levonorgestrel amplifies.

The medicines containing the listed below active ingredients can reduce efficiency levonorgestrel – the containing drugs: barbiturates (including Primidonum), Phenytoinum, carbamazepine, drugs of a St. John’s wort (Hypericum perforatum), rifampicin, ritonavir, rifabutin, griseofulvin.

Drugs of levonorgestrel can enhance toxicity of cyclosporine due to suppression of his metabolism.

Special indications

of the Tablet Escapelle are intended for emergencies. They does not replace regular contraception at all.

Drugs of urgent contraception not in all cases prevent conception. Probability of fertilization is high in cases when time of sexual intercourse is definitely not known and when from the moment of the sexual intercourse unprotected by contraception there passed more than 72 hours in the period of one menstrual cycle. In such cases the reception of the tablet Escapelle after the second sexual intercourse will not bring desirable result. At a periods delay more than for 5 days and also in case in due time come periods proceed unusually, or suspicion on pregnancy for any other reasons takes place, it is necessary to perform gynecologic examinations for a pregnancy existence exception.

The pregnancy which followed against the background of use of the tablets Escapelle can be extrauterine, especially, at women with pains in the lower part of a stomach, at appearance of faints, existence in the anamnesis of ectopic pregnancy, operation on bodies of a small pelvis or their inflammation.

In heavy abnormal liver functions the use of the tablets Escapelle is not recommended. At disturbances of absorption in digestive tract (e.g., Crohn’s disease) reduce efficiency of contraceptive drug. Drug use, usually, does not break regularity and the normal nature of periods. Sometimes, perhaps premature emergence of periods or its delay (approximately? 2 days). After use of the tablet Escapelle, it is recommended to provide further regular contraception. If Escapelle is applied because of the mistake made in regular hormonal contraception and at the same time in the corresponding seven-day break of periods will not follow, it is necessary to exclude pregnancy existence.

It is necessary to avoid repeated use of the tablets Escapelle during the same menstrual onoff cycles avoidance of disturbances of a menstrual cycle.

In comparison with usual regular contraceptives of the tablet Escapelle are less effective. The women who are often resorting to means of urgent contraception should offer any method of regular contraception.

Urgent contraception does not replace need for protection against venereal diseases.

The lactation

Levonorgestrel gets into breast milk. Influence on the child levonorgestrel can be reduced, taking the drug directly after feeding by a breast or abstaining from feeding by a breast after administration of drug.

Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms

of Researches on influence of the drug Escapelle on ability to run vehicles and other mechanisms it was not carried out.

Overdose

Symptoms: nausea, disturbances of a menstrual cycle.
Treatment: symptomatic, specific antidote there is

no Form of release and packing

On 1 tablet in blister strip packaging from PVC and aluminum foil.

On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a pack from cardboard

Storage conditions

to Store at a temperature from +15 °C to +25 °C.

To store out of children’s reach!

Not to use a period of storage of 5 years after expiry date.

Prescription status

According to the prescription

Budapest JSC Gideon Richter producer 1103, Djemrei St., 19-21, Hungary

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:

Representative office of JSC Gideon Richter in RK

E-mail:

Phone number: 8-(7272)-58-26-22, 8-(7272)-58-26-23

To develop richter@nursat.kz

Additional information

Ingredient

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