El Eva EC 72 (Levonorgestrel) 0.75 mg, 2 film-coated tablets

Instruction for medical use


of EL medicine EVE EK 72

Trade name
El Ewa EK 72

International unlicensed


name Levonorgestrel Dosage Form
of the Tablet, film coated.

Structure
One tablet contains
active agent - levonorgestrel of 0.7725 mg (3% surplus),
excipients: povidone, disubstituted phosphate of calcium, corn starch, lactose, talc purified magnesium stearate, starch sodium glycollate
structure of a cover: titan dioxide, hydroksipropilmetiltsellyuloza, makrogol-6000, propylene glycol.

The description
Biconvex tablets of round shape of white color, film coated, with risky on one party.

Pharmacotherapeutic group
Sex hormones and modulators of function of genitals, progestogens.
The code of automatic telephone exchange G03A C03

the Pharmacological


Pharmacokinetics Absorption Levonorgestrel properties is quickly and completely soaked up after oral administration (the bioavailability is about 100%) and is not exposed to effect of the first passing.
Metabolism
Levonorgestrel in plasma, generally contacts the globulin connecting sex hormones (SHBG). The majority of the metabolites circulating in plasma are sulfates 3a, 5b-tetrahydrolevonorgestrel while removal of drug happens, generally in the form of glucuronides. A small amount of not changed levonorgestrel also circulates in plasma in the form of 17b-sulfate. After reception of an oral single dose, levonorgestrel is not exposed to extensive metabolism in a liver. The main metabolites are 3a, 5a- and 3a, 5b-tetrahydrolevonorgestrel, is also found 16b-hydroxynorgestrelum. Together these metabolites make less than 10% of initial substance in plasma. In urine metabolites, hydroxylated in 2a- and 16b-situation are defined. Small amounts of metabolites are present at plasma in the form of sulfates and glyukuronidny conjugates
Removal
Elimination half-life of levonorgestrel after reception of a single dose of 0.75 mg makes about 24 hours. At prolonged use, levonorgestrel and its metabolites, are generally removed with urine, smaller quantity – with a stake.
The pharmacodynamics
El Ewa of EK 72 is contraceptive for emergency contraception. The main mechanism of action is prevention of an ovulation or fertilization due to change of transport of sperm and an ovum on uterine tubes. In addition drug can oppress implantation due to endometrium change. Drug is inefficient if implantation process already began or pregnancy already occurred.

Indications
- contraception in the first 72 hours

the Route of administration and doses
One pill El Ewa EK 72 should be taken inside within the first 72 hours after sexual contact. The second pill should be taken within 12 hours after reception of the first dose.
The efficiency of drug is higher if to take a pill as soon as possible after the unprotected sexual contact. El Ewa EK 72 can be accepted during any period of a menstrual cycle.
The maximum single dose - 1 tablet.
The maximum daily dose - 2 tablets.

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
- disturbance of tolerance to glucose with increase in level of insulin in


Contraindication plasma
- pregnancy or suspicion on pregnancy
- hypersensitivity to one of drug components
- pathological uterine bleeding of not clear genesis
- women are more senior more than 7 days than 65 years
- girls till the puberty period

Medicinal interactions
Pharmaceutical interaction
Progestogens can suppress cyclosporine metabolism that leads to increase in concentration of cyclosporine in plasma and to increase in risk of toxic reactions.
Pharmakodinamichesky interaction
Efficiency low-dose progestin - the containing tablets decreases at combined use with such drugs inducing liver enzymes as anticonvulsants Phenytoinum, carbamazepine and barbiturates and also antitubercular drug rifampicin.
As progestogens can change effect of glucose-lowering drugs, correction of doses of anti-diabetic means can be required.

Special instructions
Before prescribing of drug El Ewa EK 72 needs to study carefully a case history and to perform gynecologic inspection for an exception of possible pregnancy. Before appointment it is necessary to investigate causes of infringement of a menstrual cycle, such as oligomenorrhea and amenorrhea. The period between medical examinations depends on a condition of each specific patient. If prescribing of drug El Ewa of EK 72 can affect latent or obvious diseases it is necessary to plan the corresponding control inspections. At drug use El Ewa of EK 72, irregular vaginal bleedings can be observed. If bleeding becomes frequent and irregular, it is necessary to consider the possibility of use of other contraceptive means. If symptoms do not disappear, it is necessary to exclude organic lesions. Treatments of an amenorrhea during administration of drug depends on whether a pill according to recommendations is taken, and can include the test for pregnancy. In case of pregnancy the reception of tablets should be stopped.
El Ewa does not protect EK 72 from infection of HIV (AIDS) and other diseases which are transmitted sexually.
The efficiency of oral contraceptives which contain only progestogen can decrease in case of the passed tablet in case of gastrointestinal disturbances or at parallel intake of other drugs.
During a usage time of oral contraceptives which contain only progestogen at some women the vaginal bleeding can become more frequent and long, and at others - accidental or in general to stop. These changes often happen the reason that the woman refuses to take a pill or not strictly adheres to the recommendations of the doctor. At observance of the instruction for use of drug El Ewa of EK 72, it is possible to improve the acceptability of nature of bleeding. Assessment of vaginal bleeding has to be carried out on a regular basis and include researches that the malignant disease or pregnancy allow to exclude.
When using low doses of hormonal contraceptives the development of follicles is possible, and the follicle can sometimes continue to grow to the sizes which exceed the sizes at a normal menstrual cycle. As a rule, such increased follicles disappear spontaneously. Often they do not give symptoms, and can be in certain cases connected with insignificant abdominal pain. They seldom demand surgical intervention.
At a delay of the beginning of periods more than for a week, it must be kept in mind a possibility of development of pregnancy.
The women sick with diabetes have to be under observation of the doctor at use El Ewa of EK 72
the lactation Period
At the feeding women accepting constantly the contraceptives containing one progestin for long contraception, a small amount of progestin gets into breast milk, at the same time in the child's plasma the level of steroids is 1% - mother has 6% of the plasma level of steroids. Nevertheless, intake of the contraceptives containing one progestin has no effect on quantity and quality of breast milk or on health (growth and development) of the child.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
was not reported About influence of drug on concentration of attention

Overdose
Symptoms: nausea and bleeding.
Treatment: gastric lavage, intake of activated carbon for the termination of further absorption of drug.

The form of release and packing
On 2 tablets pack into blister strip packaging from a film of PVC and aluminum foil.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a cardboard pack.


To Store storage conditions in the dry, protected from light place at a temperature not over 250C.
To store out of children's reach!


2 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription



Plethico Pharmaceuticals Ltd/Pletkhiko Pharmasyyutikalz Ltd Adres Producer of location:
F-25, Indastrial Isteyt, Gorva, Baroda – 390,016, India.
Legal address:
37/37A, Industrial of Isteyt, Polograund, Indore (L. S.), 452,015, India.

The owner of the registration certificate
of Plethico Pharmaceuticals Ltd/Pletkhiko Pharmasyyutikalz Ltd, India

the Address of the organization accepting in the territory of the Republic of Kazakhstan consumers on quality a produktsiipredstavitelstvo in RK Rezlov LTD LLP, Karaganda, Ermekov St. 100009 Karaganda, Ermekov St., 110/2tel.:/7212/481644, 431534, 43-15-63.48-17-67, ph./fax:/7212/48 17 44,






To develop e-mail of rezlov_ltd@mail.ru, rezlov-ltd@rambler.ru