Laktinet® (Desogestrel) 0.075 mg, 28 coated tablets

The instruction for medical use

of Laktinet®-Rihter medicine

the Trade name
of Laktinet®-Rihter

the International unlicensed


name Dezogestrel Lekarstvennaya
the Tablet form, film coated 0.075 mg

Structure
One tablet contains
active agent - dezogestret 0.075 mg,
excipients: full racemate of α-tocopherol, silicon dioxide colloidal anhydrous, stearic acid, K30 povidone, potato starch, lactoses monohydrate,
structure of a cover: Opadray II pink 85F28751: talc, macrogoal 3000, titan dioxide (E171), polyvinyl alcohol.

The description
of the Tablet, film coated white or almost white color of round shape, with a biconvex surface, with an engraving of D on one party and 75 on other party, with a diameter about 5.5 mm.

Pharmacotherapeutic group
Sex hormones and modulators of a reproductive system. Hormonal contraceptives for system use. Progestogens. Dezogestrel
the ATX G03AC09 Code




intake dezogestret the Pharmacological Pharmacokinetics Absorption At properties is soaked up quickly and metabolized in etonogestret which is biologically active metabolite of a dezogestrel. Average maximum concentration in blood serum is reached in 1.8 hours (Tmax) after reception of a tablet. The bioavailability etonogestret - 70%.

Etonogestrel's distribution to 95.5-99% contacts proteins of blood plasma, generally albumine and to a lesser extent the globulin, connecting sex hormones (G,CSH).
Metabolism
Dezogestrel by hydroxylation and a degidrogenation is metabolized in an active metabolite etonogestret. Etonogestrel is metabolized by formation of sulphatic and glyukuronidny conjugates.
Removal
Average elimination half-life of an etonogestrel about 30 hours. Stable concentration (steady state) is established for 4-5 days. The plasma clearance of an etonogestrel is about 10 l/hour Etonogestrel and his metabolites are removed with urine and a stake (in the ratio 1.5:1) in the form of free steroids and conjugates. Etonogestrel is allocated with breast milk in the ratio 0.37-0.55 milks/plasmas. On the basis of these data the possible quantity of an etonogestrel which can get to the child's organism is 0.01-0.05 micrograms at amount of milk of 150 ml/kg/day.
The pharmacodynamics
of Laktinet®-Rihter is a contraceptive which contains only progestogen (dezogestret). Drug well is suitable for use during feeding by a breast and also to those women who cannot, or do not want to accept estrogen. The mechanism of contraceptive effect of drug is reached, generally due to suppression of an ovulation that is proved by an ultrasonic method of a research of ovaries and also lack of raising of progesterone in the second phase of a menstrual cycle and peak of LG in the middle of a menstrual cycle. Except above-mentioned actions dezogestret has property to increase viscosity of mucous discharges of a neck of the uterus.
During the research conducted during 2 cycles (where the level of progesterone was considered as confirmation of an ovulation the 16th nmol/l within 5 days in a row is higher) the frequency of an ovulation did not exceed 1%, after cancellation of a dezogestrel during 2 cycles (56 days in a row), on average, the ovulation was observed in 7-30 days (on average in 17 days).
According to the comparative research of efficiency (allowing reception of the passed tablets at most in 3 hours after appropriate time of reception) in the group which began to take the drug value of the Perlya index for a dezogestrel made 0.4. The Perlya index for a dezogestrel is comparable to the Perlya index of the combined oral contraceptives. Administration of drug leads to decrease in level of oestradiol to the values corresponding to an early follicular phase. Clinically significant impact on carbohydrate metabolism and also on lipidic exchange and a hemostasis is not revealed.

Indications
- oral contraception

the Route of administration and doses
begin Reception of tablets from the first day of a menstrual cycle on one tablet a day, following in the direction specified on packing, whenever possible at the same time day that the break between reception of two tablets made 24 hours, as necessary with a small amount of liquid. This drug does not demand a break in reception. Each following packing should be begun right after the termination previous.
The first administration of drug.
Women who last month did not accept oral contraceptives:
Reception of tablets should be begun in the first day of a natural menstrual cycle of the woman (the first day of menstrual bleeding is in the first afternoon). It is allowed to begin administration of drug for 2-5 day of a cycle, however during the first cycle it is recommended to use a barrier method of contraception during the first 7 days of reception of tablets.
Women who pass from other the combined oral contraceptive (COC) to Laktinet®-Rihter:
Administration of drug should be begun next day after reception of an active tablet of COC. In this case use of additional methods of contraception is not required.
Women who pass from the monocomponent drugs containing only progestogen (mini-saw, the injections, implants or intrauterine contraceptives emitting progestogen):
upon transition from mini-drank administration of drug it is possible to begin in any day, in case of injections – in day when it would be necessary to do the next injection, in case of an implant - in day after its removal.
In all listed cases use of barrier methods of contraception during the first 7 days is recommended.
Administration of drug after abortion in the first trimester of pregnancy:
after abortion in the first trimester of pregnancy the administration of drug is recommended to be begun at once after abortion, and in this case there is no need for use of additional methods of contraception.
Administration of drug after the delivery, or after termination of pregnancy in the second trimester:
administration of drug can be begun for 21-28 day after termination of pregnancy in the second trimester or after the delivery. If administration of drug is assumed to be begun later, then for the first 7 days it is necessary to use barrier method of contraception. Besides, if before use of drug the sexual contact took place, then before beginning administration of drug it is necessary to exclude a possibility of repeated pregnancy or to postpone the beginning of administration of drug to the first day of the following periods.
The passed (forgotten) tablets.
Contraceptive protection can decrease if between reception of two tablets there passed more than 36 hours. If after the admission of reception of a tablet there passed less than 12 hours, the woman has to take the passed pill at once as soon as she remembers it, the following pill should be taken in usual time. If after the admission of reception of a tablet there passed more than 12 hours, the woman has to use an additional method of contraception during the next 7 days. If reception of tablets was missed within the first week and the woman had a sexual intercourse within the week preceding that when reception of tablets was missed it is necessary to consider the possibility of approach of pregnancy.
The measures taken in case of vomiting.
If within 3-4 hours after reception of a tablet the vomiting develops, then the tablet is soaked up not completely. In this case it is necessary to arrive the same as in case of the passed tablets. If the patient does not wish to deviate the usual mode of administration of drug, then the necessary tablet (necessary tablets) should be filled from other packing.

Side effects
Often (≥1/100)
- an acne
- changes of mood, a depression
- decrease in a libido
- mammary gland pain
- disturbance of periods, irregular bloody discharges, an amenorrhea
- a headache
- increase in body weight
- nausea
not often (≥1/1000 до<, 1/100)
- an alopecia
- intolerance when carrying contact lenses
- fatigue
- infectious diseases of a vagina, a vaginitis
- a dysmenorrhea, oothecomas
- vomiting
Seldom (& lt, 1/1000)
- erubescence, a small tortoiseshell, a knotty erythema, rash, urtikarny rash
- discharges from mammary glands, ectopic pregnancy
- development of a Quincke's disease and/or exacerbation of an inborn Quincke's disease

of the Contraindication
- hypersensitivity to any of drug components
- arterial or venous thrombosis (deep vein thrombosis, a pulmonary embolism, a myocardial infarction, vascular brainstorming)
- the states contributing to arterial thrombosis (stenocardia, a passing ischemic attack)
- a serious illness of a liver before normalization of indicators of function of a liver
- a benign or malignant tumor of a liver
- a hormonedependent malignant tumor of genitals or mammary glands
- vaginal bleeding of an unknown etiology
- in the presence or suspicion on pregnancy
- the intolerance of a galactose, a lactose intolerance of Lapp or malabsorption of glucose galactose

Medicinal interactions
can lead Interaction between hormonal contraceptives and other medicines to developing of breakthrough bleedings and/or inefficiencies of contraceptive drug. Metabolism in a liver: interaction with the medicines inducing microsomal enzymes can develop (such as, hydantoins (for example, Phenytoinum), barbiturates (for example, phenobarbital), Primidonum, carbamazepine and rifampicin) that can lead to increase in clearance of sex hormones. Besides, interaction with okskarbazepiny, topiramaty, felbamaty, ritonaviry, nelfinaviry, the griseofulvin and drugs containing the St. John's wort made a hole (Hypericum perforatum) is possible. The maximum induction of enzymes is noted not earlier than in 2-3 weeks and can remain up to 4 weeks after the therapy termination. To the women accepting others enzyme - the inducing drugs, it is recommended to use temporarily additional barrier methods of contraception or other non-hormonal method of contraception. At simultaneous use of above-mentioned drugs with Laktinet®-Rihter, the use of a barrier method of contraception throughout all course of treatment and within 7 days (for rifampicin – 28 days) after the end of therapy is recommended.
Antibiotics (e.g., ampicillin and tetracycline) reduce efficiency of oral contraceptives (the mechanism of interaction is not installed).
At intake of activated carbon, absorption of steroids of a tablet can decrease, also the efficiency of contraception will decrease therefore.
Hormonal contraceptives can influence metabolism of other medicines. Respectively, their concentration in blood plasma and fabrics can how to increase (for example, cyclosporine), and to decrease.

Special instructions
In case any of following states / risk factors is observed, it is necessary to weigh carefully expected advantages and possible risk of use of a contraceptive, and it should be discussed with the consumer of drug. It is necessary to warn the woman that if she during administration of drug observes emergence, strengthening or change of any of following states / risk factors, she needs to see a doctor immediately. After that the doctor has to resolve an issue of a possibility of continuation of administration of drug.
Medical examination
Before prescribing of this drug is recommended to collect the full medical anamnesis and to perform careful gynecologic examination of the patient for the purpose of a pregnancy exception. It is necessary to consider such disturbances of a menstrual cycle as an oligomenorrhea and an amenorrhea in advance. The interval between inspections depends on specific features of each separate case (frequency of surveys – not less than 1 time a year). If the appointed drug potentially can affect a latent or obvious disease of the patient, it is necessary to perform control examinations in due time.
The breast cancer
Risk of developing a breast cancer increases with age. During use of oral contraceptives (OK) the risk of diagnosing of a breast cancer is a little increased. This increased risk gradually decreases within 10 years after the reception termination OK, it is connected not with duration of use of contraceptives, and with age the woman accepting Apprx. Risk at the women applying the oral contraceptives containing only gestagen is similar to that when using of the combined oral contraceptives.
The liver tumor
In an acute or chronic abnormal liver function should direct the woman to inspection and consultation to the corresponding expert. As it is impossible to exclude biological effect of progestogen on development of cancer of liver, it is necessary to estimate individually a ratio advantage/risk at the women having liver cancer.
Women need to be informed that the drug Laktinet®-Rihter does not protect from a HIV-infection (AIDS) and other diseases, sexually transmitted.
Diabetes
At administration of drug by sick diabetes is recommended careful monitoring of glucose of blood as progestogens can have effect on peripheral insulin resistance and tolerance to glucose though there are no proofs confirming need of change in therapy of those patients with diabetes which accepts monocomponent contraceptives which part progestogen is.
Venous thromboembolic diseases, a deep vein thrombosis, an embolism of lungs
Epidemiological researches showed communication between the use of the combined contraceptives and increase in frequency of venous thromboembolic diseases (VTE, a deep vein thrombosis, a pulmonary embolism). Though the clinical value of these data concerning the dezogestrel used in contraceptives without estrogenic component is unknown, in case of development of thrombosis (for example, at appearance of an inexplicable stethalgia, short wind, unusual cough, severe pain or hypostasis in one of the lower extremities), administration of drug needs to be stopped. It is necessary to refuse use of the drug Laktinet®-Rihter in case of a long immobilization owing to surgery or a disease. The women having tromboembolic episodes in the anamnesis have to be informed on possible complications.
Hloazma
In sporadic cases, first of all, if in the anamnesis there is a pregnancy hloazma case – during reception of oral contraceptives the hloazma can develop, the danger of emergence of a hloazma can be reduced, avoiding fire or ultra-violet radiation.
Arterial hypertension
If at administration of drug of Laktinet®-Rihter develops steady arterial hypertension or if slightly increased arterial blood pressure does not decrease in response to hypotensive therapy, administration of drug of Laktinet®-Rihter should be stopped.
Protection against an extrauterine pregnancy
At administration of drug, which part only progestogen is, protection against an extrauterine pregnancy is less productive, than at reception of the combined contraceptives that is presumably caused by emergence of frequent ovulations at administration of drugs, which part is only, progestogen (dezogestret). In spite of the fact that Laktinet®-Rihter consistently suppresses an ovulation, the possibility of an extrauterine pregnancy in terms of differential diagnostics needs to be taken into account if at the women taking the drug the amenorrhea takes place or at appearance of pain in a stomach.
Decrease in contraceptive action
Contraceptive action decreases at irregular use of drug, gastrointestinal disorders, or at use of the interacting drugs.
Disturbance of regulation of the menstrual
cycle Administration of drugs which part progestogen is only can cause frequent bloody discharges, or increase in duration of menstrualnopodobny bleeding in some women, only sometimes the developing bleeding can also take place or throughout administration of drug the bleeding can not develop at all. If bleedings are irregular and are observed very often, it is necessary to consider the possibility of use of other method of contraception. If these symptoms do not disappear, it is necessary to exclude the organic reasons.
Actions at an amenorrhea during reception of tablets depend on whether a pill according to the instruction was taken, and can include test for pregnancy. At pregnancy approach the administration of drug should be stopped.
Development of follicles
At reception of all low-dosed hormonal contraceptives happens development of follicles, occasionally the size of a follicle can reach the sizes exceeding those in a normal cycle. Generally, these increased follicles disappear spontaneously. Often it proceeds without symptoms, slight pain in the bottom of a stomach is in certain cases noted.
Laboratory tests
the Data obtained for the combined oral contraceptives showed that use of hormonal contraceptives can influence results of certain laboratory analyses, including biochemical indicators of function of a liver, thyroid gland, adrenal glands and kidneys, concentration (transport) proteins in serum, for example, the globulin connecting corticosteroids on fractions of lipids/lipoproteins, indicators of carbohydrate metabolism and indicators of blood clotting and a fibrinolysis. As a rule, changes remain within normal values.
Bone mineral density
leads Administration of drug of Laktinet®-Rihter to decrease in concentration of oestradiol in blood serum to the level corresponding to an early follicular phase. So far it is unknown whether this decrease has any clinically significant impact on bone mineral density.
Both during pregnancy, and during a usage time of sex steroid hormones, the following diseases which connection using progestogens is not established were registered: jaundice and/or an itching connected with a cholestasia, formation of stones in a gall bladder, a porphyria, a system lupus erythematosus, a gemolitiko-uraemic syndrome, Sydenham's chorea, herpes of pregnant women, a hearing loss connected with an otosclerosis, (hereditary) Quincke's disease.
In a lactose intolerance it is necessary to take into account that Laktinet®-Rihter contains 67.445 mg of lactose in each tablet. To the patients suffering from hereditary intolerance of a galactose, a lactose intolerance of Lapp or malabsorption of glucose galactose, administration of drug of Laktinet®-Rihter is contraindicated.
Pregnancy and the period of a lactation
during the extensive epidemiological researches no increase in risk of inborn malformations at the children born from women who before pregnancy accepted oral contraceptives, teratogenic action in case of inadvertent use of contraceptives in the early stages of pregnancy was revealed. If during administration of drug of Laktinet®-Rihter there occurred pregnancy, it is necessary to stop its reception immediately.
Лактинет®-Рихтер does not influence development of breast milk and its quality. - etonogestret a small amount of a metabolite of a dezogestrel it is allocated with maternal milk. Thereof in day 0.01-0.05 micrograms of an etonogestrel on kilogram of body weight of the child (can get to an organism of the child at amount of milk of 150 mg/kg/day). According to 7 monthly observation the risk for babies is not revealed. The available data allowed to draw a conclusion that drug can be used during a lactation. Nevertheless, it is necessary to make observation of development and growth of children.

Drug has no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms or has insignificant impact on ability of control of vehicles and on work with moving mechanisms.

Overdose
Symptoms: nausea, vomiting, young girls have a small vaginal bleeding.
Treatment: symptomatic. There is no specific antidote

the Form of release and packing
On 28 tablets place in blister strip packaging from PVH/PVDH of a film and aluminum foil. Each blister strip packaging place the laminated bag from aluminum foil.
On 1 or 3 bags of blister strip packaging together with a cardboard case and the instruction for medical use in the state and Russian languages put in a cardboard pack.


To Store storage conditions in original packing, in the dry and protected from light place at a temperature not over 30 of 0C.
To store out of children's reach!


3 years
not to use a period of storage after expiry date.


Prescription status
According to the prescription

the Name and the country
of the JSC Gideon Richter manufacturing organization,
Hungary 1103 Budapest, Dyomryoi St., 19-21, Hungary

the Name and the country of the owner of the registration certificate
of JSC Gideon Richter, 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: info@richter.kz Phone number: 8-(7272)-58-26-22, 8-(7272)-58-26-23



To develop