Laktinet

Laktinet – gestagenny drug for peroral contraception.

Form of release and structure

Dosage form – tablets, film coated: almost white or white color, a round biconvex form, on one party there is a marking of "D", on another – "75" (on 28 pieces in blisters, in a cardboard pack 1 or 3 blisters).

– dezogestret active ingredient of Laktinet, in 1 tablet – 0,075 mg.

Auxiliary components: silicon dioxide colloid, D, L-α-токоферол, stearic acid, potato starch, lactoses monohydrate, K30 povidone, magnesium stearate.

Structure of a film cover: опадрай the II white (macrogoal 3000, titanium dioxide (E171) CI 77891, polyvinyl alcohol, talc).

Indications to use

Laktinet's use is shown to women for peroral contraception.

Contraindications

• Liver failure, including the anamnesis;
• Heavy abnormal liver functions, including the anamnesis (before recovery of indicators of function of a liver);
• Venous thromboembolism, including a deep vein thrombosis of the lower extremities and a thromboembolism of a pulmonary artery (including specified in the anamnesis);
• The assumed or diagnosed malignant hormonedependent new growths, including cancer of a liver and mammary gland;
• Vulval bleedings of an unspecified etiology;
• Insufficiency of lactase, lactose intolerance, glyukozo-galaktozny malabsorption;
• The long immobilization caused by a serious illness or the undergone surgery;
• The confirmed pregnancy or suspicion on its existence;
• Hypersensitivity to drug components.

With care it is necessary to appoint Laktinet to patients with the resistant arterial hypertension developing against the background of lack of effect of anti-hypertensive therapy or administration of drug, a system lupus erythematosus hloazmy (especially at the instruction to a hloazma during pregnancy in the anamnesis), a porphyria, herpes (during pregnancy in the anamnesis), a diabetes mellitus.

Route of administration and dosage

Laktinet is accepted inside, on 1 tablet of 1 times a day, washing down with a small amount of liquid.

Having defined for itself reception time, the woman has to adhere strictly to it throughout the entire period of therapy, the break between reception of two tablets should not exceed 24 hours.

Laktinet's use does not assume a break in reception, next day after the termination of tablets in the blister it is necessary to take a pill from the new blister.

If the woman did not use peroral contraceptive drugs in the previous menstrual cycle, it is possible to begin reception in the first day of menstrual bleeding and further to follow in the direction specified on packaging. Additional measures of contraception in this case are not required.

At the beginning of administration of drug from 2 to 5 day of periods during the first 7 days of reception of tablets from the first blister it is necessary to use additional contraceptives.

Upon transition from other oral combined contraceptive the first pill of Laktinet needs to be taken next day after the last tablet of the previous drug, without resorting to additional measures of contraception.

Upon transition from a progestagennny contraceptive (mini-drank) it is possible to begin administration of drug in any day, with injection – in day of an estimated next injection, with an implant – in day of its removal. In any of the listed cases it is necessary to use the first 7 days barrier contraceptives.

When performing abortion in the I trimester of pregnancy it is recommended to begin reception of tablets directly in day of abortion without use of additional methods of contraception.

Laktinet's reception when performing abortion in the II trimester of pregnancy or after the delivery should be begun in 21-28 days. In case of later beginning of therapy it is necessary to use barrier contraceptives during the first 7 days. Moreover, women who during the specified period had sexual contact (unprotected) have to exclude existence of pregnancy or begin administration of drug in the first day of the following menstrual bleeding (when resuming a menstrual cycle).

Efficiency of tablets decreases in case of a break between reception of two tablets more than 36 hours.

If the woman forgot to take a pill at the scheduled time and remembered it within the next few 12 hours, the effect of drug does not decrease. Use of the following tablets should be continued in the usual mode without additional resources of contraception.

If delay of reception exceeds 12 hours (more than 36 hours from the moment of reception of the last tablet) possibly decrease in contraceptive effect of drug. Therefore in the closest 7 days of the subsequent peroral contraception it is necessary to use additional contraceptive methods.

If delay of reception of the next tablet more than for 12 hours happened on the first week of use of drug, and during this period the woman had an unprotected sexual contact, then there is a big risk of approach of pregnancy.

If after Laktinet's reception within the first 3-4 hours the woman pulled out, then process of absorption of drug did not come to the end. For preservation of the reached contraceptive effect of drug it is necessary to take the corresponding pill from new packaging.

Disturbances of periods can arise also at regular reception of tablets. If menstrualnopodobny bleeding develops irregularly and very often, it is necessary to consider a question of use of other drug or methods of contraception. At preservation of frustration of a menstrual cycle it is necessary to exclude existence of the organic reason.

Emergence of an amenorrhea during use of drug can be caused by disturbance of the mode of reception and existence of pregnancy. At confirmation of pregnancy it is necessary to stop reception of tablets immediately.

Laktinet does not protect from infection with diseases, sexually transmitted, including HIV infection (AIDS).

Side effects

Laktinet's use can cause side effects:

• Often: disturbance of a menstrual cycle, nausea, acne, changes of mood, headache, decrease in a libido, increase in body weight, morbidity of mammary glands;
• Infrequently: a dysmenorrhea, vomiting, an alopecia, discomfort when carrying contact lenses, fatigue, a vaginitis, oothecomas;
• Seldom: rash, erubescence, knotty erythema, small tortoiseshell;
• Perhaps: exact connection with administration of drug is not established – a skin itch, cholestatic jaundice, a chorea, a cholelithiasis, herpes of pregnant women, deafness, an otosclerosis, emergence of a gemolitiko-uraemic syndrome.

In case of emergence or aggravation of the specified undesirable reactions of an organism to drug it is necessary to see the attending physician behind consultation.

Special instructions

Laktinet's use should be begun according to the recommendation of the doctor who on the basis of clinical indications and risk factors has to make the conclusion about degree of safety of hormonal contraception for the specific patient.

At emergence of side effects against the background of reception of tablets or risk factor it is necessary to see urgently a doctor behind consultation.

Regular medical observation is required to women with a diabetes mellitus during the first months of therapy.

Prevention of ectopic pregnancy by progestagensoderzhashchy contraceptives is less expressed, than when using of the combined oral contraceptives.

Drug inhibits an ovulation, nevertheless, it is impossible to exclude existence of an extrauterine pregnancy at emergence of abdominal pains or an amenorrhea.

Laktinet promotes decrease in level of oestradiol in blood to the indicators corresponding to an early follicular phase.

Use of drug during breastfeeding is shown.

Against the background of reception of tablets development of a hloazma is possible, is more often at patients with hloazmy than pregnant women in the anamnesis. Women, inclined to a hloazma, are recommended to avoid direct sunshine and ultra-violet radiation during administration of drug.

Because of contents in monohydrate lactose tablets, women cannot accept drug with such rare hereditary pathologies as deficit of lactase, a lactose intolerance, glyukozo-galaktozny malabsorption.

Use of drug does not exert impact on ability to control of vehicles and mechanisms.

Medicinal interaction

At simultaneous use of Laktinet with inductors of microsomal enzymes of a liver, such as Phenytoinum and other derivatives of hydantoin, топирамат, рифабутин, Primidonum, barbiturates, griseofulvin, rifampicin, carbamazepine, окскарбазепин, фелбамат occurs decrease in contraceptive effect of drug and increase in risk of breakthrough bleeding. In case of need reception of the specified means it is necessary to use barrier methods of contraception temporarily in addition. Achievement of the maximum induction of microsomal enzymes of a liver comes not earlier than 2-3 weeks of therapy by the corresponding inductor and no more than 4 weeks after the reception termination continue to remain.

With other medicines specialized researches on interaction of a dezogestrel were not conducted.

Ampicillin, tetracycline and other antibiotics reduce efficiency of contraceptive peroral drugs. Therefore during the entire period of treatment by these drugs and 7 days after their cancellation the woman needs to use barrier contraceptives in addition.

In case of a concomitant use of absorbent carbon, additional contraception is required within 7 days after its cancellation.

Terms and storage conditions

To store at a temperature up to 25 °C. To protect from children.

Period of validity – 3 years.