Lindynette 20 pills №21 * 3

Active ingredient and dosage form

Lindynette 20
Coated Tablets light yellow, round, biconvex; on a break of white or almost white color with a light yellow edging; both sides without inscription.
1 pill contains ethinyl estradiol 20 mcg; Gestodena 75 mcg;
Excipients: sodium Calcium edetate, Magnesium stearate, colloidal anhydrous silicon, povidone, corn starch, lactose monohydrate;
Shell composition: D + C yellow N 10 C.I. 47005, E104, Povidone, titanium oxide C.I. 7791, E171, macrogol 6000; talc, calcium carbonate, sucrose;
in a blister strip package 21 pcs., in a box of 1 or 3 pcs.

Lindynette 30
Coated tablets: round, biconvex, yellow, on a break of white or almost white color with a yellow border, both sides without an inscription.
1 pill contains ethinyl estradiol 30 mcg; Gestodena 75 mcg;
Excipients: sodium calcium edetate, magnesium stearate, colloidal anhydrous silicon, povidone, corn starch, lactose monohydrate;
Shell composition: D + C yellow N 10 C.I. 47005, E104, Povidone, titanium oxide C.I. 7791, E171, macrogol 6000; talc, calcium carbonate, sucrose;
in a blister strip package 21 pcs., in a box of 1 or 3 pcs.

P №015122 / 01-2003 30.06.03

Mechanism of action

Monophasic gestagen-estrogen contraceptive drug.Inhibits the secretion of pituitary gonadotropic hormones, inhibits the maturation of follicles and interferes with the process of ovulation. It increases the viscosity of cervical mucus, making it difficult for sperm to enter the uterus.
Lindynette 20, in addition to preventing pregnancy, has a positive effect on the menstrual cycle (when it is disturbed): the monthly cycle becomes regular, the volume of blood loss during menstruation and the frequency of iron deficiency anemia decreases, the frequency of dysmenorrhea decreases, the incidence of functional ovarian cysts decreases, the frequency of ectopic decreases of pregnancy.
The use of the drug reduces the incidence of fibroadenomas and fibrous cysts in the mammary glands, inflammatory diseases of the pelvic organs and endometrial cancer. Improves skin condition with acne.

Indications and usage

Contraception.

Contraindications

- Diseases accompanied by severe liver dysfunction;
- liver tumors (including in history);
- thrombosis and thromboembolism (including in history);
- myocardial infarction (including a history);
- heart failure;
- cerebrovascular disorders (including in history);
- conditions preceding thrombosis (including transient ischemic attacks, angina);
- coagulopathy;
- sickle cell anemia;
- estrogen-dependent tumors, including breast tumors (including history);
- diabetes mellitus complicated by microangiopathies;
- uterine bleeding of unknown etiology (until the cause is clarified);
- idiopathic jaundice and itching during pregnancy;
- the presence of genital herpes in the history of herpes;
- otosclerosis with deterioration during a previous pregnancy;
- pregnancy;
- hypersensitivity to the drug.

Dosage and administration

The drug should be taken from the 1st to the 5th day of menstruation at 1 pill / day (if possible at the same time of day) for 21 days, followed by a 7-day break. During a 7-day break, menstrual bleeding appears. After a 7-day break, regardless of whether the bleeding has ended or is just beginning, continue taking the drug from the next package. Thus: 3 weeks - taking pills, 1 week - a break. Taking the drug from each new package starts on the same day of the week.
First reception drug Lindynette 20 must begin with 1-5-th day of the menstrual cycle.
After abortion in the first trimester of pregnancy You can start taking the drug Lindynette 20 immediately after surgery. In this case, there is no need to use additional methods of contraception.

After childbirth The drug can be started in 21-28 days, if the woman is not breastfeeding. Nursing women are recommended to start taking pills 6 months after delivery. In these cases, in the first 7 days it is necessary to apply additional methods of contraception. If after childbirth or abortion there was already sexual contact, then before taking the drug, you should exclude pregnancy or postpone the beginning of the reception until the first menstruation.
When skipping taking the missed pill should be taken as soon as possible. If the interval in taking pills was less than 36 hours, then the effectiveness of the drug will not decrease, and in this case there is no need to use an additional method of contraception. The remaining pills should be taken at the usual time. If the interval is more than 36 hours, the effectiveness of the drug may decrease. In this case, the woman should take the missed pill, and the next pill she should take as normal and in the next 7 days it is necessary to use additional barrier methods of contraception. If less than 7 tabs are left in the package, you should start taking the drug from the next package without interruption. In this case, menstrual-like bleeding does not occur until the completion of taking the drug from the second package, but there may be spotting or breakthrough bleeding.

If menstrual bleeding does not occur after you have finished taking the drug from the second package, then pregnancy should be excluded before continuing with the drug.
If vomiting and / or diarrhea begins within 3-4 hours after taking the drug, a decrease in the contraceptive effect is possible. If the symptoms stopped within 12 hours, then you need to take another 1 pill extra. After that, you should continue taking the pills in the usual way. If the symptoms of diarrhea continue for more than 12 hours, it is necessary to use additional methods of contraception in the next 7 days.
To delay menstruation taking the drug should be continued from the new package without a 7-day break. Menstruation can be delayed as long as necessary until the end of the last pill from the second pack. With delayed menstruation, breakthrough or spot bleeding may occur. Regular intake of the drug Lindynette 20 can be restored after the usual 7-day break.
Tablets should be taken orally, without chewing, drinking plenty of water, regardless of the meal.

Adverse reactions

Cardiovascular: rarely - thromboembolism, thrombosis (including retinal vessels), increased blood pressure.
Gastrointestinal: sometimes nausea, vomiting.
From the reproductive system: sometimes - intermenstrual bleeding, changes in vaginal secretion.
On the part of the endocrine system: sometimes - a feeling of tension in the mammary glands, changes in body weight, changes in libido.
From the side of the central nervous system: emotional lability, depression, dizziness, headaches, migraine, weakness, fatigue.
Other: abdominal pain, chloasma, discomfort when wearing contact lenses, fluid and sodium retention in the body, allergic reactions, impaired glucose tolerance.

Pregnancy and breastfeeding

The drug is contraindicated for use in pregnancy.
If necessary, the appointment of the drug during lactation should decide on the termination of breastfeeding.The active ingredients of the drug in small quantities are excreted in breast milk, affecting the quantity and quality of milk.

Special notes

WITH extra care the drug should be prescribed if there are cases of breast cancer in the family history, during chorea of ​​pregnant women (previous prescription can worsen the course of chorea during pregnancy), in diabetes mellitus, epilepsy, gall bladder diseases, especially cholelithiasis (including history), liver failure, cholestatic jaundice (including in pregnant women in history), arterial hypertension, prolonged immobilization, major surgical procedures, depression (including in history), migraines.
Smoking during the period of use of hormonal contraceptives increases the risk of cardiovascular complications. This risk increases with age (over 35 years). Therefore, women taking Lindynette 20, it is recommended to stop smoking or reduce the number of cigarettes smoked.
Women with a history of hypertension or kidney disease, during the period of taking Lindynette 20 should carefully monitor blood pressure and, if there is a significant increase in it, the drug should be stopped. In most patients with discontinuation of the drug, blood pressure returns to normal.
The risk of venous thromboembolic diseases (VTZ) in women taking oral hormonal contraceptives is slightly higher than that of non-taking.However, this risk is less significant than the risk of VTZ pregnant women. Out of 100,000 pregnant women, approximately 60 have VTZ, while the incidence of VTZ among women who take gestodene in combination is about 30-40 cases out of 100,000 women per year.
The risk of the onset of arterial or venous thromboembolic diseases is increased by the following factors: age over 35, smoking, a positive family history of high-temperature control, obesity (body mass index higher than 30 kg / m²), impaired fat metabolism, arterial hypertension, valvular disease, atrial fibrillation, prolonged immobilization, severe surgery, surgery on the legs, severe injury.
Due to the fact that the risk of thromboembolic diseases increases in the postoperative period, it is necessary to stop taking the drug 4 weeks before the planned operation and resume taking 1 week after the patient is activated.
With the onset or worsening of migraine or the appearance of a constant or unusually severe headache, the drug should be stopped.
Taking Lindynette 20 should be stopped immediately when a generalized itching occurs, with the development of an epileptic seizure.
While taking hormonal contraceptives, there may be a decrease in carbohydrate tolerance.
When using Lindynette 20, especially in the first 3 months of administration, intermenstrual (spotting or breakthrough) bleeding may appear.If the bleeding persists longer or appears after regular cycles have formed, pregnancy should be excluded or other causes should be identified. Often the cause of such bleeding is an irregular pill.
In some cases, menstrual bleeding does not appear during the 7-day interval. If before that the treatment regimen was violated or if there is no bleeding after taking the second package, pregnancy should be excluded before continuing the course of taking the drug.
Before you begin using the drug, you should collect a detailed family and personal history, conduct a general medical and gynecological examination (measurement of blood pressure, examination of the mammary glands, examination of the pelvic organs, cytology of the smear), as well as the necessary laboratory tests (functional indicators of the liver, kidneys, adrenal glands, thyroid) glands, blood coagulation and fibrinolytic factors, lipoprotein and transport protein levels).
The patient should be warned that the use of the drug does not protect her from sexually transmitted infections, in particular from AIDS.
In acute or chronic liver dysfunction, discontinue use of the drug until normalization of indicators.
In the case of depression when taking Lindynette 20, it is advisable to cancel the drug and temporarily switch to another method of contraception to clarify the relationship between the development of depression and taking the drug.Prescribing the drug to patients who had a history of depression is possible only under close supervision, and should be discontinued when signs of depression appear.
With oral contraceptives, the concentration of folic acid in the blood may decrease. This is of clinical importance only in the case of pregnancy within a short period of time after completion of the course of oral contraceptive use.
Under the action of oral contraceptives, some laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, blood clotting and fibrinolytic factors, levels of lipoproteins and transport proteins) may change.

Symptoms: nausea, vomiting, vaginal bleeding.
Treatment: prescribed symptomatic therapy, there is no specific antidote.

The contraceptive activity of Lindynette 20 is reduced when taken simultaneously with ampicillin, Tetracycline , rifampicin, barbiturates, Carbamazepine , phenylbutazone, phenytoin, Griseofulvin , topiramate , felbamate, oxcarbazepine. During the reception of Lindynette 20 with the above drugs, as well as within 7 days after completion of the course of their reception, you must use additional non-hormonal (condom, spermicidal gels) methods of contraception.When using rifampicin, additional contraceptive methods should be used within 4 weeks after completing the course of its administration.
With simultaneous use with Lindynette 20, any drug that increases gastrointestinal motility decreases the absorption of active substances and their level in blood plasma.
Drugs that inhibit the activity of liver enzymes (including itraconazole, fluconazole), increase the concentration of ethinyl estradiol in the blood plasma.
With the simultaneous use of Lindynette 20 with preparations of Hypericum (including infusion), the concentration of active substances in the blood decreases, which can lead to breakthrough bleeding, pregnancy. The reason for this is the inducing effect of Hypericum on liver enzymes, which continues for another 2 weeks after completing the course of Hypericum.
Ethinyl estradiol sulfation occurs in the intestinal wall. Preparations that also undergo sulfation in the intestinal wall (including ascorbic acid) competitively inhibit the sulfation of ethinyl estradiol and thereby increase the bioavailability of ethinyl estradiol.
Ethinyl estradiol by inhibiting liver enzymes or accelerating conjugation (primarily glucose) may affect the metabolism of other drugs (including cyclosporine, theophylline); the concentration of these drugs in the blood plasma may increase or decrease.
Ritonavir reduces ethinyl estradiol AUC by 41%. In this regard, during the application of ritonavir should be applied hormonalcontraceptive with a higher content of ethinyl estradiol or use additional non-hormonal methods of contraception.

List B. The drug should be stored at a temperature not exceeding 30 ° C, out of the reach of children.

- 2 years.
Pharmacy sales terms
The drug is available on prescription.