Lindinet 20 - combined monophasic oral contraceptive.
Release form and composition
Dosage form Lindinet 20 - tablets: round, biconvex, coated light yellow (21 pieces in a blister, 1 or 3 blisters are packed in a cardboard box).
Active ingredients (in 1 tablet):
- Gestoden - 75 mcg;
- Ethinyl estradiol - 20 mcg.
Auxiliary components: magnesium stearate, corn starch, colloidal silicon dioxide, sodium calcium edetate, povidone, lactose monohydrate.
The composition of the shell: calcium carbonate, titanium dioxide, macrogol 6000, povidone, talc, sucrose, dye quinoline yellow (D + C yellow No. 10) (E104).
Indications for use
Lindinet 20 is used for contraception.
- Venous thromboembolism in history;
- Venous or arterial thrombosis / thromboembolism (including pulmonary embolism, stroke, myocardial infarction, deep leg vein thrombosis), including a history of;
- Present or past history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
- Severe and / or multiple risk factors for venous / arterial thrombosis (such as hypertension with a blood pressure equal to or greater than 160/100 mm Hg, atrial fibrillation, complicated valvular heart disease, or cerebral vascular disease);
- Pancreatitis, accompanied by severe hypertriglyceridemia (including history);
- Present or in history of cholestatic jaundice (including during previous pregnancy), severe liver disease and hepatitis (until normalization of functional and laboratory parameters and within 3 months thereafter);
- Liver tumors (including in the history of the disease);
- Jaundice when using glucocorticosteroids;
- Gallstone disease, incl. in the anamnesis;
- Diabetes mellitus, accompanied by angiopathy;
- Syndromes of Gilbert, Dubin-Johnson, Rotor;
- Severe itching, otosclerosis or its progression with the use of glucocorticosteroids or during previous pregnancy;
- Migraine, characterized by focal neurological symptoms, in history including;
- Vaginal bleeding of unknown origin;
- Hormone-dependent malignant neoplasms of the genitals and mammary glands or suspicion of them;
- Surgical intervention with prolonged immobilization;
- Pregnancy or suspicion of it;
- Lactation period;
- Intensive smoking (more than 15 cigarettes per day) over the age of 35;
- Hypersensitivity to the drug.
Special care should be taken in such cases:
- Age over 35 years;
- Predisposition to thrombosis (violation of cerebral circulation or myocardial infarction in someone of very close relatives at a young age);
- Obesity (body mass index more than 30 kg / m 2 );
- Hereditary angioedema;
- Diseases (including herpes in pregnancy, chloasma, porphyria, small chorea), which first appeared or worsened during a previous pregnancy or as a result of a previous intake of sex hormones;
- Liver diseases (both acute and chronic);
- Hemolytic uremic syndrome;
- Valvular heart disease;
- Arterial hypertension;
- Atrial fibrillation;
- Severe injury;
- Surgical intervention on the lower limbs;
- Extensive surgical intervention;
- Prolonged immobilization;
- Varicose veins or superficial thrombophlebitis;
- Diabetes without vascular disorders;
- Crohn's disease;
- Sickle cell anemia;
- Hypertriglyceridemia (including in family history);
- Ulcerative colitis;
- Systemic lupus erythematosus;
- Severe depression, including a history of;
- The postpartum period (21 days after delivery for non-nursing women, the period after completion of lactation for nursing mothers);
- Changes in biochemical parameters (protein C or S deficiency, hyperhomocysteinemia, antithrombin III deficiency, resistance of activated protein C, antiphospholipid antibodies, including lupus anticoagulant, antibodies to cardiolipin).
Dosing and Administration
Lindinet 20 take 1 tablet per day for 21 days, preferably at the same time of day. Then make a 7-day break, during which there is withdrawal bleeding. The next day after the break (i.e., on the 8th day after taking the last pill from the package or 4 weeks after taking the first pill, on the same day of the week), taking the drug is resumed.
The first pill should be taken from the 1st to the 5th day of the menstrual cycle.
When switching from another combined oral contraceptive, take the first pill of Lindinet 20 on the next day after taking the last pill of another contraceptive, i.e. on the first day of withdrawal bleeding.
Guidelines for switching from drugs containing only progestogen: if it is a mini-drink, you can start taking Lindinet 20 on any day of the cycle; if it is an implant - the day after its removal; if it is an injection, on the eve of the last injection. In all of these cases, additional contraceptive methods are recommended for the first 7 days.
After an abortion in the first trimester of pregnancy, you can start taking Lindinet 20 immediately after surgery, then additional methods of protection are not needed.
After an abortion in the second trimester and after childbirth, you need to start taking the drug for 21-28 days, during the first 7 days you must additionally use a barrier method of contraception. If before the start of contraception there was a sexual contact, then it is recommended to postpone taking Lindinet 20 until the first menstruation or to exclude pregnancy.
In case of skipping the next admission:
- If this is less than 12 hours, there is no need to apply additional methods of contraception, since the contraceptive effect of the drug is not reduced. The missed pill should be taken as soon as possible, then taken at the usual time;
- If the interval is more than 12 hours, you should not replenish the missed dose. Lindinet 20 continue to take as usual, but over the next 7 days use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, then there is no need to take a break. In this case, withdrawal bleeding does not occur until the second package is completed, but breakthrough or spot bleeding may occur. If, after the end of the second packaging, the removal of bleeding does not occur, it is necessary to exclude pregnancy.
In the case of vomiting and / or diarrhea within 3-4 hours after taking the pill, the contraceptive effect of the drug may be reduced, therefore it is recommended to do the same as in the case of the missed dose.
With Lindinet 20, you can speed up the onset of menstruation. To do this, reduce the duration of the break in taking the drug. The shorter this interval, the more likely the occurrence of spotting or breakthrough bleeding when taking the second package.
To delay the onset of menstruation, you must continue taking Lindinet 20 from a new package without taking a 7-day break. You can delay the menstruation as long as necessary, until the last pill from the second pack is taken. In this case, possible spot bleeding or breakthrough bleeding. Regular intake of the drug can be restored after the usual 7-day break.
Possible side effects that require cancellation of Lindinet 20:
- Cardiovascular system: arterial hypertension; rarely, venous and arterial thromboembolism (including thromboembolism of the pulmonary artery, deep vein thrombosis of the lower limbs, stroke, myocardial infarction); very rarely, venous or arterial thromboembolism of the renal, mesenteric, retinal, hepatic arteries and veins;
- Sense organs: hearing loss as a result of otosclerosis;
- Other: porphyria, hemolytic-uremic syndrome, rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passes after discontinuation of the drug).
Other side effects are less severe, but occur more often. The feasibility of taking the drug in the event of their development should be decided by the doctor individually for each patient, taking into account the ratio of benefits and risks:
- The reproductive system: pain, increase and tension of the mammary glands, the development of inflammatory processes of the vagina, galactorrhea, candidiasis, acyclic bleeding / bleeding from the vagina, changes in the state of vaginal mucus, amenorrhea after discontinuation of the drug;
- Digestive system: Crohn's disease, nausea, vomiting, ulcerative colitis, epigastric pain, liver adenoma, hepatitis, cholelithiasis, the occurrence or exacerbation of jaundice and / or itching caused by cholestasis;
- Central nervous system: headache, migraine, depression, mood lability;
- Metabolism: hyperglycemia, reduced tolerance to carbohydrates, increased levels of thyroid-stimulating hormone, weight gain, fluid retention in the body;
- Sense organs: hearing loss, when wearing contact lenses - increased sensitivity of the cornea;
- Dermatological reactions: increased hair loss, nodular or exudative erythema, chloasma, rash;
- Other: allergic reactions.
Before prescribing Lindinet 20, a woman should undergo a general medical examination (laboratory tests, blood pressure measurement, personal and family history) and gynecological (including cytological analysis of cervical smear, examination of the pelvic organs and mammary glands). Such surveys are carried out every 6 months the entire period of taking the drug.
Every woman should be warned that the drug does not protect against sexually transmitted diseases, including HIV infection.
After suffering acute viral hepatitis, the drug can be taken only after full normalization of liver function, but not earlier than after 6 months.
Research on the effect of Lindinet 20 on the rate of psychophysical reactions and the ability to concentrate was not conducted.
The following drugs reduce contraceptive efficacy Lindinet 20: ampicillin, tetracycline, barbiturates, rifampicin, carbamazepine, primidone, phenytoin, phenylbutazone, felbamate, topiramate, oxcarbazepine, griseofulvin, hydantoin, rifabutin. In addition, when taking this combination of frequent violations of menstruation and breakthrough bleeding. If combined use of these drugs is necessary, additional non-hormonal methods of contraception should be used for the entire period of their simultaneous use and for 7 days after the end of treatment, and for 4 weeks after discontinuation of rifampicin.
Ethinyl estradiol sulfation, one of the active ingredients in Lindinet 20, occurs in the intestinal wall. All drugs that also undergo sulphation in the intestinal wall (including ascorbic acid) competitively inhibit the sulphation of ethinyl estradiol, which enhances its bioavailability.
Liver enzyme inhibitors (for example, fluconazole and itraconazole) increase the concentration of ethinyl estradiol in the blood plasma.
Drugs that increase the motility of the gastrointestinal tract, reduce the absorption of active substances Lindinet 20 and their levels in the blood plasma.
Hypericum preparations reduce the concentration of the active substances of the drug, which can lead to breakthrough bleeding and even pregnancy. Therefore, this combination is not recommended.
Ritonavir reduces the total concentration of ethinyl estradiol by 41%, therefore during treatment with this drug it is recommended to use additional non-hormonal methods of contraception or to take an oral contraceptive with a higher content of ethinyl estradiol.
Lindinet 20 can reduce carbohydrate tolerance, increase the need for oral antidiabetic drugs or insulin.
By inhibiting liver enzymes or accelerating conjugation (primarily glucuronidation), ethinyl estradiol can affect the metabolism of other drugs (including theophylline and cyclosporine). It should be borne in mind that the concentration of these substances in the blood plasma can both decrease and increase.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C, protected from light and moisture, inaccessible to children.
Shelf life - 3 years.