Lindinet 30 is a monophasic oral contraceptive with a combination formulation.
Release form and composition
Dosage form Lindinet 30 - tablets: round, biconvex, coated yellow (21 pieces in a blister, in a cardboard box 1 or 3 blisters are packed).
Active ingredients (in 1 tablet):
- Gestoden - 75 mcg;
- Ethinyl estradiol - 30 mcg.
Auxiliary components: corn starch, lactose monohydrate, colloidal silicon dioxide, povidone, magnesium stearate, sodium calcium edetate.
The composition of the tablet shell: titanium dioxide, talc, calcium carbonate, macrogol 6000, povidone, sucrose, and the dye quinoline yellow (D + C yellow No. 10) (E104).
Indications for use
Lindinet 30 is used for contraception.
- Severe and / or multiple risk factors for venous / arterial thrombosis (these include, among others, complicated valvular heart disease, atrial fibrillation, vascular diseases of the coronary arteries and brain, arterial hypertension with arterial pressure of 160/100 mm Hg . and more);
- Venous / arterial thrombosis / thromboembolism (including deep vein thrombosis of the lower leg, pulmonary embolism, myocardial infarction and stroke) currently or in history;
- Presence of thrombosis precursors (including angina pectoris or transient ischemic attack), including a history of;
- Gallstone disease, incl. in the anamnesis;
- Jaundice due to the use of glucocorticosteroids (GCS);
- Pancreatitis, accompanied by severe hypertriglyceridemia (including in the history of the disease);
- Liver tumors (including in the anamnesis);
- Present or current history of severe liver diseases, cholestatic jaundice, incl. during a previous pregnancy, or hepatitis (the drug can be used no earlier than 3 months after the normalization of the functional and laboratory parameters of the liver);
- Hormone-dependent malignant neoplasms of the genitals or mammary glands or suspicion of their presence;
- Vaginal bleeding of unknown origin;
- Severe itching, otosclerosis or its progression when using GCS or during a previous pregnancy;
- Surgical intervention with prolonged immobilization;
- Syndromes of Gilbert, Dubin-Johnson, Rotor;
- Diabetes mellitus, accompanied by angiopathy;
- Migraine, characterized by focal neurological symptoms, in history including;
- Smoking over the age of 35 years (more than 15 cigarettes per day);
- Pregnancy or suspicion of it;
- Hypersensitivity to the drug.
Relative (Lindinet 30 can only be assigned after a balance of benefits and risks):
- Obesity (body mass index more than 30 kg / m 2 );
- Prolonged immobilization;
- Extensive surgical intervention;
- Surgical intervention on the lower limbs;
- Severe injury;
- Age over 35 years;
- The postpartum period (21 days) - for non-nursing women, the period after the end of lactation - for nursing;
- Severe depression, including a history of;
- Diabetes without vascular disorders;
- Varicose veins or superficial thrombophlebitis;
- Crohn's disease;
- Sickle cell anemia;
- Hypertriglyceridemia (including in family history);
- Systemic lupus erythematosus;
- Hereditary angioedema;
- Hemolytic uremic syndrome;
- Ulcerative colitis;
- Liver diseases (acute and chronic);
- Arterial hypertension;
- Valvular heart disease;
- Atrial fibrillation;
- Predisposition to thrombosis (indications in the family history of the presence of myocardial infarction or impaired cerebral circulation in some of the closest relatives at a young age);
- Diseases that were aggravated or appeared for the first time during a previous pregnancy or previous intake of sex hormones, such as porphyria, chloasma, small chorea, herpes of pregnancy;
- Changes in biochemical parameters (antithrombin III deficiency, hyperhomocysteinemia, resistance of activated protein C, deficiency of protein C or S, antiphospholipid antibodies, including lupus anticoagulant and antibodies to cardiolipin).
Dosing and Administration
Start taking the drug should be 1-5 day of the menstrual cycle.
Lindinet 30 is designed for a 21-day course of administration - 1 tablet per day, if possible at the same time. Then put a 7-day break, during which there is menstrual withdrawal bleeding. The day after the break, i.e. exactly 4 weeks later (on the same day of the week) after taking the first pill, they start taking the drug from a new package.
In the case of switching to Lindinet 30 with other drugs containing only progesterone, you should start taking the pills:
- Mini-drank - on any day of the cycle;
- Implant - the day after its removal;
- Injections - on the eve of the latter.
In any of these cases, additional non-hormonal methods of contraception should be used during the first week.
When switching to Lindinet 30 from another oral contraceptive with a combination formulation, the first pill should be taken on the first day of withdrawal bleeding, i.e. the day after taking the last pill of another drug.
After an abortion in the first trimester, it is allowed to start taking this contraceptive immediately after abortion. To use additional methods of contraception in this case is not necessary.
After an abortion in the II trimester, as well as after giving birth, the drug can be started on days 21-28. In the first 7 days, an additional method of contraception is required. However, if sexual intercourse took place during this period, it is recommended to postpone Lindinet 30 until the first menstruation, or a test should be done to rule out pregnancy.
Rules for admission Lindinet 30 in case of skipping the next admission:
- If less than 12 hours have passed: the contraceptive effect of the drug persists, so you should take the missed pill as soon as possible, and then take it at the usual time;
- If more than 12 hours have passed: the contraceptive effect of the drug is reduced, so you should not replenish the missed dose, you need to continue taking the drug 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, you need to start a new package without interruption. In this case, the withdrawal bleeding will be absent until the completion of the new packaging, but there is a possibility of spotting or breakthrough bleeding. If, after the end of the tablets from the second packaging, the withdrawal bleeding has not occurred, then pregnancy should be excluded.
In the case of diarrhea and / or vomiting, Lindinet 30 should be taken in accordance with the rules for skipping the next admission, because may decrease the contraceptive effect of the drug.
To speed up the onset of menstruation, you should reduce the duration of a break in taking the drug (the usual 7-day). However, it should be borne in mind: the shorter the break, the greater the likelihood of lung or breakthrough bleeding during the period of taking the tablets from the next package.
To delay the onset of menstruation, you should continue taking the drug from a new package without a 7-day break. Thus, menstruation can be postponed as long as necessary, but not more than until the end of the last pill from the second package. In this case, there is also the likelihood of breakthrough or spot bleeding. Regular intake of Lindinet 30 can be restored after the usual 7-day break.
Possible adverse reactions, with the development of which the drug should be canceled:
- Sense organs: hearing loss (as a result of otosclerosis);
- Cardiovascular system: arterial hypertension; rarely, venous / arterial thromboembolism (including deep venous thrombosis of the lower extremities, pulmonary embolism, stroke and myocardial infarction); very rarely, venous or arterial thromboembolism of the mesenteric, renal, hepatic, retinal arteries and veins;
- Other: hemolytic uremic syndrome, porphyria; in rare cases, exacerbation of reactive systemic lupus erythematosus; extremely rarely - Sydenham's chorea (disappears after stopping the drug).
The following side effects occur more often, but are less severe. In any of the cases described below, the decision on the appropriateness of taking Lindinet 30 should be decided with the doctor based on the ratio of benefits and possible risks:
- Dermatological reactions: chloasma, increased hair loss, rash, nodular or exudative erythema;
- Sense organs: hearing loss; in women wearing contact lenses - increased sensitivity of the cornea;
- Central nervous system: depression, mood lability, headache, migraine;
- Digestive system: ulcerative colitis, nausea, epigastric pain, Crohn's disease, vomiting, cholelithiasis, liver adenoma, hepatitis, development or exacerbation of jaundice and / or itching associated with cholestasis;
- Metabolism: an increase in body weight, an increase in the level of thyroid-stimulating hormone, hyperglycemia, a decrease in carbohydrate tolerance, fluid retention in the body;
- The reproductive system: bloody discharge from the vagina or acyclic bleeding, inflammation of the vagina, changes in the state of vaginal mucus, galactorrhea, candidiasis, pain, an increase and exertion of the mammary glands, and amenorrhea after discontinuation of the drug;
- Other: allergic reactions.
Before prescribing any hormonal contraceptives, the physician should individually assess the benefits and possible negative effects of their use. This question should be discussed with the patient, who must make a final decision on the appropriateness of using hormonal or any other method of contraception.
Before the appointment of Lindinet 30, a general medical examination (including blood pressure measurement, laboratory tests, family and personal history) and gynecological examinations (including pelvic and breast examinations, cytological smear from the cervical canal), are shown. Repeated examinations should be carried out every 6 months the entire period of taking the drug.
Every woman who is prescribed hormonal contraceptives should keep in mind that these drugs do not protect against HIV infection and other sexually transmitted diseases.
There are rare reports of liver tumor development (both benign and malignant) in women who have taken hormonal contraceptives. This information should be taken into account when conducting differential-diagnostic assessment of abdominal pain, because they may be due to intraperitoneal bleeding or an increase in liver size.
The effectiveness of Lindinet 30 may decrease if, after several months of its administration, there are spotting, irregular or breakthrough bleeding. In this case, taking the pills should be continued until the end of the next package. If at the end of the second cycle does not begin menstrual bleeding, or acyclic bleeding does not stop, you should cancel the drug and eliminate pregnancy.
After suffering acute viral hepatitis, Lindinet 30 can be prescribed no earlier than 6 months after the normalization of liver function.
Studies about the influence of Lindinet 30 on the ability to drive vehicles and work with mechanisms were not conducted.
The following drugs reduce the contraceptive efficacy of Lindinet 30: barbiturates, felbamate, phenylbutazone, topiramate, phenytoin, oxcarbazepine, carbamazepine, rifampicin, primidone, tetracycline, griseofulvin, rifabutin, ampicillin, hydantocinline, ampicillin, hydroantocin, hydrofluorine, tetracycline, griseofulvin, rifabutin, ampicillin. If necessary, the use of such a combination of the entire period of treatment and within 7 days after its completion (in the case of the use of rifampicin - within 4 weeks), you must use additional methods of contraception.
Hypericum preparations reduce the concentration of Lindinet 30 in the blood, which can lead to breakthrough bleeding and pregnancy. For this reason, this combination is not recommended.
Liver enzyme inhibitors (including fluconazole and itraconazole) help to increase the concentration of ethinyl estradiol in the blood plasma.
Drugs that undergo sulphation in the intestinal wall competitively inhibit the sulphation of ethinyl estradiol, thus enhancing its bioavailability. The same applies to ascorbic acid.
Drugs that increase the motility of the digestive tract, reduce the absorption of Lindinet 30, which reduces the concentration of its active substances in the blood plasma.
Ritonavir reduces the total concentration of ethinyl estradiol by 41%. For this reason, when using this combination, you should additionally use a non-hormonal method of contraception, or take another oral contraceptive containing more ethinyl estradiol.
Like all oral contraceptives, Lindinet 30 can reduce carbohydrate tolerance, increase the need for insulin and oral antidiabetic agents.
Ethinyl estradiol can affect the metabolism of other drugs, which may change their concentration in the blood (increase or decrease), so the possibility of simultaneous use of any other drug should be agreed with your doctor.
Terms and conditions of storage
To store in protected from light and moisture, the place, inaccessible for children, at a temperature not exceeding 25 ° C.
Shelf life - 3 years.