Gestarella
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Prices in online pharmacies:
from 250 rubles.
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Gestarella is a monophasic oral contraceptive drug.
Release form and composition
Dosage form - coated tablets: round biconvex, white, with a shiny surface (21 pcs. In a blister, in a cardboard box 1 or 3 blisters).
1 tablet contains:
- active ingredients: ethinylestradiol - 0.02 mg, gestodene - 0.075 mg;
- auxiliary components: povidone 25, sodium calcium edetate, magnesium stearate, corn starch, lactose monohydrate;
- shell composition: calcium carbonate, sucrose, macrogol 6000, povidone 90 F, mountain wax glycolic, talc.
Indications for use
The use of Gestarella is indicated for women for oral contraception.
Contraindications
- migraine with focal neurological symptoms (including history);
- pulmonary embolism, deep vein thrombosis, myocardial infarction and other pathologies associated with thromboembolism or venous and arterial thrombosis (including history);
- angina pectoris and other conditions preceding thrombosis;
- transient ischemic attack, stroke (including history);
- severe or multiple risk factors for arterial or venous thrombosis, including uncontrolled arterial hypertension, complicated lesions of the heart valve apparatus, diseases of the coronary arteries of the heart or cerebral vessels, atrial fibrillation, severe dyslipoproteinemia, extensive surgical or neurosurgical surgery, prolonged immobilization by air (including four hours), surgical interventions on the pelvic organs and lower limbs, smoking over the age of 35;
- predisposition to arterial or venous thrombosis (congenital or acquired): Leiden factor V, resistance to activated protein C, lack of protein C, lack of antithrombin III, lack of protein S, the presence of antibodies to phospholipids (lupus anticoagulant, anticardiolipysteine), hyperhoma;
- hormone-dependent malignant tumor (including genitals or mammary gland), including if it is suspected;
- pancreatitis with severe hypertriglyceridemia (including history);
- diabetes mellitus with vascular complications;
- severe liver disease (including Rotor or Dubin-Johnson syndrome);
- liver failure;
- benign or malignant neoplasms of the liver (including history);
- age before the onset of the first menstrual bleeding;
- vaginal bleeding of unknown origin;
- extensive trauma;
- obesity [body mass index (BMI) above 30 kg per 1 m 2];
- period of pregnancy or suspicion of it;
- breast-feeding;
- syndrome of glucose-galactose malabsorption, fructose intolerance, sucrase or isomaltase deficiency;
- individual hypersensitivity to the components of the drug.
With caution, after a careful assessment of the potential risk and expected benefit from the use of Gestarella, a combined contraceptive drug should be prescribed if the patient has one of the risk factors for thrombosis and thromboembolism [hereditary predisposition (thrombosis, cerebrovascular accident, myocardial infarction in the next of kin at a young age), dyslipoproteinemia, migraine without focal neurological symptoms, BMI more than 25 kg per 1 m 2, arterial hypertension, uncomplicated valvular heart disease, smoking], with diabetes mellitus, hemolytic-uremic syndrome, oncological pathologies, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, sickle cell anemia, phlebitis of superficial veins, hereditary angioedema, hypertension depression, epilepsy; in case of occurrence or aggravation of jaundice, cholestasis, herpes (during pregnancy), otosclerosis with hearing impairment, diseases of the gallbladder, porphyria, Sydenham's chorea and other pathologies against the background of previous use of sex hormones or during pregnancy; in the period immediately after childbirth.
When symptoms of these diseases or conditions appear for the first time while taking the drug, it is necessary to immediately cancel it.
Method of administration and dosage
The tablets are taken orally with plenty of water.
Dosage regimen: 1 piece per day at the same time (individually set, convenient for a woman). Duration of admission is 21 days, strictly adhering to the sequence indicated on the blister. Then there is a break in taking the drug for 7 days. During this period, menstrual bleeding occurs, which usually occurs on the 2nd or 3rd day of the break. On the 8th day, on the day of the week of taking the first tablet from the first blister, you should start taking the tablets from the second blister, even if the bleeding has not completely ended.
If hormonal contraception has not been used in the previous month, pills are taken on the first day of natural menstrual bleeding, without using additional methods of contraception.
If the use of tablets is started in the period from the second to the fifth day of bleeding, in the first cycle it is necessary to additionally use barrier contraception during the first 7 days.
When switching from another oral combination contraceptive, it is preferable to start taking Gestarella the day after taking the last tablet containing the active substance of the previous drug. You can start using the drug on the 8th day (but not later) after the usual 7 days break (for products containing 21 tablets in a blister) or after taking placebo tablets (for products with 28 tablets in a blister).
When switching from a transdermal patch or vaginal ring, the drug should be taken the next day after they are removed, but not later than the day the next patch is glued or a new ring is inserted.
You can start using the tablets when switching from "mini-pili" at any time, from the intrauterine system or an implant - on the day they are removed, from injections - on the day of the next injection. In these cases, during the first 7 days of taking Gestarella, additional use of a barrier method of contraception is required.
After an abortion in the first trimester of pregnancy, use is started immediately without the use of additional contraceptives.
After childbirth, in the absence of lactation, or abortion in the second trimester of pregnancy, it is recommended to start taking pills during the period from 21 to 28 days after childbirth or abortion. At a later start of taking the drug, it is necessary to use additional barrier methods of contraception during the first 7 days. If a woman has had sexual intercourse, then before starting oral contraception, it is necessary to exclude the presence of pregnancy or wait for the first menstrual bleeding.
After taking the drug from the first blister, it is possible to lengthen the menstrual cycle by 7 days. If the cycle does not recover after the end of the use of 2-3 blisters, you should consult a doctor.
In case of an accidental delay in taking the next dose at the set time, the contraceptive protection of the drug is not violated if the pill is taken within the next 12 hours. The next pill is taken at the usual time.
Since the necessary suppression of the hypothalamic-pituitary-ovarian system occurs after 7 days of regular pill intake and their intake should never be interrupted for more than 7 days, a delay of more than 12 hours in taking the next pill may reduce the effect of contraceptive protection.
If you are more than 12 hours late in taking the next pill in the first week of taking the drug, you need to take the missed pill as soon as you remember, even if it corresponds to taking two pills at once. Then the pills are taken at the usual time, but during the next 7 days it is necessary to additionally use barrier methods of contraception, including condoms. If a woman had sexual intercourse in the previous 7 days, the possibility of conception must be taken into account. The risk of pregnancy is the higher, the more tablets are missed and the closer the pass is to the onset of a break in taking the drug.
If a delay of more than 12 hours occurred during the second week of taking the drug, the missed pill should be taken as soon as you remember, even if this would correspond to taking two pills at once. Then the tablets are taken at the usual time. The use of additional contraception is not required if the pill is taken regularly for 7 days before the first pass. If a long delay is not the first in this cycle and the pill intake was irregular, additional contraceptive measures are required over the next 7 days.
If a delay of more than 12 hours occurred during the third week of taking the drug, the upcoming break in taking it increases the risk of reducing the reliability of the contraceptive effect of Gestarella. Contraceptive protection can be maintained, provided that the pills are taken regularly for 7 days before the first delay, if immediately, as soon as they remember, take the missed pill, even if this corresponds to taking two pills at the same time. Then continue taking at the usual time. After the end of taking all the tablets from the current blister without the prescribed 7 days of interruption in taking the drug, you must immediately start taking from the next blister. Before it is over, withdrawal bleeding is unlikely, but there is a risk of minor bleeding or breakthrough vaginal bleeding. The second option is to interrupt taking the pills from the current blister, take a break of 7 days, including the days of missing, and then start taking the pills from the new blister.
If there are gaps in taking the drug from the current blister, the absence of menstrual bleeding during the prescribed break may indicate pregnancy. Therefore, you can start a new blister only after excluding conception.
If, within 4 hours after taking the next dose, a woman has vomiting or diarrhea, due to a possible incomplete absorption of the drug and a violation of its action, additional contraceptive measures should be taken, as when skipping a pill.
If it is necessary to postpone the day of the onset of menstrual bleeding, then taking the drug without interruption should be continued from a new blister. You can continue taking pills from the next blister until the end of all its pills. During this period, breakthrough bleeding or spotting is possible. After a 7-day break, continue to take the drug regularly.
If the onset of menstrual bleeding needs to be postponed to another day of the week, for this you should shorten the pill-taking interval by the desired number of days. The risk of withdrawal bleeding and breakthrough bleeding or spotting during the period of taking the drug from the next blister increases with a greater reduction in this interval.
Side effects
- from the immune system: rarely - hypersensitivity reactions; frequency unknown - exacerbation of systemic lupus erythematosus;
- from the nervous system: often - migraine, headache; frequency unknown - exacerbation of chorea, dizziness;
- on the part of nutrition and metabolism: often - fluid retention, increased body weight; rarely - weight loss; frequency unknown - exacerbation of porphyria;
- from the side of the vessels: rarely - venous and / or arterial thromboembolism;
- mental disorders: often - mood swings, depression of mood; infrequently - decreased libido; rarely - increased libido; frequency unknown - nervousness, depression;
- from the hepatobiliary system: rarely - cholelithiasis;
- from the gastrointestinal tract: often - nausea, vomiting; infrequently - diarrhea, abdominal pain; very rarely - pancreatitis; frequency unknown - colitis, bloating;
- on the part of the organ of vision: rarely - unpleasant sensations when wearing contact lenses; frequency unknown - optic neuritis;
- on the part of the genitals and mammary gland: often - vaginal discharge, breast tenderness, feeling of tension; infrequently - an increase in the mammary glands; rarely - discharge from the mammary glands; frequency unknown - vaginitis, soreness of menstrual bleeding, chest pain, vulvovaginal candidiasis;
- dermatological reactions: infrequently - skin rash (including urticaria); rarely - erythema (multiforme or nodular); frequency unknown - hirsutism, acne, alopecia;
- laboratory and instrumental parameters: infrequently - hyperlipidemia;
- others: possibly - chloasma, cerebrovascular disorders, venous and arterial thromboembolic disorders, increased blood pressure (BP), decreased glucose tolerance, hypertriglyceridemia, impaired peripheral insulin resistance, impaired liver function indicators, benign and malignant liver tumors.
The relationship between the use of Gestarella and the onset or worsening of conditions associated with the appearance of jaundice and / or itching against the background of cholestasis, the formation of stones in the gallbladder, herpes of pregnant women, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, hearing loss due to otosclerosis, or cervical cancer.
special instructions
Before starting the use of Gestarella, a woman should undergo a general medical and gynecological examination, to exclude the presence of pregnancy and disorders of the blood coagulation system.
The use of a combined oral contraceptive increases the likelihood of developing venous and arterial thrombotic and thromboembolic pathologies, including myocardial infarction, venous thrombosis, transient ischemic attack, stroke, pulmonary embolism. Therefore, women with risk factors or conditions that may contribute to the exacerbation or development of these diseases should agree with their doctor about the possibility of using Gestarella and carefully weigh the potential health risks and benefits of contraception.
Since the stable contraceptive effect of the drug occurs 14 days after the start of taking the pills, during this period it is recommended to additionally use barrier contraceptives.
The risk of developing venous thromboembolism while using the drug doubles. It is highest in the first year of hormonal contraception and for 4 or more weeks when it is resumed after a break.
In case of prolonged immobilization, major elective surgery or trauma, any surgical intervention in the pelvic region or on the lower extremities, neurosurgery, the use of tablets is recommended to be discontinued and resumed 2 weeks after complete remobilization. The use of the drug should be canceled 4 weeks before the planned operation, if the drug was not stopped in advance, antithrombotic therapy is required.
A woman is at increased risk of thromboembolism within 6 weeks after giving birth.
If symptoms of venous thromboembolism appear, a woman should immediately consult a doctor and be sure to inform about taking the drug. Symptoms of deep vein thrombosis include: unilateral swelling of the foot and / or lower limb or along a vein in the lower limb, fever in the affected lower limb, pallor or redness of the lower limb that is felt only when walking or standing, pain in the lower limbs or tenderness to touch … Symptoms of pulmonary embolism include: acute chest pain, dizziness, nausea, vomiting, fainting, sudden onset of shortness of breath, rapid breathing, cough (including accompanied by hemoptysis), not associated with respiratory tract infections, irregular or rapid heartbeat. In addition, sudden pain may become a sign of vessel occlusion,edema and mild cyanosis of the limb.
Violation of the patency of the vessels of the eyes is manifested by painless blurred vision, which can cause loss of vision.
An increase in the frequency or severity of migraine while taking Gestarella may indicate the development of cerebrovascular diseases, therefore, a decision must be made about the advisability of further oral contraception.
The effect of the drug on the development of cervical or breast cancer has not been established.
The appearance of liver tumors is possible, this must be taken into account in the differential diagnosis of severe pain in the abdomen, signs of intra-abdominal bleeding or enlargement of the liver.
The risk of developing pancreatitis may be increased with hypertriglyceridemia (including a family history).
With the development of a persistent, clinically significant increase in blood pressure, the drug should be discontinued. Continuation of hormonal contraception is possible with positive dynamics of antihypertensive therapy.
If you are prone to chloasma, prolonged exposure to direct sunlight and ultraviolet radiation should be avoided.
Since the simultaneous use of drugs can reduce the effect of the drug, with concomitant therapy, barrier methods of contraception should be additionally used.
The effect of the drug on the results of some laboratory tests does not exceed the limits of their normal values.
During the period of taking the tablets (usually from the first blister), spotting bleeding or breakthrough bleeding may occur. If the condition does not stabilize after three menstrual cycles, it is necessary to establish the cause of the irregular bleeding in order to rule out the presence of pregnancy or malignant tumor.
Taking hormonal contraceptives can affect the properties of cervical mucus, the frequency and duration of menstrual bleeding, and rectal temperature.
Hormonal contraceptives do not protect against sexually transmitted diseases, including HIV infection (AIDS).
Due to possible visual impairment, dizziness during the use of Gestarella, it is recommended to be careful when driving vehicles and mechanisms.
Drug interactions
To avoid the development of undesirable side reactions, the simultaneous use of a hormonal contraceptive with any medications should be agreed with the doctor.
Analogs
Analogues of Gestarella are: tablets - Lindinet 20, Logest, Lindinet 30, Femoden.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C in a dark place.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Gestarella: prices in online pharmacies
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Drug name Price Pharmacy |
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Gestarella 75 mcg + 20 mcg film-coated tablets 21 pcs. RUB 250 Buy |
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Reviews Gestarella RUB 250 Buy |
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Gestarella 75 mcg + 20 mcg film-coated tablets 63 pcs. 841 RUB Buy |
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Reviews Gestarella 841 RUB Buy |
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
