Gynera 21 tablets

Properties:

Combined oral hormonal contraceptive.

The gestagenic component is a derivative of 19-nortestosterone – gestodene, which is superior in strength and selectivity of action not only to the natural hormone of the corpus luteum progesterone, but also to other synthetic gestagens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has practically no effect on lipid and carbohydrate metabolism.

The estrogenic component of the combination is ethinyl estradiol, a synthetic analogue of the follicular hormone estradiol, which, together with the corpus luteum hormone, participat in the regulation of the menstrual cycle.

Along with the indicated central and peripheral mechanisms that prevent the maturation of an ovum capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of mucus in the cervix, which makes it relatively impassable for sperm.

Indications:

Oral contraception.

Method of administration and dosage:

Oral tablets.

The tablets should be taken every day, at about the same time of day, with a little water if necessary.

The tablets should be taken in the direction indicated by the arrow on the blister.

Dosing regimen:

You should take one tablet of the drug  sequentially for 21 days, before taking the last tablet of this package. Taking the tablets from the next package should be started after a 7day break in taking the tablets. Withdrawal bleeding may occur during a pill break, which usually starts 2-3 days after the last pill is taken and may not end by the time the first pill is taken from the new package.

Start taking it

If in the previous month the woman did not use hormonal contraceptives:

Taking Gynera’s drug should be started on the first day of the cycle, i.e. on the first day of the onset of menstruation.

You can start taking Gynera’s drug from the 2nd – 5th day of the cycle, in this case, during the first 7 days of taking the pills, you must use additional barrier methods of contraception.

Contraindications:

Presence of risk factors for venous thromboembolism; the presence of risk factors for the development of arterial thromboembolism; severe liver disease

(including history) before normalization of liver function indicators; liver tumor (including a history); severe chronic renal failure or acute renal failure; known or suspected hormonedependent malignant tumors (including genitals or breast); bleeding from the vagina of unclear etiology; pregnancy; lactation period (breastfeeding).

Precautions:

The benefits of hormonal contraception should be assessed individually for each woman and discussed with her before starting hormonal contraceptives.

Combined hormonal contraceptives should be used with caution, incl. fixed combinations of gestodene / ethinylestradiol for conditions that increase the risk of developing venous or arterial thrombosis / thromboembolism: age over 35 years, smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), hemolytic uremic syndrome, hereditary angioedema, liver disease, diseases that first appeared or worsened during pregnancy or against the background of previous intake of sex hormones (including porphyria, herpes of pregnant women, chorea, Sydenham’s chorea, chloasma), obesity (BMI more than 30 kg / m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, antithrombin Ill deficiency, protein C or S deficiency, antiphospholipid antibodies, incl. antibodies to cardiolipin, lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn’s disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic liver diseases. antithrombin Ill deficiency, protein C or S deficiency, antiphospholipid antibodies, incl. antibodies to cardiolipin, lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn’s disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic liver diseases.

In case of suspected or established venous or arterial thromboembolism, the use of combined hormonal contraceptives should be discontinued. If anticoagulant therapy is initiated, adequate alternative contraception should be initiated to avoid the teratogenic effects of anticoagulant therapy (coumarins

The use of any combined oral contraceptive pill

increases the risk of venous thromboembolism.

Side effects:

From the side of the cardiovascular system: arterial hypertension; rarely – arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); very rarely – arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss due to otosclerosis.

From the reproductive system: acyclic bleeding / spotting from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes in the vagina, candidiasis, tension, pain, enlargement of the mammary glands, galactorrhea.

From the digestive system: epigastric pain, nausea, vomiting, Crohn’s disease, ulcerativ colitis, the onset or exacerbation of jaundic and / or itching associated with cholestasis, cholelithiasis, hepatitis, liver adenoma.

On the part of the skin and its appendages: erythema nodosum, exudative erythema, rash, chloasma, increased hair loss.

From the neurological system: headache, migraine, mood lability, depression.

From the senses: hearing loss, increased sensitivity of the cornea (when wearing contact lenses).

From the side of metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates, hyperglycemia, increased TG levels.

Others: allergic reactions, hemolytic uremic syndrome, porphyria; rarely – exacerbation of reactive systemic lupus erythematosus; very rarely – Sydenham’s chorea.

Storage method:

At a temperature not higher than 30 degre