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Generess Fe Review


Generess Fe is a chewable birth control drug. The main components are ethinyl estradiol, norethindrone and Ferrum ferrate. It is a monophasic medication the main aim of which is ovulation inhibition.

Contents:

Indications for use

  • Contraception;
  • Acne vulgaris treatment;
  • Treatment of severe premenstrual syndrome (PMS).

Mechanism of action

Generess Fe is a low dose monophasic hormonal contraceptive containing ethinyl estradiol and norethindrone. The contraceptive effect is mainly achieved due to suppression of ovulation, increased viscosity of cervical secretion and changes the endometrium. In women taking COC, the menstrual cycle becomes more regular, less painful. The intensity of menstrual bleeding decreases and the risk of iron deficiency anemia is reduced. In addition, there is an evidence of a reduced risk of developing endometrial and ovarian cancer.

Mode of application and dosage

The drug is prescribed in the 28-regimen course. Every pill should be taken daily at one and the same time. The pills are washed down with water. A 7-day break should be followed. The menstruation comes when a woman takes placebo pills. Even if the menstruation is not completed the pills from the next package should be started.

Contraindications

  • Breast cancer: diagnosed, suspected or in the anamnesis;
  • Diagnosed or suggested estrogen-dependent malignant neoplasms;
  • Vaginal hemorrhages of unknown genesis;
  • Untreated endometrial hyperplasia;
  • Deep vein thrombophlebitis, thrombosis, pulmonary embolism or idiopathic thromboembolism in the anamnesis;
  • Disorders accompanied by arterial thromboembolism (angina pectoris, myocardial infarction);
  • Acute or previous hepatic disease, at which the hepatic function was not normalized;
  • Hypersensitivity to the active substance or other drug components;
  • Porphyria;
  • Pregnancy;
  • Lactation.

The experience of treating women over the age of 65 is limited.

Precautions

If diagnosed early or there is currently any of the diseases listed below and/or worsened during pregnancy or previous hormonal treatment, the patient should undergo constant medical examination:

  • leiomyoma or endometriosis;
  • predisposition to thromboembolism or thromboembolism in the anamnesis;
  • risk factors for the development of estrogen-dependent tumors (eg, breast cancer in relatives);
  • arterial hypertension;
  • hepatic disorders;
  • diabetes mellitus;
  • chololithiasis;
  • migraines or severe headaches;
  • systemic lupus erythematosus;
  • hyperplasia of the endometrium in the anamnesis;
  • epilepsy;
  • bronchial asthma;
  • otosclerosis.

Side effects

The most frequently reported side effects during Generess Fe clinical trials were vaginal bleeding. According to the results of a 6-month clinical study, 11% of patients have registered bleeding or the appearance of spotting during the first month of taking the drug, 15% at the 4th month of therapy and 11% at the end of the clinical trial.

A higher incidence of side effects was observed among patients receiving Generess Fe compared to patients receiving placebo. Below are presented all the side effects, which, according to general opinion, had a probable connection with this kind of contraception.

Very often (1/10 is more than 1 in 10):

Disorders from the reproductive system and mammary glands: vaginal bleeding.

Often (1 / 100)

Impaired nervous system: headache.

Disorders from the gastrointestinal tract:

  • nausea;
  • abdominal pain.

Disorders of the musculoskeletal system and connective tissue:

  • backache;
  • pain in the cervical spine;
  • pain in the extremities.

Reproductive system and mammary glands disorders:

  • hyperplasia of the endometrium.
  • vulvovaginal mycoses.

Rarely (1/1000)

  • depressive conditions or severe depression.
  • increased excitability.
  • Nervous system disorders:

    • migraine;
    • dizziness.

    Disorders from the gastrointestinal tract:

    • bloating;
    • dyspepsia.

    Disturbances from the skin and subcutaneous system:

    • alopecia;
    • acne;
    • itching or hives.

    Disorders of the musculoskeletal system and connective tissue:

    cramps in the calf muscles.

    Disorders of the reproductive system and mammary glands:

    • tenderness of mammary glands;
    • discomfort in mammary glands.

    General violations in the place of an introduction:

    • peripheral edema.
    • mammary cancer.

    The risk of developing breast cancer among women currently taking in the recent trials increases in proportion.

    In women with a uterus, the risk of developing hyperplasia and endometrial cancer increases with a long-lasting use of estrogens without the side effect of progesterone. Addition of progesterones to estrogen significantly reduces the risk of developing endometrial cancer.

    Interactions

    • Possible acceleration of the metabolism of estrogens and progesterones: microsomal enzymes, especially cytochrome P450 enzymes, such as anticonvulsant drugs (eg phenobarbital, phenytoin, carbamazepine) and anti-infective drugs (eg rifampicin, rifabutin, nevirapine, efavirenz)
    • Induced properties of steroid hormones: ritonavir and nelfinavir,
    • Stimulation of estrogen and progestogens: phytopreparations, which include St. John’s wort (Hypericum perforatum).
    • Elevated metabolism of estrogens and progestogens can clinically be manifested by a decrease in the drug effect and a change in the character of uterine bleeding.
    • Drugs that inhibit the activity of microsomal hepatic enzymes, including ketoconazole, can magnify the concentration of circulating active components of Generess Fe.

    What if I miss a dose?

    If a woman takes the drug less than 12 hours, the contraceptive protection is not decreased.

    Take the pill as soon as possible, take the next pill at the common period of time. If the delay in taking the drug is more than 12 hours, contraceptive protection can be decreased. The more pills missed and the closer the time to the 7-day break (if present), the greater the likelihood of pregnancy is. In this case, you can follow these two basic rules:

    • the drug should never be discontinued for more than 7 days;
    • to reach an adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous intake of tablets are required. Accordingly, if the delay in taking the tablets is more than 12 hours (the interval from the time of taking the last tablet is more than 36 hours), the woman should use additional methods of contraception and consult a doctor.

    Generess Fe and pregnancy

    The use of Generess Fe during pregnancy and breastfeeding is contraindicated. In the case of pregnancy on the background of this medication application – the application should be immediately discontinued.

    Limited data on the drug use during pregnancy indicate the side effects of norethisterone on the fetus. The use of hormones in doses that are used for oral contraception leads to the increase in testosterone of the female fetus.

    The results of most epidemiological studies on the unintended effects on the fetus of combined therapy with estrogens and progesterones indicate that it has no teratogenic or fetotoxic effect.

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