Natazia is a combination birth control pill which is used to prevent pregnancy. It contains 2 hormones: dienogest and estradiol valerate.
Contents:
Indications for use
- Oral contraception.
Mechanism of action
The dienogest + estradiol valerate combination suppresses ovulation and increases the viscosity of the secretion of the cervix, as a result of which it becomes impenetrable for spermatozoa.
Dosage and mode of application
Each Natazia pack contains 28 tablets:
- 2 tablets containing estradiol valerate 3mg;
- 5 tablets containing dienogest 2mg + estradiol valerate 2mg;
- 17 tablets containing dienogest 3mg + estradiol valerate 2mg;
- 2 tablets containing estradiol valerate 1mg;
- 2 inert tabs.
Take 1 tablet a day, at the same time of day, for 28 days in a row, according to the directions on the blister.
Begin taking tablets from the next packaging the day after the previous one is finished.
Side effects
Natazia birth control pills can cause the following side effects:
- infectious and parasitic diseases: vaginitis / vulvovaginitis, vaginal candidiasis or other fungal vulvovaginal infections; salpingoophoritis (adnexitis), urinary tract infections, cystitis, mastitis, cervicitis, fungal infections, candidiasis, herpetic infection of the oral cavity, influenza, bronchitis, sinusitis, upper
- respiratory infections, viral infection;
- benign, malignant and unspecified neoplasms (including cysts and polyps): uterine myoma, breast lipoma;
- hemopoietic system: anemia;
- immune system: allergic reactions;
- endocrine system: virilism;
- metabolism and nutrition: increased appetite; anorexia;
- disorders of the psyche: decreased mood; depression, mental disorders, insomnia, sleep disorders, aggression; mood changes, decreased libido, increased libido;
- nervous system: headache; dizziness, migraine; ischemic stroke, cerebrovascular disorders, dystonia;
- vision: dryness of the mucous membrane of the eyes, irritation of the mucous membrane of the eyes, oscilloscopy, visual impairment; intolerance to contact lenses (discomfort);
- hearing organ and labyrinthine disturbances: sudden hearing loss, tinnitus, dizziness, hearing loss;
- cardiovascular system: increased blood pressure, lower blood pressure; cardiovascular disorders, tachycardia, venous and arterial thromboembolic complications, thrombophlebitis, diastolic hypertension, orthostatic circulatory dystonia, “hot flashes”, varicose veins, pathology of veins, pain in the veins;
- respiratory system: bronchial asthma, hyperventilation;
- gastrointestinal tract: pain in the abdomen, including pain in the upper and lower abdomen, discomfort / bloating, nausea, vomiting, diarrhea; gastritis, enteritis, dyspepsia;
- skin and subcutaneous tissues: acne, alopecia, rash (including macular rash), itching (including generalized itching); allergic dermatitis, atopic dermatitis / neurodermatitis, eczema, psoriasis, hyperhidrosis, chloasma, pigmentation disorder / hyperpigmentation, seborrhea, dandruff, hirsutism, skin pathology, skin reactions, “orange peel”, vascular sprouts; hives, erythema nodosum, erythema multiforme;
- musculoskeletal system: back pain, discomfort in the muscles and skeleton, myalgia, pain in the extremities;
- genitals and breast: pain in the mammary gland, a feeling of discomfort, engorgement of the mammary glands; infrequent changes in the volume, duration and interval of menstrual bleeding (including abundant menstrual-like bleeding / bleeding, meager or rare menstrual bleeding, lack of menstrual bleeding, acyclic bleeding), enlargement of the mammary glands, swelling and swelling of the mammary glands, swelling of the breast, painful menstrual-like bleeding / bleeding, discharge from the genital tract / discharge from the vagina a, ovarian cysts, pelvic pain; dysplasia of the cervix, cysts of the uterine appendages, pain in the appendages of the uterus, cysts of the mammary glands, fibrocystic mastopathy, dyspareunia, galactorrhea, menstrual period disorder; discharge from the mammary glands;
- general disorders and disorders at the injection site: fatigue, asthenia, poor health; chest pain, peripheral edema, influenza-like phenomena, inflammation, fever, irritability; fluid retention;
- influence on the results of laboratory and instrumental studies: change in body weight (increase, decrease and fluctuations in body weight); an increase in the concentration of triglycerides in the blood, hypercholesterolemia.
Contraindications
Natazia tablets are contraindicated for use in the following cases:
- hypersensitivity to estradiol valerate, dienogest or other components of the drug;
- thromboses (venous and arterial) and thromboembolism (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris);
- migraine with focal neurologic symptoms;
- diabetes mellitus with vascular complications;
- multiple or expressed risk factors for venous or arterial thrombosis;
- uncontrolled arterial hypertension;
- serious surgical intervention with prolonged immobilization;
- smoking over the age of 35;
- pancreatitis with severe hypertriglyceridemia;
- liver failure and severe liver disease (before normalization of liver tests);
- liver tumors (benign or malignant);
- identified hormone-dependent malignant diseases;
- vaginal bleeding of unknown origin;
- pregnancy;
- breastfeeding period.
With caution:
- risk factors for thrombosis and thromboembolism: smoking; obesity (dyslipoproteinemia); arterial hypertension; migraine; heart valve flaws; prolonged immobilization, serious surgical interventions, extensive trauma; hereditary predisposition to thrombosis (thrombosis, myocardial infarction, or impaired cerebral circulation at a young age in any of the next of kin);
- violations of peripheral circulation: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn’s disease and nonspecific ulcerative colitis; sickle-cell anemia; phlebitis of superficial veins;
- hereditary angioedema;
- hypertriglyceridemia;
- liver disease;
- diseases that first appeared or worsened during pregnancy or on the background of the previous use of hormonal contraceptives (jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes pregnant, Sydenham’s chorea);
- postpartum period.
Interactions
Some drugs can reduce the effectiveness of Natazia. These include drugs used to treat epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (rifampicin, rifabutin) and HIV infection (ritonavir, nevirapine); antibiotics for the treatment of certain other infectious diseases (penicillin, tetracyclines, griseofulvin), medicines based on St. John’s Wort (used primarily for the treatment of reduced mood).
The contraceptive may affect the metabolism of other drugs (cyclosporine and lamotrigine).
Inform your doctor about all medicines you are taking. In some cases, a doctor may recommend that you use additional methods of contraception (condoms).
Pregnancy and breastfeeding
The use of Natazia is contraindicated during pregnancy and lactation. If the pregnancy is detected or suspected during the use of birth control pills, the drug should be immediately canceled. However, extensive epidemiological studies have not revealed any increased risk of developmental defects in children born to women who used hormonal contraceptives before pregnancy or during early pregnancy.
If you are pregnant or breastfeeding, consult your doctor before taking any medication.
What if I miss a pill?
If you missed tablets without active ingredients (inert):
If you miss one of the inert tablets (2 last tablets in the blister), you do not need to take it later because they do not contain any active substances and you are still protected from pregnancy.
However, it is important that you throw out the missed inert tablet and continue taking the next pills at the usual time. Otherwise, protection from unwanted pregnancy can be reduced (as a result of an unintended extension of the period during which active tablets are not taken).
If you forgot to take the last inert tablet from the current package, in spite of this, you should take the first tablet from the next package at the due time.
If you missed active tablets of Natazia (tablets 1-26 in the blister):
Depending on the day of the menstrual period, you may need to apply additional contraceptive measures, for example, condoms.
Take the pill according to the following principles:
- If the delay in taking a dose is less than 12 hours, the contraceptive effect of the drug is preserved. Take the pill immediately, as soon as you remember it, and take the rest of the pills at the usual time;
- If the delay in taking a dose is more than 12 hours, the contraceptive reliability of the drug may decrease. Depending on the day of the menstrual period, use additional contraceptive measures, for example, condoms.
If you missed more than one active tablet:
- Seek advice from your doctor;
- Do not take more than 2 active tablets on the same day to make up for the missed tablets;
- If you forget to start a new package or missed one or more active tablets from on days 3-9, there is a risk that you are already pregnant (if you have had sexual intercourse within 7 days before missing the pill). In this case, contact your doctor. The more active pills are missed and the closer they are to the phase of taking inactive tablets, the higher the probability of pregnancy.
Precautions
If you had vomiting or diarrhea (upset stomach) 3-4 hours after taking a birth control pill, the active ingredients may not have been fully absorbed. In this case, follow the instructions for missed pills.
If you have any of the diseases / conditions / risk factors mentioned below, the potential risk and the expected benefit of using Natazia in each individual case should be discussed with a doctor before taking the preparation.
Diseases of the cardiovascular system:
The risk of developing thrombosis and thromboembolism increases:
- with age;
- for smokers (especially in women older than 35 years);
- family history of thrombosis and thromboembolism;
- obesity;
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- heart valve diseases;
- atrial fibrillation;
- prolonged immobilization; extensive surgical intervention.
An increased risk of thromboembolism in the postpartum period should be considered. Violations of peripheral circulation can also occur in women with diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and sickle cell anemia. An increase in the frequency and severity of a migraine during the use of Natazia contraceptive may be the reason for the immediate withdrawal of this drug.
Biochemical factors that indicate hereditary or acquired predisposition to arterial or venous thrombosis include resistance to activated protein C, hyperhomocysteinemia, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, antiphospholipid antibodies.
Bear in mind that treatment of the conditions mentioned above can reduce the risk of thrombosis associated with it.
Tumors:
In rare cases, benign / malignant liver tumors developed on the background of using hormonal contraceptives, which led to life-threatening intraabdominal bleeding. If you have severe pain in the upper abdomen, increased liver size, or signs of intra-abdominal bleeding, you need to exclude liver tumors.
Other conditions:
Women with hypertriglyceridemia have an increased risk of developing pancreatitis during the use of Natazia tablets.
Women with hereditary forms of angioedema, the drug can induce or worsen the symptoms of angioedema.
Acute or chronic liver dysfunction may require the withdrawal of the drug until liver function returns to normal.
Although the drug can affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients who use this contraceptive. Nevertheless, women with diabetes mellitus should be closely monitored during the treatment with this preparation.
There were rare cases of Crohn’s disease and ulcerative colitis in the background of the using the mediation.
Women who are prone to chloasma should avoid exposure to sun or UV radiation during hormonal contraception.
Effect on laboratory tests:
Estradiol valerate and dienogest can affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney functions, the concentration of transport proteins in the plasma. These changes usually remain within the limits of laboratory norms.
Medical examinations:
Before taking birth control pills, it is necessary to carefully evaluate the contraindications to the drug based on anamnesis of life, family history of the woman, as well as general medical and gynecological examination. T
Natazia does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Decreased efficiency:
The effectiveness of Natazia can be reduced by missing tablets with active ingredients, gastrointestinal disorders or on the background of concomitant drug treatment.
Insufficient control of the menstrual period:
Women may have irregular menstrual bleeding (spotting or breakthrough uterine bleeding) when using this contraceptive, especially in the first months of use. The period of adaptation usually lasts 3 menstrual periods.
Influence on the ability to drive a car or work with mechanisms:
The preparation does not affect the ability to drive a car and work with mechanisms, but patients who have side effects such dizziness and impaired concentration should be careful.