Norocarmena 21 tablets

Trade name:

Norocarmena

Norocarmena

Compound:

Each tablet contains:

drospirenone 3 mg

ethinylestradiol 0.03 mg

Auxiliary components:

lactose monohydrate, corn starch, pregelatinized corn starch, povidone-K25, magnesium stearate.

The composition of the film shell (Opadray Il white Colorcon 85G18490): polyvinyl alcohol, titanium dioxide, macrogol-3350, talc, soy lecithin.

Properties:

The drug Norocarmen@ is a combined

(estrogen + gestagen) oral contraceptive drug (COC). The contraceptive effect of the drug is carried out through complementary mechanisms, the most important of which are: suppression of ovulation and changes in the endometrium, which prevent the implantation of a fertilized egg.

If used correctly, the Pearl index (an indicato reflecting the number of pregnancies in 10 women using contraceptives within one year is less than 1. If pills are missed or misused, the Pearl index may increase.

In women taking COCs, the cycle becomes more regular, painful menstrual bleeding is less common, the intensity and duration of bleeding decreases, as a result of which the risk of iron deficiency anemia decreases.

The progestogenic component of the drug, drospirenone, has a weak antiandrogenic effect (helps to reduce acne, seborrhea) and mild antimineralocorticoid properties (it can prevent weight gain and the appearance of other symptoms, for example, edema associated with estrogen-dependent fluid retention). Clinical studies show that the antimineralocorticoid properties of drospirenone lead to a negligible anti-mineralocorticoid effect.

Does not have estrogenic, glucocorticoid or antiglucocorticoid effects. This provides drospirenone with a pharmacological profile similar to natural progesterone. This should be taken into account when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well for women with acne and seborrhea.

Indications:

– oral contraception.

Method of administration and dosage:

The tablets should be taken orally in the order indicated on the package, every day at about the same time, with a little water. Take 1 tablet per day continuously for 21 days. Taking the pills from the next pack begins after a 7-day break, during which menstrual bleeding usually develops (“withdrawal” bleeding). As a rule, it starts 2-3 days after taking the last pill and may not end before taking pills from a new package. Taking pills from a new package should be started on the same day of the week, so the withdrawal bleeding will occur every month at about the same time.

Start taking the drug (hormonal contraceptive was not used in the previous month)

Taking Norocarmen@ begins on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is allowed to start taking on days 2-5 of the menstrual cycle, in this case it is recommended to additional use a barrier method of contraception (for example, a condom) during the first 7 days of

taking the pills from the first package.

Contraindications:

• venous thrombosis or thromboembolism (VTE), incl. deep vein thrombosis (DVT) and pulmonary embolism (PE), currently or in history;
• arterial thrombosis or thromboembolism (ATE), incl. myocardial infarction and stroke; or prodromal conditions (transient ischemic attack, angina pectoris);

-revealed hereditary or acquired predisposition to VT E or ATE, including resistance to activated protein C, hyperhomocysteinemia, antithrombin Ill deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);

• the presence of pronounced or multiple risk factors for VTE or ATE (smoking over the age of 35 years, obesity with a BMI of 30 kg / m2 or more, any surgery on the lower extremiti in the pelvic area or neurosurgical surgery, complicated heart valve defects, atrial fibrillation) , or one serious risk factor such as:

uncontrolled arterial hypertension;

• diabetes mellitus with diabetic angiopathy;

-severe dyslipoproteinemia;

• volumetric surgical interventions with prolonged immobilization;
• migraine with focal neurological symptoms at present or in anamnesis;
• severe chronic renal failure or acute renal failure;
• liver failure, acute or chronic severe liver disease (until the normalization of liver function tests);
• liver tumors (benign or malignant), currently or in history;

-diagnosed hormone-dependent malignant neoplasms (including genitals or mammary glands) or suspicion of them;

• bleeding from the genital tract of unknown etiology;
• hypersensitivity to drospirenone, ethinyl estradiol or any of the excipients in the drug;
• hypersensitivity to peanuts or soy;

-pregnancy, incl. supposed;

-the period of breastfeeding.

Precautions:

Consideration should be given to the increased risk of thromboembolism in the postpartum period.

Peripheral circulatory disorders can also occur in 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 o migraines (which may precede cerebrovascular disorders) during the use of COCs is the basis for immediate discontinuation of these drugs.

Side effects:

From the nervous system: often – headache, emotional lability, depression; infrequently decreased libido.

From the endocrine system: often – menstrual irregularities, intermenstrual bleeding, pain in the mammary glands; rarely – discharge from the mammary glands.

From the senses: rarely – hearing loss, poor tolerance of contact lenses.

From the digestive system: often – nausea, abdominal pain.

Skin and subcutaneous tissue disorders: infrequently – acne, eczema, skin rash, urticaria, erythema nodosum, erythema multiforme, pruritus, chloasma (especially if there is a history of chloasma in pregnant women).

From the vascular system: often – migraine;

infrequently – an increase or decrease in blood pressure.

Systemic disorders and complications at the injection site: often – an increase in body weight; infrequently – fluid retention.

On the part of the reproductive system and mammary glands: often – acyclic vaginal bleeding (spotting spotting or breakthrough uterine bleeding), engorgement, soreness, enlargement of the mammary glands, vaginal candidiasis.

Storage method:

At a temperature not higher than 30 degrees.

Packaging:

The cardboard box contains 1 blister of 21 tablets, paper instructions.