Novinet tabs #21

Novinet instruction for use

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Composition

The basis of the drug is 20 mcg ethinyl estradiol and 150 mcg desogestrel.
As an auxiliary component, Novinet contains: E 104 (quinoline yellow dye), α-tocopherol, magnesium stearate, povidone, colloidal silica, potato starch, stearic acid, lactose monohydrate.
The composition of p / o: hypromellose, macrogol 6000, propylene glycol.

Form of issue

Tablets p / o (20 + 150) mcg. Packed in blisters, packing number 21 or number 63.

pharmachologic effect

Estrogen-progestogen, contraceptive.

Pharmacodynamics and pharmacokinetics

The composition of the drug includes synthetic estrogenic and gestagenic components, which are more active than natural sex hormones.
The effect is achieved primarily by preventing the release of pituitary hormones follitropin and luteotropin, which prevents the process of ovulation. Its enhancement is promoted by the increased viscosity of mucus in the cervical canal and, consequently, its relative obstruction for spermatozoa.
A distinctive feature of Novinet tablets is that the estrogen component is present in them in minimal concentration, which reduces the risk of the appearance of estrogen-dependent side effects (pain in the mammary glands, thromboembolic complications, nausea, weight gain, etc.).
Desogestrel is a gestagen of the second generation. The substance favorably affects the metabolism of lipids, maintaining the cholesterol balance and normalizing the lipidogram indices.
In addition, against the background of the use of tablets:
    blood loss is reduced;
    improves skin condition;
    the cycle of menstrual days is normalized;
    the risk of developing gynecological diseases (including including diseases of tumor nature) is reduced.
Ethinyl estradiol and desogestrel are absorbed in the proximal small intestine. Absorption is fast and almost 100%. The main product of the metabolism of desogestrel is 3-keto-desogestrel, other metabolites are not pharmacologically active.
Bioavailability of ethinylestradiol - 60%. For desogestrel, this index varies from 62 to 81%. Both substances have a high degree of binding to plasma proteins (more than 90%). Their concentration in the blood reaches the maximum values ​​in 1-1,5 hours after taking the pill.
The components of the drug are well distributed in tissues and organs, while ethinyl estradiol is characterized by the ability to accumulate in adipose tissue. Approximately one tenth of the dose is absorbed into the milk of a nursing woman.
T1 / 2 - an average of 24 hours, desogestrel - an average of 30 hours.
The metabolic products of desogestrel are excreted by the kidneys. The metabolites of ethinyl estradiol are eliminated with urine and bile.

Indications for use

Prevention of pregnancy.

Contraindications

Contraindications to the use of tablets are:
    increased sensitivity to the constituent substances;
    thrombosis / thromboembolism of veins / arteries;
    presence of precursors of thromboembolism;
    migraine with manifestations of focal neurological symptoms;
    complicated by vascular pathologies of diabetes mellitus;
    increased risk of vein / artery thrombosis;
    Pancreatitis with severe hypertriglyceridemia;
    serious liver pathology (taking pills is contraindicated until the functional indicators of the body return to normal);
    tumor tumor of the liver;
    hormone-dependent tumors (identified or suspected);
    vaginal bleeding, to establish the nature of origin which is not possible;
    otosclerosis;
    smoking;
    age over 35 years;
    pregnancy;
    breast-feeding.

Side effects

Side effects of Novinet are manifested:
    acyclic vaginal discharge;
    amenorrhea after withdrawal of tablets;
    Candidiasis;
    change in the condition of mucus in the vagina;
    development of inflammatory processes in the vagina;
    pain, tension and increase in mammary glands, the discharge of milk from them;
    nausea;
    vomiting;
    associated with cholestasis jaundice and / or itching;
    ulcerative colitis;
    nodosum or exudative erythema;
    chloasma;
    rashes on the skin;
    headaches;
    changeability of mood;
    migraine;
    depression;
    increased sensitivity of the cornea to contact lenses;
    fluid retention in the body;
    reduced tolerance to carbohydrates;
    change in body weight in the direction of its increase;
    hypersensitivity reactions.
When these symptoms appear, the question of whether to continue taking the drug is decided on an individual basis.

Severe side effects of Novinet, which require immediate withdrawal of the drug:

    hypertension;
    acute occlusion of veins / arteries with blood clots (rarely - myocardial infarction, DVT, PE, stroke, etc., extremely rare - acute blockage of large retinal and mesenteric vessels, veins and arteries of the liver, kidneys);
    otosclerosis and, as a result, hearing loss;
    HUS;
    exacerbation of Liebman-Sachs disease (rarely);
    Sydenham's chorea (develops extremely rarely, symptoms disappear after stopping the taking of tablets);
    porphyria.

Tablets Novinet: instructions for use

Contraceptive tablets Novinet take per os one at a time, washing down with liquid. The reception begins no later than the 5th day of the menstrual cycle. The tablets are drunk without omissions and breaks for a full three weeks, at the same time. From 22 to 28 a day they take a break.
If the first tablet is drunk between 2 and 5 days of the cycle, in the first 7 days of the course additional measures of protection from pregnancy are applied.
On day 29 (the day of the week corresponds to the day of the week when the first tablet was taken), the reception of the remedy is resumed using a new pack.
In the case of strict adherence to the recommendations described in the instructions for use of Novinet, the contraceptive effect persists between 22 and 29 days of the cycle.

How to take the pill after childbirth / abortion

In the absence of lactation, Novinet is allowed to take the first day of the first independent menstruation. Before you start taking the doctor's consultation. Additional contraception is not needed.
In the presence of sexual contact after childbirth, the drug is delayed until the next menstruation. If the decision to take the pill is taken later than 3 weeks after the birth, the first 7 days of the course shows the use of additional measures of protection.
After an artificial abortion or spontaneous termination of pregnancy, the taking of tablets begins immediately without the use of other contraceptives.

Switching to Novinet from other contraceptives

After taking other COC, the first pill is drunk the next day after the completion of the course of the previous contraceptive (the break is not done, waiting for another menstruation is not necessary). In the transition from progestogen-containing agents, Novinet's administration starts from the first day of the cycle.
The use of additional measures of protection in all described cases is not necessary.
By additional measures of protection, the use of barrier contraceptives or the denial of sexual relations throughout the "dangerous" period is implied. It is not recommended to resort to the calendar method of protection.

Postponement of menstruation

If it is necessary to delay the onset of the cycle, the birth control pills are drunk in the usual way for the necessary time without taking a break. In this case, smearing / breakthrough vaginal bleeding is possible, which does not affect the efficacy of the agent. Regular reception is resumed after a standard interval of 7 days.

Skip the tablet

The full contraceptive effect is preserved provided that the drug is taken regularly, in which the maximum delay in taking the tablet does not exceed 12 hours. If a forgotten tablet is drunk within 36 hours after the previous one, Novinet continues to take the standard scheme.
A missing tablet is the situation where more than 12 hours have passed since the last drug intake.
If the tablet skip occurred in the first 14 days of the cycle, the next day at the usual time you should drink a double dose of the drug. Later it is accepted as usual.
If the pass occurred between 15 and 21 days of the cycle, you must take the missed dose of the drug and continue to receive further without a seven-day break.
In the case of missing a pill, the risk of spotting and / or ovulation increases, which is associated with a minimal estrogen content in the preparation. In connection with this, additional contraception is required (until a new cycle).
When vomiting and / or diarrhea, the absorption of the drug can not be complete. If the symptoms have disappeared within 12 hours, it is recommended to take the second pill additionally (further reception - as usual); if the symptoms persist longer, throughout the entire period of the disease, and also throughout the next week, additional contraception is needed.

Overdose

Signs of an overdose of the drug are nausea and vomiting; spotting (when taking the girls).
If an overdose is noticed in a timely manner, in the first hours after taking the tablets, rinse the stomach. Treatment is symptomatic, there is no antidote.

Interaction

The efficacy of COC for per os administration is reduced in combination with liver enzyme inducing agents: Hypericum perforatum preparations, Carbamazepine, Griseofulvin, barbiturates, Hydantoin, Rifampicin, Primidone, Felbamate, Topiramate, Oxcarbazepine.
In addition, these drugs increase the risk of bleeding from a breakthrough.
The level of induction reaches a maximum within 14-20 days, but it can also persist up to 4 weeks after the withdrawal of the drug.
If you need to use Novinet in combination with tetracycline and Ampicillin throughout the course of treatment and a week after it is completed, additional contraception is required (these drugs reduce the effectiveness of the drug).
When taking Rifampicin, additional measures of protection are necessary within 4 weeks after discontinuation of treatment with the drug
COCs reduce tolerance to carbohydrates and increase the need for antidiabetic agents for oral ingestion or in insulin.

With care, you should use Novinet in combination with:

    tricyclic antidepressants;
    anticoagulants indandionic or coumarinic series;
    blockers of β-adrenergic receptors;
    bromocriptine;
    hepatotoxic agents (in particular, with Dantrolen).

Storage conditions

At temperatures from 15 to 30 ° C. Keep away from children.
Shelf life - 3 years.

special instructions

After viral hepatitis, the taking of tablets is necessary after the indicators of the functional state of the liver come to normal (not earlier than six months after the illness).
The contraceptive effect is reduced when:
    vomiting / diarrhea;
    missing a tablet;
    simultaneous application with drugs that reduce the effectiveness of COCs.
The effectiveness of tablets can be reduced in cases where, after several cycles of their use, women appear irregular, breakthrough or spotting. In such situations, it is advisable to continue taking the drug before the end of the tablets in the next package.
If at the end of the 2 cycle bleeding abolition acyclic discharge did not stop or the withdrawal bleeding started, the drug should be discontinued. Renew it after only after pregnancy is excluded.
Tablets do not protect against STDs and AIDS.
The estrogen component of the drug can change individual laboratory parameters, including including hemostasis, functional status of the adrenal glands, kidneys, thyroid, liver, transport protein level and lipoprotein level.

In pregnancy

In pregnancy, taking tablets Novinet is contraindicated.
COC suppresses lactation, in addition, a small amount of the substances entering into their composition penetrates into the milk. Therefore, during breastfeeding, these drugs can not be considered a means of choice.
When lactation, taking pills is allowed from the sixth month.

Reviews about Novinet

On the contraceptive pill Novinet reviews are mostly positive: most women taking the drug its main advantages are high efficiency, ease of use and affordable price.
However, there is a certain percentage of patients who remained unhappy with the drug. Negative reviews about Novinet are mainly due to the fact that the tablets provoke side effects (in particular, reduce the libido) and provoke a hormonal failure in the body.
With regard to pregnancy after Novinet, then the reviews diverge - some women write that they drank the drug in small courses in order to stimulate pregnancy, and became pregnant already in the first-second cycle, while others complain that after taking the drug, the monthly disappeared for quite a while a long period, and the eggs did not mature for a year or more.
Analyzing the doctors' reviews about Novinet, one can conclude that the reaction to taking COC is always unpredictable and very individual, so the opinion about these remedies is often the opposite.
Due to the minimal concentration of hormones in the drug is minimal, doctors recommend taking it to young, not giving birth to women. But for women with children, the dose of active substances may not be sufficient.
Another positive aspect of Novinet application is its ability to stop the growth of fibroids. With myomas, the agent is prescribed if the size of the node is small, and also in situations where it is necessary to preserve the childbearing function of the woman.