Instructions for use Diane-35: indications, price and analogues


Composition of Diane-35

Diane-35 tablets contain the active components cyproterone acetate and ethinyl estradiol , as well as a number of additional components: lactose monohydrate, povidone , corn starch, magnesium stearate, magnesium hydrosilicate.
The tablet shell consists of povidone 700,000, sucrose, macrogol 6000 , calcium carbonate , magnesium hydrosilicate, glycerol, titanium dioxide, mountain glycol wax, iron oxide.

Pharmacotherapeutic group and properties

The drug belongs to the modulators of the reproductive system, estrogens, antiandrogenic and sex hormones. The contraceptive properties of the drug are achieved by suppressing the process of maturation and release of the egg, as well as by increasing the viscosity of cervical mucus.

In addition, the components of the drug reduce the activity of the sebaceous glands, so the product is used to treat acne. Also, in women of fertile age, Diane-35 hormonal tablets reduce the manifestations of hirsutism (excessive body hair growth) and suppress the process of hair loss, which often occurs with seborrhea of ​​the scalp.

pharmachologic effect

Diane-35 is a monophasic combined oral contraceptive that has antiandrogenic, estrogenic, contraceptive, and gestagenic effects. This is a combination product that contains estrogen - ethinyl estradiol, as well as the antiandrogen substance cyproterone acetate, which demonstrates gestagenic properties.

Under the influence of the drug, the increased viscosity of the cervical mucus remains, which makes it difficult for sperm to enter the uterine cavity. As a result, a contraceptive effect is noted. The substance cyproterone acetate blocks androgen receptors and reduces the phenomenon of androgenization in women, reducing the severity of sebum production, hair loss, and the growth of unwanted hair. Also provides treatment for diseases associated with excess production of androgens or high sensitivity to them.

In the process of taking Diane-35 in women, the severity of acne , and the number of new acne decreases. The substance also exhibits gestagenic activity, inhibiting the ovulation process.

The contraceptive effect of the drug is observed by the 14th day from the start of its use and remains during a seven-day pause in use. When using a contraceptive, the menstrual cycle is normalized, menstruation becomes less painful, the intensity of bleeding decreases and, as a result, the likelihood of iron deficiency anemia .

Analogs

The most popular analogues of the contraceptive hormonal drug Diane-35 include the following names of oral contraceptives:

  1. Bellune-35. The medication contains a combination of cyproterone and ethinyl estradiol. The product is available in tablet form. It is used not only to protect against unplanned pregnancy, but also for therapeutic purposes for acne, seborrhea and alopecia.
  2. Chloe. The medication contains ethinyl estradiol at a dosage of 0.035 mg and cyproterone acetate at a dosage of 2 mg. Used for contraceptive purposes, as well as for the treatment of androgen-dependent pathologies in women.
  3. Erica-35. Refers to monophasic combined contraceptive pills that inhibit the gonadotropic function of the pituitary gland. It is prescribed to women for contraceptive purposes, as well as for the treatment of moderate acne, mild hirsutism, and androgen-dependent alopecia.

Pharmacokinetics and pharmacodynamics

The highest concentration of cyproterone acetate is observed 1.6 hours after taking the pills. Its bioavailability is 88%. In the first and second phases of elimination, the half-life of the substance cyproterone acetate is 3-4 hours and 2 days.

Ethinyl estradiol is rapidly absorbed after oral administration, the highest concentration in the blood is observed after 1.6 hours. The bioavailability of the substance is 45%. Almost completely nonspecifically binds to albumin. The half-life of the substance ethinyl estradiol occurs in two phases - 1-3 hours and 1 day.

In breast milk, approximately 0.2% of the dose of cyproterone acetate and approximately 0.02% of ethinyl estradiol are determined.

Indications for use

The drug is used to prevent pregnancy in women who exhibit androgenization (that is, the manifestation of male traits provoked by the action of male sex hormones).

The drug is also indicated for manifestations of androgenization : seborrhea, acne, mild forms of alopecia , hirsutism .

Sometimes the medicine is recommended for diseases of the female reproductive system, in particular, polycystic ovary syndrome .

Contraindications

The following indications for the use of the drug Diane-35 are determined:

  • period of pregnancy and breastfeeding, suspicion of pregnancy;
  • liver damage;
  • history of itching or idiopathic jaundice during pregnancy;
  • thrombosis and thromboembolism ;
  • angina pectoris , transient ischemic attacks;
  • Dubin-Johnson and Rotor (hereditary liver diseases);
  • and breast cancer
  • disorders of fat metabolism;
  • history of blistering dermatosis
  • otosclerosis , worsening during previous pregnancies;
  • diabetes mellitus , accompanied by vascular complications;
  • hormone-dependent malignant diseases;
  • vaginal bleeding.

Pharmacological properties

According to its pharmacological characteristics, the drug Diane-35 is a monophasic type combined contraceptive with a low-dose chemical formula.

This medication has the following properties:

  • suppresses the synthesis of androgens and also reduces their concentration in the bloodstream, which allows for successful treatment of diseases associated with the individual sensitivity of the body to hormones of this type;
  • changes the consistency of cervical mucus secretion, which becomes thicker (this property of Diane-35 disrupts the possibility of sperm penetration into the cavity of the reproductive organ, which eliminates the possibility of conceiving a child);
  • reduces the activity of sweat and sebaceous glands, the hyperfunctionality of which was caused by an imbalance of female sex hormones;
  • prevents the onset of ovulation;
  • reduces the intensity of hair loss (this property of the drug is realized if alopecia is caused by a violation of the level of sex hormones);
  • reduces the severity of clinical manifestations of hirsutism in women of childbearing age;
  • promotes the complete disappearance of excess oily hair and skin;
  • cleanses epithelial tissues from pimples, acne, dermatitis, seborrhea, which is hormonal in origin.

A distinctive feature of the drug Diane-35 is that it reduces the frequency of vaginal bleeding. In this regard, patients undergoing therapy with this medication minimize the risk of developing iron deficiency anemia. The pharmacological properties of Diane-35 are realized only if it is taken as a course for a period of time established by the attending physician.

Side effects of Diane-35

During administration, the following side effects of Diane-35 may occur:

  • endocrine system: soreness of the mammary glands, the appearance of discharge from them, weight changes;
  • reproductive system: the appearance of bleeding between menstruation, changes in libido, changes in vaginal secretion;
  • nervous system: migraine , headaches, unstable mood;
  • digestive system: vomiting, nausea;
  • other manifestations: allergic manifestations, poor tolerance of contact lenses, chloasma.

These side effects rarely develop when taking the drug. As a rule, negative manifestations occur in the first months of taking Diane-35; over time, their severity decreases.

Many women are concerned about the connection between taking Diane-35 and weight gain. As a rule, weight gain when using a contraceptive occurs only in some cases. If such a side effect develops, a woman needs to adjust her diet and lifestyle, and also consult a doctor.

Side effects and overdose

Breakthrough bleeding is possible while taking the tablets. Judging by the reviews of patients, this phenomenon occurs quite often in the first months of using the pills. This is due to the body’s adaptation to the drug and does not require discontinuation of Diane-35. If bleeding continues for a long time, it is necessary to undergo a gynecological examination to rule out pregnancy and tumors of the genital organs.

Other side effects are possible:

  • swelling of the mammary glands, pain in the breasts and nipples;
  • enlargement of the mammary glands;
  • mood swings, depression;
  • allergic rashes;
  • headache;
  • decreased libido;
  • weight gain;
  • swelling.

In more rare cases, the following are observed:

  • discharge from nipples and vagina;
  • increased libido;
  • weight loss;
  • increased eye sensitivity to contact lenses;
  • Erythema nodosum.

Like other hormonal contraceptive drugs, Diane-35 increases the risk of blood clots in blood vessels. For this reason, the drug is prescribed with caution to women prone to thrombosis and thromboembolism.

Overdoses of Diane-35 are rare. If the therapeutic dose of the drug is exceeded, uterine bleeding, nausea, and vomiting are observed. Symptomatic treatment is carried out.

Diane-35 tablets, instructions for use (Method and dosage)

The provided instructions for use of Diane-35 provide for oral administration of the pill. To ensure the necessary contraception of active substances in the body, you need to take the drug regularly.

If a woman has used any other hormonal contraceptives, stop using Diane-35 before taking it.

The dosage regimen of this contraceptive is the same as that of other oral contraceptives. If you do not take this medication regularly, acyclic bleeding may occur and the therapeutic and contraceptive effect may decrease.

Diana-35 calendar pack contains 21 tablets. For ease of use, each pill is marked with the day of the week on which it should be taken. You need to swallow the pills at the same time, washing down the drug with liquid. You need to take the pills in the direction of the arrow until all the pills have been taken. After completing the dose, you do not need to drink the drug for 7 days. During these days – usually on days 2-3 – withdrawal bleeding begins. After a seven-day break, you need to start the next package, adhering to this regimen, even if the bleeding has not stopped. That is, a woman always starts a new package of Diana-35 on the same day of the week.

You should start taking the pills on the first day of your monthly bleeding. For convenience, you should use the first tablet marked with the day of the week on which you begin taking it. Next, the pills are taken in order.

The contraceptive effect is observed from the first day of administration, therefore, there is no need to use other contraceptives .

You can start drinking Diane-35 on days 2-5 of your cycle. But at the same time, barrier contraception should be used additionally during the first 7 days of admission.

If a woman switches to Diane-35 after using any other methods of contraception, she should additionally consult a gynecologist.

After an early abortion, a woman can start taking pills immediately. In this case, no additional protection is required.

After a miscarriage or spontaneous abortion, you should consult a doctor who will tell you how to take contraceptives.

After a late abortion and childbirth, it is recommended to start taking the pills on days 21-28. If a woman has already had sexual intercourse before starting to take the medicine, it is necessary to initially rule out pregnancy or wait until the first menstruation begins.

If you missed taking the pill, you need to take it as quickly as possible and take the next pill at the usual time. It should be taken into account that if you are less than 12 hours late, the contraceptive effect does not decrease.

The likelihood of conception increases the more pills a woman misses and the closer the skips are to the seven-day break. If you miss taking the drug for many days, you should consult your doctor.

If a woman experiences vomiting or diarrhea within 3-4 hours after taking the pill, it is advisable to use additional contraceptive methods.

When used for treatment, its duration depends on the severity of symptoms. As a rule, taking the medicine lasts several months. When using an anti-acne product, the period of use may be shorter, as evidenced by reviews.

Release forms and composition of the drug

Diane-35 is a drug that is produced in the form of tablets intended for oral administration. The medication is packaged in blisters made of foil and plastic. 1 drug cassette contains 21 tablets.

The main packaging of Diane-35 is a rectangular cardboard box, on the front side of which is the name of the hormonal drug. Each package of this medication is equipped with detailed instructions for its use, familiarization with which is a prerequisite for its use for therapeutic purposes.

According to reviews of the majority of women who were treated with Diane-35, the release form of this drug is convenient for daily use. The table below presents the constituent components of this drug, which have a direct effect on the hormonal levels of the female body.

Composition of Diane-35 dragees Characteristics of chemicals
Ethinyl estradiolEthinyl estradiol is the main substance of Diane-35 tablets, the mass fraction of which is 35 mcg per 1 tablet. This component of the drug is a synthetic analogue of the female sex hormone, and its pharmacological effect is to directly affect the functions of the internal genital organs, as well as their secretory activity.
Cyproterone acetateCyproterone acetate is the active component of the drug Diane-35, the dosage of which is 2 mg per 1 tablet. The main purpose of this substance is to suppress the synthesis of androgens, as well as their reduction in the bloodstream. By its nature of origin, cyproterone acetate is an antagonist of androgen-sensitive receptors. This component is capable of changing the hormonal background of the female body.
Lactose monohydrateLactose monohydrate is an excipient of Diane-35, which is milk sugar, and its use is aimed at preserving chemical processes in the composition of a ready-made medicine. This component is contraindicated for use by patients suffering from individual lactose intolerance. The concentration of this chemical compound does not exceed 31.115 mg.
Magnesium stearateMagnesium stearate is an additional substance that acts as an anti-caking agent. This component provides a dense structure to the dragees and prevents their deformation during long-term storage in a warehouse or transportation. Magnesium stearate has a neutral chemical formula, does not have a negative effect on the functions of internal organs and systems of the female body, and its mass fraction is 0.1 mg.
PovidonePovidone is an excipient of this drug, which is a water-soluble polymer. This component is used as a stabilizer for the chemical composition of Diane-35, and its concentration is 2.1 mg.
Corn starchCorn starch is a natural substance that performs auxiliary functions. This component is used as a safe thickener for the powdery structure of Diane-35 dragees. After entering the gastrointestinal tract, corn starch is completely broken down under the influence of digestive enzymes. The concentration of this component is 18 mg in 1 tablet.
TalcTalc is an auxiliary substance that is used to ensure that the produced dragees are denser and stronger, and do not break down into a powder during transportation, storage and practical use for therapeutic purposes. The mass fraction of talc is 1.65 mg.

Diane-35 (reviews from women who have taken the drug indicate its excellent medicinal properties) is a drug in the form of dragees, the protective shell of which is sucrose, ferrous oxide, glycerol, titanium dioxide (gives the drug a rich white color), calcium carbonate, glycolic wax, as well as macrogol 6000.

The active and auxiliary substances of this medication do not have toxic, mutagenic or carcinogenic properties, which is confirmed by clinical trials and practical experience in using this drug.

Interaction

A number of medications may reduce the effectiveness of this contraceptive. These are drugs for the treatment of epilepsy ( phenytoin , primidone , barbiturates ), tuberculosis ( Rifampicin ), a number of antibiotics ( tetracyclines , Ampicillin , Griseofulvin ).

Before starting to take Diane-35, a woman must inform her doctor about all the drugs she is taking.

Drug interactions

The drug Diane-35 is not recommended for simultaneous use with the following medications:

  • Tetracycline;
  • Ampicillin;
  • Carbamazepine;
  • Griseofulfin;
  • all types of barbiturates;
  • Primidone;
  • Felbamate;
  • Oscarbasepine.

Combined therapy with the above medications can lead to uterine bleeding, as well as a decrease in the contraceptive effectiveness of Diane-35.

special instructions

If any of the risk factors are present, before starting to take the drug, you must carefully determine the likely risk and expected benefit. There is evidence of an increase in the incidence of thrombosis and thromboembolism when using oral contraceptives. The severity and frequency of migraines are likely to increase when using this method of contraception. There is evidence of a possible increase in the likelihood of developing cervical cancer, but this connection has not been clearly proven.

Women who are prone to developing chloasma should not spend long periods of time in the sun while taking oral contraceptives.

Women with diabetes need constant supervision by a specialist during the period of use of Diane-35.

It should be borne in mind that the use of Diane-35 may affect the results of laboratory tests.

In the first months of use, menstrual bleeding may be irregular. Sometimes during a break in taking pills there may be no withdrawal bleeding.

With prolonged use of the Diane-35 contraceptive, a woman should be examined by a gynecologist every 6 months.

It should be borne in mind that pregnancy can occur almost immediately after discontinuation of the drug. If a woman suspects that she became pregnant while discontinuing a contraceptive, she needs to consult a specialist.

Does not affect the ability to drive.

Indications and contraindications

The main indications for prescribing this pharmaceutical product include:

  1. Protection against unplanned conception in women with signs of androgenization.
  2. Therapy of androgen-dependent diseases. Such diseases include acne (acne), nodular cystic acne, pustular acne, mild form of hirsutism, androgenetic alopecia, as well as seborrhea of ​​the scalp.

Oral contraceptives Diane-35 cannot be used for contraceptive and therapeutic purposes if there are such contraindications:

  1. Previously diagnosed thromboembolic conditions, including myocardial infarction.
  2. Individual tendency to develop arterial and venous thrombosis.
  3. Migraine attacks and focal changes in the brain.
  4. Individual intolerance to one of the components of the drug.
  5. Tumor-like neoplasms in the liver area with and without signs of cellular atypia.
  6. Intermenstrual bleeding of unknown etiology
  7. Inflammation of the pancreas with severe hypertriglyceridemia.
  8. Severe functional liver disorders.

These medications should be taken with caution by women who have any peripheral circulatory disorders, heart rhythm disturbances, as well as abnormalities in the valvular apparatus of the heart.

Reviews about Diana-35

Those who have taken these birth control pills leave very different reviews. Many women note that the drug is easy to use and provides a lasting positive effect.

Reviews of Diana-35 for acne are also positive, since after a relatively short period of use, many women got rid of acne on their faces and noted a significant improvement in their skin.

In the discussion of Diana-35, doctors’ reviews are often positive. Reviews from gynecologists indicate that the drug is generally effective. However, there are many complaints online related to negative actions as a consequence of taking this contraceptive. In particular, women write about nausea, weight gain, rapid heartbeat, general decrease in tone, etc.

There are also many reviews indicating that pregnancy occurred after using this drug in cases where women had previously been unable to conceive a child.

Prices and storage conditions

The medication should be stored at a temperature no higher than +30 degrees, at a relative humidity of no more than 70%, out of the reach of children. It is also recommended to avoid direct sunlight on the packaging of tablets.

Subject to storage rules, the maximum shelf life of the medicine is 5 years.

The price of a contraceptive package may vary in different regions, taking into account the individual pricing policy of the pharmacy chain. On average, the cost of packaging a medicine is from 1140 rubles. For your reference, a table with current prices for the drug is provided.

Price Diana-35, where to buy

You can buy birth control pills at any pharmacy with a doctor's prescription. The price of Diana-35 in pharmacies is from 1000 rubles. per package.

  • Online pharmacies in RussiaRussia
  • Online pharmacies in UkraineUkraine
  • Online pharmacies in KazakhstanKazakhstan

ZdravCity

  • Diane-35 dragees 21 pcs. Bayer Weimar/Bayer Pharma
    RUR 998 order

Pharmacy Dialogue

  • Diane-35 (other No. 21)Bayer

    RUB 1,054 order

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Pharmacy24

  • Diane-35 No. 21 tablets Promotion 5+1 Bayer Pharma AG, Niemecchina/Bayer Weimar GmbH i Co.
    KG, Nimechchyna 1245 UAH. order

PaniPharmacy

  • Diane tablets Diane-35 etc. No. 21 Germany, Bayer Weimar

    273 UAH order

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Interaction with other drugs

Some medications can lead to a decrease in the concentration of Diane-35 in the body. In this case, the contraceptive and therapeutic effect of the tablets is reduced. Such drugs include:

  • tetracycline and penicillin antibiotics;
  • medications for epilepsy (Carbamazepine, Phenytoin, Primidone, Topiramate, Felbamate);
  • barbiturate hypnotics;
  • antiviral drugs (Ritonavir);
  • antifungal medications (Griseofulvin);
  • anti-tuberculosis drugs (Rifampicin);
  • herbal remedies based on St. John's wort.

If these drugs are taken together with Diane-35, then barrier contraceptives must be used. Such protection is also needed in the first week after stopping the above medications. When Diane-35 is taken simultaneously with these drugs, there is no break in taking the pills.

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