Dietsiklen - Instructions For Use, Women's Reviews, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Dieziklen

Dieziklen: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. In case of impaired renal function
11. 11. For violations of liver function
12. 12. Use in the elderly
13. 13. Use in adolescents
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Diecyclen

ATX code: G03FA15

Active ingredient: Ethinylestradiol (Ethinylestradiol), Dienogest (Dienogest)

Manufacturer: EXELTIS HEALTHCARE SL (Spain)

Description and photo update: 18.10.2018

Prices in pharmacies: from 300 rubles.

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Diecyclen is a combined hormonal contraceptive drug.

Release form and composition

The dosage form of Diecyclen is film-coated tablets: biconvex, round, the shell and core are white (21 pcs in blisters, 1 or 3 blisters are placed in a cardboard box).

Active ingredients in 1 tablet:

• ethinylestradiol - 0.03 mg;
• dienogest - 2 mg.

Additional components:

• core: povidone K30 - 1.73 mg; lactose monohydrate - 54.6 mg; magnesium stearate - 0.33 mg; talc - 1.4 mg; corn starch - 9.89 mg;
• shell: opaglos 2 transparent (soy lecithin - 0.0305 mg; sodium carmellose - 0.2708 mg; dextrose monohydrate - 0.0847 mg; maltodextrin - 0.104 mg; sodium citrate dihydrate - 0.01 mg) - 0.5 mg.

Pharmacological properties

Pharmacodynamics

Diecyclen is a low-dose, monophasic, oral hormonal contraceptive. The contraceptive effect is based on the interaction of various factors. Among the most important are the inhibition of ovulation and the change in the viscosity of cervical mucus, due to which it becomes impermeable to sperm.

The Pearl index, if used correctly, is <1. In cases of missing tablets or improper use of the drug, it may increase.

In addition, Diecycline has other concomitant positive properties: the menstrual cycle becomes more regular, the pain, duration and intensity of menstrual bleeding decreases, as a result of which the likelihood of iron deficiency anemia decreases. There is also evidence of a lower risk of ovarian and endometrial cancer.

The gestagenic component dienogest, which is part of Diecyclen, is one of the active gestagens. It has a positive effect on the lipid profile, increases the concentration of high density lipoproteins.

Pharmacokinetics

Ethinylestradiol:

• absorption: completely and quickly absorbed; after absorption and the effect of "first pass" through the liver, it is metabolized, its absolute bioavailability is about 44%;
• distribution: strongly binds to serum albumin and induces the synthesis of globulin, which binds sex hormones;
• metabolism: undergoes presystemic conjugation in the liver and the mucous membrane of the small intestine. The main pathway of metabolism is aromatic hydroxylation with the formation of many methylated and hydroxylated derivatives in the form of free metabolites, sulfates of metabolites and glucuronides;
• excretion from the body: 30–40% of metabolites are excreted through the intestines, up to 30–50% - by the kidneys. The half-life of estradiol (T _1/2) is up to 10 hours after a single dose of 1 tablet, after 3 cycles of taking the drug, it rises to 15 hours.

With regular intake, the equilibrium plasma concentration of ethinylestradiol in the blood is achieved in the second half of the cyclic intake of Diecycline.

Dienogest:

• absorption: almost completely and quickly absorbed. The maximum serum concentration in the blood (about 51 pg / ml) is reached after 2.5 hours. The absolute bioavailability is 96%; with constant intake, the equilibrium concentration in the blood plasma is achieved after 4 days;
• distribution: 90% of the total plasma concentration of dienogest in the blood binds to serum albumin (10% of the total concentration remains unbound). The volume of distribution of dienogest is about 37–45 liters;
• metabolism: predominantly metabolized by hydroxylation, but also by conjugation, hydrogenation and aromatization to form inactive metabolites. The total clearance of dienogest after taking a single dose is about 3.6 l / h;
• excretion: the ratio of dienogest excretion through the intestine and in the form of metabolites by the kidneys after taking a dose of 0.1 mg / kg is 3: 1. Only a small amount of unchanged dienogest is excreted by the kidneys. T _1/2 is in the range from 8.5 to 10.8 hours.

The serum concentration of dienogest with daily use of Diecycline increases 1.5 times.

Indications for use

• oral contraception;
• mild / moderate acne and seborrhea therapy.

Contraindications

Absolute:

• presence of multiple / significant risk factors for arterial or venous thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral or coronary arteries, uncontrolled arterial hypertension, volumetric surgery with prolonged immobilization, smoking at the age of 35 years, obesity with an index body weight> 30 kg / m ²;
• conditions that precede thrombosis, including transient ischemic attacks, angina pectoris (currently or the presence of a burdened history);
• thrombosis (venous and arterial) and thromboembolism, including stroke, myocardial infarction, deep vein thrombosis, pulmonary embolism, cerebrovascular disorders (currently or with a burdened history);
• diagnosed predisposition to the development of venous / arterial thrombosis, including antithrombin III deficiency, resistance to activated protein C, deficiency of protein C and S, lupus antigen, antibodies to phospholipids, hyperhomocysteinemia;
• hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome, as well as hypersensitivity to soy or peanuts (Diecyclen contains lactose and soy lecithin);
• diabetes mellitus, accompanied by diabetic angiopathy;
• arterial hypertension in severe form (blood pressure more than 160/100 mm Hg. Art.);
• confirmed / suspected hormone-dependent malignant diseases of the genitals or mammary glands (currently or with a burdened history);
• pancreatitis, which proceeds with severe hypertriglyceridemia (currently or with a burdened history);
• migraine with focal neurological symptoms (at present or the presence of a burdened history);
• tumors (benign or malignant) of the liver (currently or with a burdened history);
• vaginal bleeding of unknown etiology;
• severe liver disease;
• renal failure in severe / acute course;
• pregnancy (diagnosed / suspected) and breastfeeding period;
• confirmed individual intolerance to the components of the drug.

Relative (diseases and / or conditions, in the presence of which the appointment of Dieziklen requires caution and medical supervision):

• diseases in which the development of peripheral circulatory disorders may occur, including sickle cell anemia, phlebitis of superficial veins, systemic lupus erythematosus, diabetes mellitus without diabetic angiopathy, Crohn's disease, hemolytic uremic syndrome, ulcerative colitis;
• the presence of risk factors for thrombosis and thromboembolism, including extensive trauma, obesity, dyslipoproteinemia, smoking, arterial hypertension, heart valve defects, migraine without focal neurological symptoms, serious surgical interventions, prolonged immobilization, hereditary predisposition to thrombosis (burdened by family history myocardium or disorders of cerebral circulation at a young age);
• diseases, the first appearance / aggravation of which was noted during pregnancy or during the previous use of sex hormones, in particular itching / jaundice against the background of cholestasis, porphyria, hearing impairment, gallbladder disease, Sydenham's chorea, herpes during pregnancy in history;
• hereditary angioedema;
• endogenous depression;
• hypertriglyceridemia;
• epilepsy;
• liver disease;
• period after childbirth.

Instructions for the use of Dieziklen: method and dosage

Diecycline is intended for oral administration.

Tablets should be taken every day, 1 pc., With a small amount of water, preferably at the same time of the day, observing the order indicated on the package. After 21 days (after the end of the tablets in the package), a break of 7 days is required. Withdrawal bleeding (menstrual bleeding) is usually observed during this period. It usually starts 2-3 days after taking the last pill and may not end until you start taking Diecycline from the next package.

Features of starting the drug:

• not taking any hormonal contraceptives during the previous month: Diecycline should be taken on the first day of the menstrual cycle. It is also permissible to start using the drug on day 2-5 of the menstrual cycle (during the first 7 days it is recommended to additionally use a barrier method of contraception);
• transition from the use of other combined oral contraceptives: it is advisable to start taking Diecycline the next day after taking the last active pill, but no later than the next day after the usual seven-day break (for products that contain 21 tablets in the package) or after taking the last inactive tablet (for products which contain 28 tablets);
• transition from a transdermal patch / vaginal ring: it is advisable to start taking the drug on the day the patch / ring is removed, but not later than the day when a new patch should be glued or a new ring inserted;
• transition from injectable forms that contain only gestagens: Diecycline should be taken on the day the next injection should have been made (a barrier method of contraception must be used for 7 days);
• the transition from the "mini-drink": you can start taking Diecyclen without interruption on any day (you need to use a barrier method of contraception for 7 days);
• implant: Diecycline should be taken on the day of its removal (for 7 days, a barrier method of contraception should be used);
• conditions after an abortion in the first trimester of pregnancy: you can start taking Diecycline immediately (no additional measures should be taken);
• conditions after abortion in the second trimester of pregnancy / childbirth (in cases of lack of breastfeeding): Dietsiklen should be taken on days 21-28; if the use of the drug was started later, for 7 days it is additionally necessary to use a barrier method of contraception; if during this period the woman had sexual intercourse, it is impossible to take the drug until pregnancy is excluded.

If you accidentally skip a single dose, contraceptive protection lasts for 12 hours. If possible, the pill should be taken as early as possible. In the future, it is not necessary to change the usual scheme of Diecycline application.

If the interval in taking the drug is more than 12 hours, contraceptive protection may be reduced. In such cases, the following basic rules must be followed:

• the maximum break in taking the drug is 7 days;
• adequate suppression of hypothalamic-pituitary-ovarian regulation is achieved within 7 days of continuous pill intake.

Based on this, the recommendations described below should be followed.

If Dieziklen is missed on days 1-7 from the package, a single dose should be taken as soon as possible, even if you will need to drink 2 tablets at once. The further regimen of drug use should not be adjusted. Since contraceptive protection is reduced, additional barrier methods must be used for 7 days. In cases where sexual intercourse took place within 7 days before the pill was missed, the likelihood of pregnancy should be taken into account.

In the period from 8 to 15 days of taking Diecycline, the woman should take the missed pill as soon as possible, even if she will need to drink 2 tablets at once. The further regimen of drug use should not be adjusted. If during the first week of taking the drug there were no violations of the dosing regimen, there is no need to use additional contraceptive methods. In cases where at least 1 pill was missed, additional contraceptive measures must be used for 7 days.

If you skip taking a single dose in the period from 16 to 21 days, the risk of a decrease in contraceptive reliability is inevitable, which is associated with the upcoming break in taking pills. In cases of compliance with one of the 2 options proposed below, there is no need to use additional methods of contraception, provided that within 7 days that preceded the first missed pill, the drug use regimen was strictly followed. In case of violations of the regimen, a woman is advised to adhere to the first of the two options proposed below, and also use barrier methods of contraception for 7 days.

1. A woman needs to take a single dose immediately after she remembers about the skip, even if it means taking 2 tablets at once. Then, until the end of the packaging, you should not change the application scheme. You need to start taking pills from a new package without interruption, while there is a low probability of withdrawal bleeding. It must be borne in mind that breakthrough bleeding or spotting may occur.
2. Taking pills from the current package can be interrupted, which will mean the beginning of a seven-day break. After the end of this period, therapy is resumed from a new package.

If there was a missed pill, after which there is no withdrawal bleeding during the seven-day break, the likelihood of pregnancy must be taken into account.

In cases where diarrhea or vomiting was noted within 3-4 hours after taking Diecycline, the absorption of the drug may be incomplete (you should be guided by the above recommendations for skipping tablets). If you do not want to change the standard regimen of the drug, you can take an additional tablet from a spare package (maximum - 2 tablets per day). In cases of prolonged / recurring gastrointestinal disturbances, non-hormonal methods of contraception should be additionally used and, if necessary, consult a specialist.

In order to delay the onset of menstrual bleeding, tablets from a new package are taken without interruption. During this period, spotting or breakthrough uterine bleeding may occur. By shortening the break in taking Diecycline, you can postpone the onset of menstrual bleeding to another day of the week.

You can cancel the drug any day. In cases of discontinuation of Diecycline due to the desire to become pregnant, it is recommended to wait for the first normal menstruation. This method makes it easier to determine the due date.

Side effects

Estimation of the incidence of adverse reactions:> 10% - very often; > 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare; with an unspecified frequency - if it is impossible to assess the frequency of occurrence of violations:

• hematopoietic system: rarely - anemia;
• cardiovascular system: infrequently - increase / decrease in blood pressure; rarely - pain along the veins, functional disorders of the heart, thrombophlebitis, thrombosis / thromboembolism of the pulmonary artery, orthostatic dystonia, varicose veins, hot flushes;
• respiratory system: rarely - hyperventilation of the lungs, bronchial asthma;
• nervous system: often - headaches; infrequently - migraine, dizziness; rarely - cerebrovascular disorders, ischemic stroke, dystonia, mental disorders, irritability, depression, low mood;
• musculoskeletal system: rarely - myalgia, back / limb pain, bone / muscle discomfort;
• reproductive system and mammary glands: often - engorgement of the mammary glands, pain / tenderness in the mammary glands; infrequently - changes in the volume and duration of menstrual bleeding (including menorrhagia, hypomenorrhea, oligomenorrhea, amenorrhea), acyclic bleeding (including vaginal bleeding), metrorrhagia, swelling / distention of the mammary glands, enlargement of the mammary glands, dysmenorrhea, breast edema, ovarian cysts, genital tract / vaginal discharge; rarely - galactorrhea, breast cysts, dyspareunia, fibrocystic mastopathy; with an unspecified frequency - discharge from the mammary glands;
• immune system: rarely - allergic reactions;
• endocrine system: rarely - virilism;
• digestive system: infrequently - diarrhea, abdominal pain / discomfort, nausea, bloating, vomiting; rarely - gastritis, enteritis;
• psyche: infrequently - low mood; rarely - depression, sleep disturbances, mental disorders, insomnia, aggression; with an unspecified frequency - decrease / increase in libido, mood variability;
• skin and subcutaneous tissues: infrequently - itching (including generalized), rash (including macular), alopecia, acne; rarely - allergic dermatitis, chloasma, seborrhea, eczema, psoriasis, dandruff, hirsutism, pigmentation disorders / hyperpigmentation, cellulite, skin diseases, spider veins, neurodermatitis, hyperhidrosis;
• organ of vision and hearing: rarely - irritation / dryness of the mucous membrane of the eyes, tinnitus, sudden hearing loss / impairment, oscillopsia; with an unknown frequency - visual impairment, intolerance to contact lenses;
• metabolism: infrequently - increased appetite; rarely - anorexia;
• parasitic / infectious diseases: infrequently - vaginitis / vulvovaginitis, vaginal candidiasis or other fungal vulvovaginal infections; rarely - urinary tract infections, cystitis, fungal infections, herpetic lesions of the oral cavity, viral infections, bronchitis, mastitis, upper respiratory tract infections, cervicitis, sinusitis, salpingo-oophoritis, influenza, candidiasis;
• tumors (malignant and benign): rarely - uterine myoma, breast lipoma;
• laboratory tests: rarely - hypercholesterolemia, an increase in the concentration of triglycerides in the blood;
• general disorders: infrequently - asthenia, weight change, increased fatigue, poor health; rarely - an increase in body temperature, flu-like conditions, chest pains, peripheral edema.

In congenital angioedema, estrogens can aggravate / induce symptoms of angioedema.

Overdose

The main symptoms are: absence of menstrual bleeding, vomiting, nausea, irregular spotting.

If necessary, symptomatic treatment is carried out.

special instructions

Before starting the course or when resuming the use of Diecycline, it is recommended to conduct a thorough examination (general medical and gynecological). It is also necessary to exclude the presence of pregnancy and disorders of the blood coagulation system. In the future, such examinations should be repeated at least once every six months.

Irregular intake of the drug can lead to the development of acyclic bleeding and reduce its contraceptive effectiveness.

A woman should understand that taking Diecycline against sexually transmitted diseases, including HIV infection, does not protect.

During the period of therapy, the development of venous thromboembolism may occur, which manifests itself as deep vein thrombosis and / or pulmonary embolism.

There are reports of extremely rare cases of thrombosis of other blood vessels, for example, mesenteric, hepatic, renal veins / arteries or retinal veins / arteries (causal relationship has not been proven). The main symptoms include: "acute" abdomen, dizziness, movement disorders, one-sided pain / swelling of the lower limb, sudden severe chest pain with / without irradiation to the left arm, sudden shortness of breath, sudden coughing attacks, increased severity / frequency of migraines, headache (any unusual, prolonged, severe), sudden partial / complete loss of vision, diplopia, slurred speech or aphasia, collapse with or without partial seizure, weakness or very significant loss of sensation that suddenly develops in one part of the body or on one side. In cases of the appearance of these symptoms, it is necessary to cancel the drug and consult a specialist.

When prescribing the drug, it is necessary to take into account the presence of risk factors for the development of thrombosis (venous and / or arterial) and thromboembolism.

With prolonged immobilization, as well as in cases of serious surgical interventions, any operations on the legs or with extensive injuries, it is advisable to interrupt the use of Dieziklen (if an operation is planned, at least 30 days before it). You can return to taking the drug 14 days after the end of immobilization.

There is information about a slight increase in the risk of developing cervical and breast cancer, as well as an increase in blood pressure with prolonged use of Diecycline (the relationship has not been confirmed).

In rare cases, during the therapy, cases of benign, and extremely rarely - malignant liver tumors were noted, which in some cases were the cause of intra-abdominal bleeding (may be life-threatening). This should be taken into account in cases of severe abdominal pain, signs of intra-abdominal bleeding, or enlarged liver.

With hypertriglyceridemia or a family history of the disease, there is an increased likelihood of pancreatitis.

The results of some laboratory tests while taking Diecycline may be distorted. This applies to the biochemical blood test (indicators of the thyroid gland, kidney, liver and adrenal function, carbohydrate metabolism, and some others), as well as indicators of coagulation and fibrinolysis. As a rule, such changes do not go beyond normal values.

Application during pregnancy and lactation

According to the instructions, Dieciclen is contraindicated during pregnancy and lactation.

In cases of pregnancy diagnosis, therapy is immediately canceled.

With impaired renal function

Special studies of the safety profile for this group of patients have not been conducted.

No dose adjustment is reported to be required.

For violations of liver function

For women with severe liver diseases, Diecyclen is contraindicated (until the indicators normalize).

Use in the elderly

Taking Dieziklen after menopause is not indicated.

Application in adolescents

The safety profile in this group of patients has not been studied. In post-pubertal age up to 18 years, it is presumably similar to that in women over 18 years of age.

The use of Diecycline before the onset of menarche is not indicated.

Correction of the drug regimen is not required.

Drug interactions

The simultaneous use of Diecyclen with certain drugs / substances can lead to the development of the following effects:

• drugs that induce microsomal liver enzymes (including hydantoin, barbiturates, primidone, rifampicin, carbamazepine), presumably rifabutin, efavirenz, nevirapine, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, prodrugs of prodrugs: speed-increasing drugs Diecycline, which may cause severe bleeding or a decrease in contraceptive action (it may be necessary to use additional barrier methods of contraception);
• some drugs with antibacterial action that reduce the intestinal-hepatic circulation of estrogens, including tetracycline, ampicillin: decrease in the effectiveness of Diecycline (it may be necessary to use additional barrier methods of contraception);
• drugs that induce liver microsomal enzymes (long course): an increase in Diecycline doses is required; in cases of development of adverse reactions / ineffectiveness of the drug, it is additionally necessary to use other non-hormonal contraceptives;
• cyclosporine: an increase in its concentration in tissues / plasma;
• lamotrigine: decrease in its concentration in tissues / plasma;
• CYP3A4 inhibitors, including antidepressants, antifungals (ketoconazole), verapamil, cimetidine, diltiazem, macrolides (erythromycin), and grapefruit juice: increased plasma levels of diecycline in the blood.

When combined with rifampicin, as well as for another 1 month after the end of the course, additional contraceptive measures should be used (for example, the barrier method). In cases where Diecyclen packaging ends before the completion of the course of other drugs, tablets from the next package must be taken without interruption.

Analogs

Dieziklen's analogues are: Femisse Messi, Bonade, Siluet, Janine, Genetten.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Dieziklen

There are few positive reviews about Diecycline for women, as a drug with a loyal price. Its cost in pharmacies is slightly lower than some analogues.

According to women's reviews, Diecycline is an effective contraceptive drug with mild side effects.

Dieziklen price in pharmacies

The price for Dieziklen is about 385-412 rubles for a pack of 21 tablets, about 870 rubles for a pack of 63 tablets.

Dieziklen: prices in online pharmacies

Drug name Price Pharmacy

Diecyclen 2 mg + 30 mcg film-coated tablets 21 pcs. RUB 300 Buy

Diecyclen tablets p.o. 2mg + 0.03mg 21 pcs. RUB 488 Buy

Diecyclen 2 mg + 30 μg film-coated tablets 63 pcs. 800 RUB Buy

Diecyclen tablets p.o. 2mg + 0.03mg 63 pcs. 1098 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!