Regulon - Instructions For Use, Indications, Doses, Analogues

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

Regulon

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 427 rub.

Buy

Regulon is an oral monophasic contraceptive that has significant antiestrogenic and gestagenic effects, mild anabolic and androgenic activity.

Release form and composition

Release form - film-coated tablets: round biconvex, almost white or white, marked "RG" on one side and "P8" - on the other (21 pcs. In a blister, in a cardboard box 1 or 3 blisters) …

Content of active ingredients Regulon in 1 tablet:

• Ethinylestradiol: 0.03 mg
• Desogestrel: 0.15 mg.

Auxiliary components: stearic acid, alpha-tocopherol, lactose monohydrate, povidone, magnesium stearate, potato starch, colloidal silicon dioxide.

The composition of the film shell: macrogol 6000, hypromellose, propylene glycol.

Indications for use

The use of Regulon is indicated for oral contraception.

Contraindications

• Migraine with focal neurological symptoms (including history);
• Moderate or severe severity of arterial hypertension (arterial pressure (BP) above 160 per 100 mm Hg) and other severe and / or multiple risk factors for arterial or venous thrombosis;
• Venous or arterial thromboembolism or thrombosis, including stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis of the leg (including a history);
• Angina pectoris, transient ischemic attack and other precursors of thrombosis (including history);
• Pancreatitis (including history) against the background of severe hypertriglyceridemia;
• Diabetes mellitus with vascular lesions (angiopathy);
• Dyslipidemia;
• Jaundice when taking glucocorticosteroids (GCS);
• Severe liver pathologies, hepatitis, cholestatic jaundice (including during pregnancy) (including anamnesis);
• Gallstone disease (including history);
• Liver tumors (including history);
• Dubin-Johnson syndrome, Gilbert's syndrome, Rotor syndrome;
• Hormone-dependent malignant tumors of the mammary glands and genitals or suspicion of them;
• The presence of severe itching, otosclerosis and its progression during a previous pregnancy or while taking GCS;
• Smoking (over 15 cigarettes per day) over the age of 35;
• Vaginal bleeding of unknown etiology;
• The period of pregnancy or suspicion of it;
• Breast-feeding;
• Individual intolerance to the components of the drug.

Due to the increased risk of arterial or venous thromboembolism and thrombosis, caution should be exercised when prescribing the drug to women over the age of 35, smoking, an indication of a family history of thromboembolism and thrombosis, and obesity (body weight index above 30 kg per 1 m ²), patients with migraine, dyslipoproteinemia, epilepsy, arterial hypertension, atrial fibrillation, valvular heart disease, during major surgical operations, severe trauma, during prolonged immobilization, during surgery on the lower extremities, superficial thrombophlebitis, varicose veins without angiopathy, acute and chronic liver diseases, severe depression (including history), changes in biochemical parameters (hyperhomocysteinemia, antithrombin III deficiency, activated protein C resistance, protein C or S deficiency, antiphospholipid antibodies, antibodies to cardiolipin, lupus anticoagulant) -cellular anemia, Crohn's disease, systemic lupus erythematosus (SLE), ulcerative colitis, hypertriglyceridemia (including family history),in the postpartum period.

Method of administration and dosage

The tablets are taken orally 1 piece per day, preferably at the same time, for 21 days.

Use should be started on the first day of the menstrual cycle. After taking the last tablet from the first blister, take a break for 7 days, during which menstrual bleeding occurs. Taking pills from the next blister begins on the same day of the week and time of day as from the first package, after a 7-day break, even against the background of ongoing bleeding. If all recommendations are followed, the contraceptive effect of the drug persists during the break. This pill-taking scheme must be followed at all times while there is a need for contraception.

Taking pills from the first blister can be started from the second to the fifth day of menstruation, in this case, in the first cycle, during the first 7 days, additional barrier methods of contraception are required. If menstrual bleeding lasts more than 5 days, the start of Regulon application should be postponed until the next cycle.

After giving birth, you can start taking it in 21 days, after consulting your doctor. If a woman has had sexual intercourse after childbirth, then the appointment should be postponed until the start of the next menstrual cycle in order to exclude conception. In the case of starting contraceptive therapy later after childbirth, during the first 7 days of taking the pills, additional methods of contraception are required.

After an abortion, you should start taking it on the day of the operation (in the absence of contraindications) without using additional contraceptives.

When switching from another oral contraceptive with a course of 21 days, the first Regulon tablet should be taken the next day after a seven-day break from the previous cycle. When switching from a drug with a course of 28 days, the first Regulon tablet is taken the next day after taking the last tablet from the package of the previous drug. If these recommendations are followed, additional methods of contraception should not be used.

When switching from hormonal oral contraceptives mini-pills (containing only progestogen), the first pill should be taken on the first day of the menstrual cycle without additional use of barrier methods of contraception. If, against the background of the use of mini-pills, menstruation did not occur, then only after excluding pregnancy can you start taking Regulon on any day of the cycle using additional contraceptives or abstaining from sexual intercourse during the first 7 days.

To delay menstrual bleeding for the desired period, you should continue taking the pills from the new blister without a seven-day break in the usual way. During this period, the appearance of spotting or breakthrough bleeding is possible, which does not affect the contraceptive effect of the drug. Regular use can be restored after the usual interruption.

If you accidentally miss taking the next pill at the set time, if the delay does not exceed 12 hours, it should be taken as soon as you remember and continue taking it as usual. If the delay is more than 12 hours (36 hours from the moment of taking the previous pill), then the reliability of contraception may be impaired, since this is considered to be missing one dose of the drug. If the pass occurred during the first or second week of the cycle, then you should take 2 tablets at the same time and, continuing to take it as usual, until the end of the cycle, use additional barrier methods of contraception. If an accidental skip occurred in the third week of the cycle, then after taking the pill, you should continue to regularly use the drug until the end of the current blister and start taking it from the next one without a seven-day break. The risk of bleeding or conception in this case increases, so additional methods of contraception are required.

The occurrence of vomiting or diarrhea after taking the next pill can lead to inadequate absorption and disrupt the contraceptive effect of the drug. If within 12 hours the symptoms of discomfort have stopped, then after taking an additional pill, contraception is continued in the prescribed manner. If vomiting or diarrhea continues for more than 12 hours, the need to use additional contraceptive methods exists both during the period of vomiting or diarrhea, and during the next 7 days.

Side effects

Side effects that require drug withdrawal:

• Cardiovascular system: arterial hypertension; rarely - stroke, myocardial infarction, deep vein thrombosis of the lower extremities, pulmonary embolism and other thromboembolism of arteries and veins; very rarely - arterial or venous thromboembolism of the renal, hepatic, retinal, mesenteric arteries and veins;
• Sense organs: otosclerosis, complicated by hearing loss;
• Others: porphyria, hemolytic uremic syndrome; rarely - a period of exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (transient).

In addition, against the background of the use of Regulon, less severe side effects may develop, but they appear more often:

• Nervous system: depression, migraine, headache, mood lability;
• Reproductive system: spotting from the vagina or acyclic bleeding, amenorrhea against the background of drug withdrawal, violation of the state of vaginal mucus, candidiasis, inflammation in the vagina, galactorrhea, breast enlargement, tension and pain;
• Dermatological reactions: rash, erythema nodosum, chloasma, exudative erythema;
• Digestive system: cholelithiasis, jaundice and / or itching (development or exacerbation) against the background of cholestasis, nausea, vomiting, ulcerative colitis, Crohn's disease;
• Metabolism: increased body weight, fluid retention in the body, decreased carbohydrate tolerance;
• Organ of vision: when wearing contact lenses - increased sensitivity of the cornea;
• Others: the development of allergic reactions.

The decision on the advisability of continuing contraceptive therapy is made individually, after comparing the benefits of use and the real risk.

special instructions

It is not recommended to start taking the drug without consulting a gynecologist, since Regulon can only be used as directed by a doctor based on the results of a preliminary general medical and gynecological examination. The doctor should study in detail both the general condition of the woman (family and personal history, laboratory tests, blood pressure), and the results of examination of the pelvic organs, mammary glands, cytological analysis of a cervical smear. The decision on hormonal oral contraceptive therapy must be balanced, taking into account all the benefits and negative effects.

A woman should be warned about the need for regular (once every 6 months) preventive examination during the period of taking the pills. With the appearance or aggravation of diseases of the hemostasis system, abnormalities in laboratory parameters of liver function, signs of renal and / or cardiovascular failure, migraine, epilepsy, diabetes mellitus not complicated by vascular disorders, severe depression, estrogen-dependent tumors or gynecological diseases, sickle cell anemia taking the drug must be stopped and use non-hormonal methods of contraception.

There is a risk of developing thromboembolic diseases while taking hormonal contraceptives, but it is not higher than during pregnancy. In rare cases, the appearance of arterial or venous thromboembolism of the vessels of the retina or renal, hepatic, mesenteric vessels is possible. Their likelihood increases in women with heavy smoking, over 35 years of age, obesity, arterial hypertension, heart valve pathologies complicated by hemodynamic disorders, atrial fibrillation, dyslipoproteinemia, prolonged immobilization, diabetes mellitus complicated by vascular lesions, as well as in the presence of thromboembolic diseases in the family history (parents, sister, brother).

Before elective surgery on the lower extremities or major surgical intervention, the drug should be temporarily discontinued and resumed after remobilization after 2 weeks.

Symptoms of thromboembolism include sudden chest pain radiating to the left arm, shortness of breath, severe headache accompanied by diplopia, partial or complete sudden loss of vision, dizziness, aphasia, collapse, weakness, severe numbness of half of the body, focal epilepsy, acute abdomen, impaired movement functions, expressed unilateral pain in the gastrocnemius muscle.

Women who are prone to chloasma should avoid exposure to direct sunlight and ultraviolet radiation.

The effectiveness of the drug can be disrupted by concomitant therapy with other drugs, in which case additional barrier methods of contraception are required.

In the presence of acyclic bleeding or the absence of menstrual bleeding after regularly taking tablets from two blisters, taking the tablets should be discontinued and an examination should be made to exclude pregnancy.

The estrogenic components of oral contraceptives can affect the level of laboratory parameters of the functional parameters of the thyroid gland, kidneys, adrenal glands, hemostasis, liver, the content of transport proteins and lipoproteins.

The use of Regulon in women with menorrhagia significantly reduces the loss of menstrual blood, normalizes the menstrual cycle, has a beneficial effect on the condition of the skin, especially with acne vulgaris.

In severe liver pathologies, hepatitis, cholestatic jaundice, the administration of the drug is possible only 3 months after recovery and maintenance of normal laboratory and functional parameters.

The drug does not protect against sexually transmitted diseases, including HIV infection (AIDS).

Taking pills does not affect a woman's ability to drive a car or other mechanisms.

Drug interactions

The risk of breakthrough bleeding increases with the simultaneous administration of drugs that induce liver enzymes, including rifampicin, hydantoin, primidone, barbiturates, carbamazepine, felbamate, topiramate, St. John's wort, griseofulvin, oxcarbazepine. In addition, these drugs reduce the contraceptive effectiveness of oral contraceptives. It should be borne in mind that the maximum level of induction can continue for 28 days after their cancellation.

If it is necessary to take Regulon together with ampicillin and tetracycline, additional barrier methods of contraception must be used during the entire course of treatment and 7 (for rifampicin - 28) days after their cancellation.

In patients with diabetes mellitus, the drug may increase the need for hypoglycemic oral agents or insulin.

Analogs

Regulon's analogs are: Marvelon, Mersilon, Tri-Mercy, Novinet.

Terms and conditions of storage

Store at 15-30 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Regulon: prices in online pharmacies

Drug name Price Pharmacy

Regulon 30 mcg + 150 mcg film-coated tablets 21 pcs. 427 r Buy

Regulon tablets p.p. 21 pcs. 455 RUB Buy

Regulon 30 mcg + 150 mcg film-coated tablets 63 pcs. 1070 RUB Buy

Regulon tablets p.p. 63 pcs. 1122 RUB Buy

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