Regulon

Регулон Drug photo

The description is actual on 18.01.2015

  • Latin name: Regulon
  • ATH code: G03AA09
  • Active ingredient: Ethinylestradiol + Dezogestrel (Ethinylestradiol + Desogestrel)
  • Producer: JSC Gideon Richter, Hungary

Structure

30 mkg of ethinylestradiol and 150 mkg of a dezogestrel, and also auxiliary components are Regulon's part: magnesium stearate (Magnesium stearate), α-tocopherol ((((((((((Alpha-tocopheryl acetate), silicon dioxide colloid (Silicon dioxide colloidal), stearic acid (Stearic acid), povidone (Povidone), potato starch (Solani amylum), lactoses monohydrate (Lactose monohydrate).

The film cover is made with use of a macrogoal of 6000 (Macrogol 6000), propylene glycol (Propylene glycol), gipromelloza (Hypromellose).

Release form

Regulon comes to drugstores in the form of film coated tablets. Tablets are packaged on 21 pieces in blisters, on 1 or on 3 blisters in one cardboard packaging.

Pharmacological action

Drug belongs to group of the combined monophase peroral contraceptives. Pharmacological action of Regulon — contraceptive, it is oestrogenic-progestagennoye.

Pharmacodynamics and pharmacokinetics

According to the summary, ability of its active agents to suppress synthesis of gonadotrophins a hypophysis is the cornerstone of the mechanism of effect of drug (in particular, luteinizing and follicle-stimulating hormones).

It complicates an ovulation, promotes increase of density of cervical slime and, as a result, prevents penetration of spermatozoa into internal space of a body of the womb.

Ethinylestradiol represents synthetic analog of oestradiol which begins to be developed in the woman's organism, since the first periods.

Dezogestrel renders the expressed gestagenny and anti-oestrogenic effect similar to that which renders endogenous progesterone. Substance is characterized by weak anabolic and androgenic activity.

During reception of tablets Regulon at the woman (in case of an initial menorrhagia) is significantly reduced blood loss during periods and the condition of an integument improves (in particular in the presence of vulgar eels).

Also dezogestret, and ethinylestradiol and are quickly and almost in full soaked up from a digestive tract. Dezogestrel is at once metabolized with formation of biologically active metabolite — 3-keto-dezogestrela.

Plasma concentration reaches the maximum:

  • 1,5 hours later — for a dezogestrel (an indicator of plasma concentration — 2 ng in 1 ml);
  • 1-2 hours later — for ethinylestradiol (an indicator of plasma concentration — 80 pg in 1 ml).

Bioavailability indicator:

  • for a dezogestrel — from 62 to 81%;
  • for ethinylestradiol — about 60% (it is connected with presistemny conjugation and effect of the first passing of substance through a hepatic barrier).

Elimination half-life:

  • for 3-keto-dezogestrela — 30 hours (products of a metabolism are excreted with urine and contents of intestines in a proportion 4:6);
  • for ethinylestradiol — 24% (about 40% of substance and its metabolites are removed with urine, the remained about 60% — with intestines contents).

Indications to use

In the summary to Regulon it is specified that the main purpose of drug — protection from undesirable pregnancy.

However researches confirm that in addition to contraceptive effect, Regulon is characterized also by existence of effect medical. So, on a question "tablets — from what they?" the instruction to drug answers that Regulon's use is reasonable at dysfunctional uterine bleedings, a premenstrual syndrome, dysmenorrhea etc.

Drug effectively kills periodically arising aching pains in the lower part of a stomach, promotes reduction of morbidity and a profuseness of menstrual bleedings, a dispaureniya, eliminates insignificant allocations of dark color from a genital tract in the perimenstrualny period, and also morbidity of mammary glands.

It is quite often appointed for increase of efficiency of the therapy appointed at endometriosis. At a hysteromyoma means is appointed with the purpose to stop growth of a tumor (it reasonablly if diameter of the last does not exceed 2 cm). Besides, Regulon promotes a rassasyvaniye of retentsionny cysts of ovaries.

After 40 flyings when the woman, as a rule, already resolved issues of planning of a family and the birth of necessary number of children, Regulon allows to prevent abortion and its adverse effects (if to trust statistics, the most part of pregnancies at this age comes to an end with artificial abortion).

Contraindications

Contraindications to Regulon's use are:

  • intolerance of any component of drug;
  • pregnancy;
  • lactation;
  • serious diseases of a liver;
  • functional (high-quality) hyperbilirubinemias (including rare hereditary pigmental hepatoses);
  • the jaundice of pregnant women specified in the anamnesis;
  • family forms of lipidemias;
  • the liver tumors specified in the anamnesis;
  • moderately expressed or heavy arterial hypertension;
  • the fibrinferments or thromboembolisms, existence of obviously expressed and/or multiple factors of risk of their development, and also existence in the anamnesis of data specified in the anamnesis that at the woman thrombosis harbingers took place;
  • migraine;
  • herpes of the II type;
  • vulval bleedings of not clear nature of an origin;
  • the found estrogenzavisisymy tumors or existence of suspicions on them;
  • severe forms of a diabetes mellitus (with an angiopatiya);
  • diabetes of pregnant women;
  • narushenya systems of hemocoagulation;
  • the severe itch, otospongiosis (or their progressing) connected with the previous pregnancy or reception of glucocorticosteroids.

Side effects of Regulon

The most dangerous side effects of Regulon which demand drug withdrawal belong:

  • arterial hypertension;
  • thromboembolisms of veins and arteries (including formation of blood clots in deep veins, a stroke, a myocardial infarction, etc.);
  • thromboembolism of veins and arteries of a liver and kidneys, and also thromboembolism of retialny and/or mezenterialny veins and arteries (very seldom);
  • the hearing loss provoked by an otospongiosis;
  • porphyrinic illness;
  • gemolitiko-uraemic syndrome;
  • aggravation of a current of a reactive system lupus erythematosus (in rare instances);
  • the rheumatic chorea disappearing after cancellation of means (in extremely exceptional cases).

Treat group of less serious side effects of drug:

  • the acyclic bleedings which are not connected with periods, and also emergence of bloody vulval allocations;
  • the amenorrhea which is noted after cancellation of means;
  • changes of a condition of cervical (vulval) slime;
  • increase, intensity and morbidity of mammary glands;
  • emergence of inflammatory processes in a vagina;
  • milkwoman;
  • galactorrhoea;
  • nausea;
  • vomiting;
  • development or aggravation connected with hoyelstazy an itch and/or jaundices;
  • illness Krone (granulematozny enteritis);
  • cholelithiasis;
  • knotty or exudative erythema;
  • emergence of an enanthesis;
  • hloazma;
  • headaches;
  • changeability of mood;
  • migraine;
  • depression;
  • hypersensitivity of a cornea of an eye;
  • decrease in tolerance (tolerance) to carbohydrates;
  • increase in weight;
  • accumulation of liquid in an organism;
  • allergic reactions.

Contraceptive tablets Regulon: application instruction

How it is correct to accept Regulon?

Tablets begin to drink from 1 day of a menstrual cycle, on one in day, at the same time days, for 3 weeks (21 day). After the last tablet will be drunk up, it is necessary to sustain a seven-day interval during which there has to pass bleeding, similar to menstrual.

For the 8th day after the last tablet was drunk up (in 4 weeks after the beginning of administration of drug, weeks on the same day) even if bleeding did not stop, reception of tablets is resumed from the next blister.

How it is long possible to accept Regulon?

According to the above described scheme a pill is taken until the need for contraception remains. If the woman drinks tablets, following all rules and recommendations specified in the instruction on Regulon, the contraceptive effect remains also during a seven-day interval.

First reception of a tablet

The first tablet of drug is drunk in 1 day of a cycle. At the same time in use of additional methods of contraception there is no need. If reception is begun in an interval between 2 and 5 days of a cycle, then for the first 7 days of the first cycle of use of Regulon it is necessary to resort to use of barrier contraceptives.

If after the beginning of menstrual bleeding there passed more than 5 days, it is reasonable to begin administration of drug in the following cycle.

How to drink Regulon after the delivery?

If the woman does not nurse, 21 day later after the delivery she can begin reception of tablets (after preliminary consultation with the gynecologist). In a similar situation need for use of additional resources of contraception is absent.

If sexual contact after the delivery took place, then the beginning of reception of Regulon is recommended to be postponed until the following cycle.

If drug begins to be accepted later than in 3 weeks after the delivery, in the first 7 days of the first cycle of reception it is necessary to resort to additional methods of contraception.

Reception of tablets after abortion

If there are no contraindications, tablets are allowed to be drunk from 1 day after abortion, and without supplementing them with other contraceptives.

Also Regulon quite often appoint after a scraping.

Expediency of purpose of tablets after an abortion/scraping (in particular, after the stood pregnancy) is caused by need to recover normal function of ovaries and to prevent development of inflammatory complications which are according to the statistics noted approximately at every third woman who transferred repeated abortion.

Drugs which part vysoaktivny gestagenny substance which does not possess side effects, and, in particular, the tablets released by the company Gideon Richter Regulon is are considered as optimum means.

Administration of drug allows to compensate the deficit of progesterone caused by abortion and development of the related proliferatichny processes in reproductive system (including a hyperplasia of a tekatkana, a polycystosis of ovaries, an adenomyosis, a fibromyoma, a hyperplasia of an endometria, endometriosis, a hyper thecosis, a mastopathy, etc.).

Transition to Regulon from other hormonal drugs

Upon transition to drug from other contraceptive the first medicine should be taken next day after completion of the packaging calculated on 28 days (21 days of reception + 7 days of a break). There is no need to use additional contraceptives.

Upon transition to Regulon from mini-saw, the first pill is taken in 1 day of a cycle, without supplementing reception with use of other methods of contraception.

If during reception mini-saw there was no menstrual bleeding, Regulon it is possible to begin to accept in any day of a cycle, but only after pregnancy is excluded.

In the first 7 days of the first cycle of reception there is a need for additional measures of protection for what usually use a condom, a cap with spermicidal gel or abstain from sexual contacts. The calendar method of contraception in this case is inefficient.

Periods delay

When it is necessary to delay periods, a pill continues to be taken, without doing a break in 7 days. At a delay of menstrual bleeding there can be breakthrough bleedings or the smearing allocations which however do not reduce contraceptive effect of drug.

Regular reception of tablets is recovered after a 7-midnevny interval.

How to take Regulon at the admission a pill?

If after the admission of reception of a tablet there passed no more than 12 hours, the forgotten pill is taken at once after remembered it. Further reception is continued about the usual scheme.

If the interval between receptions more than 12 hours, reliability of drug in this cycle cannot be considered as absolute. Therefore to the following cycle it is necessary to use additional contraceptives.

At the admission of 1 tablet in the first 7-14 days of a cycle it is necessary to take 2 pill at once next day then reception is continued according to the usual scheme with use of additional contraceptives before end of a cycle.

If the tablet was passed in an interval between 14 and 21 day, regular reception is continued, having taken the forgotten pill and not doing a 7-midnevny break.

At the admission of reception the risk of an ovulation and\or emergence of bloody vulval allocations increases. It is caused by the fact that the minimum dose of estrogen is a part of drug, and demands use of additional contraceptives.

Overdose

Symptoms of overdose by Regulon are:

  • dyspepsia;
  • nausea;
  • vomiting;
  • the expressed headache;
  • spasms of gastrocnemius muscles;
  • the bloody allocations which are not connected with periods from a vagina.

As means has no specific antidote, for stopping of symptoms of overdose resort to purpose of symptomatic therapy. First aid after reception of a high dose of Regulon is a gastric lavage (it is recommended to be made in the first two-three hours after reception of tablets).

Interaction

Efficiency of contraceptives for oral administration decreases in combination with drugs which induce liver enzymes: rifampicin, hydantoin, carbamazepine, barbiturates, okskarbazepiny, felbamaty, Primidonum, topiramaty, drugs of a St. John's Wort ordinary, grizeovulfiny.

Besides, these drugs used in a combination with Regulon increase probability of developing of breakthrough bleedings.

Level of induction reaches a maximum not earlier than 2-3 weeks later, however can remain till 4 weeks after drug withdrawal.

Disturbance of a menstrual cycle and decrease in contraceptive effect can be noted at simultaneous use with:

  • antibiotics (in particular with Tetracycline and Ampicillin);
  • barbiturates;
  • some antispasmodics;
  • purgatives;
  • antidepressants.

In a case when reception of above-mentioned drugs is necessary, it is recommended to be protected with use of barrier contraceptives (during the entire period of treatment, and also for additional 7-28 days, depending on what medicine was appointed).

In need of use of anticoagulants during Regulon's reception it is necessary to carry out additional monitoring of a prothrombin time. In separate situations correction of the mode of dosing of anticoagulant can be required.

Because of the increased probability of complications it is not necessary to combine Regulon with hepatotoxic means.

Against reception of oral contraceptives can:

  • to decrease tolerance to carbohydrates;
  • to raise need for peroral anti-diabetic drugs and insulin.

Terms of sale

According to the recipe.

Storage conditions

Optimum temperature condition for Regulon's storage — from 15 to 30 degrees Celsius. To protect from children.

Period of validity

36 months.

Special instructions

If Regulon's reception is followed by deterioration in indicators of hepatic tests, it is recommended to stop reception of tablets at once.

In the first several months of administration of drug acyclic intermenstrual bleedings which are not the basis for cancellation of tablets can be noted. Nevertheless, if they proceed for three months and more, it is necessary to pass detailed inspection.

As at the smoking women Regulon's reception is followed by the increased risk of tromboembolic episodes, they are recommended to resolve an issue of smoking cessation.

If monthly after Regulon do not come in the second cycle, it is necessary to exclude probability of pregnancy.

Teratogenic action of Regulon is not proved. For this reason if there came pregnancy at reception of tablets, in its interruption there is no need.

How it is long possible to accept Regulon?

During reception of tablets Regulon in an organism of the woman there are changes characteristic of the first weeks of pregnancy. At the woman who already have children in reproductive system the same processes which would arise if she gave rise are noted and brought up several children.

It is well-known that the birth of a large number of children is the most effective method of protection against oncological diseases of bodies of a reproductive system and mammary glands.

Thus, long reception of Regulon strengthens medical effect of drug. It is allowed to take a pill until before the woman there is a question of planning of the child.

Regulon and monthly

As a rule, menstrual bleeding at Regulon's reception becomes scantier. However it happens and so that at the woman accustoming to drug which is most often shown in the form of the smearing allocations can develop.

The termination of reception of tablets usually is followed by strengthening of work of ovaries. Therefore very plentiful menstrual bleedings can become one of effects of cancellation of Regulon.

If after cancellation is not present monthly, it can be also connected with failure of function of ovaries. As a rule, it and, therefore, a menstrual cycle, are recovered a month later after the termination of reception of Regulon. For determination of level of hormones in an organism gynecologists recommend to make necessary tests after a month after drug withdrawal.

Regulon and weight: whether get fat from hormonal tablets?

It is considered to be that reception of hormonal contraceptives is capable to provoke increase in body weight. However doctors claim that they at observance of all Regulations of Admission of Regulon, and also a day regimen and food of a tablet do not exert any impact on the woman's weight.

Usually increase in weight against reception of contraceptive tablets can be connected with what being their part dezogestret is characterized by ability to detain in an organism liquid (so, exactly progesterone is the reason of hypostases during pregnancy).

The sex hormones which are contained in Regulona promote acceleration of biochemical reactions of lipids and carbohydrates. If the level of exercise stresses is estimated as sufficient, excess calories are easily processed into energy, and here at insufficient loadings they settle on a body in the form of extra kilos.

Whether it is possible to become pregnant, accepting drug?

At the correct reception of Regulon probability of approach of pregnancy it is insignificant it is small. Efficiency of drug is very close to 100%.

The risk to become pregnant is highest during change of a contraceptive, in cases when there were admissions of reception of tablets, disturbances of the scheme of reception (a pill was taken every time at different times) and also if action of a tablet was neutralized (for example, absorbent).

Analogs

Similar drugs on structure (synonyms) are Marvelon, Mersilon, Three - Mercy, Novinet.

In a case when interests the woman, than it is possible to replace means, the doctor can advise her one of below the listed drugs: Belara, Dailla, Jes, Evra, Jeanine, Zhenetten, Lindinett 20, Lindinett 30, Rigevidonum, Silest, Femoden, Tsiklo-Proginova, Egestrenol, Yarina, Dimia, Oralkon, Bonade.

What it is better — Regulon or Novinet?

Regulon and Novinet are drugs-generics. They have identical structure, indications to use and contraindications, but are issued various companies.

Regulon or Jeanine — what is better?

Both Regulon, and Jeanine is the low-dosed monophase contraceptives. They have the similar mechanism of action, however differ in structure. Regulon is a combination of ethinylestradiol and a dezogestrel, and as a part of Zhanin ethinylestradiol is added diyenogesty (at the same time a dose of a progestagenny component in Jeanine's dragee a little higher, than in Regulona).

The most significant difference of drugs is their price — Regulon costs much cheaper than the analog.

Zdravzona

  • Regulon No. 21 tabletkigedeon Richter
  • Regulon No. 21х3 tabletkigedeon Richter

Drugstore of IFC

  • Regulon tbl p / about No. 21, Gedeon Richtervengriya
  • Regulon tbl p / about No. 63, Gedeon Richtervengriya
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Apteka24

  • Regulongedeon Richter (Hungary)
  • Regulongedeon Richter (Hungary)

Paniapteka

  • Regulon of the tab. No. 21 Gideon Richter
  • Regulon of the tab. No. 21 Gideon Richter

BIOSPHERE

  • Regulon No. 21 tabl.p.p.o.
  • Regulon No. 21х3 tabl.p.p.o.
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Section: Contraceptives
PAY ATTENTION! Information on drugs on the website is help generalizing, collected from public sources and can form the basis for making decision on use of medicines it is not aware of treatment. Before medicine use Regulon surely consult with the attending physician.