Tri-Regol pills №21

Active ingredient and dosage form

THREE-REGOL
Sugar coated tablets three kinds.
Pink pills (6 pcs.) contain 0.03 mg of ethinyl estradiol and 0.05 mg of levonorgestrel,
whites pills (5 pcs.) contain 0.04 mg of ethinyl estradiol and 0.075 mg of levonorgestrel,
pills dark yellow (10 pcs.) Contain 0.03 mg of ethinyl estradiol and 0.125 mg of levonorgestrel each;
in a blister 21 pcs. (6 pills of pink color, 5 - white color, 10 - dark yellow color); 1 or 3 blisters in a carton box.

Tri-Regol 21 + 7
Sugar coated tablets four kinds.
Pills pink colors, glossy, biconvex, disk-shaped; on the fracture white, visible around the edges of the shell color (6 pieces in a pack.) contain 0.03 mg of ethinyl estradiol and 0.05 mg of levonorgestrel.
Pills white colors, glossy, biconvex, disk-shaped; on the fracture white, visible around the edges of the shell color (5 pieces in a pack.) contain 0.04 mg of ethinyl estradiol and 0.075 mg of levonorgestrel each.
Pills dark yellow colors, glossy, biconvex, disk-shaped; on the fracture white, visible around the edges of the shell color (10 pieces in a pack.) contain 0.03 mg of ethinyl estradiol and 0.125 mg of levonorgestrel each.
Pills reddish brown colors, glossy, biconvex (7 pieces in a pack.) contain 76.05 mg of iron fumarate.
28 pcs. -in a blister, 1 blister in a carton box.

TRI-REGOL - P No.015005 / 01-2003, 05/27/03
Tri-Regol 21 + 7 - P №015002 / 01-2003, 27.05.03

Mechanism of action

Contraceptive. Suppresses ovulation by blocking the secretion of FSH and LH in the pituitary gland, contributes to the secretory transformation of the endometrium, increases the viscosity of cervical mucus.
Sequential use of pills containing different amounts of gestagen (levonorgestrel) and estrogen (ethinyl estradiol) allows you to replenish and ensure the concentration of sex hormones in the blood, close to physiological, followed by normalization of menstrual disorders.

Indications and usage

Oral contraception. Functional disorders of bleeding, violation of the monthly cycle, dysmenorrhea, premenstrual syndrome.

Contraindications

Hypersensitivity to the drug; pregnancy; breastfeeding period; severe liver disease; congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes); cholelithiasis; the presence or indication in the history of severe cardiovascular and cerebrovascular changes; thromboembolism and predisposition to them; liver tumors; malignant tumors, especially breast cancer or endometrium; familial forms of hyperlipidemia; severe forms of hypertension; severe diabetes, other diseases of the endocrine glands; sickle cell anemia; chronic hemolytic anemia; vaginal bleeding of unknown etiology; migraine; otosclerosis; history of idiopathic jaundice in pregnant women; severe pruritus during pregnancy; herpes pregnant.

Dosage and administration

Take one pill per day (at the same time of the day), starting from the first day of menstruation, for 21 days. This is followed by a 7-day break, during which menstrual bleeding occurs. On the 8th day, you should start taking the pills from the next package (even if the bleeding has not yet stopped). The correct sequence of administration: first 6 pink, then 5 white, 10 dark yellow tablets. To facilitate reception on the package indicated the number and arrow. If the package contains 28 pills (TRI-REGOL 21 + 7), then after the last white one, go to the reception of the brown tablets, and the next 28-day course should start without interruption (4 weeks after taking the first pink pill, on the same day of the week).
When switching to Tri-Regola after another oral contraceptive, a similar scheme is used.
After delivery, the drug should be started no earlier than the first day of menstruation after the first two-phase cycle. After an abortion, it is recommended to start taking the drug immediately or on the second day after the operation.
As a rule, the first two-phase cycle is shortened due to premature ovulation. If the drug starts already when the first spontaneous bleeding occurs, the prevention of premature ovulation may not occur, therefore, contraception may not be reliable in the first two weeks of the cycle.
If the woman did not take the drug within the prescribed period, you should take the missed pill within the next 12 hours. 36 hours after taking the last pill, contraception cannot be considered reliable. However, in order to avoid premature bleeding, the use of Tri-Regol should be continued minus the missed pills from the already started packaging.
In this case, it is recommended to additionally use a different, non-hormonal method of contraception (with the exception of methods for measuring temperature and "calendar").
This does not apply to brown pills that do not contain hormones.

Pregnancy and Breastfeeding

Contraindicated in pregnancy and during breastfeeding.

Adverse reactions

Nausea, vomiting, headache, breast tension, change in body weight and libido, change in mood, bloody intermenstrual discharge, in some cases, a feeling of discomfort when wearing contact lenses.
Rarely: an increase in triglycerides, blood sugar, reduced glucose tolerance, increased blood pressure, thrombosis and venous thromboembolism, jaundice, skin rashes, changes in vaginal secretion, vaginal candidiasis, increased fatigue, diarrhea.
Very rarely (with a longer reception): chloasma.
Fumarate iron, which is part of the reddish-brown sugar-coated tablets, can cause irritation of the mucous membrane of the gastrointestinal tract, nausea, vomiting, diarrhea, constipation and dye black in feces.

Drug interactions

The use of Tri-Regol pills requires caution when simultaneously with the contraceptive take the following drugs:
- ampicillin, rifampicin, chloramphenicol, neomycin, penicillin B, sulfonamides, tetracyclines, dihydroergotamines, tranquilizers, phenylbutazone, the latter can weaken the contraceptive effect, at the same time it is recommended to use an additional, non-hormonal method of contraception;
- anticoagulants, coumarin or indandion derivatives (it may be necessary to determine the prothrombin index and to change the dose of the anticoagulant out of turn);
- tricyclic antidepressants, maprotiline, beta-blockers (perhaps an increase in their bioavailability and toxicity);
- oral antidiabetic drugs, insulin (it may be necessary to change their dose);
- Bromocriptine (reduced efficacy of bromocriptine);
- drugs with potential hepatotoxic action, for example, dantrolen. The risk of hepatotoxicity increases with age, especially in women over 35 years of age.

Overdosage

Cases of toxic effects due to overdose are unknown.

Before you prescribe the drug, it is necessary to exclude the presence of pregnancy, conduct a general medical examination (measurement of blood pressure, laboratory tests of liver function and blood sugar levels, etc.) and gynecological examination (condition of the mammary glands, cytological analysis of vaginal smear).
While taking the drug, such general medical and gynecological examinations should be carried out regularly, every 6 months.
For women with thromboembolic diseases at a young age or with increased blood clotting in the family history, the use of Tri-Regol pills is not recommended.
Caution is required in the presence of diabetes, diseases of the cardiovascular system, hypertension, renal dysfunction, varicose veins, phlebitis, otosclerosis, multiple sclerosis, epilepsy, minor chorea, intermittent porphyria, latent tetany, bronchial asthma. The use of oral contraception is allowed no earlier than 6 months after the transferred viral hepatitis, subject to the full normalization of hepatic functions.
With the appearance of sharp pain in the upper abdomen, hepatomegaly and signs of intra-abdominal hemorrhage, a liver tumor may be suspected. If necessary, the drug should be discontinued. If there are abnormal liver functions that occur while taking the drug, it is necessary to consult a therapist.
If intermenstrual bleeding occurs, the use of Tri-Regola should be continued, since in most cases, these bleedings spontaneously stop. If intermenstrual bleeding does not disappear or recur, a medical examination is required to rule out organic pathology of the reproductive system.
In the case of vomiting or diarrhea, the drug should be continued while simultaneously using an additional, non-hormonal method of contraception. Women over 35 years old who are taking oral contraceptives should stop smoking, because smoking while taking hormonal contraceptive increases the risk of diseases of the cardiovascular system.
3 months before the planned pregnancy is recommended to stop taking the drug.
The drug should be stopped:
in case of occurrence for the first time or intensification of existing migraine-like pains, or the occurrence of unusually severe headaches;
with acute deterioration of visual acuity;
if you suspect a thrombosis or heart attack;
with a sharp increase in blood pressure;
with the appearance of jaundice or hepatitis without jaundice, generalized itching;
with an increase in epileptic seizures;
before the planned operation (6 weeks before the operation), with prolonged immobilization;
during pregnancy.

List B. Store at 15–30 ° C.

5 years.