Tri-regol (estradiol, levonorgestrel) coated tablets №63

Description

Tri-regol (estradiol, levonorgestrel) coated tablets №63

Composition

active substances: ethinyl estradiol, levonorgestrel;

1 pink tablet contains: ethinyl estradiol 0.03 mg, levonorgestrel 0.05 mg;

1 white tablet contains: ethinyl estradiol 0.04 mg, levonorgestrel 0.075 mg;

1 tablet of dark yellow color contains: ethinyl estradiol 0.03 mg, levonorgestrel 0.125 mg;

excipients:

1 pink tablet contains: colloidal anhydrous silica, magnesium stearate, talc, corn starch, lactose monohydrate, carmellose sodium, povidone, polyethylene glycol (macrogol 6000), iron oxide red (E 172), copovidone, titanium dioo1 calcium carbonate, sucrose;

1 white tablet contains: colloidal anhydrous silica, magnesium stearate, talc, corn starch, lactose monohydrate, carmellose sodium, povidone, polyethylene glycol (macrogol 6000), copovidone, titanium dioxide (E 171), calcium carbonate, carbonic carbonate;

1 dark yellow tablet contains: colloidal anhydrous silica, magnesium stearate, talc, corn starch, lactose monohydrate, carmellose sodium, povidone, polyethylene glycol (macrogol 6000), iron oxide yellow (E 172), copovidone, titanium oxide ), calcium carbonate, sucrose.

Dosage form

Coated tablets.

Main physical and chemical properties: pink round biconvex tablets, coated, with a glossy surface.

White round biconvex, film-coated tablets with a glossy surface.

Dark yellow round biconvex, film-coated tablets with a glossy surface.

Pharmacotherapeutic group

Hormonal contraceptives for systemic use. Progestogens and estrogens for sequential use. ATX code G03A B03.

Pharmacological properties

Combined oral contraceptives block the action of gonadotropins. Although the primary action is aimed at inhibiting ovulation, the subsequent action is aimed at changing the cervical mucus and endometrium (the first action makes it difficult for sperm to pass into the uterine cavity, the second – prevents the implantation of a fertilized egg).

Indications

Tri-regol coated tablets is a three-phase oral hormonal contraceptive drug that inhibits ovulation in order to prevent unwanted pregnancy.

Contraindications

Oral contraceptives are not advised to prescribe for hypersensitivity to ethinylestradiol or levonorgestrel, venous or thromboembolic diseases, in particular, with thrombophlebitis associated with smoking, risk of arterial or venous thromboembolism, heart disease, symptoms of blood circulation, diabetes, cerebral artery disease associated with impaired vascular function, severe liver disease, up to its normalization, malignant tumors, vaginal bleeding of unknown origin.

Application during pregnancy and lactation

It is forbidden to use if there is a possibility that a woman is pregnant and during breastfeeding.

Method of administration and dosage

Tri-regol coated tablets is taken regularly, one tablet per day, starting from the first day of the menstrual cycle for 21 days. The first six days – 1 yellow tablet, then five days – 1 orange tablet, and the last ten days – 1 white tablet. The colors in different packages during the release of different series may differ, therefore, when taking Tri-regol, you should focus primarily not on the color of the pill, but on the arrows, numbers and instructions printed on the back of the blister.
When the course of admission on day 21 is completed, it is necessary to take a break of 7 days, on the second or third day after which bleeding appears, similar to menstruation. A new course of taking Tri-regol is started regardless of whether this bleeding has occurred and how long it lasted. The new course begins on the 8th day after the end of the last pill of the previous course. From this day, a new course is calculated on day 21.
With regular use of Tri-regol, the contraceptive effect continues during this break week.
If a woman wants to stop taking, she should complete a 21-day course, after which, with normal body functioning, ovulation is restored in the first 1-3 months after Tri-Regol is canceled.
The tablets are taken at the same time. If a woman for some reason was unable to take another pill, it should be taken within the next 12 hours. The contraceptive effect will remain.
When taking it, it should be borne in mind that with vomiting and diarrhea, the drug can be excreted from the body and not have its effect. In this cycle, contraceptive action may not occur, therefore additional methods of contraception should be adopted.

Overdose

Headache, indigestion. In case of a significant overdose, gastric lavage and drug withdrawal are indicated.

Side effects

Side effects such as otosclerosis, vaginitis, candidiasis, breast swelling, weight gain, mood swings, changes in libido, and gallbladder disease have been reported. Thrombosis, embolism, arterial hypertension, varicose veins disorders, myocardial infarction were rarely recorded. The appearance of acne, erythema nodosum, alopecia, ameroea, dysmenorrhea is possible. A change in the body’s tolerance to glucose is possible.