Tri-Regol

Tri-Regol – three-phase peroral the contraceptive is oestrogenic-gestagenny.

Form of release and structure

Dosage form of Tri-Regola – coated tablets: round, biconvex, glossy, on a break – white color (on 21 pieces in blisters, in cardboard to a box 1 or 3 blisters). 3 types of tablets enter one packaging.

Active ingredients of tablets of pink color (6 pieces in the blister):

• Ethinylestradiol – 30 mkg;
• Levonorgestrel – 50 mkg.

Active ingredients of tablets of white color (5 pieces in the blister):

• Ethinylestradiol – 40 mkg;
• Levonorgestrel – 75 mkg.

Active ingredients of tablets of dark yellow color (10 pieces in the blister):

• Ethinylestradiol – 30 mkg;
• Levonorgestrel – 125 mkg.

Auxiliary components: magnesium stearate, silicon dioxide colloid, talc, lactoses monohydrate, starch corn.

Structure of a cover: titanium dioxide (E171), calcium carbonate, коповидон, talc, macrogoal 6000, povidone, silicon dioxide colloid, karmelloza of sodium, sucrose. Tablets of pink color, besides, contain dye ferrous oxide red (E172), in tablets of dark yellow color – ferrous oxide yellow (E172).

Indications to use

Tri-Regol it is applied for the purpose of contraception (the prevention of undesirable pregnancy).

Contraindications

Absolute:

• Cholecystitis;
• Cholelithiasis;
• Chronic colitis;
• The pancreatitis which is followed by the expressed lipidemia and a gipertriglitseridemiya (including in the anamnesis);
• Serious illness and tumors of a liver;
• The jaundice which developed owing to administration of drugs, containing steroids;
• Inborn hyperbilirubinemias (syndromes Cudgel Johnson, Gilbert, Rotor);
• Family forms of a lipidemia;
• Vulval bleeding of an unknown etiology;
• The diagnosed or suspected hormonedependent malignant new growths of generative organs and mammary glands;
• Surgical interventions on the lower extremities;
• Phlebitis of deep veins of the lower extremities;
• Chronic hemolitic anemia;
• Sickemia;
• The otosclerosis with deterioration in a current which developed in time of the previous pregnancy;
• Severe forms of a diabetes mellitus;
• Herpes, idiopathic jaundice or heavy skin itch during the previous pregnancy;
• Arterial hypertension with systolic/diastolic arterial pressure from 160/100 mm hg;
• Existence heavy cardiovascular (including dekompensirovanny heart diseases) and cerebrovascular changes (or the instruction on them in the anamnesis), thromboembolisms or predisposition to them;
• Migraine;
• Insufficiency of lactase, glyukozo-galaktozny malabsorption, lactose intolerance;
• Vesical drift;
• Extensive injuries;
• Long immobilization;
• Smoking is aged more senior than 35 years;
• Pregnancy;
• Lactation period;
• The age is more senior than 40 years;
• Hypersensitivity to drug components.

The relative contraindications demanding care: arterial hypertension with systolic/diastolic arterial pressure up to 160/100 mm hg, the compensated diabetes mellitus without vascular complications, multiple sclerosis, a varicosis, epilepsy, a porphyria, a hysterical chorea, a tetany, bronchial asthma, a mastopathy, a hysteromyoma, tuberculosis, a depression, teenage age (without regular ovulatory cycles).

Route of administration and dosage

Tri-Regol it is necessary to accept inside, swallowing entirely and washing down with enough liquid, daily on 1 tablet, at the same time days, it is desirable in the evening, within 21 days since 1st day of a menstrual cycle. Further do a 7-day break during which there comes menstrualnopodobny bleeding of cancellation. For the 8th day begin new packaging.

Duration of use of drug is defined by need of contraception.

In case of transition to Tri-Regol from other peroral contraceptive drug it is necessary to adhere to the similar scheme.

After abortion it is recommended to begin administration of drug in the same or next day after operation.

In case of the admission of the next tablet if there passed no more than 12 hours, it is necessary to accept a contraceptive as soon as possible. If there passed 36 hours, efficiency of Tri-Regola decreases. To avoid intermenstrual bloody allocations, it is necessary to continue administration of drug from the current packaging minus the passed tablet (-current). During this period it is recommended to apply an additional non-hormonal method of contraception, for example, barrier.

Side effects

• Reproductive system: intermenstrual bleedings, decrease in a libido, nagrubaniye of mammary glands; seldom – vagina candidiasis, strengthening of vulval allocations;
• Alimentary system: nausea, vomiting; seldom – diarrhea, jaundice, liver adenoma, hepatitis, diseases of a gall bladder (including cholecystitis and a cholelithiasis);
• Metabolism: increase in body weight; seldom – decrease in tolerance to glucose, increase in glucose and triglycerides in blood;
• Sense bodys: in some cases – a vision disorder, conjunctivitis, discomfort when carrying contact lenses, the century swelled (these phenomena passing and disappear after cancellation of Tri-Regola without purpose of the corresponding treatment); very seldom at long reception – decrease in hearing;
• Integuments: hloazma; seldom – a hair loss, skin rash; at long reception it is very rare – a generalized itch;
• Others: seldom – fibrinferments and venous thromboembolisms, increase in arterial pressure, increased fatigue; very seldom at long reception – coarsening of a voice, a spasm of gastrocnemius muscles.

Special instructions

Before reception of a contraceptive it is necessary to exclude pregnancy, to conduct the all-medical and gynecologic examination including the cytologic analysis of a smear and inspection of mammary glands. Further it is necessary to have examination at the gynecologist each half a year during the entire period of use of drug.

Tri-Regol it is possible to accept after the delivery, but only if the woman does not nurse.

It is necessary to begin reception not earlier than the first day of a menstrual cycle.

Pains in an upper part of a stomach, a hepatomegalia and intraabdominal hemorrhage can demonstrate existence of a tumor in a liver therefore in case of symptoms it is necessary to stop administration of drug and to see a doctor.

The patients who had a viral hepatitis can accept a contraceptive not earlier than in 6 months and only on condition of normalization of hepatic functions.

When diagnosing abnormal liver functions the doctor has to solve, whether reasonablly further use of Tri-Regola.

It must be kept in mind that oral contraceptives can influence results of some laboratory parameters, in particular indicators of fibrinolitic factors and a blood coagulation, levels of lipoproteins and transport proteins, functional indicators of adrenal glands, kidneys, a liver and a thyroid gland.

In case of acyclic bloody allocations it is possible to continue reception of Tri-Regola only after an exception of organic pathology.

In case of diarrhea or vomiting it is necessary to continue administration of drug, but in addition to apply a non-hormonal method of contraception.

Tri-Regol it is necessary to cancel immediately in the following cases:

• Pregnancy approach;
• For the first time the arisen or amplifying migrenepodobny or unusually severe headache, sharp deterioration in visual acuity, suspicion of a heart attack or thrombosis;
• Sharp increase in arterial pressure, developing of a generalized itch, emergence of jaundice or hepatitis without jaundice, increase of epileptic seizures;
• Long immobilization (for example, owing to an injury).

If planned operation is necessary, it is necessary to stop reception of a contraceptive in 6 weeks prior to the appointed date.

To the women planning pregnancy, it is necessary to cancel Tri-Regol not less than in 3 months.

Drug does not exert a negative impact on the speed of reactions and ability to concentration of attention.

Medicinal interaction

The following drugs can reduce contraceptive efficiency of Tri-Regola: tranquilizers, tetracyclines, streptocides, Neomycinum, rifampicin, ampicillin, polymyxin B, phenylbutazone, chloramphenicol, dihydroergotamine. For this reason it is necessary to apply these combinations with care, and during reception of the specified drugs in addition to use a non-hormonal method of contraception.

In case of simultaneous use of Tri-Regol reduces efficiency of Bromocriptinum.

At the combined use with tricyclic antidepressants, beta adrenoblockers or Maprotilinum increase in bioavailability and, as a result, increase in toxicity is possible.

At simultaneous use of derivatives of coumarin, anticoagulants or the indandiona is recommended to a thicket to define a prothrombin ratio, change of a dose of anticoagulant can be required.

At use of an oral contraceptive in a combination with the drugs possessing a potential hepatotoxic action (especially with dantroleny), the risk of strengthening of toxicity increases, especially at women 35 years are more senior.

During reception of Tri-Regola correction of insulin or peroral hypoglycemic drugs can be required.

Terms and storage conditions

To store at a temperature of 15-30 °C. To protect from children.

Period of validity – 5 years.