Tri-regol 21 + 7 - instructions for use, dose, side effects, contraindications

Sheath: sucrose - 22.013 mg. talc - 6.935 mg, calcium carbonate - 2.898 mg, titanium dioxide - 1.814 mg, copovidone - 0.828 mg, macrogol 6000 - 0.207 mg, silicon dioxide, colloid - 0.123 mg, povidone - 0.074 mg, carmellose sodium 0.025 mg, iron oxide, red -0.083 mg.

Tablets II.

Core: silicon dioxide, colloid 0.275 mg, magnesium stearate 0.550 mg, talc 1.100 mg, corn starch 19.960 mg, lactose monohydrate 33,000 mg.

Sheath: sucrose - 22.013 mg, talc - 6.935 mg, calcium carbonate - 2.898 mg, titanium dioxide - 1.897 mg. copovidone - 0.828 mg, macrogol 6000 - 0.207 mg, silicon dioxide, colloid - 0.123 mg, povidone - 0.074 mg, carmellose sodium - 0.025 mg.

Tablets III.

Core: silicon dioxide, colloid 0.275 mg, magnesium stearate 0.550 mg, talc 1.100 mg, corn starch 19.920 mg, lactose monohydrate 33,000 mg.

Sheath: sucrose - 22.013 mg, talc - 6.935 mg, calcium carbonate - 2.898 mg, titanium dioxide - 1.317 mg, kopividone - 0.828 mg, macrogol 6000 - 0.207 mg, silicon dioxide, colloid - 0.123 mg, povidone - 0.074 mg, carmellose sodium 0.025 mg, iron oxide yellow - 0.580 mg.

Tablets ki placebo Core:

silicon dioxide, colloid - 0.50 mg, croscarmellose sodium - 0.60 mg, magnesium

stearate - 1.20 mg, povidone - 2.40 mg, talc - 2.40 mg, potato starch - 2.10 mg, corn starch - 10.20 mg, lactose monohydrate - 24.55 mg.

Sheath: sahapose - 38.295 mg. talc - 11.752 mg, calcium carbonate - 5.103 mg, titanium dioxide (tsv.ipd.77891 / Е171) - 2,226 mg, kopividone - 1,124 mg, silicon dioxide, colloid - 0.240 mg, iron oxide, red (color 77441 / E172) - 0.787 mg, povidone - 0.144 mg, macrogol 6000 - 0.281 mg, carmellose sodium - 0.048 mg.

Description:

Tablets 1

Pink, round biconvex tablets, coated with a coating, with a glossy surface. On the fracture is white.

Tablets II

White, round biconvex tablets, coated with a coating, with a glossy surface. On the fracture is white.

Tablets III

Dark yellow round biconvex tablets, covered with a coating, with a glossy surface. On the fracture is white.

Tablets IV - placebo containing iron fumarate

Round biconvex glossy tablets are reddish brown, coated. At the break of a light brown color.

Pharmacotherapeutic group:contraceptive combination (estrogen + gestagen).

ATX: & nbsp

G.03.A.B Progestogens and estrogens (combinations for sequential administration)

G.03.A.B.03 Levonorgestrel and ethinyl estradiol

Pharmacodynamics:

Combined, oral three-phase contraceptive estrogen-progestational drug. Suppresses ovulation, blocking the secretion of follicle-stimulating and luteinizing hormones in the pituitary gland, promotes the secretory transformation of the endometrium, increases the viscosity of cervical mucus.

Consecutive taking medication tablets containing different amounts of progestin (levonorgestrel) and estrogen (these nil estradiol a), allows replenishing and ensuring the concentration of these hormones in the blood, close to the physiological, followed by the normalization of menstrual irregularities.

Pharmacokinetics:

Levonorgestrel quickly absorbed (less than 4 hours). Levonorgestrel has no effect of "first passage" through the liver. The half-life is 8-30 hours (on average 16 hours). Most of the levonorgestrel binds to albumin and to the globulin that binds the sex hormones.

These nil estradiol quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in the plasma is achieved in the range of 1-1.5 hours. The half-life period is 26 ± 6.8 hours. These nils to estradiol have the effect of "primary passage" through the liver. Metabolism occurs in the liver and intestines.

When ingested, these nile estradiol is excreted from the blood plasma for 12 hours. Metabolites of these nils estradiol a, which are water-soluble products of sulphate or glucuronide conjugation, enter the intestines with bile, where they disintegrate with intestinal bacteria.

Indications:Oral contraception.

Contraindications:

Hypersensitivity to any component of the drug.

Pregnancy, the period of breastfeeding, severe liver disease, liver tumors, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), cholelithiasis, cholecystitis, chronic colitis; presence or indication in the history of severe cardiovascular (including decompetitive heart diseases) and cerebrovascular changes, thromboembolism and predisposition to them, hormone-dependent malignant neoplasms of genital organs and mammary glands (including the suspicion of them) , family forms of hyperlipidemia, arterial hypertension with systolic / diastolic arterial pressure 160/100 mm Hg. and above, serious surgical interventions, surgical operations on the lower extremities, prolonged immobilization, extensive injuries, pancreatitis (including in the anamnesis), accompanied by severe hyperlipidemia, jaundice due to the use of drugs containing steroids, severe forms of diabetes mellitus, sickle cell anemia , chronic hemolytic anemia, vaginal bleeding of unknown etiology, migraine,otosclerosis with deterioration of the course during the preceding pregnancy (tei); idiopathic jaundice, severe itching, herpes of pregnant women in anamnesis; smoking over the age of 35, age over 40; lactase insufficiency, galactose intolerance, glucose galactose malabsorption (lactose is contained in the drug form of the preparation).

Carefully:

Diabetes mellitus, endocrine gland diseases, diseases of the cardiovascular system, arterial hypertension with arterial pressure up to 160/100 mm Hg, renal dysfunction, varicose disease, multiple sclerosis, porphyria, tetany, epilepsy, small chorea, bronchial asthma.

Pregnancy and lactation:During pregnancy and lactation, taking Tri-Regol® 21 + 7 is contraindicated.

Dosing and Administration:

Take inside without chewing and squeezed with a small amount of liquid.

Starting from the first day of menstruation, within 28 days daily take one tablet coated with a coat, preferably at the same time of day. During the reception of reddish-brown tablets, covered with a membrane, menstrual-like bleeding occurs.To take the tablets from the next package should proceed without observing the break between the two packages, i.e. 4 weeks after the start of taking the drug, on the same day of the week. It is important to observe the following sequence of taking tablets: first follow 6 pink, then 5 white, then 10 dark yellow, at the end - 7 reddish-brown. In order to ensure the necessary order on the numbers and the arrow are indicated. With good portability a drug take until exist need for contraception.

Transition to the preparation of Tri-Regol® 21 + 7 from another oral contraceptive is carried out according to the same scheme.

After abortion It is recommended to start taking the drug on the day of abortion or the day after the operation.

After childbirth the drug can be recommended only to women who do not breastfeed; Reception should be started no earlier than the first day of menstruation.

During lactation, the use of the drug is contraindicated.

Missed pills: the missed tablet should be taken within the next 12 hours. If 36 hours have elapsed since the last pill was taken, contraception unreliable. In such cases, to prevent possible intermenstrual bleeding reception of the drug should continue from the already started packaging except for the missed (pills) (ok).

In cases of missing timely dosing of tablets, it is recommended to use another, additional, non-hormonal method of contraception (for example, barrier).

This rule does not apply to tablets of a reddish-brown color, because they do not contain hormones.

Side effects:

Side effects observed with the use of the drug are classified into categories according to the frequency of their occurrence: very often> = 1/10; often> 1/100, = <1/10; sometimes> = 1/1000, <1/100; rarely> = 1/10000, = <1/1000; very rarely = <1/10000, including individual messages.

Usually the drug is well tolerated.

Possible side effects, which are transitory and do not require treatment: nausea, vomiting, headache, breast engorgement, weight gain, decreased libido, depressed mood, intermenstrual bleeding, in some cases - eyelid edema, conjunctivitis, visual impairment, discomfort wearing contact lenses (these phenomena are temporary and disappear after withdrawal without prescribing any therapy).Rarely are there concentrations of triglycerides, glucose in the blood, decreased glucose tolerance, increased blood pressure, hepatitis, liver adenoma, gallbladder disease (eg, cholelithiasis, cholecystitis), thrombosis and venous thromboembolism, jaundice, skin rash, hair loss, increased secretions of the vagina, candidiasis of the vagina, increased fatigue, diarrhea.

Very rarely, with longer dosing; chloasma.

Iron fumarate, which is a part of the reddish-brown tablets, covered with sugar shell, can cause irritation of the mucous membrane of the gastrointestinal tract, nausea, vomiting, diarrhea, constipation and stain the stools in black.

Overdose:In case of accidental ingestion of large doses of the drug, an overdose is possible, incl. in children. Symptoms of an overdose: nausea, uterine bleeding. If signs of overdose occur in the first 2-3 hours, gastric lavage and symptomatic treatment are recommended. There is no adytotitis.

Interaction:

The use of Tri-Regol® 21 + 7 tablets requires caution when the following drugs are taken concomitantly with the contraceptive:

- ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbugazone, t. 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 indanedione derivatives (it may be necessary to determine the prothrombin index and change the anticoagulant dose in an emergency);

- tricyclic antidepressants, maprotiline, beta-blockers (possibly increasing their bioavailability and toxicity);

- oral hypoglycemic drugs, insulin (there may be a need to change their dose);

- bromocriptine (decreased effectiveness of bromocriptine);

- drugs with a potential hepatotoxic effect, for example, dantrolene. The risk of hepatotoxicity increases with age, especially in women older than 35 years.

Special instructions:

Before prescribing the drug, it is necessary to exclude the presence of pregnancy, to conduct a general medical examination (including blood pressure measurement, laboratory tests of liver function and blood sugar level) and gynecological examination (breast condition, cytological analysis of the vaginal smear).

During the reception of the drug, such general medical and gynecological examinations should be carried out regularly, every 6 months.

The use of oral contraception is allowed no earlier than 6 months after the transferred viral hepatitis, provided that the liver functions are completely normalized.

When there are sharp pains in the upper abdominal areas, hepatomegaly and signs of intra-abdominal hemorrhage, there may be a suspicion of a liver tumor. In this case, the drug should be discontinued.

If violations of liver function are detected during application of the drug, the question of whether to continue taking Tri-Regol® 21 + 7 should be resolved. When acyclic bleeding occurs, it is possible to continue taking tri-regol® 21 + 7 tablets after excluding organic pathology by the treating physician. In the case of vomiting or diarrhea, the drug should be continued while using an additional, non-hormonal contraceptive method.

At least 3 months before the planned pregnancy should stop taking the drug.

Under the influence of oral contraceptives (in connection with the estrogen component), the functional parameters of the liver,kidney, adrenal, thyroid, blood clotting and fibrinolytic factors, levels of lipoproteins and transport proteins.

The drug should be discontinued:

- in case of occurrence for the first time or strengthening already available migraine-like pains, or occurrence of unusually strong headaches; with acute deterioration of visual acuity; at suspicion of a thrombosis or a heart attack; with a sharp increase in blood pressure;

- with the appearance of jaundice or hepatitis without jaundice, generalized itching; with increased epileptic seizures;

- before the planned operation (6 weeks before the operation), with prolonged immobilization;

- at approach of pregnancy.

Effect on the ability to drive transp. cf. and fur:Studies to study the effect of the drug on the ability to drive a car and others associated with an increased risk of injury, mechanisms have not been carried out.

Form release / dosage:

The tablets covered with a cover.

Packaging:

Tablets I pink color - 6 pcs.

Tablets II white - 5 pcs.

Tablets III dark yellow color - 10 pcs.

Tablets IV reddish brown - 7 pcs.

28 tablets (I, II, III, IV) in the blister A1 / Г1ВХ.

1 or 3 blisters in a cardboard box with instructions for use.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015002 / 01

Date of registration:25.05.2009

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER OJSC Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp02.10.2015

Illustrated instructions

Instructions

Tri-regol® 21 + 7 (Tri-regol® 21 + 7)