ORGAMETRIL PILLS 5 MG

Indications

- polymenorrhea;

- menorrhagia and metrorrhagia;

- some cases of primary or secondary amenorrhea or oligomenorrhea;

- endometriosis;

- some cases of endometrial carcinoma;

- benign breast diseases;

- to suppress ovulation (not for the purpose of contraception), ovulatory pain and menstruation;

- dysmenorrhea;

- to delay normal menstruation;

- addition to estrogen replacement therapy in perimenopause and postmenopause to prevent endometrial hyperplasia.

Dosage and administration

Drug should be accepted inside, washing down with a small amount of water or other liquid. If the reception of a regular pill is delayed, a woman should take a pill as soon as she remembered about it, except for the case when the delay in taking is more than 24 hours.

The first day of the cycle is the first day of menstrual bleeding.

Polymenorrhea: 5 mg (1 tab.) / Day from 14 to 25 days of the menstrual cycle.

Menorrhagia and Metrorrhagia: on 10 mg (2 tab.) / days within 10 days. Usually, bleeding stops within a few days after starting the drug. The course of treatment should be repeated over the next 3 menstrual cycles of 5 mg (1 tab.) Daily from 14 to 25 days of each menstrual cycle. If the therapy performed is ineffective, then additional diagnostic and therapeutic measures should be taken.

Some cases of primary or secondary amenorrhea or oligomenorrhea: treatment should be started with estrogen, for example, 20-50 μg of ethinyl estradiol per day for 25 days. Against the background of estrogen intake Orgametril ® appoint 5 mg (1 tab.) / day from 14 to 25 day of the menstrual cycle. After the end of the medication, menstrual bleeding usually begins after 3 days. Treatment continues (second cycle), starting from day 5, counting from the onset of bleeding: an estrogen drug is prescribed from day 5 to day 25 of the menstrual cycle, orgametril® appointed from 14 to 25 days. The course of treatment should be repeated in at least one more cycle.

Endometriosis: on 5-10 mg (1-2 tab.) per day for at least 6 months in continuous mode.

Some cases of endometrial carcinoma: 30-50 mg (6-10 tab.) Per day for long periods.

Benign breast diseases: 5 mg (1 tab.) per day from 14 to 25 days of the menstrual cycle for at least 3-4 months.

To suppress ovulation, ovulatory pain and menstruation; dysmenorrhea: taking the drug Orgametril® at a dose of 5 mg (1 tab.) per day should be started from the 1st day of the menstrual cycle, but no later than the 5th day of the menstrual cycle. Treatment may continue for many months (without interruption). If, during the treatment, breakthrough vaginal bleeding appears, the dose of the drug can be increased to 10-15 mg (2-3 tab.) Per day for 3-5 days.

To delay normal menstruation: taking the drug in 5 mg (1 tab.) per day should begin 2 weeks before the expected date of the onset of menstruation.If treatment is started less than 1 week before the date of menstruation, the dose should be increased to 10-15 (2-3 tab.) Per day. However, in this case, a delay of more than 1 week is undesirable. The likelihood of breakthrough bleeding from the vagina increases with a late start of treatment. For this reason, it is not recommended to start treatment if less than 3 days remain before the expected menstruation comes.

Supplement to estrogen replacement therapy in perimenopause and postmenopause to prevent endometrial hyperplasia: Orgametril® prescribed 2.5-5 mg (1 / 2-1 tab.) daily for 12-15 days per month (for example, during the first 2 weeks of each month) in this case, estrogen replacement therapy can be carried out in a continuous mode in the least effective dose.

Adverse effects

Adverse reactions reported in the literature and during post-registration observation

* - frequency of adverse reactions: often (> 10%), infrequently (1-10%), rarely (<1%).

** Increase in LDL cholesterol and decrease HDL cholesterol.

*** With long-term use of the drug Orgametril® metrorrhagia often occurs (bloody spotting or breakthrough bleeding from the vagina). During the cyclic administration of the drug Orgametril® the appearance of metrorrhagia is also possible, but more rare. In general, the frequency of occurrence of metrorrhagia is greatest during the first 2 months of treatment. In the future, its frequency is progressively reduced. A temporary increase in the dose of the drug allows you to control bleeding in most cases.

Contraindications

- pregnancy or suspected pregnancy;

- breastfeeding period;

- Ectopic pregnancy (in history);

- severe liver disease, such as cholestatic jaundice or hepatitis (or a history of severe liver disease, if the liver function indicators have not returned to normal), hepatoma;

- Rotor syndrome;

- Dubin-Johnson syndrome;

- Gilbert's syndrome;

- bleeding from the vagina of unknown etiology;

- conditions (currently or in history), which can be aggravated by taking sex steroid hormones (including gestational herpes, gestational jaundice, otosclerosis, pregnant chloasma, severe itching, porphyria);

- severe depression;

- diabetes;

- congenital cholesterol metabolic disorders;

- violation of blood clotting;

- thrombosis / thromboembolism (deep vein thrombosis, thromboembolism of the pulmonary artery, heart attack, cerebrovascular disorders);

- hypersensitivity to the drug.

Carefully

Patients should be regularly monitored for any of the following conditions: chronic heart failure ; arterial hypertension; thromboembolism (in history); depression (in history).

Use during pregnancy and lactation

The drug is contraindicated for use in pregnancy.

The safety of the drug Orgametril® in the period of lactation has not yet been established.

Application for violations of the liver

It is forbidden to use the drug for liver diseases (jaundice), liver tumors.

special instructions

Treatment should be interrupted if test results indicate abnormal liver function.

When taking drugs containing estrogen and / or progestogen, especially in women with a history of pregnant chloasma, chloasma is sometimes observed.Women who are prone to chloasma should avoid exposure to skin sunlight or artificial UV radiation.

Taking sex hormones can affect specific laboratory tests. In many patients during treatment with Orgametril® possible increase in blood levels of LDL and lowering levels of HDL. Changes in the parameters of liver function, carbohydrate metabolism, blood clotting system are possible.

With long-term treatment, systematic medical examinations are indicated; monitoring of lipid and carbohydrate metabolism, bilirubin concentrations, transaminases, coagulation systems. The frequency and nature of systematic medical examinations depend on the circumstances in each individual case and should be determined in accordance with the clinical opinion, but at least 1 time in 6 months.

Due to the effect of linestrenol on the level of the sex hormone globulin, Orgametril® may exhibit some androgenic activity. This can be expressed in mild signs of virilization (mainly acne or seborrhea).

Epidemiological studies have identified the association of progestogen in combination with estrogen with an increased incidence of venous thromboembolism (deep vein thrombosis and pulmonary thromboembolism). Although the clinical significance of this data for linestrenol without an estrogen component is unknown. In the case of thrombosis, you should stop taking the drug Orgametril®. You should also consider the need to stop taking the drug Orgametril® in case of prolonged immobilization due to surgery or disease. Women with a history of thromboembolic disease should be informed of the possibility of their recurrence.

It is necessary to constantly monitor the condition of patients with circulatory disorders (as well as, if they are in history), since the risk of certain cardiovascular diseases or cerebrovascular conditions increases slightly when oral estrogen / progestin contraceptives are taken.

While taking the drug Orgametril® It is recommended to limit the intake of fats and carbohydrates (which is especially important for women with initially high body mass).

In diabetes, the glycemic profile should be monitored (an increase in insulin dosage may be required).

With a predisposition to hypertension, it is necessary to control blood pressure (to reduce fluid intake to 1.5-2 l / day).

In the case of dysfunctional uterine bleeding in women of reproductive age, it is recommended to begin therapy after therapeutic and diagnostic curettage of the uterus.

The ineffectiveness of therapy (recurrence of bleeding and endometrial hyperplastic processes) requires clarification of the causes of bleeding.

With a long delay of menstruation during therapy with the drug Orgametril® ectopic pregnancy should be excluded.

Orgametril® contains in its composition lactose as an excipient. Therefore, this drug should not be administered to patients with rare hereditary disorders, such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption.

Influence on ability to drive motor transport and control mechanisms

Since the drug may cause dizziness, patients should exercise caution when driving vehicles or other equipment.

Overdose

Symptoms: nausea, vomiting.

Treatment: conducting symptomatic therapy.

Drug interaction

Although there is insufficient data, it is possible drug interaction Orgametryl® with other drugs. The following interaction has been described with the use of synthetic progestogens or combined oral contraceptives, also related to the drug Orgametril®.

Rifamycin, hydantoin derivatives (including phenytoin), barbiturates (including primidone), Carbamazepine and aminoglutetimid, laxatives, Activated carbon can reduce the effectiveness of the drug Orgametril®. Conversely, Orgametril® may enhance the therapeutic, pharmacological, or toxicological effects of cyclosporine, theophylline, troleandomycin, and beta-blockers.

Orgametril® may reduce the effectiveness of insulin.

With simultaneous use of macrolide antibiotics may increase the risk of developing toxic liver damage.

Terms and conditions of storage

The drug should be stored out of the reach of children, dry, protected from light, at a temperature of 2 ° to 30 ° C.