Orgametril ® tablets are used for the following indications:
polymenorrhea; menorrhagia and metrorrhagia; individual cases of primary or secondary amenorrhea and oligomenorrhea with insufficient levels of endogenous estrogen; endometriosis; benign breast tumors; individual cases of endometrial carcinoma; suppression of ovulation, pain during ovulation and menstruation; to delay normal menstruation; as an adjunct to estrogen therapy in the peri- and postmenopausal period - to prevent endometrial hyperplasia.
Composition
The active substance is lynestrenol (one tablet contains 5 mg of lynestrenol).
Excipients: potato starch; alpha-tocopherol, glycerin; magnesium stearate; talc; lactose monohydrate.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of Orgametril®; pregnancy or its probability; severe forms of liver disease, such as cholestatic jaundice or hepatitis (or a history of severe liver disease in the absence of normalization of pathologically altered liver function tests), hepatocellular tumors, Rotor syndrome and Dubin-Johnson syndrome; conditions that are affected by taking sex steroid hormones and which first appeared or worsened during pregnancy or during treatment with sex hormones, such as severe itching, cholestatic jaundice, herpes in pregnant women, porphyria and otosclerosis; venous thromboembolic disorders in the active phase; vaginal bleeding of unknown etiology.
Method of application
Orgametril ® tablets should be taken orally and preferably washed down with water or other liquid.
The missed dose should be taken as soon as possible, except if more than 24 hours have passed since the missed tablet.
Polymenorrhea: one tablet per day from the 14th to the 25th day of the cycle.
Menorrhagia and metrorrhagia: two tablets for 10 days. In most cases, bleeding stops a few days after the start of treatment. Repeat the treatment for 3 menstrual cycles, taking one tablet per day from the 14th to the 25th day of each cycle. If the complaints do not disappear during treatment or after its completion, it is necessary to conduct a further examination of the patient.
Isolated cases of primary or secondary amenorrhea and oligomenorrhea with insufficient levels of endogenous estrogen. Treatment should begin with the use of estrogen, for example, 0.02-0.05 mg of ethinylestradiol per day for 25 days. At the same time, one tablet of the drug "Orgametril ®" should be taken daily from the 14th to the 25th day of the cycle. In most cases, withdrawal bleeding begins within 3 days after stopping treatment. Estrogen treatment should be resumed on the 5th day of withdrawal bleeding and continued until the 25th day of the cycle. Then again from the 14th to the 25th day of the cycle, one tablet of the drug "Orgametril ®" should be used. This treatment should be repeated for at least one more cycle.
Endometriosis: 1-2 tablets per day for at least 6 months.
Benign breast tumors: one tablet per day every day from the 14th to the 25th day of the cycle for at least 3-4 months.
Individual cases of endometrial carcinoma: 6-10 tablets per day for a long period of time.
Suppression of ovulation, pain during ovulation and menstruation. Treatment with one tablet per day is best started on the 1st day of the cycle, but no later than the 5th day of the cycle. Treatment should be continued for many months (taking the drug every day, without skipping days). If, despite treatment, breakthrough bleeding occurs, the dose of the drug should be increased to 2 or 3 tablets per day for 3-5 days.
To delay normal menstruation. Treatment with one tablet per day is best started two weeks before the expected onset of menstruation. If treatment is started less than one week before the expected onset of menstruation, the dose should be 2-3 tablets per day. In this case, a delay of more than one week is undesirable. If treatment is started later, the possibility of breakthrough bleeding increases. Therefore, treatment should not be started later than 3 days before the expected onset of menstruation.
As an adjunct to estrogen therapy in the peri- and postmenopausal period - for the prevention of endometrial hyperplasia: one tablet per day for 12-15 days per month (for example, during the first 2 weeks of each calendar month). The estrogen preparation should be taken daily, without skipping days, in the minimum effective dose.
Application features
Children
The drug is not used in children, therefore there is no information about this group of patients.
Drivers
Caution is advised when driving or using machinery, as dizziness has been reported in some patients.
Overdose
The toxicity of lynestrenol is very low. In case of overdose (for example, if a child takes several tablets at the same time), intoxication is not expected. Symptoms such as nausea and vomiting may occur. No specific treatment is necessary. If necessary, symptomatic treatment can be used.
Side effects
The frequency of adverse reactions is defined as “common” (more than 10%).
Gastrointestinal: often - nausea, vomiting, abdominal pain, diarrhea, constipation.
On the part of the reproductive system and mammary glands: with a continuous regimen of use of the drug "Orgametril ®", metrorrhagia often occurs.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C, out of the reach of children.
Shelf life - 5 years.
