Orgametril
Gynecology

Orgametril

Orgametril

Orgametril – a drug belonging to the group of sex hormones and modulators of the reproductive system, estrogen derivatives. It is recommended for polymenorrhea, endometriosis, as an adjunct to estrogen therapy in the period before and after menopause. For more information about the methods of use and contraindications, see the instructions.

Information

Indications for use (instruction): Orgametril

  • 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 addition to estrogen therapy during the period of peri- and postmenopause, with the aim of preventing endometrial hyperplasia.

How to use

Orgametril® tablets should be used orally and preferably washed down with water or another liquid.

The missed dose should be taken as soon as possible, unless more than 24 hours have passed after skipping the pill.

Polymenorrhea
1 tablet per day from the 14th to the 25th days of the cycle.

Menorrhagia and metrorrhagia
2 tablets for 10 days. In most cases, bleeding stops a few days after the start of treatment. Repeat treatment for 3 menstrual cycles, taking 1 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, a further examination of the patient is necessary.

Individual 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 ethinyl estradiol per day for 25 days. Along with this, 1 tablet of the drug Orgametril® is taken daily from the 14th to the 25th day of the cycle. In most cases, withdrawal bleeding begins within 3 days after discontinuation of treatment. Estrogen treatment restore on the 5th day of withdrawal bleeding and extend until the 25th day of the cycle. Then again from the 14th to the 25th day of the cycle, apply 1 tablet of the drug Orgametril®. Such treatment should be repeated for at least one more cycle.

Endometriosis
1–2 tablets per day for at least 6 months.

Benign breast tumors
1 tablet per 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 1 tablet per day is best started on the 1st day of the cycle, but no later than on the 5th day of the cycle. Treatment should be continued for many months (taking the drug daily, without days of admission). 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 1 tablet per day is best started 2 weeks before the expected onset of menstruation. If the course of treatment is started less than 1 week before the expected start of menstruation, the dose should be 2–3 tablets per day. In this case, a delay of more than 1 week is undesirable. If the course of 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 addition to estrogen therapy during the period of peri- and postmenopause – with the aim of preventing endometrial hyperplasia
1 tablet per day for 12–15 days per month (for example, during the first 2 weeks of each calendar month). An estrogenic drug should be taken daily, without days of admission, at the minimum effective dose.

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

Children. The drug is not used for children, so there is no information about this group of patients.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients that make up the drug Orgametril®.
  • Pregnancy period or its probability.
  • Severe forms of liver disease, for example, 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.
  • Vaginal bleeding of unknown etiology.
  • Conditions that are affected by the intake of sex steroid hormones and which first appeared or worsened during pregnancy or during treatment with sex steroid hormones, such as severe itching, cholestatic jaundice, herpes in pregnant women, porphyria and otosclerosis.
  • Venous thromboembolic disorders in the active phase.

Composition

Active ingredient: lynestrenol (linestrenol);

1 tablet contains 5 mg of linestrenol.

Excipients: potato starch; alpha-tocopherol, glycerin, magnesium stearate, talc, lactose, monohydrate.

Release form

30 tablets in a blister, 1 blister in a carton.

Storage conditions

Store in the original package at a temperature not exceeding 30 °C. Keep out of the reach of children.

Manufacturer

N.V. Organon

Legal address: 5349 AB Oss, Kloosterstraat 6, The Netherlands

Location of business: Molenstraat 110, 5342 SS Oss, The Netherlands.

Sanitary and hygienic conclusion

No. 2691 dated 12/27/2019
Registration Certificate No. UA/2844/01/01