Primoliut-Nor (norethisterone acetate) tablets 5 mg. №60

Description

Primoliut-Nor Composition
active substance: 5 mg norethisterone acetate;
Excipients: lactose monohydrate, corn starch, polyvidone 25000, talc, magnesium stearate.

Dosage form
Tablets.

Pharmacological properties
Norethisterone is a progestogen. In women who are sensitive to estrogen, a course of oral administration of 100-150 mg of norethisterone during one menstrual cycle can achieve a continuous change in the endometrium, ie from proliferative to secretory.
Gonadotropin secretion and anovulation are inhibited by daily administration of 0.5 mg of norethisterone acetate.
Norethisterone is a pyrogenic substance and affects the basal body temperature.

Indication
Secondary amenorrhea and endometriosis.

Contraindication
Primoliut-Nor should not be used in the presence of any of the conditions or diseases listed below. If one of them occurs during treatment with the drug, the drug should be discontinued immediately.

• Pregnancy or suspicion of it;
• Breast-feeding;
• Venous or arterial thrombotic / thromboembolic events (eg myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary thromboembolism) now or in the anamnesis;
• Presence or history of thrombosis precursors (such as transient ischemic attack, angina);
• The presence of high risk factors for arterial thrombosis;
• Migraine with a history of focal neurological symptoms;
• Diabetes mellitus with vascular complications;
• Severe liver disease now or in the past, until liver function tests return to normal;
• Dubin-Johnson syndrome, Rotor syndrome, as well as jaundice or severe skin itching during previous pregnancies;
• Previous cases of pemphigoid in pregnant women (herpes of pregnant women).
  Benign or malignant liver tumors present or past;
• Malignant tumors that are dependent on the influence of sex hormones, or suspicion of their presence (eg, genitals or breast);
• Hypersensitivity to norethisterone or to any of the excipients;
• Presence of a history of idiopathic jaundice or severe itching during pregnancy;
• Vaginal bleeding of unknown etiology;
• Untreated endometrial hyperplasia;
• Use of direct-acting antiviral drugs containing ombitasvir, paritaprevir, or dasabuvir, or combinations thereof.

Method of application and dosage
Non-hormonal contraceptive methods (barrier) should be used to prevent pregnancy.
Dosage:

• Secondary amenorrhea
  Hormonal treatment of secondary amenorrhea can be carried out only after the exclusion of pregnancy.
  Before starting treatment for secondary amenorrhea, the presence of a pituitary tumor that secretes prolactin should be ruled out. It cannot be ruled out that macroadenomas increase in size under the action of high doses of estrogen over a long period of time.
  Before using Primoliut-Nor, the endometrium should be prepared with estrogen (for example, for 14 days). After that, take 1-2 tablets of the drug Primolyut-Nor per day for 10 days. Withdrawal bleeding begins a few days after the last pill.
  When the body achieves sufficient estrogen production, it is possible to try to stop estrogen treatment and cause cyclic bleeding by using 1 tablet of Primoliut-Nor 2 times a day from the 16th to the 25th day of the cycle.
• Endometriosis
  Treatment is started between the 1st and 5th day of the cycle with the drug Primoliut-Nor 1 tablet 2 times a day. In case of blood smear it is necessary to increase the dose and take 2 tablets 2 times a day. After the bleeding has stopped, the dose can be reduced to the initial dose. The duration of treatment is at least 4-6 months. With continuous daily use of the drug ovulation and menstruation are usually absent.

Application method
The tablets are taken with a small amount of liquid and not chewed.

Children
The drug should not be used in children.

Overdose
Acute toxicity studies have not shown a risk of acute adverse reactions with accidental administration of the drug in a dose several times higher than the daily therapeutic dose.

Side effects:

• From the immune system: Hypersensitivity reactions;
• From the nervous system: Headache, migraine;
• From the eyes: Visual impairment;
• From the respiratory system, mediastinum and chest: Shortness of breath;
• From the gastrointestinal tract: Nausea;
• From the skin and subcutaneous tissue: Urticaria, rash;
• From the reproductive system and mammary glands: Uterine / vaginal bleeding, including blood smears,
• Intense menstruation (hypomenorrhea), Amenorrhea;
• General disorders: Edema.

Expiration date
5 years.

Storage conditions
Store at a temperature not exceeding 30 ºC out of reach of children.