Primolut-Nor 5mg. 30 tablets

Active substance: norethisterone acetate Important information, please read carefully! Sastav1 tablet Primolut Nor 5 contains 5 mg norethisterone acetate.
Excipients: monohndrat lactose, corn starch, polyvidone 25,000, talc, magnesium stearate
Nor Primolut 5 comes in a glass bottle containing 20 tablets.

Evidence
Dysfunctional uterine bleeding, primary and secondary amenorrhea, premenstrual syndrome, mastopathy, regulate menstruation, endometriosis.

Dosage and Administration
Before starting treatment with 5 Primolut Nor must be thoroughly general medical and gynecological examination (including breast screening smear of the cervix) and exclude bremennost.Kato precaution checkups should be performed approximately 6 months prolonged treatment with Primolut Nor 5. The tablets should be swallowed whole with some liquid.
The following dosage regimens are recommended, unless the doctor prescribes otherwise:
Dysfunctional uterine bleeding
Administration of one tablet Primolut Nor 5 twice daily for 10 days resulted in the arrest of uterine bleeding not associated with organic lesions within 1 -4 days. In individual cases, bleeding diminishes during the first few days after the tablet and stops 5 to 7 days after. For treatment to be successful, the application of Primolut Nor 5 should be continued regularly even after arrest of bleeding (up to 20 table. Primolut Nor 5) Around 2-4 days after discontinuation of treatment a withdrawal bleeding will occur resembling a normal menstruation in intensity and duration.
Slight bleeding during tablet-taking
Sometimes after the initial arrest of bleeding may again appear slightly bleeding. In these cases tablet not preustanovyava.Nespirashto bleeding, heavy breakthrough bleeding If the bleeding does not stop in spite of regular tablet, be considered an organic cause. The attending physician must be informed immediately ,, as are necessary further measures. This applies to cases where after initial arrest of bleeding, fairly heavy bleeding reoccurs during the tablets.

Prevention of relapse bleeding
To prevent dysfunctional bleeding is recommended to appoint Primolut Nor 5 prophylactically during the next three cycles napr.1 table. Nor Primolut 5 twice daily from the 19th to the 26th day of the cycle (the first day of the cycle = first day of the last bleeding). Withdrawal bleeding occurs some days after the last tabletka.Samo doctor can decide whether these measures are necessary. Its decision is then based on the progress of the basal body temperature, which should be measured daily.

• Primary and secondary amenorrhea
In the case of secondary amenorrhoea hormone treatment should begin as early as 8 weeks after the last menstruatsiya.S to cause bleeding similar to a menstrual period prior to treatment with 5 Primolut Nor is taken estrogen (eg. Progynon Depot 10 mg) .Before beginning therapy should exclude the presence of a pituitary tumor, producing prolactin, since according to the existing data hitherto can not be ruled macroadenoma to increase in size when treated with higher doses of estrogen over a prolonged period of time .
Home treatment
2 ampoules Progynon Depot 10 mg intramuscularly into the first day of treatment 1 ampoule and Progynon Depot 10 mg intramuscularly on the 14th day of treatment, followed by 1 tablet Primolut Nor 5 twice a day from the 19th to the 26th day of treatment . Withdrawal bleeding begins on the 28th day.

Continuation of treatment (minimum 2-3 tsikala-)
1 ampoule Progynon Depot 10 mg im on the 6th and 16th day of the artificial cycle followed by one tablet Primolut Nor 5 days from 19th to 26th day of the cycle (first day of bleeding = 1 st day of the cycle).
Then it can try to stop the estrogen treatment etc. to induce a cyclical bleeding by administration of 1 tablet. Nor Primolut 5 days from 19th to 26th day of tsikala.Izklyuchenie: Patients can be safely assumed that endogenous estrogen production is insufficient (primary amenorrhoea in gonadal genesis of the ovaries).

Caution:
Contraception should be practiced with non-hormonal methods (with the exception of the rhythm and temperature methods). If withdrawal bleeding that occurs at regular intervals of about 28 days fails to occur under the therapeutic scheme (see above) the possible presence of pregnancy despite precautions. Then treatment should be discontinued until the situation is clarified by differential diagnosis.
• Premenstrual syndrome, mastopathy
Premdenstrualni symptoms such as headaches, depressive mood swings, fluid retention, a feeling of tension in the chest, can be relieved or palliated by taking one tablet Primolut Nor 5 once or twice a day from 19th to 26th day tsikala.Posochenoto in "Warning" for the indication "Primary and secondary amenorrhoea" apply sagtso in these indications.
• Timing of menstruation
The monthly bleeding can be advanced or postponed if special circumstances warrant it. To accelerate preferred combination progestagen-estrogen, as in inhibiting ovulation is excluded pregnancy. Unlike acceleration postponement of menstruation calls for the use of Primolut Nor 5, when necessary exclusion of pregnancy can be problematic. Nor Primolut 5 should be taken at a time when it can not be ruled out pregnancy by using modern research methods. Therefore, this method remains restricted to those cases where there is no possibility of early pregnancy in the cycle.
Dosage: 1 tablet. Nor Primolut 5 twice a day for no more than 10-14 days, beginning three days before the expected menstruation. Bleeding will occur 2-3 days after stopping the drug. If it does not appear necessary advice.

• Endometriosis
Treatment starts on the fifth day of the cycle with 1 tablet. Nor Primolut 5 twice daily, increasing to 2 tablets. 5 rag twice daily. When the bleeding stops, the initial dosage can be restored. Duration of treatment - at least 4-6 months. During treatment, ovulation and menstruation can occur. After discontinuation of hormone treatment will appear withdrawal bleeding.

Adverse reactions
In rare cases nausea. Different skin complaints.

Contraindications
Pregnancy, severe liver dysfunction syndrome Dubin- Johnson, syndrome Rotor, liver tumors or a history of such a history of jaundice or severe pruritus during pregnancy, a history of herpes in pregnancy, thromboembolic processes.
Increased sensitivity to the active substance or any of the other ingredients of the product ..
Reasons for immediate discontinuation of the tablets
First appearance of migraine headaches or more frequent occurrence of unusually severe headaches, sudden perceptual disorders (eg. Visual or hearing), first signs of thrombophlebitis or thromboembolic symptoms (eg. Unusual pain in swelling of the legs, stabbing pains when breathing or coughing of unknown cause), feeling of pain and tightness in the chest, pending operations (six weeks beforehand) and immobilization (eg after an accident), the occurrence of hepatitis or jaundice, itching, significant rise in blood pressure, pregnancy .

Special notes
The doctor should be informed if the patient suffers from diabetes, since this disease requires special nablyudenie.Neobhodimostta of oral antidiabetics and insulin may change. Epidemiological studies have found that the use of estrogen / progesterone containing oral inhibitors of ovulation is accompanied by an increased frequency of thromboembolic diseases. Although Primolut Nor 5 does not contain estrogen should be given the possibility of an increased risk of thromboembolic events, particularly those with a history of thromboembolic disorders or in the presence of severe diabetes with vascular changes or syrpovidno B cell anemia.
In rare cases, after use of hormonal substances similar to that contained in Primolut Nor 5 were benign and in even rarer cases -zlokachestveni liver tumors leading in isolated cases to life-threatening bleeding. The doctor should therefore be informed of the presence of unusual symptoms in the upper abdomen that do not resolve spontaneously a short time.
Modern research confirms that norethisterone acetate is partly metabolized to ethinylestradiol. Once estrogen activity norethisterone was postulated and subsequently proven in clinical practice, further disclosure of metabolic properties will not change existing recommendations for use.
All medicines to be stored as directed and to keep out of reach of children