NORKOLUT 5MG 20 TABS — MADE IN HUNGARY — FREE SHIPPING

Composition

Active substance: norethisterone; 17α-ethynyl-17β-hydroxy-4-estren-3-one (one tablet contains 5 mg of norethisterone).

Excipients: potato starch, magnesium stearate, anhydrous colloidal silicon dioxide, gelatin, talc, corn starch, lactose monohydrate.

Contraindications

Do not use the preparation  "Norkolut®" in the presence of any of the conditions or diseases listed below:

• pregnancy or suspicion of it;
• lactation;
• Blood clot formation in the veins (thrombosis), for example, in the blood vessels of the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• high risk of venous or arterial thrombosis;
• conditions preceding thrombosis (including transient ischemic attack, angina pectoris) in history;
• migraine with a history of focal neurological symptoms;
• diseases associated with poor circulation in the arteries, such as myocardial infarction or stroke, now or in the past;
• diabetes mellitus with vascular complications;
• severe liver disease, now or in the past, until liver function tests return to normal (symptoms of liver disease may include, for example, yellowing of the skin and / or itching of the whole body);
• Dubin-Johnson syndrome, Rotor syndrome, and jaundice or cases of severe pruritus during previous pregnancies;
• previous cases of pemphigoid pregnant (herpes pregnant);
• benign or malignant liver tumors now or in the past;
• malignant tumors, dependent on the influence of sex hormones (for example, of the breast or genitals), which are present or were in the past;
• vaginal bleeding of unknown etiology;
• untreated endometrial hyperplasia;
• hypersensitivity to norethisterone or to any of the auxiliary components of the preparation .

If any of the above conditions occurs for the first time while taking the preparation , you should immediately stop taking it and consult your doctor.

Application methods

Take the tablets whole with liquid, without chewing.

The effectiveness of Norkolut® tablets may be reduced if the patient forgets to take the tablet as indicated. The patient should only take the last missed pill as soon as she remembers, and then continue taking the pills at the usual time the next day.

If contraceptives are needed, non-hormonal methods of contraception should be used additionally.

Secondary amenorrhea

Any hormonal therapy for secondary amenorrhea can be performed only after pregnancy has been ruled out. In some cases, secondary amenorrhea is caused by prolactinoma, which should be excluded before using the preparation  "Norkolut®".

The doctor prescribes a preparation  containing estrogens (for example, within 14 days) before the use of Norkolut® is started. After that, take one tablet of the preparation  "Norkolut®" 1-2 times a day for 10 days. Withdrawal bleeding begins a few days after the last pill is taken.

When a sufficient level of estrogen production is reached, you can try to stop estrogen therapy and cause cyclic bleeding using one tablet of the preparation  "Norkolut®" 2 times a day from the 16th to the 25th day of the cycle.

Endometriosis

Treatment should be started between the first and fifth day of the cycle, using one tablet of Norkolut® twice a day. In case of bleeding, it is necessary to increase the dose and take two tablets of the preparation  "Norkolut®" twice a day. After the bleeding has stopped, you can reduce the dose to the initial one. The duration of the course of treatment is at least 4-6 months. With continuous daily use of the preparation , ovulation and menstruation are absent. After the completion of hormone therapy, withdrawal bleeding occurs.

Application features

Children

The preparation  should not be used in children.

Drivers

There was no difference in the effect on the ability to drive or operate machinery.

Overdose

Acute toxicity studies have not demonstrated the risk of acute adverse reactions in case of accidental intake of the preparation  in a dose that is several times higher than the daily therapeutic dose.

Side effects

Side effects more often occur in the first months after the start of taking the preparation  "Norkolut®".

Such adverse events have been reported in patients taking norethisterone, although causation has not always been possible to confirm.

On the part of the reproductive system and mammary glands: very frequent (≥ 1/10) - uterine / vaginal bleeding, including spotting; hypomenorrhea.

Storage conditions

Store at a temperature not exceeding 30 ° C, out of the reach of children.

The shelf life is 5 years.

Norkolut use Instruction.

Active substance Norethisterone.

Pharmacological groups: Estrogens, gestagens; Their homologues and antagonists.

Nosological classification:

Other benign neoplasms of the uterus:

Fibromyoma of the uterus, Myoma, Uterine fibroids, Fibromyoma, Myoma of the uterus, Fibrrios, Meigs syndrome, Tumors of the uterus.

Mastodinia: Mastalgia, Soreness of the mammary glands, Cooper's disease.

Endometriosis: Endometrioid endometriosis

Lack of menstruation, meager and rare menstruation:

Amenorrhea, Amenorrhea hypogonadotropic, Amenorrhea is prolactin-dependent, Oligomenorrhoea, Shortening of the secretory phase of the menstrual cycle, Menstrual disorders, Menstruation disorders, Prolactin-dependent amenorrhea without galactorrhea.

Abundant, frequent and irregular menstruation:

Metromenorragii, Menorrhagia, Menorrhagia primary, Polymenorea, Idiopathic menorrhagia, Menorrhagia, Functional metronormorragia, Primary menorrhagia.

Other abnormal bleeding from the uterus and vagina:

Atonic uterine bleeding, Prolonged menstruation, Blood loss during menstruation, Bleeding from the genitourinary system, Bleeding uterine dysfunctional, Bleeding from the genital tract of organic etiology, Uterine bleeding, Menorrhagia with fibroids, Functional uterine bleeding, Abnormal bleeding from the genitals in women.

 Premenstrual tension syndrome:

Pronounced premenstrual syndrome, Menstrual psychosomatic disorder, Menstrual syndrome, Premenstrual tension, Premenstrual status, Premenstrual period, Premenstrual syndrome, Menstruation syndrome.

Dysmenorrhea Unspecified:

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya.

Monitoring contraceptive use:

Local Contraception, Contraception oral, Local contraception, Episodic prevention of pregnancy, Hormonal Contraception, Contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Contraceptive intrauterine, Contraception in women with androgenization phenomena, Installation and removal of the intrauterine device, Prevention of pregnancy (contraception).

General advice and advice on contraception:

Safe sex, Intrauterine device contraception, Contraception, Contraceptive intrauterine, Oral contraception, Oral contraception during lactation and with estrogen contraindications, Postcoital contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Emergency Contraception, Episodic prevention of pregnancy, Contraception in adolescents, Prevention of pregnancy (contraception).

Composition and form of release: Tablets 1 table. Norethisterone 5 mg, each of 20 pieces.

pharmachologic effect: Pharmacological action - progestagenic.

Promotes the transition of the proliferative phase of the menstrual cycle into the secretory. Inhibits the secretion of gonadotrophin by the pituitary gland, preventing the maturation of follicles and ovulation.

Indication of Norkolut: Premenstrual syndrome, dysmenorrhea with a contraction of the secretory phase, dysfunctional uterine bleeding, cystic glandular hyperplasia of the endometrium, endometriosis, uterine fibroids, mastalgia, prevention and cessation of lactation, contraception.

Contraindications: Malignant tumors of the mammary gland and genital organs.

Side effects: Dyspepsia, nausea, headache, fatigue, paresthesia, mastalgia, intermenstrual bleeding, swelling, changes in body weight.

Interaction: Preparations that activate microsomal liver enzymes (barbiturates, etc.), accelerate metabolism and weaken the effect; On the contrary, inhibitors (cimetidine and others) - strengthen it.

Dosing and Administration: Inside. With premenstrual syndrome, mastalgia, dysmenorrhea: from 16 to 25 days of the menstrual cycle of 5-10 mg per day in combination with estrogens.

With dysfunctional uterine bleeding, cystic glandular hyperplasia of the endometrium: to stop bleeding - 5-10 mg per day for 6-12 days; To prevent bleeding - 5-10 mg per day from 16 to 25 day of the cycle for 6 months.

To stop lactation: the first 3 days - 20 mg per day, then 4 days - 15 mg, then 3 more - 10 mg.

Contraception: 1,25-2,5 mg per day from 1-5 days of the menstrual cycle for 21 days (in combination with ethinyl estradiol), then break for 7 days.

storage Conditions: At a temperature of 15-30 ° C. Keep out of the reach of children.

Shelf life: 5 years. Do not use after the expiry date printed on the package.