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Instruction for use: Danodiol

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ATX Code G03XA01 Danazol

Active substance: Danazol

Pharmacological group

Hormone Hypothalamus, Hypophyse, Gonadotropin und deren Antagonisten

Nosological classification (ICD-10)

N60.1 Diffuse cystic mastopathy

Benign cystic change in mammary glands, Cystic fibrosis mastopathy, Fibrous-cystic mastopathy, Pre-cancerous condition of mammary glands, Benign mammary gland disease, Benign breast tumor

N62 Hypertrophy of the breast (breast) gland

Gynecomastia, Hypertrophy of the mammary glands, Macromastia

N80 Endometriosis

Endometrioid endometriosis

N92 Abundant, frequent and irregular menstruation

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

N94.3 Premenstrual tension syndrome

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

N97 Female infertility

Female infertility in anovulation, Hyperprolactinemic infertility, Hyperprolactinaemia with infertility, Endocrine infertility, Infertility due to hypothalamic-pituitary dysfunction, Infertility infertility, Infertility, Infertility on the background of hyperprolactinaemia, Functional infertility, Marriage is infertile, Infertility of ovarian genesis, Stimulation of the growth of a single follicle

T78.3 Angioedema

Edema Quincke, Laryngeal exacerbation with angioneurotic edema, Recurrent angioedema, Allergic edema, Recurrent swelling of Quincy


1 tablet contains danazol 200 mg; In the package of 30 pcs.

pharmachologic effect

The pharmacological action is antigonadotropic.

Inhibition of pituitary FSH and LH secretion.


Endometriosis and the resulting infertility; Benign diseases of the mammary glands, including gynecomastia, fibrocystic mastopathy, hypertrophy of the mammary glands at pubertal age; Primary menorrhagia, premenstrual syndrome, hereditary angioedema.


Pregnancy, lactation.

Side effects

Amenorrhea, hot flashes, sweating, changes in the size of the mammary glands, libido, vaginitis, androgenic effects (acne, increased skin fatigue, edema, hirsutism, voice change, etc.), GI disorders, headache, dizziness, depression, sleep disturbance, tremor , Muscle spasms, convulsions, increased functional hepatic parameters, skin rashes.

Dosing and Administration


In endometriosis - in the usual initial dose of 400 mg per day in 2-4 doses, starting on the first day of the menstrual cycle; Can appoint up to 800 mg / day; Course of treatment - 6 months.

At the initial menorrhagia - 100-400 mg in 2-4 admission, starting from the first day of the menstrual cycle (the dose is set individually).

In benign breast diseases - 100-400 mg per day in several receptions.

At early puberty in children - on 100-400 mg / day (proceeding from age and reaction).

Precautionary measures

Before beginning treatment of patients with amenorrhea, pregnancy should be excluded (if pregnancy occurs during treatment, it is immediately stopped). With caution appoint for violations of the heart, liver, kidney, migraine, epilepsy, diabetes.

storage Conditions

In a dry, cool place.

Keep out of the reach of children.

Shelf life

5 years.

Do not use after the expiry date printed on the package.

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