cyproterone | Androkur tablets 10 mg, 15 pcs.

Packaging

15 pcs

Indications

Manifestations of androgenization of moderate severity in women, such as: moderate hirsutism (pathological hair growth of the face and body of moderate severity)

androgenic alopecia of moderate severity (androgen-induced baldness of moderate severity) srdlk severe acne), accompanied by inflammation, nodule formation, or the risk of scarring, and seborrhea.

Contraindications

pregnancy

breastfeeding

liver disease (including Dubin-Johnson syndrome, Rotor syndrome, liver tumors, incl. a history of)

idiopathic jaundice or persistent itching during a previous pregnancy

herpes pregnant women with a history of

cachexia

severe chronic depression

meningioma (including history)

thrombosis or arterial thrombosis (thrombosis) (including thrombosis, deep vein thrombophlebitis, pulmonary thromboembolism, myocardial infarction, stroke, cerebrovascular disorders)

severe diabetes mellitus with diabetic angiopathy

sickle cell anemia

lactase deficiency, lactose intolerance, glucose-galactose malabsorption

hypersensitivity to any of the components of the drug

adolescence (until puberty is completed).

Contraindications for the use of Diane®-35, which is prescribed in combination with Androcur®, should also be taken into account.

Caution: Patients with diabetes have a disease / condition requiring precautions when using Diane®-35.

Pregnancy and lactation

Androkur is contraindicated in pregnancy.

If necessary, the appointment of the drug during lactation should decide on the termination of breastfeeding.

Composition

1 tablet contains:

Active ingredients: cyproterone acetate, micro 20 - 10 mg

Excipients: lactose monohydrate - 63.4 mg, corn starch - 44 mg, povidone 25 000 - 1.35 mg, colloidal silicon dioxide micronized - 1 mg, magnesium stearate - 0.25 mg.

Dosage and administration of

For women

In cases of moderate androgenization, the drug is taken in the form of 10 mg tablets daily from the 1st to the 15th day of the menstrual cycle at a dose of 10 mg 1 time / day. Androcur in the form of 10 mg tablets is taken with Diane-35 to obtain the necessary contraceptive effect and to exclude intermenstrual bleeding.

To stabilize the cycle and for the purpose of reliable contraception, patients with androgenization phenomena additionally take Diane-35, 1 tablet / day at the same hours from the 1st to the 21st days of the cycle. Both drugs should be taken on the 1st day of the cycle (first day of bleeding). After stopping the use of Androkur (the 10th or 15th day of the cycle), for the next days of the cycle, the remaining tablets are taken from the calendar package of Diane-35 (a total of 21 days). Then follows a break of 7 days, during which bleeding should occur. After a 7-day pause, administration is continued from the following calendar packs of Androkur and Diane-35 preparations, regardless of whether the bleeding has ended or is still ongoing. If bleeding has not occurred after the pill has been taken, treatment should be discontinued and screened.

The duration of treatment is determined by the doctor and depends on the type, as well as the severity of the pathological phenomena of androgenization and treatment results. Acne and seborrhea are usually treatable sooner than alopecia.

Androkur tablets are taken orally after a meal, washed down with a small amount of liquid.

Side effects

Benign, malignant and unspecified neoplasms (including cysts and polyps): benign and malignant tumors of the liver (see "Special instructions").

On the part of the immune system: hypersensitivity reactions.

From the side of metabolism and nutrition: weight loss, weight gain, hyperglycemia.

Mental disorders: depression, increased libido, decreased libido.

From the gastrointestinal tract: intra-abdominal bleeding (see "Special instructions").

From the liver and biliary tract: impaired liver function, jaundice, hepatitis.

From the skin and subcutaneous tissue: rash.

From the genitals and mammary gland: tension, tenderness of the mammary glands, lack of ovulation, acyclic bleeding or lack of menstrual bleeding, spotting from the vagina.

Drug Interaction

When used with Androcur, changes in the efficacy of hypoglycemic drugs and insulin may occur.

The antiandrogenic action of cyproterone acetate is enhanced when it is co-administered with GnRH agonists, and under the action of cyproterone acetate, the initial increase in testosterone production by GnRG agonists is reduced.

Overdose

Acute toxicity studies of Androkur have shown that cyproterone acetate can be attributed to very low toxicity.

The chance of developing intoxication should not be expected with the accidental intake of several Androkur tablets.

Storage conditions

No specific storage conditions.

Expiration

5 years.

Active ingredient

cyproterone

dosage form

dosage form

tablets

Bayer Pharma AG, Germany