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2 Box androcur 50 mg Total 100Tablets Cyproterone Acetate

AN55847

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ANDROCUR® 50 mg tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: Each tablet contains 50 mg cyproterone acetate.

Each tablet contains 110.5 mg lactose monohydrate (105.5 mg lactose).

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$84.00


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Therapeutic indications

Women;

Severe indication of androgenesis;

• Degree of hair loss in face and body (severe hirsutismus),

• Intensive hair loss (severe androgenetic alopecia), which is linked to androgens and can reach up to the limit, which are often in the form of severe acne and / or seborrhea

In men;

• Reduction of sexual dysfunction in sexual deviations

4.2. Posology and application form

Posology / application frequency and duration:

Women

Women with childbearing potential:

AndROCUR® should not be used in gardens. For this reason, it must be ensured that you are not pregnant before treatment.

Women in the age of sexual maturity begin the first day of the treatment cycle (day 1 of the bleeding). Only the treatment recommended by the physician in amenorrhea women is started immediately and the treatment is accepted as the 1st day of the day of the beginning of the treatment and the application is continued as given below.

Cycle 1. days (10 days), 2 tablets of ANDROCUR® 50 mg daily are taken with some liquid after meals. In addition, one tablet of DIANE-35® is taken daily during the 1st and 21st days of the cycle (21 days) to stabilize the cycle and protect against pregnancy.

Women who use combined cyclic therapy should take tablets at certain times of the day.

After 21 days of treatment, a 7-day break is given. In this interim period, there will be a withdrawal bleed. Just four weeks after the start of treatment, which is again the same day of the week, a new cyclic combined treatment begins regardless of whether the bleeding is stopped or continued.

Following clinical recovery, during the first 10 days of combined treatment with DIANE-35® daily

ANDROCUR® 50 mg may reduce to 1 or 1/2 tablet. Sometimes DIANE-35® alone may suffice.

The jump of the wing:

If the bleeding does not occur during the absence of the tablets, treatment should be discontinued and the possibility of pregnancy should be ruled out before resuming tablet ingestion.

Skipped tablets:

Patients using combined cyclic therapy should take tablets every day at the same time. If the patient normally has more than 12 hours to get DIANE-35®, the safety of the contraception for that cycle may be reduced. Special precautions in the short product information of DIANE-35® (especially those concerning contraceptive safety and skipped tablets) should be observed. If the bleeding does not occur after this cycle, the possibility of pregnancy should be excluded before resuming tablet ingestion.

Skipped ANDROCUR® tablets can reduce therapeutic efficacy and cause interstitial bleeding. Skipped ANDROCUR® tablet should be discarded (two doses should not be taken to compensate for missing dose) and tablets should be continued with DIANE-35 at any time.

Patients with postmenopausal or hysterectomy:

ANDROCUR® can be administered alone after menopause or in women who have undergone hysterectomy. The average dose should be 1 or 1/2 tablets per day for 21 days according to the severity of the complaints and should be interrupted for 7 days in a row.

males

The maximum daily dose is 300 mg.

Reduction of sexual nudity in sexual deviations:

Generally, the starting dose is 1 ANDROCUR® 50 mg tablet twice daily. The dose may need to be raised to 2 tablets twice a day, or even 2 tablets three times a day for a short time. When adequate results are obtained, it is necessary to protect the therapeutic effect at the lowest possible dose. Usually 1/2 tablet twice a day may be enough. The dose should be gradually reduced, not abruptly, when the dose is discontinued or treatment is discontinued. It is advisable to apply one tablet daily, at a few weeks intervals, with a better reduction of 1/2 tablet. The long-term administration of ANDROCUR® should be combined with psychotherapeutic measures, if possible, to stabilize the treatment success.

Antiandrogen therapy in unoperable prostate carcinoma: 2 tablets of ANDROCUR® 50 mg (= 200-300 mg) 2-3 times daily

After recovery or remission, treatment should not be discontinued or the dose should not be reduced.

In combination with GnRH-agonists, to reduce initially elevated levels of androgen:

2 tablets (= 200 mg) ANDROCUR® 50 mg alone twice daily for 5-7 days, then two tablets twice daily with 3- and 4-week GnRH agonist ANDROCUR 50 mg (= 200 mg ) is recommended.

To treat hot flashes in patients who have undergone orchiectomy or are treated with combined therapy with GnRH agonists:

1-3 tablets per day ANDROCUR® 50 mg (50-150 mg), if necessary, can be gradually increased up to 2 tablets (300 mg) 3 times a day.

Method of Application :

Women

The tablets are taken with some liquid after meals. males

The tablets are taken with some liquid after meals. 
Additional information on special populations:

Renal insufficiency: There is no data supporting the need for dose adjustment in patients with renal insufficiency.

Hepatic insufficiency: The use of ANDROCUR® in patients with hepatic impairment is contraindicated unless the liver function values ​​return to normal.

Pediatric population: Not recommended for use in boys and adolescents under the age of 18, as there is insufficient data on safety and efficacy.

There is no safety and efficacy data from clinical trials on the use of ANDROCUR® in girls and adolescents under 18 years of age. ANDROCUR® should not be given before puberty, nor can it exert adverse effects on its length and endocrine function axes that have not yet stabilized. ANDROCUR® 50 is indicated in women adolescents only after puberty. No data is available to support dose adjustment.

4.3. contraindications

In women,

• Pregnancy,

• Breast-feeding,

• Liver diseases,

• Dubin-Johnson Syndrome,

• Rotor Syndrome,

• Past jaundice or persistent pruritus in previous pregnancies,

• Previous pregnancy head,

• Previous or existing liver tumors,

• Meningiomic existence or story,

• Diseases causing weight loss,

• Severe chronic depression,

• Previous or existing thromboembolic processes,

• severe diabetes mellitus,

• Sickle cell anemia,

• Hypersensitivity to any of the ingredients in the ANDROCUR® formula. Contraindications in the short product information of the preparation DIANE-35® used in addition to ANDROCUR® should also be taken into account in the cyclic combination treatment of severe androgenesis symptoms.

In men,

Reduction of sexual dysfunction in sexual deviations:

• Liver diseases,

• Dubin-Johnson Syndrome,

• Rotor Syndrome,

• Previous or existing liver tumors,

• Meningiomic existence or story,

• Diseases causing weight loss,

• Severe chronic depression,

• Previous or existing thromboembolic processes,

• severe diabetes mellitus,

• Sickle cell anemia,

• Hypersensitivity to any of the ingredients in the ANDROCUR® formula.

Use of antiandrogen therapy in unoperated prostate carcinoma:

• Liver diseases,

• Dubin-Johnson Syndrome,

• Rotor Syndrome,

• Previous or existing liver tumors (if not only due to prostate carcinoma metastases),

• Meningiomic existence or story,

• Diseases that cause weight loss (other than unoperable prostate cancer),

• Severe chronic depression,

• Current thromboembolic processes,

4.4. Special use warnings and precautions

Liver

Direct liver toxicity including jaundice, hepatitis and hepatic failure was observed in patients treated with ANDROCUR®. 100 mg and over-dosing cases have also been reported. Most reported fatal cases are men with advanced prostate carcinoma. Toxicity is due to dozza and usually develops months after treatment begins. Liver function tests should be performed before the onset of treatment, at regular intervals during treatment and when symptoms and signs suggest hepatotoxicity. In men, ANDROCUR® therapy should be discontinued if hepatotoxicity is confirmed, or if it can not be explained by other causes such as metastatic disease; and in the presence of another cause, ANDROCUR® treatment should be continued only if the expected benefit is more than a risk. In women, when hepatotoxicity is confirmed,

After the use of ANDROCUR®, benign and malignant liver tumors (very rare in males), which may lead to life-threatening intrabdominal bleeding, have been observed. When severe upper abdominal complaints, liver enlargement or intraabdominal bleeding are seen, liver tumor should be considered at the differential diagnosis.

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4.3. contraindications

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Thromboembolic events

Thromboembolic events have been reported in patients using ANDROCUR®, but no causal relationship has been established. Patients with arterial or venous thrombotic / thromboembolic events (such as deep venous thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular event stories or advanced malignancies are at increased risk for thromboembolic events.

(Males);

The benefit and risk of ANDROCUR® treatment should be assessed individually and individually in patients with non-operative prostate carcinoma with a history of severe diabetes accompanied by thromboembolic process or sickle cell anemia or vascular changes.

Anemia (in males);

Anemia has been reported during ANDROCUR® therapy. Therefore, the number of red blood cells should be checked regularly during treatment.

Diabetes

4.3. contraindications

Shortness of breath

Some patients may experience a shortness of breath under high-dose ANDROCUR® therapy. Respiratory stimulant effects should also be considered in such cases when the differential diagnosis is accompanied by progesterone and synthetic progestagens, hypocapnia and compensated respiratory alkalosis and does not require treatment.

Adrenocortical function

Preclinical studies Adrenocortical function should be checked regularly during treatment, as ANDROCUR® indicates a possible suppression due to the corticoid-like effect (see Section 5.3 Preclinical safety data).

Combination therapy (in women)

If staining occurs during combined treatment, the tablet intake should not be interrupted.

In addition, in connection with the mandatory use of DIANE-35, all information concerning the use in the short product information of this preparation should be taken into consideration.

Other situations (in men)

If ANDROCUR® is used with the intention of suppressing sexual stimulation, alcohol may reduce this stimulatory-suppressive effect of ANDROCUR®.

Lactose:

ANDROCUR® 50 contains 105.5 mg lactose per tablet.

Patients with rare hereditary galactose intolerance, Lapp lactose deficiency or glucose galactose malabsorption problem should not use this drug.

4.5. Interactions with other medicinal products and other forms of interaction

Although clinical interaction studies have not been conducted, ketoconazole, itraconazole, clotrimazole, ritonavir and

Other potent inhibitors of CYP3A4 are expected to inhibit the metabolism of cyproterone acetate. It is also known that CYP3A4 inducers, e.g. products containing rifampicin, phenytoin, and St. John's wort may reduce cyproterone acetate levels.

In vitro inhibition studies have shown that high doses of therapeutic cyproterone acetate at 100 mg three times a day may be able to inhibit the cytochrome P450 enzymes CYP2C8, 2C9, 2C19, 3A4 and 2D6.

Because they share the same metabolic pathway, the risk of myopathy or rhabdomyolysis due to statins may increase when HMGCoA inhibitors (statins) metabolized by CYP3A4 as primers are used in combination with high therapeutic doses of cyproterone acetate.

Additional information on special populations

4.6. Pregnancy and lactation

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