Medicinal Products

CYPROTERONE ACETATE TEVA 100 mg

Generic drug of Androcur
Therapeutic class: Oncology and hematology
active ingredients: Cyproterone acetate
laboratory: Teva Sante

Tablet breackable
Box of 60
All forms

Indication

· Anti-androgenic palliative treatment of prostate cancer.

· Reduction of sexual urges in paraphilias in combination with psychotherapeutic care.

Dosage ACETATE OF CYPROTERONE TEVA 100 mg Tablet breakable Box of 60

Oral way.

In prostate cancer: 200 to 300 mg, or 2 to 3 tablets a day without interruption.

The maximum dosage is 300 mg per day.

In reducing sexual drive in paraphilias:

It is necessary to associate this treatment with psychotherapeutic care.

Treatment will be initiated at a dose of 100 mg / day. The dose can be increased to 200 mg / day and up to 300 mg / day over a short period. The search for the minimum effective dose (which may be 50 mg / day) will be performed as soon as possible.

When stopping treatment, a gradual reduction of the dose over several weeks is recommended.

Information about special populations

· Children and adolescents

In adolescents, verification of bone age is necessary before any initiation of treatment, CYPROTERONE ACETATE TEVA 100 mg, scored tablet is contraindicated in the growing adolescent (see Contraindications section Contraindications indications).

· Elderly

No data suggest the need for dose adjustment in elderly patients.

· Hepatic insufficiency

The use of CYPROTERONE ACETATE TEVA 100 mg, scored tablet is contraindicated in patients with severe hepatic disease (see section 4.3 ).

· Renal insufficiency

No data suggest the need to adjust the dosage in patients with renal impairment.

Against indications

· Severe hepatic disorders, hepatic tumors (except metastases of prostate cancer), Dubin-Johnson syndrome, Rotor syndrome.

· Tuberculosis and Cachectic Diseases (excluding prostate cancer).

· Existence or history of thromboembolic events.

· Severe chronic depression.

· Sickle cell anemia.

· In the indication reduction of sexual impulses in the paraphilias, in the teenager in the course of growth.

· Existence or history of meningiomas.

Hypersensitivity to cyproterone acetate or any of the excipients.

Adverse effects Cyproterone Teva Acetate

The most serious adverse reactions associated with taking cyproterone acetate are hepatic toxicity, benign or malignant liver tumors that may lead to intra-abdominal hemorrhage and thromboembolic events (see Warnings and Precautions section). employment ).

Reproductive organs and breast disease

· Inhibition of spermatogenesis usually reversible upon discontinuation of treatment (may result in temporary infertility).

Gynecomastia usually reversible upon discontinuation of treatment.

· Incapacity.

· Decreased libido.

· Modification of the secondary sexual characteristics reversible at the end of the treatment (decrease of the pilosity, testicular atrophy, decrease of the musculature).

Endocrine disorders

· Weight variation.

· As described with other antiandrogens, the use of cyproterone acetate in humans may induce bone loss which is a risk factor for possible osteoporosis. Very rare cases have been reported during prolonged treatment with cyproterone acetate at an average dosage of 100 mg per day. This effect was not observed during a short treatment.

Psychiatric disorders

· States of agitation, depressed mood.

Respiratory, thoracic and mediastinal disorders

· Dyspnea.

Vascular disorders

· Aggravation of venous insufficiency of the lower limbs.

· Thromboembolic events.

Nervous system disorders

· Migraines and headaches.

Hepatobiliary disorders

Jaundice, cytolytic hepatitis, fulminant hepatitis, liver failure.

· Benign liver tumors could be observed, even malignant liver tumors leading to isolated cases of abdominal hemorrhage.

General disorders and administration site conditions

· Fatigability, asthenia.

· Hot flashes and sweating.

Skin and subcutaneous tissue disorders

· Rash.

Immune system disorders

· Hypersensitivity reaction.

Blood and lymphatic system disorders

· Anemia.

Benign, malignant and unspecified tumors (incl cysts and polyps)

Cases of meningioma have been reported with prolonged use (several years) of cyproterone acetate at doses of 25 mg per day and above (see sections Contraindications and Warnings and Precautions for Use ).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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