Halotest tablets

International Common Name (ICN) of the active substance

Fluoxymesteronum
COMPOSITION OF PREPARATION
1 tablet contains:
The active substance: fluoximeestone 10 mg;
Excipients: magnesium stearate, FD & C Yellow colorant no. 5, colorant FD & C Blue no. 1, Ludipress® (lactose, polyvidone, crospovidone).
PHARMACEUTICAL FORM
Tablets.
PREPARATION DESCRIPTION
Green tablets of square shape, compact and homogeneous structure with a “BP” dividing line and incrustation on one side and with the inscription “10” on the other, with tapering edges, the side surface with rounded edges. A marble is allowed on the surface of the tablets.
THE PHARMACOTERAPEUTICAL GROUP and the ATC Code
Androgenic hormone, G03B A01.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Fluoximeestone is an androgenic hormone. It is responsible for the growth and development of male sexual organs and secondary sexual characteristics (maturation of the prostate, seminal vesicles, penis and scrotum), male hair distribution (face, pubis, chest), laryngeal development, body muscles and fat distribution. Retains nitrogen, sodium, potassium and phosphorus, increases anabolism and reduces protein catabolism. The premature increase in plasma levels of androgenic hormones in the prepubertal period causes the closure of the epiphyses and the cessation of growth. Stimulates the production of erythropoietin and erythrocytes. At high doses, the feedback mechanism inhibits the secretion of luteinizing hormones and pituitary-like pituitary glands and causes the suppression of spermatogenesis.
In women inhibits pituitary gonadrophic function, ovarian function, mammary glands. It manifests beneficial action during the climacteric period.

Pharmacokinetic properties
In the blood, about 98% is associated with plasma proteins. Biotransformation occurs in 4 up to various 17-ketosteroid, which after conjugation with glucuronic or sulfuric acid is eliminated with urine (about 90%).
THERAPEUTICAL INDICATIONS
In men – substitution hormone treatment in testosterone deficiency disorders:
– restraining sexual maturity;
– eunucoidism, non-development of genitals;
– impotence of hormonal origin;
– hypopituitarism;
– male climax symptoms (decreased libido and physical and intellectual activity);
– post-castration syndrome (androgen deficiency after castration);
– osteoporosis caused by androgen insufficiency.
In women:
– breast cancer;
– breast swelling in the postpartum period.
DOSES AND METHOD OF ADMINISTRATION
Internal.
For children: to retain sexual maturity in the boy: 2.5-20 mg/day for 4-6 months.
For adults:
Men: hypogonadism – 5-20 mg/day.
Women:
– Breast cancer: 10-40 mg/day in several intakes for 1-3 months.
– Breast swelling in the postpartum period: 2.5 mg after birth, then 5-10 mg/day in several intakes for 4-5 days.
SIDE EFFECTS
Benign, malignant and unspecified disorders: prostate abnormalities.
Endocrine disorders: in women with prolonged administration, tumors of virilization, hirsutism, gynecomastia.
Metabolism and nutrition disorders: sodium and water retention with edema, symptoms of hypercalcaemia.
Psychiatric disorders: depression, aggression, anxiety, sleep disturbances.
Nervous system disorders: headache, paraesthesia.
Vascular disorders: thrombophilia.
Gastrointestinal disorders: nausea.
Hepato-biliary disorders: cholestatic jaundice, increased hepatic transaminase levels (normalizes upon discontinuation of treatment).
Skin and subcutaneous tissue disorders: seborrhoea, acne, fat, hair loss.
Musculoskeletal and connective tissue disorders: premature closure of epiphyses.
Reproductive system and breast disorders: in males – priapism and other symptoms of sexual hyperstimulation (frequent erection).
Pre-teenagers – speeding up sexual development. Increasing the frequency of erections, increasing the sexual organ in dimensions. Impairment of spermatogenesis and dysregulation of sperm maturation, oligospermia and reduction of ejaculate volume.
In women – bleeding from the genital pathways, intensification of libido.
CONTRAINDICATIONS
Individual hypersensitivity to the preparation, prostate or breast carcinoma; prostatic hyperplasia with mood disorder symptoms; nephrotic or nephroidic phase, edema; hypercalcemia; liver function disorder; diabetes mellitus; cardiac or coronary insufficiency, past history of myocardial infarction, atherosclerosis in elderly men; pregnancy, lactation period.
OVERDOSE
In acute overdose, toxicity is quite low. Chronic overdose is possible to develop priapism. In this case it is necessary to discontinue the administration of the preparation, and after the symptoms disappear – to resume treatment in lower doses.
WARNINGS AND SPECIAL PRECAUTIONS FOR USE
In case of androgen-dependent adverse reactions, it is necessary to discontinue the administration of the preparation. After disappearance of adverse reactions to resume treatment at lower doses.
Patients with latent or manifest heart failure, renal dysfunction, hypertension, epilepsy or migraine (or the presence of these previous conditions) will be under constant surveillance, as androgen may in some cases cause sodium and water retention. In long-term treatment, hepatic function will be monitored. In breast cancer patients, hypernephroma, lung cancer with bone metastases will be controlled calcium levels in the blood and urine. In adolescents during the prepubertal period, androgen should be administered with caution to avoid premature growth and premature puberty.
INTERACTIONS WITH OTHER MEDICINES, OTHER TYPES OF INTERACTION
Increases the effectiveness of anticoagulants and antidiabetics (dose adjustment is required), inhibits the elimination of ciclosporin. Hepatic enzyme inducers (barbiturates, rifampicin, carbamazepine, phenylbutazone, phenytoin) reduce the effect of the preparation.
PRESENTATION, PACKAGING
10 mg tablets.
Twenty (20) tablets in beige contour foil together with the instruction for administration are placed in a cardboard box.
STORAGE
Keep at temperatures below 25 °C.
Do not freeze.
Store in the original package in order to protect from light and moisture.
Keep out of the reach and sight of children.
TERMS OF VALIDITY
Three (3) years. Do not use after the expiry date stated on the pack!
LEGAL STATUS
It is issued with prescription.
CERTIFICATE OF REGISTRATION
SC Balkan Pharmaceuticals SRL N. Grădescu str., 4, MD-2002, or. Chisinau, Republic of Moldova.
The manufacturer
SC Balkan Pharmaceuticals SRL Industrial Street, 7 / A, MD-2091, or. Singera, Republic of Moldova.

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