The active substance of this preparation is turned into testosterone by your body. Testosterone is the natural male hormone, necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. Preparations containing Testosterone are usually prescribed to replace the hormone if the body is unable to produce enough on its own. Testosterone are soft oval glossy capsules, transparent, orange-red colour, with an oily fill.

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution.

Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

Testosterone plays a key role in male sexual differentiation and is involved in regulation of hematopoiesis, body composition, and bone metabolism. As a result, Testosterone replacement therapy in males with hypogonadism can result in improved sexual function, increased lean body mass, bone density, erythropoiesis, prostate size, and changes in lipid profiles.

Testosterone is produced by Leydig cells and exerts it's effects by binding to androgen receptors throughout the body. Testosterone affects the voice, genitalia, mood, and influences muscle growth and protein expression. Accordingly, males with low levels of Testosterone often experience decreased libido, fatigue, mood changes and dysphoria. Exogenous sources of Testosterone are designed to mimic the effects of endogenous Testosterone.

40 mg capsule: Usually, the dosage is 3-4 capsules daily during the first 2-3 weeks, followed by a gradual decrease to 1-3 capsules daily. You must take Testosterone with a meal. Swallow the capsules whole without chewing, using some water or other fluid. Take half of the daily dose in the morning and the other half in the evening. If the daily dose is an uneven number of capsules, take the larger number in the morning. If you have the impression that the effect of Testosterone is too strong or too weak, inform your doctor immediately.

If you forget to take Testosterone, do not take a double dose to make up for the forgotten individual dose. When treatment with Testosterone is stopped, complaints as those before treatment may re-occur within a few weeks.

112.5 mg capsule: Prior to initiating Testosterone, confirm the diagnosis of hypogonadism by ensuring that serum Testosterone concentrations have been measured in the morning on at least two separate days and that these serum Testosterone concentrations are below the normal range. The recommended dosage of Testosterone is 225 mg (taken as two 112.5 mg capsules), orally twice daily, once in the morning and once in the evening. Take with food

Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.

Corticosteroids: The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease.

Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Concomitant administration of these medications with Testosterone may lead to additional increases in blood pressur.

Testosterone is contraindicated in:

• Patients with carcinoma of the breast or known or suspected carcinoma of the prostate.
• Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman
• Known hypersensitivity to testosterone undecanoate or any of Testosterone's ingredients.
• Men with hypogonadal conditions, such as "age-related hypogonadism", that are not associated with structural or genetic etiologies. The efficacy of Testosterone has not been established for these conditions, and Testosterone can increase BP that can increase the risk of MACE.

The most common side effects of Testosterone include:

• increased prolactin in your blood
• increased weight
• high blood pressure
• headache
• increased red blood cell count
• joint and muscle pain

Polycythemia: Monitor hematocrit approximately every 3 months during the first year after beginning Testosterone and then every 6 months thereafter during treatment. Discontinue Testosterone if necessary.

Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Evaluate patients for prostate cancer, including monitoring prostate specific antigen (PSA) prior to initiating and during treatment with androgens.

Venous thromboembolism (VTE): VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Discontinue Testosterone if VTE is suspected and initiate appropriate workup and management.

Abuse of Testosterone and Monitoring of Serum Testosterone: If testosterone use at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids is suspected, check serum testosterone concentration.

Potential for Adverse Effects on Spermatogenesis: Testosterone may cause azoospermia.

Edema: Edema, with or without congestive heart failure (CHF) may occur in patients with preexisting cardiac, renal, or hepatic disease. Discontinue Testosterone and initiate appropriate workup.

Sleep Apnea: Testosterone may potentiate sleep apnea in those with risk factors.

Lipid Changes: Testosterone may affect serum lipid profile. Monitor patient lipid concentrations; if necessary, adjust dosage of lipid lowering drug(s) or discontinue Testosterone.

Increases in Prolactin: Monitor serum prolactin levels prior to initiation of Testosterone and 3 to 4 months after starting Testosterone. Discontinue Testosterone if serum prolactin levels remain elevated.

If you have taken several capsules at once, there is no need for great concern. However, you should consult your doctor. The oily substance in the capsule may cause diarrhoea.

Keep Testosterone out of reach and sight of children. Store at 8°C-30°C. Store in the original package in order to protect from light. Do not use Testosterone after the expiry date stated on the package, sachet and blister.