1. Name of the medicinal product
Restandol TestocapsTM 40 mg capsule.
2. Qualitative and quantitative composition
Each capsule contains Testosterone Undecanoate 40.0 mg which is equivalent to 25.3 mg testosterone.
3. Pharmaceutical form
Soft oval, glossy capsules, transparent, orange in colour, with a yellow oily fill.
4. Therapeutic indications
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Examples of hypogonadal disorder are:
- after castration
- endocrine impotence
- male climacteric symptoms like decreased libido and decreased mental and physical activity
- certain types of infertility due to disorders of spermatogenesis
Testosterone therapy may also be indicated in osteoporosis due to androgenic deficiency.
5. Dosage of administration
In general, the dose should be adjusted according to the response of the individual patient.
The initial dosage required will usually be 120-160 mg daily for 2-3 weeks. Subsequent dosage (40-120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy.
It should be noted that smaller and less frequent doses may achieve the same response.
Safety and efficacy has not been determined in children and adolescents. Pre-pubertal children treated with Restandol Testocaps should be treated with caution.
6. Method of administration
To ensure absorption, Restandol Testocaps must be taken with a normal meal, if necessary with a little fluid, and be swallowed whole without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. If an uneven number of capsules is taken daily, the greater part should be taken in the morning.
7. Side effects
All adverse reactions listed by system organ class and frequency; common (≥ 1/100 to < 1/10) and not known (cannot be estimated from the available data).
|System Organ Class||Common||Not known|
|Neoplasms benign, malignant and unspecified (incl. cysts and polyps)||Prostatic cancer1|
|Blood and lymphatic system disorders||Polycythaemia|
|Metabolism and nutrition disorders||Fluid retention|
|Hepatobiliary disorders||Hepatic function abnormal|
|Skin and subcutaneous tissue disorders||Pruritus
|Musculoskeletal and connective tissue disorders||Myalgia|
|Renal and urinary disorders||Urinary obstruction|
|Reproductive system and breast disorders||Gynaecomastia
Benign prostatic hyperplasia2
Red blood cell count increased
1 Progression of a sub-clinical prostatic cancer
2 Prostatic growth (to normogonadal size)
3 Decrease in serum LDL-C, HDL-C and triglycerides
The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.
With high doses and prolonged treatment electrolyte changes (sodium, potassium, calcium, inorganic phosphate and water retention), hypertension, oligozoospermia, or azospermia, priaprism, changes in lipid metabolism, polycythaemia.
In a few patients diarrhoea and abdominal pain or discomfort have been reported during use of Restandol Testocaps.
8. Shell life