Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
Known or suspected carcinoma of the prostate or breast (see section 4.4).
History of liver tumours.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
Physicians should consider monitoring patients receiving Restandol Testocaps before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin and haematocrit, liver function tests and lipid profile.
Patients, especially the elderly, with the following conditions should be monitored for:
Tumours: Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, also during androgen therapy. The latter can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia should first be treated appropriately and after restoration of normal calcium levels, hormone therapy can be resumed.
Tumours and other histological abnormalities and disturbances of liver function have been reported in patients subjected to prolonged treatment with some testosterone derivatives. Most of these compounds were 17-alpha alkyl derivatives but a smaller number of cases have occurred with certain 17-beta esters of testosterone. The possibility that such changes result from the use of Restandol Testocaps has not been excluded.
Pre-existing conditions: In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately.
Patients who experienced myocardial infarction, cardiac, hepatic or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration or reoccurrence of disease. In such cases, treatment must be stopped immediately. In addition to discontinuation of the drug, diuretic therapy may be required.
Testosterone may cause a rise in blood pressure and Restandol Testocaps should be used with caution in men with hypertension
Diabetes mellitus: Androgens in general and Restandol Testocaps can improve glucose tolerance in diabetic patients (see section 4.5).
Anti-coagulant therapy: Androgens in general and Restandol Testocaps can enhance the anti-coagulant action of coumarin-type agents (see section 4.5).
Clotting disorders: Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy.
Sleep Apnea: There is insufficient evidence for a recommendation regarding the safety of treatment with testosterone esters in men with sleep apnea. Good clinical judgment and caution should be employed in patients with risk factors such as adiposity or chronic lung diseases.
Androgen therapy should only be used in male hypogonadism in which testosterone levels have been demonstrated to be low.
In treating males, stimulation to the point of increasing nervous, mental and physical activities beyond the patient’s cardiovascular capacity should be avoided.
If androgen-associated adverse reactions occur (see section 4.8), treatment with Restandol Testocaps should be discontinued and upon resolution of complaints resumed with a lower dose.
Patients who participate in competitions governed by the World Anti-Doping Agency (WADA) should consult the WADA-code before using this product as Restandol Testocaps can interfere with anti-doping testing. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with other anabolic androgenic steroids. Abuse of testosterone and other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events. Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use. The abuse of testosterone and other anabolic androgenic steroids carries serious health risks and is to be discouraged.
Restandol Testocaps contains Sunset Yellow (E110, FD&C Yellow no. 6) which may cause allergic reactions.
In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Restandol Testocaps in high dosages may accelerate epiphyseal closure and sexual maturation.
There is limited experience on the safety and efficacy of the use of Restandol Testocaps in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiological testosterone serum levels are lower with increasing age.
Concurrent administration of liver enzyme inducing drugs such as rifampicin, barbiturates, carbamazepine, dichloralphenazone, phenylbutazone, phenytoin or primidone may decrease the effect of Restandol Testocaps.
Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic patients (see section 4.4). Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Restandol Testocaps treatment.
High doses of androgens may enhance the anti-coagulant action of coumarin-type agents (see section 4.4). Therefore close monitoring of the prothrombin time, and if necessary a dose reduction of the anti-coagulant is required during therapy.
The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation: thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema (see section 4.4).
Androgens may decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Restandol Testocaps must be taken with a normal meal to ensure absorption (see section 4.2).
Restandol Testocaps are not indicated for treatment in women and therefore must not be used by pregnant or breast-feeding women. If used during pregnancy Restandol Testocaps pose a risk of virilisation of the fetus.
In men treatment with androgens can lead to fertility disorders by repressing sperm-formation (see section 4.8).
Restandol Testocaps has no influence on the ability to drive or use machines.
The following adverse reactions have been associated with androgen therapy in general. The most appropriate MedDRA term to describe a certain adverse event is listed.
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).
Not known: Prostatic cancer1
Not known: Polycythaemia
Not known: Fluid retention
Not known: Depression, Nervousness, Mood altered, Libido increased, Libido decreased
Not known: Hypertension
Not known: Nausea
Not known: Hepatic function abnormal
Not known: Pruritus, Acne
Not known: Myalgia
Not known: Urinary obstruction
Not known: Gynaecomastia, Oligozoospermia, Priapism, Benign prostatic hyperplasia2
Common: Hematocrit increased, Red blood cell count increased, Haemoglobin increased
Not known: Lipids abnormal3, PSA 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.
The following undesirable effects have been reported in pre-pubertal children using androgens (see section 4.4): precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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