Adverse reactions : תופעות לוואי

4.8 Undesirable effects
 a. Summary of the safety profile

The most frequently observed adverse drug reactions at the recommended dosage of 5 g of gel per day were skin reactions at the application site, erythema, acne, dry skin.
 b. Tabulated list of adverse reactions

Clinical trial data
Adverse drug reactions reported in 1 - <10% of patients treated with this medicine in the controlled clinical trials are listed in the following table:

Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1,000;<1/100); rare (≥1/10,000;<1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).

MedDRA                           Adverse reactions
Organ system class             Common adverse reactions (>1/100; 1/10) 
Psychiatric disorders                   Mood disorders

Nervous system disorders                Dizziness, paraesthesia, amnesia, hyperaesthesia


Vascular disorders                      Hypertension
Gastro-intestinal disorders             Diarrhoea


Skin and subcutaneous disorders         Alopecia, urticaria
Reproductive and system and             Gynaecomastia (which may be persistent, is a breast disorders                        common finding in patients treated for hypogonadism), mastodynia, Prostatic disorders

General disorders and                   Headache administration site conditions
Investigations                          Changes in laboratory tests (polycythemia, lipids), Haematocrit increased, Red blood cell count increased, Haemoglobin increased


Post-marketing experience
The following table includes adverse reactions identified during post-approval use of this medicine in addition to other known undesirable effects reported in the literature following testosterone oral, injectable or transdermal treatment.

Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1,000;<1/100); rare (≥1/10,000;<1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).


MedDRA                                             Adverse reactions System Organ         Frequency not              Common               Rare            Very rare Class               known (cannot be         (≥1/100; <1/10) (≥1/10,000;<1/1,000)   (<1/10,000) estimated)
Neoplasms           Prostate cancer                          Hepatic neoplasm benign,             (Data on prostate malignant and       cancer risk in unspecified         association with
(including cysts    testosterone therapy and polyps)         are inconclusive)
Metabolism and      Weight gain,
nutrition           electrolyte changes disorders           (retention of sodium,
chloride, potassium,
calcium,
inorganic phosphate and water) during high dose and/or prolonged treatment
Psychiatric         Nervousness,
disorders           depression, hostility
Respiratory         Sleep apnoea thoracic and mediastinal disorders
Hepatobiliary                                                                       Jaundice disorders

Skin and            acne, seborrhoea,
subcutaneous        balding tissue disorders

Musculoskeletal     Muscle cramps and connective tissue disorders
Renal and           Urinary obstructions urinary disorders
Reproductive       Libido changes,                              Priapism system and         increased frequency breast disorders   of erections; therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis,
thereby reducing the size of the testicles;
prostate abnormalities,
General            High dose or long- disorders and      term administration administration     of site conditions    testosterone occasionally increases the occurrences of water retention and oedema;
hypersensitivity reactions may occur.
Because of the alcohol contained in the product, frequent applications to the skin may cause irritation and dry skin
Investigations                               Haematocrit                         Liver function increased,                          test haemoglobin                         abnormalities increased, red blood cell count increased


Reporting suspected adverse reactions
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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il.
Additionally, you can also report to Padagis.co.il.