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 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).
Adverse reactions - Preferred Term
MedDRA
Common adverse reactions (>1/100;<1/10)
Organ system class

Psychiatric disorders                              Mood disorders
Dizziness, paraesthesia, amnesia,
Nervous system disorders hyperaesthesia vascular disorders                                 Hypertension
Gastro-intestinal disorders                        Diarrhoea
Skin and subcutaneous disorders                    Alopecia, urticaria gynaecomastia (which may be persistent, is a
Reproductive and system and breast                 common finding in patients treated for disorders                                          hypogonadism), mastodynia, Prostatic disorders
General disorders and administration site
Headache conditions
Changes in laboratory tests (polycythemia,
Investigations                                     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 – Preferred Term System Organ            Frequency not          Common            Rare               Very Rare Class                   known (cannot
(≥1/100;<1/10)    (≥1/10,000;       (<1/10,000) be estimated
<1/1,000)

Prostate cancer                           Hepatic
Neoplasms              (Data on prostate                         neoplasm benign,                cancer risk in malignant and          association with unspecified            testosterone
(including             therapy are cysts       and        inconclusive) polyps)
Metabolism and         Weight gain,
nutrition              electrolyte disorders              changes
(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 disorders                                                                      Jaundice Skin and             acne,
subcutaneous         seborrhoea,
tissue disorders     balding
Musculoskeletal      Muscle cramps and connective tissue disorders
Renal and            Urinary urinary              obstructions disorders
Reproductive         Libido changes,
system and           increased                               Priapism, breast               frequency of disorders            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 disorders and        long-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/