TESTOGEL

e. 50 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day (100 mg testosterone).

5 g of gel steps. Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment by this medicine. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (one week seems reasonable).

The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day. Patients suffering from severe renal or hepatic insufficiency.

4: Special warnings and precautions for use. Paediatric population The safety and efficacy of this medicine in males under 18 years of age have not been established. No data are available. Use in women This medicine is not indicated for use in women.

Method of administration Transdermal use. 4). The gel should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms or the abdomen. After opening the sachets, the total contents must be extracted from the sachet and applied immediately onto the skin.

The gel should be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow drying for at least 3-5 minutes before dressing. • Wash hands thoroughly with soap and water after applying the gel. • Once the gel has dried, cover the application site with clean clothing (such as a T- shirt) • After applying this medicine patients should wait at least 1 hour before showering or bathing.

Do not apply to the genital areas as the high alcohol content may cause local irritation. 4 (Skin to skin transfer).

The adverse reactions listed in the table are based on post-marketing data, clinical trials and class-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) and emotional symptoms.

b. Tabulated list of adverse reactions Adverse reactions reported in clinical trials and derived from post-marketing experience via spontaneous reports or literature cases are listed below 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).

Within each frequency category, adverse reactions are presented in order of decreasing seriousness. Adverse Reaction Tabulation for Transdermal Testosterone. Adverse reactions – preferred term MedDRA System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to ≥1/100) Rare (≥1/10,000 to <1/1,000) Very Rare (<1/10,000) Frequency not known (cannot be estimated from the available data) Neoplasms benign, malignant and unspecified (incl.

cysts and polyps) Hepatic Neoplasm Prostate Cancer Metabolism and nutrition disorders Weight gain, electrolyte changes (retention of sodium, chloride, potassium, calcium, inorganic phosphate and water) during high dose and/or prolonged treatment Psychiatric disorders Mood Disorders, Emotional symptoms (mood swings, affective disorder, anger, aggression, impatience, insomnia, abnormal dreams, increased libido) Nervousness, Depression, Hostility Nervous system disorders Dizziness, Paraesthesia, Amnesia, Hyperaesthesia, Headache , Vascular disorders Hypertension Malignant hypertension, Hot flushes/flushing, Phlebitis Respiratory, thoracic and mediastinal disorders Sleep apnoea Gastrointestinal disorders Diarrhoea Oral pain, Abdominal distension Hepatobiliary disorders Jaundice, Liver function test abnormalities Skin and subcutaneous tissue disorders Alopecia, Urticaria Acne, Hirsutism, Rash, Dry Skin, Seborrhoea, Skin lesions, Contact dermatitis, Hair colour changes, application site hypersensitivity, application site pruritus skin reactions2 Adverse reactions – preferred term MedDRA System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to ≥1/100) Rare (≥1/10,000 to <1/1,000) Very Rare (<1/10,000) Frequency not known (cannot be estimated from the available data) Renal and urinary disorders Urinary tract obstruction Musculoskeletal and connective tissue disorders Muscle Cramps Reproductive system and breast disorders Gynaecomastia1 Nipple Disorder, Prostate- abnormalities, Testicular pain, Increased frequency of erections Priapism Libido changes, therapy with high dose of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles General disorders and administration site conditions Application site reaction Pitting oedema Asthenia, Malaise, oedema, hypersensitivity reactions, increases the occurrences of water retention and oedema3 Investigations Changes in laboratory tests (polycythaemia, lipids), Haematocrit increased, Haemoglobin increased, Red blood cell count increased PSA increased 1.

). e. 50 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day (100 mg testosterone).

5 g of gel steps. Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment by this medicine. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (one week seems reasonable).

The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per day. Patients suffering from severe renal or hepatic insufficiency.

4: Special warnings and precautions for use. Paediatric population The safety and efficacy of this medicine in males under 18 years of age have not been established. No data are available. Use in women This medicine is not indicated for use in women.

Method of administration Transdermal use. 4). The gel should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms or the abdomen. After opening the sachets, the total contents must be extracted from the sachet and applied immediately onto the skin.

The gel should be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow drying for at least 3-5 minutes before dressing. • Wash hands thoroughly with soap and water after applying the gel. • Once the gel has dried, cover the application site with clean clothing (such as a T- shirt) • After applying this medicine patients should wait at least 1 hour before showering or bathing.

Do not apply to the genital areas as the high alcohol content may cause local irritation. 4 (Skin to skin transfer). 4 Special warnings and precautions for use This medicine should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other etiology, responsible for the symptoms, has been excluded before treatment is started.

1 - Known or suspected prostate cancer or breast carcinoma