TESTOGEL

e. 5 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the physician depending on the clinical or laboratory response in individual patients, not exceeding four pump actuations or 81 mg testosterone per day.

The adjustment of posology should be achieved by increments of one pump actuation of gel. The dose should be titrated based on the pre-dose morning testosterone blood levels. Steady state blood testosterone levels are reached usually by the second day of treatment with this medicine.

In order to evaluate the need to adjust the testosterone dosage, blood testosterone levels should be measured in the morning before application of the product, after the steady state is reached. Testosterone blood levels should be assessed periodically to ensure that the patient is on the correct dose.

The dose may be reduced if the testosterone blood levels are raised above the desired level. If the levels are low, the dosage may be increased stepwise, to a daily administration of 81 mg of testosterone (four actuations of gel) per day.

25 g gel, equivalent to one pump actuation) or if blood testosterone levels in the normal range cannot be achieved with the highest dose of 81 mg (5 g gel, equivalent to four pump actuations). Patient suffering from severe renal or hepatic insufficiency Please see section

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 clinical adverse drug reactions at the recommended dosage per day were skin reactions at the application site, (erythema, acne, dry skin), anxiety and asthenia.

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. Within each frequency category, adverse reactions are presented in order of decreasing seriousness.

0 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.

0 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 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 Weight gain 1.

May develop and persist in patients treated for hypogonadism with testosterone 2. skin reactions, because of the alcohol contained in the product, frequent applications to the skin may cause irritation and dry skin 3. 0 Reporting of 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

). e. 5 mg of testosterone) applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the physician depending on the clinical or laboratory response in individual patients, not exceeding four pump actuations or 81 mg testosterone per day.

The adjustment of posology should be achieved by increments of one pump actuation of gel. The dose should be titrated based on the pre-dose morning testosterone blood levels. Steady state blood testosterone levels are reached usually by the second day of treatment with this medicine.

In order to evaluate the need to adjust the testosterone dosage, blood testosterone levels should be measured in the morning before application of the product, after the steady state is reached. Testosterone blood levels should be assessed periodically to ensure that the patient is on the correct dose.

The dose may be reduced if the testosterone blood levels are raised above the desired level. If the levels are low, the dosage may be increased stepwise, to a daily administration of 81 mg of testosterone (four actuations of gel) per day.

25 g gel, equivalent to one pump actuation) or if blood testosterone levels in the normal range cannot be achieved with the highest dose of 81 mg (5 g gel, equivalent to four pump actuations). 4 Special warnings and precautions for use.

Paediatric population The safety and efficacy of this medicine in males under 18 years have not been established. No data are available. Use in women This medicine is not indicated for use in women. The gel should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms.

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 to dry 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(s) 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. To obtain a full first dose, it is necessary to prime the canister pump.

To do so, with the canister in the upright position, slowly and fully depress the actuator three times. Safely discard the gel from the first three actuations. It is only necessary to prime the pump before the first dose. 25 g of this medicine into the palm of the hand and then apply to the upper arms and shoulders.

Skin to skin contact Before close physical contact with another person (adult or child), wash the application site with soap and water once the recommended time period (at least 1 hour) has passed and cover again with clean clothing.

4 (subsection Skin to skin transfer). 1 - Known or suspected prostate cancer or breast carcinoma. 0 This medicine should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other aetiology, responsible for the symptoms, has been excluded before treatment is started.

) and confirmed by two separate blood testosterone measurements. Currently, there is no consensus about age-specific testosterone reference levels. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.

Due to variability in laboratory values, all measures of testosterone for any given individual should be carried out by the same laboratory. Prior to testosterone initiation, all patients should undergo a detailed examination in order to exclude a risk of pre-existing prostate cancer.

Careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods (digital rectal examination and estimation of serum prostate specific antigen (PSA)) in patients receiving testosterone therapy at least once yearly and twice yearly in elderly patients and at risk patients (those with clinical or familial risk factors).

Androgens may accelerate the progression of sub-clinical prostate cancer and benign prostate hyperplasia. This medicine should be used with caution in cancer patients at risk of hypercalcaemia (and associated hypercalciuria), due to bone metastases.

Regular monitoring of blood calcium levels is recommended in these patients. In patients suffering from severe cardiac, hepatic or renal insufficiency, or ischaemic 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. In addition, diuretic therapy may be required. Testosterone may cause a rise in blood pressure and this medicine should be used with caution in men with hypertension. Testosterone should be used with […]

1 - Known or suspected prostate cancer or breast carcinoma.