TESTOMAX 25 MG

Israel - English - Ministry of Health

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Active ingredient:
TESTOSTERONE
Available from:
PERRIGO ISRAEL PHARMACEUTICALS LTD
ATC code:
G03BA03
Pharmaceutical form:
GEL
Composition:
TESTOSTERONE 25 MG/DOSE
Administration route:
TRANSDERMAL
Prescription type:
Required
Manufactured by:
PERRIGO ISRAEL PHARMACEUTICALS LTD
Therapeutic group:
TESTOSTERONE
Therapeutic area:
TESTOSTERONE
Therapeutic indications:
Testosterone replacement therapy for males hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Authorization number:
136 20 31297 00
Authorization date:
2012-02-28

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

22-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

05-08-2020

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with a doctor’s prescription only

TESTOMAX 25 mg

Gel

TESTOMAX 50 mg

Gel

Each 2.5 g sachet contains: Testosterone 1% (25 mg/2.5 g(

Each 5 g sachet contains: Testosterone 1% (50 mg/5 g(

Inactive ingredients - see section 6.

Read this leaflet carefully in its entirety before using the medicine. This

leaflet contains concise information about the medicine. If you have further

questions, refer to the doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may

harm them, even if it seems to you that their medical condition is similar.

The medicine is not intended for children and adolescents below the age

of 18.

This medicine is not intended for women.

Important information for your consideration:

∙ It is unknown if the medicine is safe or efficient for the treatment of men

suffering from deficiency in testosterone hormone (hypogonadism( resulting

from aging.

∙ Women and children should avoid contact with the patient’s exposed or

unwashed area where the gel has been applied. In order to lower the risk

of such secondary transfer of the gel from the patient’s body to others,

follow the instructions below:

∘ Apply the gel only to areas that will be covered by a short sleeve T-shirt.

These areas are the shoulders, upper arms or abdomen area.

∘ Wash your hands with water and soap immediately after applying the

gel.

∘ After the gel has dried, cover the application area with clothing. Keep

the area covered until you have washed it well or have showered.

∘ Before skin-to-skin physical contact occurs with another person, wash

the application area well with water and soap.

∘ If a woman or child makes contact with the gel application area of the

body, they should immediately wash thoroughly the contact area of their

body with water and soap.

1. WHAT IS THE MEDICINE INTENDED fOR?

The medicine is intended as hormone replacement therapy in men in cases

of testosterone deficiency (hypogonadism(, which has been confirmed by

clinical characteristics and laboratory tests.

Therapeutic group: Androgens.

2. BEfORE USING THE MEDICINE

Do not use the medicine if:

∙ You are sensitive (allergic( to the active ingredient or to any of the

additional ingredients contained in the medicine (for a list of the inactive

ingredients see section 6(.

∙ Prostate cancer has been diagnosed or is suspected.

∙ You have breast cancer.

∙ You are pregnant, trying to get pregnant or breastfeeding (see “Pregnancy

and breastfeeding” section(.

Special warnings regarding use of this medicine

Before beginning treatment with Testomax, tell the doctor if:

∙ you are suffering from problems in the urinary system due to an enlarged

prostate gland.

∙ you are suffering from impaired function of the heart.

∙ you are suffering from impaired function of the liver or kidneys.

∙ you are suffering from breathing difficulties while sleeping (sleep apnea(.

∙ you are suffering from any other medical problem.

Additional warnings:

∙ The attending doctor will refer you to blood tests before starting, and

during, treatment.

∙ In order to prevent inadvertent risk to those around you, wait for a prolonged

period of time to elapse from applying Testomax until you have any physical

contact. In addition, it is advisable to wear a shirt with sleeves during close

physical contact, in order to cover the area where you applied Testomax

after it has dried, or alternately, to shower before such contact.

∙ It is unknown whether use of Testomax is safe or efficient in children and

adolescents below the age of 18. Improper use of Testomax can effect

bone development in children.

Caution! flammable substance, keep away from fire. Do not light a

cigarette or be exposed to an open flame until the preparation has

completely dried. Testomax is a flammable substance until it has dried.

∙ For the attention of athletes: This medicine contains an active ingredient

(testosterone( that will yield positive results in drug tests performed in

athletes.

If you are taking, or have recently taken, other medicines, including

non-prescription medicines or nutritional supplements, tell the doctor

or pharmacist, especially if you are taking:

∙ Insulin

∙ Corticosteroids

∙ Anticoagulants

Pregnancy and breastfeeding

The medicine must not be used in women who are pregnant, trying to get

pregnant or breastfeeding

Pregnant women, women trying to get pregnant or women who are

breastfeeding should avoid contact with this medicine or with area where

the gel has been applied. The medicine may harm the unborn or breastfeeding

baby. In case of contact, wash the area of contact with water and soap

immediately.

Smoking

Do not light a cigarette or be exposed to an open flame until the

preparation has completely dried. Testomax is a flammable substance

until it has dried.

3. HOW SHOULD yOU USE THE MEDICINE?

Always use according to the doctor’s instructions. Check with the doctor or

pharmacist if you are uncertain.

The dosage and treatment regimen will be determined by the doctor only.

The usual dosage is generally 5 g of gel (50 mg testosterone( once a day, at

a fixed time, in the morning hours. The medicine is intended for use by adult

males only. The gel should be applied after showering or bathing. The doctor

may instruct you to increase the dosage, but do not exceed a dosage of 10 g

of gel per day. Do not exceed the recommended dose.

Do not swallow. for external use only.

Directions for opening:

- Tear open the sachet along the line.

- Squeeze the sachet from the bottom to the top so all of the gel comes out

into the palm of your hand and apply to the designated areas. You may

also apply the gel from the packet directly to the designated areas.

- Apply the gel immediately after opening the sachet.

- Wash your hands with water and soap immediately after applying the

gel.

Apply the gel to the shoulders, upper arms

or abdomen when the skin is dry, clean and

healthy (not broken(. Apply to areas that can

be covered by a short sleeve shirt (T-shirt( -

see Figure 1.

Do not apply Testomax to other body parts,

such as genitals, chest, armpits, knees or

back.

Wash your hands with water and soap

immediately after applying the gel. Avoid showering, swimming or bathing

for at least 5 hours after application of the gel.

Do not light a cigarette or be exposed to an open flame until the

preparation has completely dried. Testomax is a flammable substance

until dried.

Wait until the gel dries and then you can get dressed.

Tests and follow-up

∙ The attending doctor will refer you to blood tests before starting, and

during, treatment.

∙ Androgens may increase the risk of benign prostatic enlargement or

prostate cancer. Examinations for diagnosis of prostate cancer or other

prostate problems should be carried out before and during the course of

treatment, as recommended by the doctor.

If you took an overdose, or if a child has accidentally swallowed the medicine,

refer immediately to a doctor or proceed to a hospital emergency room, and

bring the package of the medicine with you.

If you forgot to apply the gel at the required time, do not apply a double

dose. Apply the next dose as soon as you remember and consult the doctor.

If you accidentally applied a double dose, consult the doctor. Adhere to the

treatment regimen recommended by the doctor.

Do not take medicines in the dark! Check the label and the dose each time

you take medicine. Wear glasses if you need them.

If you have further questions regarding use of the medicine, consult the

doctor or pharmacist.

4. SIDE EffECTS

As with any medicine, use of Testomax may cause side effects in some

users. Do not be alarmed when reading the list of side effects. You may not

suffer from any of them.

Also, side effects may occur in women and children who are not treated with

the medicine, but who come in contact with area of the patient’s skin that

has gel applied to it and remains exposed or unwashed.

Discontinue use and refer to the doctor immediately if:

∙ The following signs and symptoms of early puberty appear in children

accidentally exposed to the preparation due to contact with men treated

with this preparation: enlarged penis or clitoris, early appearance of pubic

hair, increased erection or increased sex drive and aggressive behavior.

∙ The following signs and symptoms appear in women accidentally exposed

to the preparation due to contact with men treated with this preparation:

changes in body hair, large increase in acne.

Women and children should avoid contact with exposed or unwashed skin

applied with Testomax.

Testomax can cause the following serious side effects:

∙ If you suffer from an enlarged prostate gland - your symptoms can get

worse while using the preparation. The symptoms include: increased

urination at night, difficulty passing urine, increased frequency and urgency

of urination, enuresis, urine retention or weak urine flow.

∙ Possible increased risk of prostate cancer.

∙ Blood clots in the legs or lungs. Symptoms of a blood clot in your leg

include: Pain, swelling or redness. Symptoms of a blood clot in your lungs

include: difficulty breathing or chest pain.

∙ Possible increased risk of heart attack or stroke.

∙ Use in large dosages may lower the sperm count.

∙ Swelling (edema( of the ankles, feet, or body, with or without heart

failure.

∙ Enlarged or painful breasts.

∙ Breathing difficulties while sleeping (sleep apnea(.

Refer to the doctor immediately if you experience any of the serious side

effects described above.

The most common side effects include:

Irritation of treatment area, acne, changes in laboratory test results and an

increase in PSA (Prostate Specific Antigen(.

Additional side effects:

Nausea, weight gain, aggression, depression, amnesia, anxiety, breathing

difficulties, sweating, redness, dry skin, headaches, hair loss, prostate gland

dysfunction, dizziness, weakness, high blood pressure, mood changes,

changes in blood profile (blood test results(, decreased libido, skin sensitivity,

tingling, sleep disturbances, fluid accumulation in the body, more frequent

erections than usual or prolonged erections.

If a side effect occurs, if one of the side effects worsens, or if you suffer from

a side effect not mentioned in this leaflet, consult with the doctor.

Reporting side effects:

Side effects can be reported to the Ministry of Health by clicking on the

“Reporting side effects following drug treatment” link found on the Ministry

of Health homepage (www.health.gov.il( or at the following link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=

AdversEffectMedic@moh.gov.il

In addition, report to Perrigo via the following address:

www.perrigo-pharma.co.il

5. HOW SHOULD THE MEDICINE BE STORED?

∙ Avoid poisoning! This medicine, and any other medicine, must be kept in

a safe place out of the reach of children and/or infants in order to avoid

poisoning. Do not induce vomiting unless explicitly instructed to do so by

the doctor.

∙ Do not use the medicine after the expiry date (exp. date( that appears on

the package. The expiry date refers to the last day of that month.

∙ Store in the original package below 25°C.

6. fURTHER INfORMATION

∙ In addition to the active ingredient, the medicine also contains:

Dehydrated alcohol, carbomer homopolymer type C, isostearic acid,

sodium hydroxide, purified water.

∙ What the medicine looks like and the contents of the package:

Testomax 25 mg: the package contains 10 or 30 aluminum sachets of 2.5

grams clear, colorless gel.

Testomax 50 mg: the package contains 10 or 30 aluminum sachets of 5

grams clear, colorless gel.

∙ Manufacturer and registration holder: Perrigo Israel Pharmaceuticals Ltd.,

P.O.B. 16, Yeruham.

∙ This leaflet was checked and approved by the Ministry of Health in October

2015.

∙ Registration number of the medicine in the National Drug Registry of the

Ministry of Health:

Testomax 25 mg: 13620.31297

Testomax 50 mg: 13621.31298

Summary of Product Characteristics

1. NAME OF THE MEDICINAL PRODUCT:

TESTOMAX 50 mg

TESTOMAX 25 mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:

TESTOMAX 50 mg: Testosterone 0.05 g per 5 g sachet

TESTOMAX 25 mg: Testosterone 0.025 g per 2.5 g sachet

For excipients, see 6.1.

3. PHARMACEUTICAL FORM: Gel

Clear, transparent colorless gel,

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Testosterone replacement therapy for males hypogonadism when testosterone

deficiency has been confirmed by clinical features and biochemical tests.

4.2 Posology and administration route

Cutaneous use

Adults and elderly

The recommended dose is 5 g of gel (i.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. The adjustment of posology should be achieved

by 2.5 g of gel steps.

The application should be administered by the patient himself, onto clean, dry,

healthy skin over the shoulders, or both arms or abdomen.

After opening the sachet, the total content must be extracted from the sachet and

applied immediately onto the skin. The gel has just to 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 with soap and water after applications.

Do not apply to the genital areas as the high alcohol content may cause local

irritation.

Steady state plasma testosterone concentrations are reached approximately on the

2nd day of treatment with Testomax. 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.

Children

Testomax is not indicated for use for children and has not been evaluated clinically in

males under 18 years of age.

4.3 Contraindications

Testomax is contraindicated:

- In case of known or suspected breast carcinoma or prostatic cancer,

- In case of known hypersensitivity to testosterone or any of the excipients listed in

section

4.4 Special warnings and special precautions for use

Testomax should be used only if hypogonadism (hyper- and hypogonadotrophic) has

been demonstrated and if other etiology, responsible for the symptoms, has not been

excluded before treatment is started. Testosterone insufficiency should be clearly

demonstrated by clinical features (regression of secondary sexual characteristics,

change in body composition, asthenia, reduced libido, erectile dysfunction, etc.) and

confirmed by two separate blood testosterone measurements. Currently, there is no

consensus about age specific testosterone reference values. 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 should be carried

out in the same laboratory.

Testomax is not a treatment for male sterility or impotence.

Prior to testosterone initiation, all patients must undergo a detailed examination in

order to exclude any risk of pre-existing prostatic 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 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 factors).

Androgens may accelerate the progression of sub-clinical prostatic cancer and

benign prostatic hyperplasia.

Testomax should be used with caution in cancer patients at risk of hypercalcaemia

(and associated hypercalciuria), due to bone metastases. Regular monitoring of

serum calcium concentration is recommended in these patients.

In patients suffering from severe cardiac, hepatic or renal insufficiency or ischemic

heart disease, treatment with Testomax may cause severe complications

characterized by oedema with or without congestive cardiac failure. In such case,

treatment must be stopped immediately. In addition, diuretic therapy may be

required.

Testomax should be used with caution in patients with ischemic heart disease.

Testosterone may cause a rise in blood pressure and Testomax should be used with

caution in men with hypertension.

Clotting disorders

Testosterone should be used with caution in patients with thrombophilia, as there

have been postmarketing studies and reports of thrombotic events in these patients

during testosterone therapy.

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.

Beside laboratory tests of the testosterone concentrations in patients on long-term

androgen therapy the following laboratory parameters should also be monitored

regularly: haemoglobin, hematocrit (to detect polycythaemia), liver function tests, and

lipids profile.

There is limited experience on the safety and efficacy of the use of Testomax 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

physiologically testosterone serum levels are lower with increasing age.

Testomax should be used with caution in patients with epilepsy and migraine as

these conditions may be aggravated.

There are published reports on increased risk of sleep apnoea in hypogonadal

patients treated with testosterone esters, especially in those with risk factors such as

obesity and chronic respiratory disease.

Improved insulin sensitivity may occur in patients treated with androgens, who

achieve normal testosterone plasma concentration following replacement therapy.

Certain clinical signs such as: irritability, nervousness, weight gain, prolonged or

frequent erections may indicate excessive androgen exposure requiring dosage

adjustment.

If the patient develops a severe application site reaction, treatment should be

reviewed and

discontinued if necessary.

The attention of athletes is drawn to the fact that this medicinal product contains an

active substance (testosterone) which may produce a positive reaction in anti-doping

tests.

Testomax should not be used by women, due to possible virilizing effects.

Potential testosterone transfer

If no precaution is taken, testosterone gel can be transferred to other persons

by close skin to skin contact, resulting in increased testosterone serum levels

and possibly adverse effects (e.g. growth of facial and/or body hair, deepening

of the voice, irregularities of the menstrual cycle) in case of repeated contact

(inadvertent androgenization).

The physician should inform the patient carefully about the risk of testosterone

transfer and about safety instructions (see below). Testomax should not be

prescribed in patients with a major risk of non-compliance with safety

instructions (e.g. severe alcoholism, drug abuse, severe psychiatric disorders).

This transfer is avoided by wearing clothes covering the application area or

showering prior to contact.

As a result, the following precautions are recommended:

For the patient:

Wash hands with soap and water after applying Testomax.

Cover the application area with clothing once the gel has dried.

Shower before any situation in which this type of contact is foreseen

For people not being treated with Testomax:

In the event of contact with an application area which has not been washed or

is not

covered with clothing, wash the area of skin onto which testosterone may have

been

transferred as soon as possible, using soap and water.

Report the development of signs of excessive androgen exposure such as

acne or hair modification.

According to in vitro absorption studies of testosterone conducted with

Testomax, it seams preferable for patients to observe at least 6 hours between

gel application and bathing or showering. Occasional baths or showers taken

between 1 and 6 hours after the application of the gel should not significantly

influence the treatment outcome.

To guarantee partner safety the patient should be advised for example to

observe a long interval between Testomax application and sexual intercourse,

to wear a T-shirt covering the application site, during contact period or to

shower before sexual intercourse.

Furthermore, it is recommended to wear a T-shirt, covering the application site,

during contact period with children, in order to avoid a contamination risk of

children skin.

Pregnant women must avoid any contact with Testomax application sites. In

case of pregnancy of the partner, the patient must reinforce his attention to the

precautions for use (see 4.6).

4.5 Interaction with other medicinal products and other forms of interaction

+ Oral anticoagulants

Changes in anticoagulant activity (the increased effect of the oral anticoagulant by

modification of coagulation factor hepatic synthesis and competitive inhibition of

plasma protein binding):

Increased monitoring of the prothrombin time and INR determinations are

recommended. Patients receiving oral anticoagulants require close monitoring

especially when androgens are started or stopped.

Concomitant administration of testosterone with ACTH or corticosteroids may

increase the risk of developing oedema. As a result, these medicinal products should

be administered cautiously, particularly in patients suffering from cardiac, renal or

hepatic disease.

Interaction with laboratory tests: androgens may decrease levels of thyroxin binding

globulin, resulting in decreased T4 serum concentrations and in increased resin

uptake of T3 and T4. Free thyroid hormone levels, however, remain unchanged, and

there is no clinical evidence of thyroid insufficiency.

4.6 Fertility, Pregnancy and Lactation

Testomax is intended for use by men only.

Testomax is not indicated in pregnant or breast feeding women. No clinical trial has

been conducted with this treatment in women.

Pregnant women must avoid any contact with Testomax application areas (see 4.4).

This product may have adverse virilizing effects on the foetus. In the event of contact,

wash with soap and water as soon as possible.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive or use machines have been

performed.

4.8 Undesirable effects

The most frequently observed adverse drug reactions at the recommended dosage

of 5 g of gel per day were skin reactions (10%); reaction at the application area,

erythema, acne, dry skin.

Adverse drug reactions reported in 1 - <10% of patients treated with Testomax in the

controlled clinical trials are listed in the following table:

Organ system class

Adverse reactions

Blood and lymphatic system disorders

Changes in laboratory tests

(polycythemia,

lipids), Haematocrit increased, Red

blood cell

count increased, Haemoglobin

increased

General disorders and administration

site

conditions

Headache

Renal and Urinary disorders

Prostatic disorders

Reproductive and system and breast

disorders

gynaecomastia, mastodynia

Nervous system disorders

Dizziness, paraesthesia, amnesia,

hyperaesthesia

Psychiatric disorders

Mood disorders

vascular disorders

Hypertension

Gastro-intestinal disorders

Diarrhoea

Skin and subcutaneous disorders

Alopecia, urticaria

Gynaecomastia, which may be persistent, is a common finding in patients treated for

hypogonadism.

According to the literature, other known undesirable effects have been reported

following testosterone oral or inject able treatment and are listed in the following

table:

Organ system

Adverse reactions

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

Musculoskeletal system

Muscle cramps

Nervous system

Nervousness, depression, hostility

Respiratory system

Sleep apnoea

Hepatobiliary disorders

In very rare cases jaundice and liver

function test abnormalities

Skin and appendages

Various skin reactions may occur

including

acne, seborrhoea, and balding

Reproductive system and breast

disorders

Libido changes, increased frequency of

erections; therapy with high doses of

testosterone preparations commonly

reversibly interrupts or reduces

spermatogenesis, thereby reducing the

size of

the testicles; testosterone replacement

therapy of hypogonadism can in rare

cases

cause persistent, painful erections

(priapism),

prostate abnormalities, prostate

cancer*,

urinary obstruction

General disorders and administration

site

conditions

High dose or long-term administration of

testosterone occasionally increases the

occurrences of water retention and

oedema;

hypersensitivity reactions may occur.

* Data on prostate cancer risk in association with testosterone therapy are

inconclusive.

Other rare known undesirable effects associated with excessive dosages of

testosterone include hepatic neoplasms.

Because of the alcohol contained in the product, frequent applications to the skin

may cause irritation and dry skin.

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 www.perrigo-pharma.co.il.

4.9 Overdose

Only one case of acute testosterone overdose following an injection has been

reported in the literature. This was a case of a cerebrovascular accident in a patient

with a high plasma testosterone concentration of 114 ng/ml (395 nmol/l). It would be

most unlikely that such plasma testosterone concentrations be achieved using the

transdermal route.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: ANDROGENS, ATC Code: G03B A03

Endogenous androgens, principally testosterone, secreted by the testes and its major

metabolite DHT, are responsible for the development of the external and internal

genital organs and for maintaining the secondary sexual characteristics (stimulating

hair growth, deepening of the voice, development of the libido); for a generaleffect on

protein anabolism; for development of skeletal muscle and body fat distribution; for a

reduction in

urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion.

Testosterone does not produce testicular development: it reduces the pituitary

secretion of gonadotropins. The effects of testosterone in some target organs arise

after peripheral conversion of testosterone to estradiol, which than binds to oestrogen

receptors in the target cell nucleus e.g. the pituitary, fat, brain, bone and testicular

Leydig cells.

5.2 Pharmacokinetic properties

The percutaneous absorption of testosterone ranges from approximately 9% to 14%

of the applied dose.

Following percutaneous absorption, testosterone diffuses into the systemic

circulation at relatively constant concentrations during the 24 hour cycle.

Serum testosterone concentrations increase from the first hour after an application,

reaching steady state from day two. Daily changes in testosterone concentrations are

then of similar amplitude to those observed during the circadian rhythm of

endogenous testosterone. The percutaneous route therefore avoids the blood

distribution peaks produced by injections. It does not produce supra-physiological

hepatic concentrations of the steroid in

contrast to oral androgen therapy.

Administration of 5 g of Testomax produces an average testosterone concentration

increase of approximately 2.5 ng/ml (8.7 nmol/l) in plasma.

When treatment is stopped, testosterone concentrations start decreasing

approximately 24 hours after the last dose. Concentrations return to baseline

approximately 72 to 96 hours after the final dose.

The major active metabolites of testosterone are dihydrotestosterone and estradiol.

Testosterone is excreted, mostly in urine, and in faeces as conjugated testosterone

metabolites.

5.3 Preclinical safety data

Testosterone has been found to be non-mutagenic in vitro using the reverse mutation

model (Ames test) or hamster ovary cells. A relationship between androgen

treatment and certain cancers has been found in studies on laboratory animals.

Experimental data in rats have shown increased incidences of prostate cancer after

treatment with testosterone.

Sex hormones are known to facilitate the development of certain tumors induced by

known carcinogenic agents.

No correlation between these findings and the actual risk in human beings has been

established.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Dehydrated alcohol, Purified water, Carbomer homopolymer type C, Isostearic acid,

Sodium hydroxide.

6.2 Incompatibilities

Not applicable.

6.3 Shelf-life

The expiry date of the product is indicated on the packaging materials.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Testomax 25 mg: aluminium sachet of 2.5 g .

Testomax 50 mg: aluminium sachet of 5 g

Pack sizes: 10, 30 sachets

7. Manufacturer and marketing authorization holder:

Perrigo Israel Pharmaceuticals LTD., POB 16, Yeruham, Israel.

8. Marketing authorization number (s):

Testomax 25 mg: 136-20-31297

Testomax 50 mg: 136-21-31298

Revised on July 2020.

העדוה

לע

הרמחה

(

עדימ

ןולעב )תוחיטב

ןכרצל

ןכדועמ(

05.2013

ךיראת

6.2015

םש

רישכת

תילגנאב

רפסמו

םושירה

Testomax 25mg

:

136

-

20

-

31297

Testomax 50mg:

136

-

21

-

31298

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לעב

םושירה

לארשי וגירפ

הקיטבצמרפ

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דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה

קרפ

ןולעב טסקט

יחכונ טסקט

שדח המדקה

...

:ךנויעל בושח עדימ

הליעי וא החוטב הפורתה םאה עודי אל

ןומרוהב רסוחמ םילבוסה םירבגב לופיטל

תונקדזהמ עבונה )םזידנוגופיה( ןורטסוטסטה

...

לפוטמה םע עגממ ענמיהל םידליו םישנ לע אל וא ףושח רתונו ל'גה חרמנ וילעש רוזאב ףוטש רבעמבש ןוכיסה תא דירוהל ידכב , ףיעס האר( םהילא רישכתה

.)יאוול תועפות , תינשמ הרבעהל ןוכיסה תא דירוהל תנמ לע וזכ בוקעל שי םירחאל לפוטמה ףוגמ ל'גה לש חא

:םיאבה םיבלשה

הצלוחש ףוגב םירוזאב קר ל'גה תא חרמ ( הרצק

T-Shirt

םה הלא םירוזא .הסכמ ) וא תועורזה לש ןוילעה קלחה ,םייפתכה רוזא .ןטבה

םימב םיידי דימ ץחר ל'גה תחירמ רחאל .ןובסבו

רחאל ,דגבב חורמה רוזאה תא הסכ .שבייתהש דע הסוכמ רוזאה תא ראשה .תחלקמ רחאל דע וא בטיה ותפיטשל

רוע םע ךרוע לש יזיפ עגמ שחרתמש ינפל תחירמ רוזא תא ץוחרל שי ,רחא םדא לש .ןובסו םימ םע בטיה ל'גה

רוזא םע עגמב םיאב דלי םא וא השיא םא בטיה ץוחרל םהילע ,ל'גה חרמנ וילעש ףוגב םימ םע םפוגב עגמה רוזא תא ידימ ןפואב .ןובסו שמתשהל ןיא םא הפורתב

...

...

הקינמ וא ןוירהל סנכיהל הסנמ ,ןוירהב ךנה

.)הקנהו ןוירה ףיעס יאר לופיטה ינפל רפס, סקמוטסטב :םא אפורל רבעב תלבס וא לבוס ךניה םא דוקפיתב יוקילמ

תכרעמ סא( המישנה

)המ

ו בלה

וא ד ילכ ,)םד ץחל רתי( ם דבכה

הילכה

ןתשה תכרעמ

תכרעמ םיבצעה םילבוסה םילוחב- ,הנרגימ וא היספליפאמ תומרל ןוכיס לש םירקמב

.דשה ןטרס ךל שי

.תינומרעה ןטרסל דשח םייק וא הנחבא תמייק

ןתשה תכרעמב תויעבמ לבוס ךנה תטולב בקע

.תלדגומ תינומרע

יוקילמ לבוס ךנה

דוקפתב

.בלה

ךנה

לבוס

יוקילמ

דוקפתב

וא דבכה

.הילכה

המישנ םוד( הניש ןמזב המישנ יישקמ לבוס ךנה .)הנישב

ןתשבו םדב ןדיס לש תוהובג םילוח ,ןטרס תלחמ בקע .רתי לקשמב

.תרחא תיאופר היעב לכמ לבוס ךנה :תופסונ תורהזא

...

...

ליעי וא חוטב סקמוטסטב שומישה םאה עודי אל ליגמ םיריעצה םידליל

ןוכנ אל שומיש .

תומצעה תלידג לע עיפשהל לולע סקמוטסטב

.םידלי לצא

ל'גה לש ושובייל דע שאמ וא ןושיעמ ענמיהל שי .ושובייל דע קילד רמוח וניה סקמוטסט .רועה לע

:הקנהו ןוירה ענמיהל תוקינמ וא ןויריהב םישנ לע .הפורתה םע עגממ דימ ףוטשל שי ,עגמ לש הרקמב םע עגמה רוזא תא

.ןובסו םימ תוסנמה ,ןוירהב םישנב שומישל הרוסא הפורתה .תוקינמ וא ןוירהל סנכיהל ,ןויריהב םישנ לע ןוירהל סנכיהל תוסנמה וא הפורתה םע עגממ ענמיהל תוקינמ רוזאה םע וא וא רבועב עוגפל הלולע הפורתה ,ל'גה חרמנ וילע קנויה קוניתב דימ ףוטשל שי ,עגמ לש הרקמב . םע עגמה רוזא תא .ןובסו םימ ןושיע

...

ל'גה לש ושובייל דע שאמ וא ןושיעמ ענמיהל שי .ושובייל דע קילד רמוח וניה סקמוטסט .רועה לע שמתשת דציכ ?הפורתב

...

הארוה רדעהב לבוקמ ןונימ :אפורמ תרחא

( ל'ג םרג

,םויב םעפ )ןורטסוטסט ג"מ .רקובה תועשב יוצר ,עובק ןמזב

...

רוזא לע ל'גה תא חורמל שי ,ןטבה וא/ו תועורזה ,םייפתכה .אירבו יקנ ,שבי רועהשכ

...

רוזא לע סקמוטסט חורמל ןיא תלוכתש ןוויכמ ,ןימה ירביא הלולע הפורתב לוהוכלאה ימוקמ יוריגל םורגל

...

ןיתמהל יוצר

ןמזמ תועש .תחלקמל דע ל'גה תחירמ הנתמהב קפתסהל ןתינ םיתיעל לש

.תחלקמל דע תועש

...

אוה ללכ ךרדב לבוקמה ןונימה

( ל'ג םרג

ג"מ עובק ןמזב ,םויב םעפ )ןורטסוטסט

יוצר תועשב רקובה

...

:החיתפ תוארוה

תיתחתמ ץוחלל שי .וקה ךרואל הזיראה תא ערק .הלעמ יפלכ תיקשה

לכ תא איצוהל תנמ לע תיקשה לע ץוחלל שי .םידעוימה תומוקמב חורמלו ךדי ףכל ל'גה םירוזאה לע ל'גה תא חורמל םג ןתינ .תיקשהמ תורישי םידעוימה

...

אל( אירבו יקנ ,שבי רועהשכ ל'גה תא חורמל שי ,םייפתכה רוזאב )קודס ןוילעה קלחב תועורזה לש .ןטבב וא

...

לע סקמוטסט חורמל ןיא ןוגכ םירחא ףוג ירביא ,ןימה ירביא בגה וא םייכרבה ,יחשה יתב ,הזחה

...

ךשמל הצחרמ וא הייחשמ ,תחלקממ ענמיהל שי

.ל'גה תחירמ ןמזמ תוחפל תועש

ל'גה לש ושובייל דע שאמ וא ןושיעמ ענמיהל שי ושובייל דע קילד רמוח וניה סקמוטסט .רועה לע

בקעמו תוקידב םע ךשוממ לופיט תפוקתב םד תוקידב ךורעל שי וז הפורת

תינומרעה לש תוקידב עצבל שי םאתהב וכלהמבו לופיטה ינפל .אפורה תצלמהל ינפל םד תוקידבל ךתוא הנפי לפטמה אפורה וכלהמבו לופיטה תלחתה

תוקידב עצבל שי תינומרעה ןטרס יוליגל לכ וא וכלהמבו לופיטה ינפל תינומרעב תרחא היעב .אפורה תצלמהל םאתהב יאוול תועפות

שומישה תא קיספהל שי :םא אפורל דימ תונפלו ,תינומרעה לודיג ,ףוגה לכב יוריג תמדאה ,ןתש ןתמב םיישק ,רועה תבהצה ,ראווצהו םינפה םייוניש ,תורומח תוירוע תובוגת הדירי ,םיטילורטקלאה תומרב הפוכת הפקיז ,ערזה תומכב תא קספה :)רידנ( תכשוממו .אפורל הנפו לופיטה

לש םיאבה םינימסתהו םינמיסה םיעיפומ תועטב ופשחנש םידליב תמדקומ תינימ תורגבתה םילפוטמה םירבג םע עגמ תובקעב רישכתל העפוה ,םילדגומ ןגדגד וא ןיפ :הז רישכתב קשח וא תרבגומ הפקיז ,הוורע רעיש לש תמדקומ .תינפקות תוגהנתהו רבגומ ינימ

לצא םיאבה םינימסתהו םינמיסה םיעיפומ

עגמ תובקעב רישכתל תועטב ופשחנש םישנ םייוניש :הז רישכתב םילפוטמה םירבג םע הנקאב תיתועמשמ הרמחה ,ףוגה רועישב

אפורל דימ תונפל שי :םא תוערפה ,תוליחב ,םירירש יבאכ המישנב תוערפה ללוכ המישנב הנישה ךלהמב

לקשמב הילע תונבצע ,טקש יא תנמ לע אפורל הנפ :)רידנ( ןונימה תא ךל םיאתיש

תינומרעה תטולב לש הלדגהמ לבוס רבכ ךנה

לופיטה ךשמב םינימסתב הרמחהמ לובסתו ןכתיי תרבגומ הנתשה :םיללוכ ךכל םינימסתה .רישכתב ןתמב תופיחדו תופיכת ,ןתש ןתמב ישוק ,הלילב ןתש תמירז וא ןתש תריצא ,ןתש תפילד ,ןתש .תשלחומ

.תינומרעה ןטרסב תולחל ירשפא ןוכיסב היילע

םינימסתה .תואירב וא םיילגרב םד ישירק םנשי תוחיפנ ,םיבאכ :םיללוכ םיילגרב םד ישירקל םיללוכ תואירב םד ישירקל םינימסתה .תוימומדאו .הזחב םיבאכ וא המישנב םיישק

.ץבש וא בל ףקתה תלבקל ןוכיסב היילע

ערזה תומכב הדירי

,םיילוסרקה לש )תקצב( תוחיפנ לש םירקמב

בל תקיפס יא אלל וא םע ףוגה וא םיילגר

םיבאוכ וא םילדגומ םיידש

הנישה ךלהמב המישנ יישק המישנ םוד(

sleep apnea

יאוולה תועפות רתויב תוחיכשה :תוללוכ

...

תוקידב תואצותב םייוניש ,הנקא ,לופיטה רוזאב יוריג -ב היילעו הדבעמ

PSA=Prostate Specific

Antigen

תינומרעה לש ילוגס ןגיטנא תקידב

העדוה

לע

הרמחה

(

עדימ

ןולעב )תוחיטב

ל

אפור ןכדועמ(

05.2013

)

ךיראת

6.2015

םש

רישכת

תילגנאב

רפסמו

םושירה

Testomax 25mg

:

136

-

20

-

31297

Testomax 50mg:

136

-

21

-

31298

םש

לעב

םושירה

לארשי וגירפ

הקיטבצמרפ

מ"עב

! דבלב תורמחהה טורפל דעוימ הז ספוט תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Introduction

---

INDICATIONS AND USAGE

Safety and efficacy of Testosterone

gel in me n with age -related

hypogonadism have not been

established. )1(

DOSAGE AND ADMINISTRATION

Prior to initiating Testosterone gel,

confirm the diagnosis of

hypogonadism by ensuring that

serum testosterone has been

measured in the morning on at

least two separate days and that

these concentrations are below the

normal range )2(.

WARNINGS AND PRECAUTIONS

Some postmarketing studies have

shown an increased risk of

myocardial infarction and stroke

associate d with use of testosterone

re placement therapy )5.5(.

WARNING: SECONDARY EXPOSURE

TO TESTOSTERONE

Virilization has been reported in

children who were secondarily

exposed to Testosterone gel

[see

Warnings and Precautions )5.2( and

Adverse Reactions )6.2(].

Children should avoid contact with any

unwashed or unclothed application sites

in men using Testosterone gel [see

Dosage and Administration )2.2(,

Warnings and Precautions

)5.2(].

Indications and

usage

Testosterone replacement

therapy for male hypogonadism

when testosterone deficiency has

been confirmed by clinical

features and biochemical tests

)see 4.4 Special warnings and

precautions for use(.

Testomax is not indicated for use

Limitations of use:

Safety and efficacy of Testosterone

gel in men with "age-related

hypogonadism" )also referred to as

"late-onset hypogonadism"( have not

been established.

Safety and efficacy of Testosterone

gel in males less than 18 years old

have not been established [see Use

in children and has not been

evaluated clinically in males under

18 years of age.

in Specific Populations )8.4(].

Topical testosterone products may

have different doses, strengths, or

application instructions that may

result in different systemic exposure.

)1, 12.3(

Dosing and Dose

Adjustment

The recommended dose is 5 g of

gel )i.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. The adjustment of

posology should be achieved by

2.5g of gel steps.

The application should be

administrated by the patient

himself, onto clean, dry, healthy

skin over either shoulders, or both

arms or abdomen.

The recommended starting dose of

Testosterone gel is 50 mg of

testosterone )two 25 mg packets or one

50 mg packet(, applied topically once

daily in the morning to the shoulders and

upper arms and/or abdomen area

)preferably at the same time every day(.

Dose Adjustment

To ensure proper dosing, serum

testosterone levels should be measured

at intervals. If the serum testosterone

concentration is below the normal

range, the daily Testosterone gel dose

may be increased from 50 mg to 75 mg

and from 75 mg to 100 mg for adult

males as instructed by the physician. If

the serum testosterone concentration

exceeds the normal range, the daily

Testosterone gel dose may be

decreased

If the serum testosterone

concentration

consistently exceeds

the normal range at a daily dose of 50

mg, Testosterone gel therapy should

discontinued. In addition, serum

testosterone concentration should be

assessed periodically.

Administration

Instructions

The application should be

administrated by the patient

himself, onto clean, dry, healthy

skin over either shoulders, or both

arms or abdomen.

After opening the sachets, the

total contents must be extracted

from the sachet and applied

immediately onto the skin. The gel

has just to 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 with soap and water after

application.

Do not apply to the genital areas

as the high alcohol content may

cause local irritation.

Testosterone gel should be applied to

clean, dry, healthy, intact skin of the

right and left upper arms/shoulders

and/or right and left abdomen. Area of

application should be limited to the

area that will be covered by the

patient’s short sleeve T- shirt. Do not

apply Testosterone gel to any other

part of the

body including the

genitals, chest, armpits )axillae(,

knees, or back. Testosterone gel

should be evenly distributed between

the right and left upper arms/shoulders

or both sides of the abdomen.

The prescribed daily dose of

Testosterone gel should be applied to

the right and left upper arms

/shoulders and/or right/left abdomen

as shown in the shaded areas in the

figure below.

After applying the gel, the application

site should be allowed to dry prior to

dressing. Hands should be washed

with soap and water after Testosterone

gel has been applied. Avoid fire, flames

or smoking until the gel has dried since

alcohol based products, including

Testosterone gel, are flammable.

The patient should be advised to avoid

swimming or showering for at least 5

hours after the application of

Testosterone gel.

Packets

The entire contents should be

squeezed into the palm of the hand

and immediately applied to the

application sites. Alternately, patients

may squeeze a portion of the gel

from the packet into the palm of

hand and apply to application sites.

Repeat until entire contents have been

applied.

Strict

adherence

to

the

following

precautions

is

advis

ed

in

order

to

minimize

the

potential

for

s

econdary

expos

ure

to

testos

terone

from

Testosterone gel

-treated

s

kin:

Children and women should

avoid contact with unwashed or

unclothed application site)s( of

men using Testosterone gel.

Patients should wash their hands

immediately with soap and water

after applying Testosterone gel.

Patients should cover the

application site)s( with clothing

)e.g., a T-shirt( after the gel has

dried.

Prior to any situation in which

skin-to-skin contact with the

application site is anticipated,

patients should wash the

application site)s( thoroughly with

soap and water to remove any

testosterone residue.

In the event that unwashed or

unclothed skin to which

Testosterone gel has been

applied comes in direct contact

with the skin of another person,

the general area of contact on

the other person should be

washed with soap and water as

soon as possible.

Contraindications

In cases of known or suspected

prostatic cancer or breast

carcinoma.

In cases of known

hypersensitivity to testosterone

or any other constitutes of the

gel.

Testosterone gel is

contraindicated in men with

carcinoma of the breast or

known or suspected carcinoma

of the prostate [see Warnings

and Precautions )5.1(, Adverse

Reactions )6.1(, and Nonclinical

Toxicology )13.1(].

Testosterone gel is contraindicated

in women who are or may become

pregnant, or who are breastfeeding.

Testosterone gel may cause fetal

harm when administered to a

pregnant woman. Testosterone gel

may cause serious adverse

reactions in nursing infants.

Exposure of a female fetus or

nursing infant to androgens may

result in varying degrees of

virilization. Pregnant women or

those who may become pregnant

need to be aware of the potential

for transfer of testosterone from

men treated with Testosterone gel.

If a pregnant woman is exposed to

Testosterone gel, she should be

apprised of the potential hazard to

the fetus [see Warnings and

Precautions )5.2( and Use in

Specific Populations )8.1, 8.3(].

Warnings And

Precautions

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 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 factors(.

Androgens may accelerate the

progression of sub-clinical

prostatic cancer and benign

prostatic hyperplasia.

If no precaution is taken,

testosterone gel can be

transferred to other persons by

close skin to skin contact,

resulting in increased

testosterone serum levels and

possibly adverse effects )e.g.

growth of facial and/or body hair,

deepening of the voice,

irregularities of the menstrual

cycle( in case of repeat contact

)inadvertent androgenization(.

The physician should inform the

patient carefully about the risk of

testosterone transfer and about

safety instructions )see below(.

Testomax should not be

prescribed in patients with a major

risk of non-compliance with safety

instructions )e.g. severe

alcoholism, drug abuse, severe

psychiatric disorders(.

Worsening of Benign Prostatic

Hyperplasia (BPH) and Potential Risk

of Prostate Cancer

Patients with BPH treated with

androgens are at an increased risk

for worsening of signs and

symptoms of BPH. Monitor patients

with BPH for worsening signs and

symptoms.

Patients treated with androgens

may be at increased risk for

prostate cancer. Evaluate

patients for

prostate cancer

prior to initiating and during

treatment with androgens [see

Contraindications )4(,

Adverse

reactions )6.1( and Nonclinical

Toxicology )13.1(].

Potential for Secondary Exposure to

Testosterone

Cases of secondary exposure

resulting in virilization of children

have been reported in postmarketing

surveillance. Signs and symptoms

have included enlargement of the

penis or clitoris, development of

pubic hair, increased erections and

libido, aggressive behavior, and

advanced bone age. In most cases,

these signs and symptoms

regressed with removal of the

exposure to Testosterone gel. In a

few cases,

however, enlarged

genitalia did not fully return to age-

appropriate normal size, and bone

age remained

modestly greater

than chronological age. The risk of

transfer was increased in some of

these cases by

not adhering to

precautions for the appropriate use

of Testosterone gel. Children and

women should

avoid contact with

unwashed or unclothed application

sites in men using Testosterone gel

[see Dosage

and Administration )2.2(,

Use in Specific Populations )8.1( and

Clinical Pharmacology )12.3(].

Inappropriate changes in genital size

or development of pubic hair or libido

in children, or changes in

body hair

distribution, significant increase in

acne, or other signs of virilization in

adult women should

be brought to

the attention of a physician and the

possibility of secondary exposure to

Testosterone gel should also be

brought to the attention of a

physician. Testosterone gel should

be promptly discontinued until the

cause of virilization has been

identified.

Polycythemia

Increases in hematocrit, reflective of

increases in red blood cell mass,

may require lowering or

discontinuation of testosterone.

Check hematocrit prior to initiating

treatment. It would also be

appropriate to re-evaluate the

hematocrit 3 to 6 months after starting

treatment, and then annually. If

hematocrit becomes elevated, stop

therapy until hematocrit decreases to

an acceptable concentration. An

increase in red blood cell mass may

increase the risk of thromboembolic

events.

Venous

T

hromboembolis

m

There have been postmarketing

reports of venous thromboembolic

events, including deep vein

thrombosis )DVT( and pulmonary

embolism )PE(, in patients using

testosterone products, such as

Testosterone gel. Evaluate patients

who report symptoms of pain, edema,

warmth and erythema in the

lower

extremity for DVT and those who

present with acute shortness of breath

for PE. If a venous

thromboembolic

event is suspected, discontinue

treatment with Testosterone gel and

initiate appropriate

workup and

management [see Adverse Reactions

)6.2(].

Cardiovascular

Risk

Long term clinical safety trials have

not been conducted to assess the

cardiovascular outcomes of

testosterone replacement therapy in

men. To date, epidemiologic studies

and randomized controlled

trials

have been inconclusive for

determining the risk of major adverse

Pregnant women must avoid any

contact with Testomax application

sites. In case of pregnancy of the

partner, the patient must reinforce

his attention to the precautions for

use.

In Patients suffering from severe

cardiac, hepatic or renal

insufficiency, treatment with

Testomax may cause severe

complications characterized by

oedema with or without

congestive cardiac failure. In this

case, treatment must be stopped

immediately.

Gynecomastia, which may be

persistent, is a common finding in

patients treated for

cardiovascular events )MACE(,

such

as non-fatal myocardial infarction,

non-fatal stroke, and cardiovascular

death, with the use of

testosterone

compared to non-use. Some studies,

but not all, have reported an

increased risk of MACE in

association with use of testosterone

replacement therapy in men. Patients

should be informed of this

possible risk when deciding whether

to use or to continue to use

Testosterone gel.

Us

e

in

Women

Due to lack of controlled evaluations

in women and potential virilizing

effects, Testosterone gel is not

indicated for use in women [see

Contraindications )4( and Use in

Specific Populations )8.1, 8.3(].

Potential

for

Advers

e

Effects

on

Spermatogenes

is

At large doses of exogenous

androgens, including Testosterone

gel; spermatogenesis may be

suppressed through feedback

inhibition of pituitary follicle-

stimulating hormone )FSH( which

could

possibly lead to adverse

effects on semen parameters

including sperm count.

Hepatic

Advers

e

Effects

Prolonged use of high doses of

orally active 17-alpha-alkyl androgens

)e.g., methyltestosterone( has

been associated with serious hepatic

adverse effects )peliosis hepatis,

hepatic neoplasms, cholestatic

hepatitis, and jaundice(. Peliosis

hepatis can be a life-threatening or

fatal complication. Long-term

therapy with intramuscular

testosterone enanthate has produced

multiple hepatic adenomas.

Testosterone gel is not known to

produce these adverse effects.

Edema

Androgens, including

Testosterone gel, may promote

retention of sodium and water.

Edema with or

without

congestive heart failure may be a

serious complication in patients

with preexisting cardiac,

renal,

or hepatic disease [see Adverse

Reactions )6.2(].

hypogonadism.

There are publisher reports on

increased risk of sleep apnea in

hypogonadal patients treated with

testosterone esters, especially in

those with risk factors such as

obesity and chronic respiratory

disease.

Beside laboratory tests of the

testosterone concentrations in

patients on long-term androgen

therapy the following laboratory

parameters should be checked

periodically: hemoglobin,

haematocrit )to detect

polycythaemia(, liver function

tests, and determination of lipids

profile.

Testomax should be used with

caution in cancer patients at risk

of hypercalcaemia )and

associated hypercalciuria(, due to

bone metastases. Regular

monitoring of serum calcium

concentrations is recommended

in these patients.

Androgens may decrease levels

of thyroxin binding globulin,

resulting in decreased T

serum

concentrations and in increased

resin uptake of T

and T

Free

thyroid hormone levels, however,

remain unchanged and there is no

clinical evidence of thyroid

insufficiency.

G

yn

ec

o

m

a

s

t

i

a

Gynecomastia may develop and may

persist in patients being treated with

androgens, including

Testosterone

gel, for hypogonadism.

Sleep

Apnea

The treatment of hypogonadal

men with testosterone products

may potentiate sleep apnea in

some

patients, especially

those with risk factors such as

obesity or chronic lung

diseases [see Adverse

Reactions )6.2(].

Lipids

Changes in serum lipid profile may

require dose adjustment or

discontinuation of testosterone

therapy.

Hypercalcemia

Androgens, including Testosterone

gel, should be used with caution in

cancer patients at risk of

hypercalcemia )and associated

hypercalciuria(. Regular monitoring of

serum calcium concentrations is

recommended in these patients.

Decreased

T

hyroxine-binding

Globulin

Androgens, including Testosterone

gel, may decrease levels of thyroxin-

binding globulin, resulting in

decreased total T4 serum

concentrations and increased resin

uptake of T3 and T4. Free thyroid

hormone

concentrations remain

unchanged, however, and there is no

clinical evidence of thyroid

dysfunction.

Flammability

Alcohol based products including

Testosterone gel are flammable;

therefore patients should be

advised to avoid fire, flame or

smoking until the Testosterone gel

has dried.

Adverse

Reactions

The most frequently observed

drug reactions at the

recommended dosage of 5 g of

gel per day were skin reactions

Table 1: Adverse Reactions to

Testosterone Gel in the 180 Day

Controlled Clinical Trial

Dose of

Testosterone

)10%(: reaction at the application

site, erythema, acne, dry skin.

Adverse reactions reported in 1

- <10% of patients treated with

Testomax in the controlled

clinical trials are listed in the

following table:

Organ system

class

Common

adverse

reactions

>1/100,<1/10)

Blood and

lymphatic

system

disorders

Changes in

laboratory tests

)polycythaemia,

lipids(

General

disorders and

administration

site conditions

Headache

Renal and

urinary

disorders

Prostatic

disorders

Reproductive

system and

breast

disorders

Gynaecomastia

, mastodynia

Nervous

system

disorders

Dizziness,

paraesthesia,

amnesia,

hyperaesthesia

Psychiatric

disorders

Mood disorders

Vascular

disorders

Hypertension

Gastro-

intestinal

disorders

Diarrhoea

Skin and

subcutaneous

disorders

Alopecia,

urticaria

*

Gynecomastia, which may be

persistent, is a common finding in

patients treated for

hypogonadism.

According to the literature, other

known undesirable effects have

been reported following

testosterone oral or injectable

treatment and are listed in the

following table:

Organ system

Adverse

reactions

Metabolism and

nutrition

disorders

Weight gain,

electrolyte

changes

)retention of

sodium,

chloride,

Adverse Reaction

Acne

Alopecia

Application Site

Reaction

Asthenia

Depression

Emotional Lability

Gynecomastia

Headache

Hypertension

Abnormal Lab

Tests *

Libido Decreased

Nervousness

Pain Breast

Prostate

Disorder**

Testis Disorder***

Other less common adverse

reactions, reported in fewer than 1%

of patients included: amnesia, anxiety,

discolored hair, dizziness, dry skin,

hirsutism, hostility, impaired urination,

paresthesia, penis disorder,

peripheral edema, sweating, and

vasodilation.

In this 180 day clinical trial, skin

reactions at the site of application

were reported with testosterone gel,

but none was severe enough to

require treatment or discontinuation of

drug.

Six patients )4%( in this trial had

adverse reactions that led to

discontinuation of testosterone gel.

These

reactions included: cerebral

hemorrhage, convulsion, depression,

sadness, memory loss, elevated

prostate specific antigen, and

hypertension. No patients on

testosterone gel discontinued due to

skin

reactions.

In a separate uncontrolled

pharmacokinetic study of 10 patients,

two had adverse reactions; these were

asthenia and depression in one patient

and increased libido and hyperkinesia in

the other.

Adverse

Reaction

Percent of

Subjects

)N = 162(

Abnormal Lab

Tests+

Skin dry

Application Site

Reaction

Acne

Pruritus

Enlarged

11.7

potassium,

calcium,

inorganic

phosphate and

water( during

high dose

and/or

prolonged

treatment

Musculoskeletal

system

Muscle cramps

Nervous system

Nervousness,

depression,

hostility

Respiratory

system

Sleep apnoea

Hepatobiliary

disorders

In very rare

cases jaundice

and liver

function test

abnormalities

Skin and

appendages

Various skin

reactions may

occur including

acne,

seborrhoea,

and balding

Reproductive

system and

breast disorders

Libido changes,

increased

frequency of

erections;

therapy with

high doses of

testosterone

preparations

commonly

reversibly

interrupts or

reduces

spermatogenesi

s, thereby

reducing the

size of the

testicles;

testosterone

replacement

therapy of

hypogonadism

can in rare

cases

cause

persistent,

painful

erections

)priapism(,

prostate

abnormalities,

prostate

cancer*, urinary

obstruction

General

disorders and

administration

site conditions

High dose or

long-term

administration

of testosterone

occasionally

increases the

occurrences of

water retention

and oedema;

hypersensitivity

reactions may

Prostate

Carcinoma of

Prostate

Urinary

Symptoms*

Testis Disorder**

Gynecomastia

Anemia

Discontinuation for adverse reactions

in this study included: two patients with

application site reactions,

one with

kidney failure, and five with prostate

disorders )including increase in serum

PSA in 4 patients,

and increase in

PSA with prostate enlargement in a

fifth patient(.

Table 3: Adverse Reactions from

Postmarketing Experience of

Testosterone Gel by MedDRA System

Organ Class

Blood and the

lymphatic system

disorders:

Elevated Hgb, Hct

)polycythemia(

Cardiovascular

disorders:

Myocardial

infraction, stroke

Endocrine

disorders:

Hirsutism

Gastrointestinal

disorders:

Nausea

General disorders

and administration

site reactions:

Asthenia, edema,

malaise

Genitourinary

disorders:

Impaired urination

Hepatobiliary

disorders:

Abnormal liver

function tests )e.g.,

transaminases,

elevated GGTP,

bilirubin(

Investigations:

Elevated PSA,

electrolyte changes

)nitrogen, calcium,

potassium,

phosphorus,

sodium(, changes in

serum lipids

)hyperlipidemia,

elevated

triglycerides,

decreased HDL(,

impaired glucose

tolerance,

fluctuating

testosterone levels,

weight increase

Neoplasms benign,

malignant and

unspecified )cysts

and polyps(:

Prostate cancer

Nervous system:

Headache,

dizziness, sleep

apnea, insomnia

Psychiatric

disorders:

Depression,

emotional lability,

decreased libido,

occur.

nervousness,

hostility, amnesia,

anxiety

Reproductive

system and breast

disorders:

Gynecomastia,

mastodynia,

prostatic

enlargement,

testicular atrophy,

oligospermia,

priapism )frequent

or prolonged

erections(

Respiratory

disorders:

Dyspnea

Skin and

subcutaneous

tissue disorders:

Acne, alopecia,

application site

reaction )pruritus,

dry skin, erythema,

rash, discolored

hair, paresthesia(,

sweating

Vascular disorders:

Hypertension,

vasodilation )hot

flushes(, venous

thromboembolism

Secondary

Exposure

to

Testosterone

in

Children

Cases of secondary exposure to

testosterone resulting in virilization of

children have been reported in

postmarket surveillance. Signs and

symptoms of these reported cases

have included enlargement of the

clitoris )with surgical intervention( or

the penis, development of pubic hair,

increased erections and libido,

aggressive behavior, and advanced

bone age. In most cases with a

reported outcome, these signs and

symptoms were reported to have

regressed with removal of the

testosterone gel exposure. In a few

cases, however, enlarged genitalia

did not fully return to age appropriate

normal size, and bone age remained

modestly greater than chronological

age. In some of the cases, direct

contact with the sites of application on

the skin of men using testosterone gel

was reported. In at least one reported

case, the reporter considered the

possibility of secondary exposure

from items such as the testosterone

gel user’s shirts and/or other fabric,

such as towels and sheets [see

Warnings and Precautions )5.2(].

Drug Interactions

Improved insulin sensitivity may

occur in patients treated with

androgens, who achieve normal

testosterone plasma

concentration following

replacement therapy.

Changes in insulin sensitivity or

glycemic control may occur in patients

treated with androgens. In diabetic

patients, the metabolic effects of

androgens may decrease blood

glucose and, therefore, may decrease

insulin requirements

Use In Specific

Testomax is intended for use by

Pregnancy

Populations

men only.

Testomax is not indicated in

pregnant or breast feeding

women. No clinical trials have

been conducted with this

treatment in women.

Pregnant women must avoid any

contact with Testomax application

sites )see section 4.4(. This

product may have adverse

virilizing effects on the fetus. In

the event of contact, wash with

soap and water as soon as

possible.

Testomax is not indicated for use

in children and has not been

evaluated clinically in males

under 18 years of age.

Testosterone gel is contraindicated

during pregnancy or in women who

may become pregnant.

Testosterone is teratogenic and may

cause fetal harm. Exposure of a

female fetus to androgens, such as

testosterone, may result in varying

degrees of virilization. If this drug is

used during pregnancy, or if

patient becomes pregnant while taking

this drug, the patient should be

apprised of the potential

hazard to a

fetus.

Nursing Mothers

Although it is not known how much

testosterone transfers into human milk,

testosterone gel is

contraindicated in

nursing women because of the

potential for serious adverse

reactions in nursing

infants.

Testosterone and other androgens

may adversely affect lactation. [see

Contraindications )4(].

Pediatric Use

Safety and efficacy of testosterone

gel in pediatric males less than 18

years old has not been

established.

Improper use may result in

acceleration of bone age and

premature closure of epiphyses.

Geriatric Use

There have not been sufficient

numbers of geriatric patients involved

in controlled clinical studies

utilizing testosterone gel to determine

whether efficacy in those over 65

years of age differs from

younger

subjects. Additionally, there is

insufficient long-term safety data in

geriatric patients to assess

potential risks of cardiovascular

disease and prostate cancer.

Geriatric patients treated with

androgens may also be at risk for

worsening of signs and symptoms of

BPH.

Overdose

Only one case of acute

testosterone overdose following

an injection has been reported in

the literature. This was a case of

a cerebrovascular accident in a

patient with high plasma

testosterone concentration of

114ng/ml )395nmol/l(. It would be

most unlikely that such plasma

concentration be achieved using

the transdermal route.

Treatment of overdosage would consist of

discontinuation of testosterone gel,

washing the application site with soap

and water, and appropriate symptomatic

and supportive care.

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