TESTEX 250 mg /Ml Roztwór Do Wstrzykiwań

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1. TESTEX 1000 mg/4 ml, injectable solution
   1. What is TESTEX and what is it used for
   2. What you need to know before using TESTEX
   3. How to use TESTEX
   4. Possible side effects
   5. How to store TESTEX
   6. Package Contents and Other Information

TESTEX 1000 mg/4 ml, injectable solution

Testosterone undecanoate

Equivalent medicine
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

• 1. What TESTEX is and what it is used for
• 2. What you need to know before you use TESTEX
• 3. How to use TESTEX
• 4. Possible side effects
• 5. How to store TESTEX
• 6. Contents of the pack and other information

1. What is TESTEX and what is it used for

TESTEX contains testosterone as its active ingredient, a male hormone. TESTEX is injected
into your body into a muscle, where it remains accumulated and from which it is gradually released for a certain
period of time. TESTEX is used to replace testosterone in adult men, for the treatment of
various health problems due to testosterone deficiency (male hypogonadism). This
condition must be confirmed with two distinct measurements of testosterone in the blood and must
include clinical symptoms such as:

• impotence
• infertility
• low sexual desire
• fatigue
• depressed mood
• loss of bone tissue due to low hormone levels.

2. What you need to know before using TESTEX

Do not use TESTEX:

• if you are allergic to testosterone undecanoate or any of the other ingredients of this medicine (listed in section 6),
• if you have androgen-dependent cancer, or suspected cancer, of the prostate or mammary gland,
• if you have or have had liver tumors. TESTEX is notintended for use in women.

Warnings and precautions
Talk to your doctor before using TESTEX if you suffer from or have suffered in the past from:

• epilepsy
• heart, kidney or liver problems
• migraine
• temporary interruptions of breathing during sleep (apnea), because they may worsen
• cancer, because it may be necessary to regularly check the level of calcium in the blood
• high blood pressure or if you are being treated for high blood pressure, as testosterone may cause an increase in blood pressure
• coagulation disorders
• bleeding disorders (i.e. hemophilia)
• thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis - blood clots in the veins)
• factors that increase the risk of blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; inactivity; if a close family member has had a blood clot in a leg, lung or other organ at a young age (e.g. under the age of about 50); or with advancing age.

How to recognize a blood clot: painful swelling of a leg or a sudden change in the
skin color, for example becoming pale, red or blue, sudden shortness of breath, sudden unexplained
cough that may cause you to cough up blood; or sudden chest pain, severe dizziness
or lightheadedness, severe stomach pain, sudden loss of vision. Seek immediate medical attention if any of these symptoms occur.

If you suffer from a severe heart, liver or kidney disease, treatment with TESTEX may
cause serious complications in the form of fluid accumulation in the body, sometimes accompanied by
heart failure (congestion).
Before and during treatment, your doctor must perform the following blood tests: testosterone levels in the blood, complete blood count.

If you have liver problems
Formal studies have not been conducted in patients with impaired liver function. You will not
be prescribed TESTEX if you have suffered from liver cancer (see “Do not use TESTEX”).

Children and adolescents
TESTEX must notbe used in children and adolescents. There is no data available on the use of
TESTEX in male patients under 18 years of age.

Elderly patients (65 years or older)
If you are over 65 years of age, your doctor does not need to adjust your dosage (see “Medical examinations/

checks”)

Muscle development and anti-doping tests
TESTEX is notindicated to promote muscle development in healthy subjects or to improve
physical performance. TESTEX may result in positive doping tests.

Drug abuse and dependence
Always take the medicine exactly as your doctor or pharmacist has told you.
Abuse of testosterone, especially if you take too much on your own or with other anabolic androgenic steroids, can cause serious health problems with the heart and blood vessels (which can lead
to death), mental health and/or liver.
Individuals who have abused testosterone may develop dependence and may experience
withdrawal symptoms when the dosage is changed significantly or stopped abruptly. Do not
abuse this medicine on your own or with other anabolic androgenic steroids as it causes
serious health risks (see “Possible side effects”).

Doping
For athletes: the use of the drug without therapeutic need constitutes doping and may
still result in a positive doping test.

Medical examinations/checks
Male hormones can promote the growth of prostate cancer and enlarged prostate gland
(benign prostatic hyperplasia). Before injecting TESTEX, your doctor will examine you to make sure
you do not have prostate cancer.
Your doctor will perform regular checks of your prostate and breasts, especially if you are
elderly. They will also perform regular blood tests.
The development of benign (non-cancerous) and malignant (cancerous) liver tumors has been observed following the use of hormonal substances such as androgenic compounds.

Other medicines and TESTEX
Tell your doctor or pharmacistif you are taking or have recently taken or might take
any other medicines, including those available without a prescription.
It may be necessary for your doctor to adjust your dosage if you are using any of the following medicines:

• ACTH hormone or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergies and asthma): TESTEX may increase the risk of fluid retention, especially if your heart and liver are not functioning well,
• tablets to thin the blood (coumarin derivatives, oral anticoagulants) as this may increase the risk of bleeding. Your doctor will check your dosage,
• medicines used to treat diabetes. It may be necessary to adjust the dosage of your medicine to lower blood sugar. Like other androgens, testosterone can increase the effect of insulin.

Please make sure to tell your doctor if you have a blood clotting disorder, because
it is important that your doctor knows this before deciding to inject TESTEX.
TESTEX may also affect the results of certain laboratory tests (e.g. those for the thyroid). Tell
your doctor or the laboratory staff that you are using TESTEX.

Pregnancy and breastfeeding
The use of TESTEX is not indicated in women and the medicine should not be used during
pregnancy or breastfeeding.

Fertility
Treatment with high doses of testosterone-based preparations usually can reversibly block
or reduce sperm production (see also “Possible side effects”).

Driving and operating machinery
TESTEX has no known effects on the ability to drive vehicles or operate machinery.

TESTEX contains benzyl benzoate
This medicine contains 2000 mg of benzyl benzoate in each vial/ampoule of 4 ml, equivalent to
500 mg/ml.

3. How to use TESTEX

The doctor will inject TESTEX (1 vial/vial) very slowly into a muscle. You will receive an
injection every 10-14 weeks. This frequency allows maintaining sufficient levels of
testosterone without leading to an accumulation of testosterone in the blood.
TESTEX must be strictly administered by intramuscular injection.
Particular attention will be paid to avoiding injecting the medicine into a blood vessel (see
“ Administration”).

Start of treatment
Before starting treatment, and in its early stages, the doctor will measure your testosterone levels in
the blood. The doctor may give you the second injection after only six weeks, in order to quickly reach
the necessary testosterone level. This will depend on your symptoms and testosterone levels.

Maintaining TESTEX levels during treatment
The interval between injections must always remain between 10 and 14 weeks, as recommended.
The doctor will regularly measure your testosterone levels at the end of an interval between one
injection and the next, to ensure they are correct. If the values found are too low, the doctor may decide
to increase the frequency of injections. If, conversely, the values are high, the doctor may decide to
decrease the frequency of injections. Do not miss your injection appointments, otherwise it will not be
possible to maintain optimal testosterone levels.
If you think that the effect of TESTEX is too strong or too weak, talk to your doctor.

If you use more TESTEX than you should
The symptoms of an excessive dose of TESTEX are:

• irritability
• nervousness
• weight gain
• prolonged or frequent erections Inform your doctor if you experience any of these symptoms. The doctor will space out the injections or stop the treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effectsare acne and pain at the injection site.

Common side effects(may affect up to 1 in 10 people):

• abnormally high levels of red blood cells
• weight gain
• hot flushes
• acne
• enlarged prostate and associated disorders
• various reactions at the injection site (e.g. pain, bruising or irritation)

Uncommon side effects(may affect up to 1 in 100 people):

• allergic reaction
• increased appetite, changes in some blood tests (e.g. increased sugar or fats in the blood)
• depression, emotional disorders, insomnia, restlessness, aggression, irritability
• headache, migraine, tremor
• cardiovascular disorders, high blood pressure, dizziness
• bronchitis, sinusitis, cough, shortness of breath, snoring, changes in voice
• diarrhoea, nausea
• changes in liver function tests
• hair loss, various skin reactions (e.g. itching, redness or dry skin)
• joint pain, limb pain, muscle problems (e.g. spasm, pain or stiffness), or an increase in creatine phosphokinase in the blood
• urinary disorders (e.g. decreased urine flow, urinary retention, need to urinate at night)
• prostate disorders (e.g. prostate dysplasia, hardening or inflammation of the prostate), changes in sexual desire, testicular pain, hardening or enlargement of the breasts, increased levels of male and female hormones
• fatigue, general feeling of weakness, excessive sweating, night sweats

Rare side effects(may affect up to 1 in 1000 people):

• TESTEX, which is an oily liquid, can reach the lungs (oily microembolic pulmonary syndrome) and this, in rare cases, can give rise to signs and symptoms such as cough, dyspnea,

general malaise, excessive sweating, chest pain, dizziness, tingling or fainting.
These reactions can occur during or immediately after the injection and are reversible.
Cases of suspected anaphylactic reaction have been reported after injection of TESTEX.
In addition to those listed above, the following side effects have been reported following treatment with preparations containing testosterone: nervousness, hostility, brief interruptions of breathing during
sleep, various skin reactions, including dandruff and oily skin, increased hair growth, more frequent erections and
very rare cases of yellowing of the skin and eyes (jaundice).
Commonly, treatment with high-dose testosterone preparations stops or reduces
sperm production, although this returns to normal after discontinuation of treatment. Testosterone replacement therapy for reduced testicular function (hypogonadism) may cause, in
rare cases, persistent and painful erections (priapism). The administration of testosterone at high doses or
for prolonged periods may occasionally lead to more frequent manifestations of fluid retention
and edema (swelling due to fluid retention).
For testosterone-containing products in general, a common risk of increased
red blood cell count, hematocrit (percentage of red blood cells in the blood) and hemoglobin (the
component of red blood cells that carries oxygen) has been observed, highlighted by periodic blood tests.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store TESTEX

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.

Do not usethis medicine after the expiry date which is stated on the package and label after
“Exp”. The expiry date refers to the last day of that month.

Do not dispose ofany medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What TESTEX contains
The active ingredient is testosterone undecanoate 250 mg/ml (corresponding to 157.9 mg of testosterone).
One vial/bottle contains 1000 mg of testosterone undecanoate (corresponding to 631.5 mg of
testosterone).
The other ingredients are benzyl benzoate and refined castor oil.

Description of the appearance of TESTEX and package contents
TESTEX is an oily liquid, of yellow to slightly yellow color.
TESTEX is supplied in an amber glass vial or an amber glass bottle with a rubber stopper and
aluminum cap with a plastic flip-off.
The package contains:
1 amber glass vial / 1 amber glass bottle containing 4 ml of injectable solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorio Farmaceutico S.I.T. S.r.l.
Via Cavour 70, 27035 Mede (PV), Italy
Manufacturer
EVER Pharma Jena GmbH
Brüsseler Str 18
07747 Jena, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:

• Netherlands: Testosteron undecanoaat SIT 1000 mg/4 ml, oplossing voor injectie
• Spain: Testosterona SIT 1000 mg/4ml, solución inyectable EFG

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The following information is intended exclusively for healthcare professionals:
Under conditions of storage at low temperatures, the properties of this oil-based solution
may temporarily change (e.g. increased viscosity, turbidity). If stored at low
temperature, the product must be brought to room or body temperature before use.
The injectable solution for intramuscular use must be visually inspected before use;
only clear solutions free of suspended particles must be used.
The contents of a vial/bottle must be injected intramuscularly immediately after opening.
The medicine is for single use only; any unused solution must be discarded.
Administration:
Take particular care to avoid intravascular injection.
As with all oily solutions, TESTEX must be injected strictly intramuscularly and
very slowly. The formation of oily microemboli can, in rare cases, lead to
signs and symptoms such as cough, dyspnea, malaise, hyperhidrosis, chest pain, a feeling of instability,
paresthesia or syncope. These reactions can occur during or immediately after the injection and are
reversible. Treatment is usually supportive, consisting, for example, in the administration of
oxygen.
Cases of suspected anaphylactic reaction have been reported after the injection of TESTEX.
Warning:
Patients taking testosterone therapy must be subjected to careful and
regular monitoring of the prostate gland (rectal examination and serum PSA determination) and the
breasts, according to recommended methods, at least once a year and twice a year for elderly patients
and those at risk (those with clinical or family factors).
In patients undergoing long-term androgen therapy, in addition to laboratory tests relating to
testosterone concentration, the following laboratory parameters must be checked periodically:
hemoglobin, hematocrit, and liver function tests and lipid profile.
In patients with severe heart, liver or kidney failure, or with ischemic heart disease, the
treatment with testosterone may induce serious complications, characterized by edema with or without
congestive heart failure. In such cases, treatment should be discontinued immediately.

Notes on handling the OPC (One-Point Cut) vial:
Below the colored point, the vial has a pre-score, which eliminates the need to use
a saw for opening it. Before opening, make sure that any solution present
in the upper part of the vial has flowed into the lower part. Use both hands to open; holding
the lower part of the vial with one hand, detach the upper part with the other hand, in the direction
opposite the colored point.

Notes on handling the bottle:
The bottle is for single use. The contents of the bottle must be injected intramuscularly immediately
after aspiration into the syringe. After removing the plastic cap (A) do not remove the metal ring (B) or the
screw cap (C).