Testomed

Patient Information Leaflet

TESTOMED 1000 mg injectable solution

testosterone undecanoate
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What TESTOMED is and what it is used for

TESTOMED contains the male hormone testosterone as the active substance. TESTOMED is
injected into the muscle. It accumulates in the muscle and is gradually released over an extended period
of time.
TESTOMED is used for testosterone replacement therapy in adult men for the treatment of various health problems caused by testosterone deficiency (male hypogonadism).
This deficiency must be confirmed by two separate measurements of testosterone concentrations in the blood. There must also be the presence of certain clinical symptoms such as:

• sexual dysfunction (impotence)
• infertility
• reduced sexual desire
• fatigue
• depressed mood
• loss of bone mass due to low hormone levels.

2. What you need to know before using TESTOMED

Do not use TESTOMED

• if you are allergic to testosterone undecanoate or to any of the other ingredients of this medicine (listed in section 6).
• if you have cancer or suspected cancer of the prostate gland or breast that is stimulated by male sex hormones (androgens)
• if you have or have had liver tumours

TESTOMED is not intended for use in women.
Warnings and precautions
Talk to your doctor before using TESTOMED if you suffer or have ever suffered from the following conditions:

• epilepsy
• heart, kidney or liver disease
• migraine
• temporary interruptions of breathing during sleep (sleep apnoea), as these may worsen
• cancer, because regular monitoring of calcium levels in the blood may be necessary
• high blood pressure or if you are being treated for high blood pressure, since testosterone may cause an increase in blood pressure
• blood clotting disorders: or bleeding disorders (such as haemophilia) or thrombophilia (a blood clotting disorder that increases the risk of blood clots in veins) or factors that increase the risk of blood clots in a vein: previous blood clots in a vein; smoking; obesity; cancer; immobility; if one of your close relatives has had a blood clot in the leg, lung or another organ at a young age (e.g. under 50 years); or if you are elderly.

How to recognize a blood clot: painful swelling of one leg or sudden change in skin colour, for example becoming pale, red or blue; sudden shortness of breath; sudden unexplained cough, which may produce blood; sudden chest pain, severe mental confusion or dizziness; severe stomach pain; sudden loss of vision. Contact a doctor immediately if you experience any of these symptoms.
If you suffer from severe heart, liver or kidney disease, treatment with TESTOMED may cause serious complications in the form of fluid retention in the body, sometimes accompanied by blood accumulation (congestive heart failure).
Before and during treatment, your doctor must carry out the following blood tests: blood testosterone levels, full blood count.
If your liver is not functioning properly
Formal studies have not been conducted in patients with impaired liver function. TESTOMED will not be prescribed to you if you have ever had liver tumours (see section “Do not use TESTOMED”).
Medical examinations/periodic checks
Male sex hormones may promote the growth of prostate cancer and enlargement of the prostate gland (benign prostatic hyperplasia). Before injecting TESTOMED, your doctor will examine you to ensure you do not have prostate cancer.
Your doctor will perform regular checks of your prostate and breast glands, especially if you are elderly. You will also undergo regular blood tests.
Benign (non-cancerous) and malignant (cancerous) liver tumours have been observed following the use of hormonal substances such as androgenic compounds.
Children and adolescents
This medicine is not intended for children and adolescents. There are no data available in male adolescents under 18 years of age.
Elderly patients (65 years or older)
If you are over 65 years of age, your doctor will generally not adjust the dosage (increase the dose) (see section “Medical examinations/periodic checks”).
Effects if used improperly for doping
The use of TESTOMED may result in a positive anti-doping test. Androgens, such as those contained in TESTOMED, are not suitable for enhancing muscle development in healthy individuals or for increasing physical performance. The health consequences of using TESTOMED as a doping agent cannot be predicted; serious health risks cannot be ruled out.
Misuse of the medicine and dependence
Always take this medicine exactly as prescribed by your doctor or pharmacist.
Abuse of testosterone, especially if taken in excessive amounts alone or together with other anabolic androgenic steroids, may cause serious health problems affecting the heart and blood vessels (which may lead to death), mental health and/or the liver.
Individuals who have abused testosterone may become dependent and withdrawal symptoms may occur when the dosage is significantly changed or abruptly discontinued. Do not misuse this medicine alone or in combination with other anabolic androgenic steroids, as this entails serious health risks (see also section 4. "Possible side effects").
Other medicines and TESTOMED
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to adjust the dose if you are taking or using one or more of the following medicines:

• ACTH hormone (adrenocorticotropic hormone – a specific pituitary hormone) or corticosteroids (adrenal cortex hormones used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma): TESTOMED may increase the risk of fluid retention in tissues, especially if you suffer from heart or liver disease
• blood-thinning tablets (oral anticoagulants derived from coumarins), as this may increase the risk of bleeding. Your doctor will monitor the dosage.
• Medicines used to treat diabetes. It may be necessary to adjust the dosage of your blood sugar-lowering medicine. Like other androgens, testosterone may enhance the effect of insulin. Taking SGLT‑2 inhibitors (such as empagliflozin, dapagliflozin or canagliflozin) together with testosterone may increase the number of red blood cells in the blood. Your doctor may need to perform blood tests more frequently.

Please ensure you inform your doctor if you have a blood clotting disorder, as it is important that your doctor is aware of this before deciding to inject TESTOMED.
TESTOMED may also affect the results of certain laboratory tests (e.g. thyroid function tests). Inform your doctor or laboratory staff that you are using TESTOMED.
Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
TESTOMED is not intended for use in women and therefore must not be used during pregnancy or while breastfeeding.
Fertility
Treatment with high doses of testosterone preparations usually reversibly blocks or reduces sperm production (see also section “Possible unwanted effects”).
Driving and using machines
TESTOMED does not alter or alters negligibly the ability to drive vehicles and use machinery.
TESTOMED contains benzyl benzoate
This medicine contains 2000 mg of benzyl benzoate in each vial (4 mL), corresponding to 500 mg of benzyl benzoate/mL.

3. How to use TESTOMED

Your doctor will inject TESTOMED very slowly into a muscle. Injections will be given every
10–14 weeks. This frequency allows sufficient testosterone levels to be maintained without
causing an accumulation of testosterone in the blood.
TESTOMED must be administered strictly by intramuscular injection. Great care must be taken
to avoid injecting the medicine into a blood vessel (see the section “The following information is intended exclusively for healthcare professionals” under the section “Administration” at the end of this leaflet).
The solution for intramuscular injection must be visually inspected before use. Only clear solutions free from particles should be used.

Starting treatment
Before starting treatment and during its initial stages, your doctor will measure your testosterone levels in the blood. Your doctor may administer the second injection after only 6 weeks in order to rapidly achieve the required testosterone level. This will depend on the signs of disease (symptoms) and how low your testosterone levels are.

Maintaining your testosterone levels during treatment
The interval between injections must always remain between 10 and 14 weeks, as recommended.
Your doctor will regularly measure your testosterone levels towards the end of the interval between injections to ensure they are appropriate. If levels are too low, your doctor may administer injections more frequently. If levels are too high, your doctor may administer injections less frequently. Do not miss your injection appointments; otherwise, it will not be possible to maintain optimal testosterone levels.
If you think that the effect of TESTOMED is too strong or too weak, talk to your doctor or pharmacist.

If you use more TESTOMED than you should
Symptoms of receiving too much TESTOMED include:

• irritability
• nervousness
• weight gain
• prolonged or frequent erections

Inform your doctor if you experience any of these symptoms. Your doctor will administer TESTOMED less frequently or discontinue treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

The most common side effects are acne and pain at the injection site.

Common (may affect up to 1 in 10 patients):
Abnormally high levels of red blood cells; weight gain; hot flushes; acne; enlarged prostate (benign prostatic hyperplasia) and associated disorders; increased levels in a specific blood test for the prostate (PSA); various reactions at the injection site (e.g. pain, bruising or irritation).

Uncommon (may affect up to 1 in 100 patients):
Allergic reactions; increased red blood cell count and increased haemoglobin (Hb) in the blood; increased appetite; changes in certain blood tests (e.g. increased blood sugar and blood lipids); depression; emotional disturbances; insomnia; restlessness; aggression and irritability; headache; migraine and tremor; cardiovascular disturbances; high blood pressure; dizziness; bronchitis; inflamed sinuses (sinusitis); cough; shortness of breath; snoring, hoarseness; diarrhoea; nausea; changes in liver function blood tests; hair loss; various skin reactions (e.g. itching, redness or dry skin); joint pain; pain in extremities; muscle problems (e.g. muscle spasms, muscle pain or stiffness); increased creatine phosphokinase in the blood (an enzyme that provides energy, e.g. for muscle contraction); urinary disorders (e.g. reduced urinary flow, urinary retention, need to urinate at night); prostate disorders (e.g. prostatic dysplasia [a precursor of prostate cancer], hardening and inflammation of the prostate); changes in sexual desire; testicular pain; pain, hardening or enlargement of the breasts; increased levels of male or female sex hormones in the blood; fatigue; general feeling of weakness; excessive sweating and night sweats.

Rare (may affect up to 1 in 1,000 patients):
TESTOMED, being an oily liquid, may reach the lungs (pulmonary microembolism due to oily solutions), leading in rare cases to signs and symptoms such as cough, shortness of breath, general malaise, excessive sweating, chest pain, dizziness, tingling or fainting. These reactions may occur during or immediately after injection and are reversible. Therefore, the patient should be observed during and immediately after each injection to allow rapid identification of any signs and symptoms of oil-induced pulmonary microembolism.

Cases of suspected hypersensitivity reactions (anaphylactic reactions) have been reported after administration of testosterone undecanoate.

In addition to the side effects listed above, the following adverse reactions have been reported with testosterone-containing preparations:

Nervousness; hostility; brief interruptions in breathing during sleep; various skin reactions including dandruff and oily skin; increased body hair; more frequent erections; and very rare cases of yellowing of the skin and eyes (jaundice).

Generally, treatment with testosterone-containing preparations at high doses suppresses or reduces sperm production. This effect usually returns to normal after discontinuation of treatment.

Testosterone replacement therapy for reduced testicular function (hypogonadism) may rarely cause persistent and painful erections (priapism). Administration of testosterone at high doses or for prolonged periods may occasionally lead to more frequent occurrences of fluid retention and oedema (swelling due to fluid retention).

Regular blood tests have shown a risk of increased red blood cell count, haematocrit (percentage of red blood cells in the blood), and haemoglobin (the component of red blood cells that carries oxygen), which is common to testosterone-containing products in general.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
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 TESTOMED

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Under conditions of low-temperature storage, the properties of this oil-based solution
may temporarily change (e.g. increased viscosity, turbidity). If stored at low
temperature, the product should be brought to room or body temperature before use.
The contents of the vial must be administered immediately after opening the vial. This
medicine is for single use only. Any unused solution must be discarded.
Do not dispose of any medicine via wastewater. 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 TESTOMED contains

• The active substance is testosterone undecanoate. 1 mL of injectable solution contains 250 mg of testosterone undecanoate, equivalent to 157.9 mg of testosterone. One 4 mL vial of injectable solution contains 1000 mg of testosterone undecanoate, equivalent to 631.5 mg of testosterone.
• The other components are benzyl benzoate and refined castor oil.

Description of the appearance of TESTOMED and contents of the pack
TESTOMED is a clear oily solution, colourless to slightly yellowish.
Pack contents:
One amber glass vial containing 4 mL of injectable solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
mibe pharma Italia S.r.l.
via Leonardo da Vinci 20/B
39100 Bolzano
Italy

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Testomed 1000 mg/4 ml Injektionslösung
Germany Testomed 1000 mg Injektionslösung
Italy Testomed
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The following information is intended exclusively for healthcare professionals:

Administration
Exercise particular care to avoid intravascular injection.
Like all oily solutions, TESTOMED must be administered strictly by intramuscular injection and very slowly (over more than 2 minutes). It must in no case be injected into the upper part of the arm or thigh. The preferred site for intramuscular injection is the middle gluteal muscle in the upper outer quadrant of the gluteal region.
The formation of pulmonary microemboli from oily solutions may, in rare cases, lead to signs and symptoms such as cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope.
These reactions may occur during or immediately after injection and are reversible. Treatment is usually supportive, e.g., administration of supplemental oxygen.
Cases of suspected hypersensitivity reactions (anaphylactic reactions) have been reported following injection of testosterone undecanoate.

Precautions
Patients receiving testosterone therapy should undergo careful and regular monitoring of the prostate gland and breasts, according to recommended methods (digital rectal examination and measurement of serum PSA), at least once a year, and twice a year in elderly patients and patients at risk (those with clinical or familial risk factors).
In patients undergoing long-term androgen therapy, in addition to laboratory tests for testosterone concentration, the following laboratory parameters should also be monitored regularly: hemoglobin, hematocrit, liver function parameters, and lipid profile.
In patients with severe heart, liver, or renal insufficiency or with ischemic heart disease, treatment with testosterone may induce serious complications characterized by edema with or without congestive heart failure. In such cases, treatment must be immediately discontinued.

Educational material
The approved educational material for this medicinal product is available by scanning the QR code below with a smartphone. The same information can be found at the following web address: https://www.dottnet.it/file/106631/materiali-educazionali-testomed-testosterone-undecanoato