Testosterone undecanoate Sun

Package leaflet: Information for the user

Testosterone undecanoate SUN 1000 mg/4 mL injectable solution

testosterone undecanoate
Equivalent medicine
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this package leaflet

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

1. What Testosterone undecanoato SUN is and what it is used for

Testosterone undecanoato SUN contains testosterone as the active substance, a male hormone.
Testosterone is injected into a muscle, where it accumulates and from which it is gradually released
over a period of time. Testosterone is used to replace testosterone in adult men for the treatment of various health problems caused by a lack of testosterone
(male hypogonadism). This condition must be confirmed by two separate measurements of testosterone in the blood and must also include clinical symptoms such as:

• impotence
• infertility
• low sexual desire
• fatigue
• depressed mood
• bone loss caused by low hormone levels

2. What you need to know before using Testosterone undecanoate SUN

Do NOT use Testosterone undecanoate SUN

• if you are allergic to testosterone undecanoate or to 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 breast
• if you have or have had a liver tumour. Testosterone undecanoate SUN is not intended for use in women.

Warnings and precautions
Talk to your doctor before using Testosterone undecanoate SUN if you have or have previously had:

• epilepsy
• heart, kidney or liver problems
• migraine
• temporary interruptions in breathing during sleep (apnoea), as these may worsen
• cancer, as it may be necessary to regularly monitor your blood calcium levels
• high blood pressure or are being treated for high blood pressure, as testosterone may cause an increase in blood pressure
• blood clotting disorders
• bleeding disorders (e.g. haemophilia)
• thrombophilia (a blood clotting disorder that increases the risk of thrombosis – blood clots in blood vessels)
• 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 a leg, lung or other organ at a young age (e.g. under approximately 50 years of age); or with ageing.

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; unexplained sudden cough, which may cause coughing up of blood; or sudden chest pain, severe dizziness or vertigo, severe stomach pain, sudden loss of vision. Contact a doctor immediately if any of these symptoms occur.
If you have severe heart, liver or kidney disease, treatment with Testosterone undecanoate SUN may cause serious complications such as fluid retention in the body, sometimes accompanied by heart failure (congestion).
Before and during treatment, your doctor must perform the following blood tests: blood testosterone levels, full blood count.

If you have liver problems
Formal studies have not been conducted in patients with hepatic impairment. You will not be prescribed testosterone if you have had liver tumours (see "Do NOT use Testosterone undecanoate SUN").

Children and adolescents
Testosterone undecanoate SUN must not be used in children or adolescents. There are no data available on the use of testosterone undecanoate in males 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 the dosage (see "Medical examinations/monitoring").

Muscle development and anti-doping tests
Testosterone undecanoate SUN is not indicated to promote muscle development in healthy individuals or to enhance physical performance.
Testosterone undecanoate SUN may lead to positive results in anti-doping tests.

Misuse of the medicine and dependence
Take this medicine exactly as directed by your doctor or pharmacist.
Abuse of testosterone, especially when excessive amounts of this medicine are taken alone or in combination with other anabolic androgenic steroids, may cause serious health problems affecting the heart and blood vessels (which may be fatal), mental health and/or the liver.
Individuals who have abused testosterone may develop dependence and may experience withdrawal symptoms when the dosage is significantly changed or abruptly discontinued.
This medicine must not be misused alone or in combination with other anabolic androgenic steroids, as it poses serious health risks. (See "Possible side effects").
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Medical examinations/monitoring
Male hormones may increase the growth of prostate cancer and enlargement of the prostate gland (benign prostatic hyperplasia). Before administering testosterone, 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.

Other medicines and Testosterone undecanoate SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those not requiring a prescription. Your doctor may need to adjust the dose if you are taking any of the following medicines:

• ACTH hormone or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma): testosterone may increase the risk of fluid retention, especially if the heart or liver is not functioning properly.
• anticoagulant tablets (oral coumarin-derived anticoagulants), 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 dose of your blood sugar-lowering medicine. Like other androgens, testosterone may enhance the effect of insulin.

Please make sure to inform your doctor if you have a blood clotting disorder, as it is important that your doctor knows this before deciding to administer Testosterone undecanoate SUN.
Testosterone may also affect the results of certain laboratory tests (e.g. thyroid gland). Inform your doctor or laboratory staff that you are taking testosterone.

Pregnancy and breastfeeding
Testosterone undecanoate SUN is not indicated for use in women and must not be used in pregnant or breastfeeding women.

Fertility
Treatment with high doses of testosterone-containing preparations may usually reversibly block or reduce sperm production (see also "Possible side effects").

Driving and using machines
Testosterone undecanoate SUN has no known effect on the ability to drive or operate machinery.

Testosterone undecanoate SUN contains benzyl benzoate
This medicine contains 2000 mg of benzyl benzoate in each 4 mL vial, equivalent to 500 mg/mL.

3. How to use Testosterone undecanoate SUN

Your doctor will inject Testosterone undecanoate SUN (1 vial) very slowly into a muscle. You will receive an injection every 10–14 weeks. This frequency allows sufficient testosterone levels to be maintained without causing testosterone accumulation in the blood.
Testosterone undecanoate SUN must be administered strictly by intramuscular injection. Care must be taken to avoid injecting into a blood vessel (see "Administration").

Starting treatment
Your doctor will measure your blood testosterone levels before starting treatment and during the initial stages of treatment. Your doctor may administer the second injection after only six weeks to rapidly achieve the required testosterone level. This will depend on your symptoms and testosterone levels.

Maintaining Testosterone undecanoate SUN levels during treatment
The interval between injections must always remain within the recommended range of 10–14 weeks.
Your doctor will regularly measure your testosterone levels at the end of an injection interval to ensure they are appropriate. If levels are too low, your doctor may decide to increase the frequency of injections. Conversely, if levels are too high, your doctor may decide to reduce the injection frequency. Do not miss scheduled injection appointments, otherwise optimal testosterone levels cannot be maintained.
If you think that the effect of Testosterone undecanoate SUN is too strong or too weak, speak with your doctor.

If you use more Testosterone undecanoate SUN than you should
Symptoms of an overdose of Testosterone undecanoate SUN include:

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

Inform your doctor if you experience any of these symptoms. Your doctor will either administer the medicine 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 side effects (may affect up to 1 in 10 people):

• abnormally high levels of red blood cells
• weight gain
• hot flushes
• acne
• prostate enlargement and related 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 blood test results (e.g. increased blood sugar or fat levels)
• depression, emotional disturbance, insomnia, restlessness, aggression or irritability
• headache, migraine or tremor
• cardiovascular disorders, high blood pressure or dizziness
• bronchitis, sinusitis, cough, breathlessness, snoring or voice changes
• diarrhoea or nausea
• changes in liver function tests
• hair loss or various skin reactions (e.g. itching, redness or dry skin)
• joint pain, limb pain, muscle problems (e.g. spasm, pain or stiffness) or increased creatine phosphokinase in the blood
• urinary disorders (e.g. reduced urine flow, urinary retention, need to urinate during the night)
• prostate disorders (e.g. prostate dysplasia, hardening or inflammation of the prostate), changes in sexual desire, testicular pain, breast pain, hardening or enlargement, or increased levels of male and female hormones
• fatigue, general feeling of weakness, excessive sweating or night sweats

Rare side effects (may affect up to 1 in 1,000 people):

• Testosterone, which is an oily liquid, may reach the lungs (pulmonary microembolism of oily solutions), which in rare cases may lead 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.

Cases of suspected anaphylactic reactions have been reported after testosterone injection.
In addition to the side effects listed above, the following side effects have been reported with treatment using testosterone-containing preparations: nervousness, hostility, brief interruptions in 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).
Treatment with high doses of testosterone preparations commonly interrupts or reduces sperm production, although this usually returns to normal after treatment is stopped. 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 fluid retention and oedema (swelling due to fluid retention).
For testosterone-based products in general, a common 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) has been observed through periodic blood tests.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, nurse, or pharmacist. You can also report side effects directly via 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 Testosterone undecanoate SUN

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Testosterone undecanoate SUN contains

• The active substance is testosterone undecanoate 250 mg/mL (equivalent to 157.9 mg of testosterone). One vial contains 1000 mg of testosterone undecanoate (equivalent to 631.5 mg of testosterone).
• The other components are benzyl benzoate and highly refined castor oil.

Description of the appearance of Testosterone undecanoate SUN and contents of the pack
Testosterone undecanoate SUN is a clear, pale yellow oily liquid. The pack contains:
Amber glass vial with a bromobutyl rubber stopper sealed with an aluminium seal cap, containing a fill volume of 4 mL.
Pack: 1 x 4 mL.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Local representative:
Sun Pharma Italia S.r.l.
Viale Giulio Richard, 3
20143 Milan, Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Testosteron undecanoaat SUN 1000 mg/4 ml oplossing voor injectie
Belgium: Testosterone SUN 1000 mg/4 ml oplossing voor injectie / Testosterone SUN 1000 mg/4 ml Injektionslösung / Testosterone SUN 1000 mg/4 ml solution injectable
Czech Republic: Testosterone undecanoate SUN
Germany: TESTOSTERON BASICS 1000 mg/4 ml Injektionslösung
Greece: TESTOSTERONE/SUN
Spain: TESTOSTERONA SUN 1000 mg/4 ml solución inyectable EFG
France: UNDECANOATE DE TESTOSTERONE SUN 1000 mg/4 ml, solution injectable
Finland: Testosterone SUN 1000 mg/4 ml injektioneste, liuos
Hungary: Testosterone SUN 1000 mg/4 ml oldatos injekció
Italy: Testosterone undecanoato SUN
Norway: Testosterone undecanoate SUN
Sweden: Testosterone SUN
Slovakia: Testosterone SUN 1000 mg/4 ml injekčný roztok

The following information is intended for healthcare professionals only:

Under conditions of storage at low temperatures, the properties of this oily 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 administration; only clear solutions free from particulate matter should be used.
The contents of a vial must be administered intramuscularly immediately after opening the vial.
The medicinal product is for single use only; any unused solution must be discarded.

Administration
Particular care must be taken to avoid intravascular injection.
Like all oily solutions, testosterone must be injected strictly by intramuscular route and very slowly. Pulmonary microembolism due to oily solutions may rarely 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, for example, administration of supplemental oxygen.
Cases of suspected anaphylactic reactions have been reported after testosterone injection.

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 those 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 be monitored periodically: hemoglobin, hematocrit, liver function tests, and lipid profile.

In patients with severe heart, hepatic, or renal insufficiency or ischemic heart disease, testosterone treatment may cause serious complications characterized by edema with or without congestive heart failure. In such cases, treatment must be immediately discontinued.

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