TESTOSTERONE SUN 1000 mg/4 ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Testosterona SUN 1,000 mg/4ml Solution for Injection EFG

Testosterone Undecanoate

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Testosterona SUN and what is it used for

Testosterona SUN contains testosterone, a male hormone, as the active ingredient.

Testosterone is administered by intramuscular injection; the medication is released over time. Testosterone is used in adult men for testosterone replacement therapy to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate testosterone measurements in the blood and also by clinical symptoms such as:

• impotence
• infertility
• low sexual appetite
• fatigue
• depressive mood
• bone loss caused by low hormone levels.

2. What you need to know before you use Testosterona SUN

Do not use Testosterona SUN

• 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 suspect you may have prostate or breast cancer
• if you have or have had a liver tumor.

Testosterone is notindicated for use in women.

Warnings and precautions

Consult your doctorbefore starting treatment with testosterone if you have or have ever had:

• epilepsy
• heart, liver, or kidney problems
• migraine
• breathing interruptions during sleep (apnea) as it may worsen with treatment
• cancer, as calcium levels in the blood should be determined
• high blood pressure or if you are being treated for high blood pressure, as testosterone may cause an increase in blood pressure
• coagulation problems
• • bleeding disorders (e.g., hemophilia)
  • thrombophilia (blood coagulation anomaly 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, inactivity, if a close relative has had a blood clot in a leg, lung, or other organ at a young age (e.g., below 50 years of age), or as you get older.

How to recognize a blood clot: painful swelling of a leg or sudden change in skin color, for example, becoming pale, red, or blue, sudden difficulty breathing, sudden and unexplained cough that may produce blood, or sudden chest pain, severe dizziness or fainting, severe stomach pain, sudden loss of vision. Seek urgent medical attention if you experience any of these symptoms.

If you have severe heart, liver, or kidney failure, treatment with testosterone may cause serious complications in the form of fluid retention, which may occasionally be accompanied by congestive heart failure.

Before starting treatment and during treatment, your doctor will check the following parameters in your blood test: testosterone level and complete blood count.

If your liver is not functioning

No formal studies have been conducted in patients with liver failure. If you have ever had a liver tumor, this medication will not be prescribed to you (see "Do not use Testosterona SUN").

Children and adolescents

Testosterone is notindicated for use in children and adolescents. There is no available information on the use of this medication in males under 18 years of age.

Older people (65 years or older)

No dose adjustment is necessary if you are over 65 years old (see "Medical examination/follow-up").

Use in athletes, bodybuilding, and doping tests

Testosterone is notindicated for increasing muscle mass in healthy individuals or for increasing physical endurance.

Testosterone may produce a positive result in doping control tests.

Drug abuse and dependence

Always use this medication exactly as your doctor or pharmacist has told you.

Abuse of testosterone, especially if you take too much of this medication alone or in combination with other anabolic androgenic steroids, can cause serious health problems to your heart and blood vessels (which can be fatal), your mental health, and/or your liver.

People who have abused testosterone may become dependent and may experience withdrawal symptoms when the dose is significantly changed or when use is suddenly stopped. Do not abuse this medication because it can cause serious health problems, whether used alone or in combination with other anabolic androgenic steroids (see "Possible side effects").

Medical examination / follow-up

Male hormones can increase the growth of prostate cancer or increase the size of the prostate gland (benign prostatic hyperplasia). Before starting treatment with testosterone, your doctor should perform a medical examination to rule out the risk of existing prostate cancer.

Your doctor should carefully monitor your prostate and breasts, especially in older patients. Your doctor will also perform periodic blood tests.

Benign (non-cancerous) and malignant (cancerous) liver tumors have been reported in patients treated with hormonal products such as androgenic compounds.

Other medicines and Testosterona SUN

Tell your doctor or pharmacistif you are using or have recently used or might use any other medicines, including those obtained without a prescription. Your doctor may need to adjust the dose if you are taking other medications, such as:

• Adrenocorticotropic hormone (ACTH) or corticosteroids (used to treat various diseases such as rheumatism, arthritis, allergic reactions, and asthma). Testosterone may increase the risk of fluid retention, especially if you have heart or liver problems.
• Medicines that make the blood more fluid (oral anticoagulants, coumarin derivatives) as they may increase the risk of bleeding. Your doctor will check your dose.
• Medicines for the treatment of diabetes. It may be necessary to adjust the dose of your antidiabetic medication. Like other androgens, testosterone may increase the effect of insulin.

Tell your doctor if you have any coagulation disorders, as it is essential for your doctor to know this information to decide if you can be treated with testosterone.

Testosterone may also affect the results of laboratory tests (e.g., thyroid gland). Inform your doctor or laboratory personnel that you are being treated with testosterone.

Pregnancy and breastfeeding

Testosterone is not indicated for use in women and should not be used in pregnant or breastfeeding women.

Fertility

Treatment with high doses of testosterone medications can interrupt or reduce sperm production in a reversible manner (see also "Possible side effects").

Driving and using machines

No effect has been observed on the ability to drive and use machines.

Testosterona SUN contains benzyl benzoate

This medication contains 2,000 mg of benzyl benzoate in each 4 ml vial, equivalent to 500 mg/ml.

3. How to use Testosterona SUN

Your doctor will inject this medication (1 vial) intramuscularly, very slowly. The treatment will be repeated every 10-14 weeks, sufficient time to maintain testosterone levels without accumulation in the blood.

Testosterone should only be administered intramuscularly. Special care should be taken to avoid injecting the product into a blood vessel (see "Administration").

Starting treatment

Before starting treatment and during the first part of it, your doctor will determine your blood testosterone levels. Your doctor may administer a second injection, as soon as 6 weeks after the first injection, to rapidly reach the necessary testosterone level. This will depend on your symptoms and testosterone levels.

Maintaining Testosterona SUN levels during treatment

The interval between injections should be maintained within the recommended limit of 10 to 14 weeks. Your doctor will regularly measure your testosterone levels at the end of an injection interval to ensure that levels are correct. If levels are too low, your doctor may increase the frequency of injections. If levels are too high, your doctor may decrease the frequency of injections. Do not forget your treatment days, as this will not maintain your testosterone levels correctly.

If you think the effect of testosterone is too strong or too weak, tell your doctor.

If you use more Testosterona SUN than you should

Symptoms of having received too much testosterone include:

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

Tell your doctor if you have any of the above symptoms. Your doctor will reduce the frequency of injections or stop treatment.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most common adverse reactionsare acne and pain at the injection site.

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

• abnormally high red blood cell counts
• weight gain
• hot flashes
• acne
• prostate enlargement and associated problems
• 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 test results (e.g., increased sugar or fat)
• depression, emotional changes, insomnia, restlessness, aggression, or irritability
• headache, migraine, or tremors
• cardiovascular changes, high blood pressure, or dizziness
• bronchitis, sinusitis, cough, shortness of breath, wheezing, or voice changes
• diarrhea or nausea
• changes in liver test results
• hair loss or various skin reactions (e.g., itching, redness, or dry skin)
• joint or limb pain, muscle problems (e.g., spasms, pain, or stiffness), or increased creatine phosphokinase in the blood
• urinary tract changes (e.g., decreased urine flow, urinary retention, urgent need to urinate at night)
• prostate changes (e.g., prostatic dysplasia, hardening, or inflammation), changes in sexual appetite, testicular pain, pain, hardening, or enlargement of the breasts, or increased levels of male and female hormones
• fatigue, general weakness, excessive sweating, or night sweats.

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

• The oily liquid of testosterone can reach the lungs (pulmonary microembolism of oily solutions) and in rare cases can cause signs and symptoms such as cough, shortness of breath, general discomfort, excessive sweating, chest pain, dizziness, or fainting. These reactions can occur during or immediately after injection and are reversible.

Anaphylactic reactions have been reported after testosterone injection.

In addition to the above-mentioned effects, the following side effects have been observed after treatment with testosterone products: nervousness, hostility, brief interruptions of breathing during sleep (apnea), skin reactions such as dandruff and seborrhea, excessive hair growth, more frequent erections, and in very rare cases, yellowing of the skin and eyes (jaundice).

Treatment with high doses of testosterone generally interrupts or reduces sperm production, although it returns to normal after stopping treatment. Testosterone replacement therapy in cases of low testicular function (hypogonadism) may rarely cause persistent and painful erections (priapism). Long-term or high-dose testosterone treatment may occasionally cause increased fluid retention and edema (swelling due to fluid retention).

In general, with testosterone-based medications, a frequent 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, identified by periodic blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Testosterona SUN

Keep this medicine out of the sight and reach of children.

Store in the original packaging to protect from light.

Do notuse this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should notbe disposed of via wastewater or household waste. Dispose of the packaging and any unused medication at the SIGRE collection point in your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Testosterona SUN

• The active ingredient is testosterone undecanoate 250 mg/ml (corresponding to 157.9 mg of testosterone). A vial contains 1,000 mg of testosterone undecanoate (which corresponds to 631.5 mg of testosterone).
• The other components are: benzyl benzoate and refined castor oil.

Appearance of the Product and Container Contents

Testosterona SUN is a clear, yellowish oily solution. The container contents are:

Ambber glass vial with a bromobutyl rubber injection stopper sealed with an aluminum flip-off cap containing a fill volume of 4 ml.

Container size: 1 vial of 4 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

or

Terapia S.A.

Str. Fabricii nr. 124,

Cluj, Napoca,

Romania

Further information on this medicinal product can be obtained from the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) 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 / Injektionslösung / solution injectable
• Czech Republic: Testosterone undecanoate SUN
• Germany: TESTOSTERON BASICS 1000 mg/4 ml Injektionslösung
• Greece: TESTOSTERONE/SUN
• Spain: Testosterona SUN 1,000 mg/4 ml solución inyectable EFG
• France: UNDECANOATE 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 injekcný roztok

Date of the last revision of this leaflet:November 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

At cold storage temperatures, the properties of this oily solution may change temporarily (e.g., increased viscosity, turbidity). If stored at cold temperatures, the product should be brought to room temperature or body temperature before use.

The intramuscular injectable solution should be inspected visually before use; only clear and particle-free solutions should be used.

The contents of an ampoule/vial should be injected intramuscularly immediately after opening the ampoule/vial.

The medicinal product is for single use only; any unused solution should be discarded.

Administration

Caution is necessary to avoid injecting the medicinal product into a blood vessel.

Like all oily solutions, this medicinal product should be injected only intramuscularly and very slowly. Pulmonary microembolism related to oily solutions can rarely cause signs and symptoms such as cough, dyspnea, discomfort, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope. These reactions can occur during or immediately after injection and are reversible. Treatment is usually supportive, e.g., administration of supplemental oxygen.

Suspected anaphylactic reactions have been reported after administration of this medicinal product.

Warnings

A careful regular check of the prostate gland and breasts should be performed according to established methods (digital rectal examination and determination of PSA in serum) in patients receiving testosterone treatment, at least once a year and twice a year in elderly and at-risk patients (those with clinical or family risk factors).

In addition to laboratory tests to determine testosterone concentration in blood in patients undergoing long-term androgen therapy, the following laboratory tests should be performed periodically: hemoglobin, hematocrit, liver function tests, and lipid profile.

In patients with severe heart, liver, or kidney failure or with ischemic heart disease, testosterone treatment may cause serious complications, characterized by edema with or without congestive heart failure. In this case, treatment should be discontinued immediately.

Handling Instructions for the Vial:

The vial is for single use. The contents of the vial should be injected intramuscularly immediately after loading into the syringe. After removing the plastic cover (A), do not remove the metal ring (B) or the rim cover (C).