User Information: Product Information

Reandron 1000mg / 4ml Injectable Solution

Testosterone, undecanoate

1.What is Reandron and how is it used

2.What you need to know before receiving Reandron

3.How to use Reandron

4.Possible adverse effects

5.Storage of Reandron

6. Contents of the package and additional information

Reandron contains testosterone, a male hormone, as the active ingredient.

Reandron is administered via intramuscular injection; the administered medication is released over time.

Reandron is used in adult men for testosterone replacement therapy to treat various health problems resulting from low testosterone levels (male hypogonadism). This must be confirmed by two separate blood tests for testosterone and the presence of clinical symptoms such as:

• impotence
• infertility
• low libido
• fatigue
• depressive mood states
• bone loss caused by low hormone levels

Do not use Reandron

• If you are allergic to undecanoate testosterone or any of the other components of this medication (listed in section 6).
• If you have hormone-dependent androgen cancer or suspect that you may have prostate or breast cancer.
• If you have or have had liver tumors;

Reandron is not indicated for use in women.

Warnings and precautions

Consult your doctorbefore starting to use Reandron if you have or have ever had:

• Epilepsy
• Heart, liver, or kidney problems
• Migraine
• Sleep apnea, as it may worsen with treatment
• Cancer, as it will be necessary to determine blood calcium levels
• High blood pressure or if you are being treated for hypertension, as testosterone may cause an increase in blood pressure.
• Bleeding disorders (e.g. hemophilia)
• Thrombophilia (blood clotting anomaly that increases the risk of thrombosis - blood clots in blood vessels)
• Factors that increase the risk of venous blood clots: previous blood clots in a vein, smoking, obesity, cancer, inactivity, if a direct relative has had a blood clot in a leg, lung, or other organ at an early age (e.g. approximately below 50 years of age), or as you age.

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 inexplicable cough that may cause bleeding, or sudden and intense chest pain, severe dizziness or vertigo, 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,Reandron treatment may cause severe complications in the form of fluid retention, which may be accompanied by heart failure (congestive) in some cases.

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 well

No formal studies have been conducted in patients with liver insufficiency. If you have ever had a liver tumor, you will not be prescribed Reandron (see “Do not use Reandron”).

Children and adolescents

Reandron is not indicated for use in children and adolescents. There is no available information on the use of Reandron in males under 18 years of age.

Older adults (65 years or more)

No dose adjustment is necessary if you are over 65 years of age. (See “Medical examination/Follow-up”).

Muscle building and doping tests

Reandron is not indicated for muscle building in healthy individuals or to increase physical resistance.

Reandron may give positive results in doping tests.

Substance abuse and dependence

Use this medication exactly as your doctor or pharmacist has instructed you.

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

People who have abused testosterone may become dependent and may experience withdrawal symptoms when the dose changes significantly or when use is suddenly stopped. Do not abuse this medication because it can cause severe health problems, whether you use it 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 Reandron, your doctor must perform a medical examination to exclude the risk of existing prostate cancer.

Your doctor must perform regular and careful follow-up of the prostate and breasts, especially in older adults. Your doctor will also perform regular blood tests.

There have been reports of benign (non-cancerous) and malignant (cancerous) liver tumors in patients treated with hormonal products such as androgenic compounds.

Use of Reandron with other medications

Inform your doctor or pharmacistif you are using or have used recently or may have touse any other medication, including those purchased 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). Reandron may increase the risk of fluid retention, especially if you have heart or liver problems.
• Medications that make the blood more fluid (oral anticoagulants, coumarin derivatives) as they may increase the risk of bleeding. Your doctor will check your dose.
• Medications for the treatment of diabetes. You may need to adjust the dose of your antidiabetic medication. Like other androgens, testosterone may increase the effect of insulin.

Inform your doctor if you have any bleeding disorder,as it is essential that your doctor knows this information to decide if you can be treated with Reandron.

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

Pregnancy and breastfeeding

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

Fertility

Treatment with high doses of testosterone-containing medications may interrupt or reduce sperm production in a reversible manner (see also “Possible side effects”).

Driving and operating machinery

No effect has been observed on the ability to drive and operate machinery.

Reandron contains benzyl benzoate

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

Your doctor will inject Reandron (1 vial/ampoule) intramuscularly, very slowly. The treatment will be repeated at 10-14 week intervals, allowing sufficient time to maintain testosterone levels without accumulation in the blood.

Reandron must only be administered intramuscularly. Special care must be taken to avoid injecting the product into a blood vessel (see “Administration”).

Starting Treatment

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

Maintaining Reandron Levels During Treatment

The interval between injections should be kept within the recommended range of 10 to 14 weeks. Your doctor will regularly measure your testosterone levels at the end of each injection interval to ensure the levels are correct. If levels are very low, your doctor may increase the frequency of injections. If levels are very high, your doctor may decrease the frequency of injections. Remember your treatment days, as otherwise your testosterone levels will not be correctly controlled.

If you think the effect of Reandron is too intense or too weak, inform your doctor.

If You Use More Reandron Than You Should

The symptoms of having received too much Reandron include:

• Irritability
• Nervousness
• Weight gain
• Frequent or prolonged erections

Inform your doctor if you experience any of the above symptoms. Your doctor will reduce the frequency of injections or discontinue treatment.

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

Themost common side effectsare 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, such as pain, hematoma, or irritation

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

• allergic reaction
• increased appetite, alterations in some blood test results, such as increased sugar or fat
• depression, emotional disturbances, insomnia, restlessness, aggression, or irritability
• headache, migraine, or tremors
• cardiovascular alterations, high blood pressure, or dizziness
• bronchitis, sinusitis, cough, shortness of breath, snoring, or voice changes
• diarrhea or nausea
• alterations in liver test results
• hair loss or various skin reactions (e.g., itching, redness, or dry skin)
• dizziness in the joints or limbs, muscle problems (e.g., spasms, pain, or stiffness) or increased creatine phosphokinase in the blood
• alterations in the urinary tract (e.g., decreased urine flow, urinary retention, or nocturia)
• alterations in the prostate (e.g., prostatic hyperplasia, prostatic inflammation, or prostatic cancer), sexual dysfunction, testicular pain, pain, breast enlargement, or increased levels of male and female hormones
• fatigue, generalized weakness, excessive sweating, or nocturnal sweating

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

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

There have been reports of suspected anaphylactic reactions after injection of Reandron.

In addition to those mentioned earlier, the following side effects have been observed after treatment with products containing testosterone: nervousness, hostility, brief interruptions in 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 hypogonadism may cause, in rare cases, persistent and painful erections (priapism). Long-term or high-dose testosterone treatments may occasionally cause an increase in 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 transports oxygen) has been observed, identified through periodic blood tests.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local SIGRE point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Reandron

The active ingredient is undecanoate of testosterone 250 mg/ml (corresponding to 157.9 mg of testosterone). 1 vial contains 1,000 mg of undecanoate of testosterone (which corresponds to 631.5 mg of testosterone).

The other components are: benzyl benzoate and refined ricin oil.

Appearance of the product and contents of the packaging

Reandron is a clear oily solution, between colorless and yellowish brown. It is presented in amber glass vials containing 4 ml of injectable solution.

Holder of the marketing authorization and responsible for manufacturing

This medicine is authorized in the member states of the European Economic Area with the following names:

• Cyprus, Czech Republic, Greece, Denmark, Luxembourg, Malta, Poland, and Portugal:Nebido
• Austria:Nebido 1000 mg/4 ml Injektionslösung
• Belgium:Nebido 1000 mg/4 ml, oplossing voor injectie
• Bulgaria:?????? 250 mg/ml ??????????? ???????
• Croatia:Nebido 1000 mg/4 ml otopina za injekcij
• Finland:Nebido 1000 mg/4 ml injektioneste, liuos
• France:Nebido 1000 mg/4 ml, solution injectable
• Germany:Nebido 1000 mg Injektionslösung
• Hungary:Nebido 250 mg/ml oldatos injekció
• Iceland:Nebido 1000 mg/4 ml stungulyf, lausn
• Italy:NEBIDO 1000 mg/4ml soluzione iniettabile
• Lithuania:Nebido 1000 mg/4 ml injekcinis tirpalas
• Netherlands:Nebido 1000 mg/4 ml
• Norway:Nebido 1000 mg/4 ml injeksjonsvæske, oppløsning
• Romania:Nebido 1000 mg/ 4 ml solutie injectabila
• Slovakia:Nebido 1000 mg/4 ml injekcný roztok
• Slovenia:Nebido 1000 mg/4 ml raztopina za injiciranje
• Spain:Reandron 1000 mg/4 ml solución inyectable
• Sweden:Nebido, 1000 mg/4 ml injektionsvätska, lösning
• United Kingdom and Ireland:Nebido 1000mg/4ml, solution for injection

Last review date of this leaflet:October 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

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

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

The contents of a vial should be injected intramuscularly immediately after opening the vial.

The medicine is for single use, and any unused solution should be discarded.

Administration

Care should be taken not to inject the medicine into a blood vessel.

As with all oily solutions, Reandron should be injected only intramuscularly and slowly. Pulmonary microembolism related to oily solutions may cause rare signs and symptoms such as cough, dyspnea, discomfort, sweating, chest pain, dizziness, paresthesia, or syncope. These reactions may occur during or immediately after injection and are reversible. Supportive treatment, such as supplemental oxygen administration, is usually sufficient.

Suspected anaphylactic reactions have been reported following administration of Reandron.

Warnings

Regular careful monitoring of the prostate gland and breasts should be performed using established methods (digital rectal examination and serum PSA determination) in patients receiving testosterone treatment, at least once a year and twice a year in elderly patients and those at risk (those with clinical or familial factors).

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

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

Instructions for opening the Reandron vial with a "One Point Cut" (UPC) system

The vial has a mark below the colored point. Before opening, ensure that there is no solution left at the top of the vial. Use both hands to open it; hold the bottom of the vial with one hand and use the other hand to press outward and break the top of the vial in the opposite direction to the colored point.

Instructions for opening the Reandron vial

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