Reandron 1000 mg/4 ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Reandron 1000mg / 4ml solution for injection

Testosterone, undecanoate

Package leaflet contents

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

1. What Reandron is and what it is used for

Reandron contains testosterone, a male hormone, as its active substance.

Reandron is administered by intramuscular injection; the medicine is released gradually over time.

Reandron is used in adult men for testosterone replacement therapy to treat various health problems caused by testosterone deficiency (male hypogonadism). This must be confirmed by two separate blood testosterone measurements, together with the presence of clinical symptoms such as:

• impotence
• infertility
• low libido
• fatigue
• depressive mood states
• bone loss due to low hormone levels

2. What you need to know before Reandron is administered to you

Do not use Reandron

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

Reandron is not indicated for use in women.

Warnings and precautions

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

• epilepsy
• heart, liver or kidney problems
• migraine
• breathing interruptions during sleep (sleep apnoea), as this may worsen with treatment
• cancer, as blood calcium levels will need to be determined
• high blood pressure or are being treated for hypertension, 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, inactivity, if a close relative has had a blood clot in a leg, lung or other organ at an early age (e.g., approximately under 50 years of age), or as you age.

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 and unexplained cough which may produce blood; or sudden 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, treatment with Reandron may cause you serious complications in the form of fluid retention, which may occasionally be accompanied by heart failure (congestive).

Before starting treatment and during treatment, your doctor will check the following parameters in your blood tests: testosterone levels and full blood count.

If your liver does not function properly

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

Children and adolescents

Reandron is not indicated for use in children and adolescents. No data are available on the use of Reandron in males under 18 years of age.

Elderly patients (65 years or older)

Dose adjustment is not required if you are over 65 years of age. (See “Medical examination/Follow-up”).

Bodybuilding and doping tests

Reandron is not indicated for increasing muscle mass in healthy individuals or for enhancing physical endurance.

Reandron may result in a positive doping test.

Substance abuse and dependence

Always use this medicine exactly as your doctor or pharmacist has instructed you.

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

Individuals who have abused testosterone may become dependent and may experience withdrawal symptoms when the dose is significantly changed or when treatment is suddenly discontinued. You must not abuse this medicine, as it may 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 may 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 rule out the risk of existing prostate cancer.

Your doctor must carry out careful periodic monitoring of the prostate and breasts, especially in elderly patients. Your doctor will also perform periodic blood tests.

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

Use of Reandron with other medicines

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

• Adrenocorticotropic hormone (ACTH) or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic reactions, and asthma). Reandron may increase the risk of fluid retention, especially if you have heart or liver problems.
• Medicines that make the blood thinner (oral anticoagulants, coumarin derivatives), as they may increase the risk of bleeding. Your doctor will monitor your 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. 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 monitor your blood more frequently.

Inform your doctor if you have any blood clotting disorders, as it is important for your doctor to know this information when deciding whether Reandron treatment is appropriate.

Reandron may also affect laboratory test results (e.g., thyroid gland tests). Inform your doctor or laboratory personnel that you are receiving treatment with Reandron.

Pregnancy and breastfeeding

Reandron 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 medicines may reversibly impair or reduce sperm production (see also “Possible side effects”).

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Reandron contains benzyl benzoate

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

3. How to use Reandron

Your doctor will inject Reandron (1 ampoule/vial) intramuscularly, very slowly. The treatment will be repeated every 10–14 weeks, which is sufficient time to maintain testosterone levels without allowing testosterone to accumulate in the blood.

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

Starting treatment

Before starting treatment and during its initial phase, your doctor will determine your blood testosterone levels. Your doctor may administer a second injection no sooner than 6 weeks after the first injection, in order to rapidly achieve the required testosterone level. This will depend on your symptoms and testosterone levels.

Maintaining Reandron levels during treatment

The interval between injections should remain 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 that levels are appropriate. If levels are too low, your doctor may increase the frequency of injections. If levels are too high, your doctor may reduce the frequency of injections. Remember your treatment dates, as otherwise your testosterone levels will not be properly controlled.

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

If you use more Reandron than you should

Symptoms of receiving 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.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Most frequent adverse reactions are acne and pain at the injection site.

Frequent adverse effects (may affect up to 1 in 10 people)

• abnormally high levels of red blood cells
• weight gain
• hot flushes
• acne
• enlargement of the prostate and associated problems
• various reactions at the injection site, such as pain, bruising, or irritation

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

• allergic reaction
• increased appetite, changes in certain blood test results, such as increased blood sugar or fat levels
• depression, emotional disturbances, insomnia, restlessness, aggression, or irritability
• headache, migraine, or tremors
• cardiovascular disorders, high blood pressure, or dizziness
• bronchitis, sinusitis, cough, shortness of breath, snoring, or voice changes
• diarrhea or nausea
• abnormalities in liver function tests
• 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 blood creatine phosphokinase
• urinary tract disorders (e.g. reduced urine flow, urinary retention, urgent need to urinate at night)
• prostate disorders (e.g. prostatic dysplasia, hardening or inflammation of the prostate), 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 adverse effects (may affect up to 1 in 1,000 patients)

• The oily liquid from Reandron may reach the lungs (oily solution microembolism), and in rare cases may cause 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 the injection and are reversible. Therefore, patients should be observed during and immediately after each injection to detect early possible signs and symptoms of oily solution microembolism.

Suspected anaphylactic reactions following Reandron injection have been reported.

In addition to those mentioned above, the following adverse effects have been observed with testosterone-containing 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 this returns to normal after treatment is stopped. Testosterone replacement therapy in cases of underactive testicles (hypogonadism) may rarely cause persistent and painful erections (priapism). Long-term treatment or high-dose testosterone therapy may occasionally lead to increased fluid retention and edema (swelling due to fluid retention).

In general, testosterone-based medicines have been associated with a frequent risk of increased red blood cell count, haematocrit (percentage of red blood cells in the blood), and haemoglobin (the oxygen-carrying component of red blood cells), identified through periodic blood tests.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Reandron

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Reandron

The active substance is testosterone undecanoate 250 mg/ml (equivalent to 157.9 mg of testosterone). 1 ampoule/vial contains 1,000 mg of testosterone undecanoate (equivalent to 631.5 mg of testosterone).

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

Appearance of the product and contents of the container

Reandron is a clear oily solution, ranging from colourless to yellowish-brown. It is supplied in amber glass ampoules/amber glass vials containing 4 ml of injectable solution.

Marketing Authorization Holder and Manufacturer Responsible

This medicinal product is authorised in the Member States of the European Economic Area under 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 injekciju
• 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/4 ml 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 injekčný 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 1000 mg/4 ml, solution for injection

Date of the most recent review of this summary: January 2026

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

This information is intended for healthcare professionals only:

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

The intramuscular injection solution must be visually inspected before use; only clear solutions free from particles should be used.

The contents of one ampoule/vial must be administered by intramuscular injection immediately after opening the ampoule/vial.

This medicine is for single use only; any unused solution must be discarded.

Administration

Extreme care must be taken to avoid injecting the medicine into a blood vessel.

As with all oily solutions, Reandron must be administered only by intramuscular injection and very slowly. Pulmonary microembolism associated with oily solutions may rarely cause signs and symptoms such as cough, dyspnoea, discomfort, hyperhidrosis, chest pain, dizziness, paraesthesia 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 reaction following administration of Reandron have been reported.

Warnings

Regular and 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 and high-risk patients (those with clinical or familial risk factors).

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

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

Instructions for opening the Reandron ampoule with the “One Point Cut” (UPC) opening system

The ampoule has a mark located below the coloured dot. Before opening, ensure that no solution remains in the upper part of the ampoule. Use both hands to open it: hold the lower part of the ampoule with one hand and use the other hand to press outward and break the upper part of the ampoule in the direction opposite to the coloured dot.

Instructions for opening the Reandron vial

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