SUSTANON 250 mg /Ml Roztwór Do Wstrzykiwań

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1. SUSTANON 250 mg/ml injectable solution
   1. What is SUSTANON and what is it used for
   2. What you need to know before using SUSTANON.
   3. How to use SUSTANON
   4. Possible side effects
   5. How to store SUSTANON
   6. Contents of the pack and other information

SUSTANON 250 mg/ml injectable solution

Testosterone esters

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is SUSTANON and what is it used for

Sustanon contains testosterone esters as its active ingredient and belongs to the group of hormones
sexual and modulators of the genital system, androgens, derived from 3-oxoandrostene (4).
Sustanon is used to replace testosterone in adult men, for the treatment of various problems due to
testosterone deficiency (male hypogonadism). This condition must be confirmed with two
distinct measurements of testosterone in the blood and must include clinical symptoms such as:

• impotence
• infertility
• decreased sexual desire
• fatigue
• depressed mood
• loss of bone tissue due to low hormone levels.

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using SUSTANON.

Do not use Sustanon

• If you are allergic to testosterone esters, other androgen hormones or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had prostate or breast cancer known or suspected (see “Warnings and precautions”).
• If you have hypertension (high blood pressure), nephrotic syndrome (a kidney disorder with protein loss in the urine), severe liver dysfunction, previous occurrence of primary liver tumors, hypercalciuria (excessive calcium loss in the urine) and hypercalcemia (high calcium concentration in the blood) established (see “Warnings and precautions”).
• If you are allergic to soy or peanuts as this medicine contains peanut oil (see “Warnings and precautions”).
• In the case of children under 3 years of age as the medicine contains benzyl alcohol (see “Warnings and precautions”).
• In case of pregnancy and breastfeeding (see “Warnings and precautions”).

Warnings and precautions
Consult your doctor or pharmacist before using Sustanon.
Doctors must consider monitoring patients to be subjected to therapy with Sustanon before
the start of treatment, every three months for the first 12 months and subsequently once a year with
observation of the following parameters:

• Rectal exploration of the prostate (manual rectal examination used to detect the presence of masses in the prostate or hardening or other abnormalities in the prostate tissues) and the determination of the PSA value (a specific laboratory test for the prostate that measures the amount of prostate-specific antigen in the blood) to exclude benign prostatic hyperplasia (enlargement of the prostate) or prostate cancer that has not yet shown symptoms,
• Hematocrit (percentage of red blood cells in the blood) and hemoglobin (the component of red blood cells that carries oxygen) to exclude polycythemia (increased red blood cells in the blood).

Before and during treatment, the doctor must perform the following blood tests: testosterone
levels in the blood, complete blood count.
If you belong to the category of patients (especially if elderly) with the conditions listed below, you must
be monitored:

• Hypercalcemia and/or conditions leading to hypercalcemia such as kidney disease, prostate cancer, breast cancer, other cancers and skeletal metastases(see “Do not use Sustanon”). Hypercalcemia can also occur during treatment with androgens. Hypercalcemia must first be treated appropriately and, after calcium levels return to normal, hormone therapy can be resumed.
• Comorbidities (other associated diseases)- If you suffer from a severe heart, liver or kidney disease, treatment with Sustanon may cause serious complications in the form of fluid accumulation in the body, sometimes accompanied by heart failure (congestion). Patients who have had myocardial infarction, heart, liver or kidney failure, high blood pressure, epilepsy or migraine should be monitored due to the risk of worsening or recurrence. In such cases, treatment should be discontinued immediately.
• High blood pressure-Tell your doctor if you suffer from high blood pressure or are being treated for high blood pressure, as testosterone may cause blood pressure to rise.
• Diabetes mellitus- Androgens in general and Sustanon may improve glucose tolerance in diabetic patients (see “Other medicines and Sustanon”).
• Anticoagulant therapy- Androgens in general and Sustanon may potentiate the anticoagulant action of coumarin-type agents (see “Other medicines and Sustanon”).
• Sleep apnea (temporary cessation of breathing while sleeping). If you have risk factors such as overweight or chronic lung disease, careful medical evaluation and caution are necessary.
• You should avoid stimulation that increases nervous, mental and physical activity beyond your cardiovascular capacity.
• If priapism (abnormal, persistent and painful erection) or other signs of excessive sexual stimulation occur, you should stop therapy (see “Possible side effects”).
• Psychic impotence - Taking Sustanon is not recommended in case of psychic impotence as its prolonged use can lead to atrophy (reduction in size) of the testicles, which are otherwise normal and perfectly functioning. Blood coagulation problems - thrombophilia (an abnormality of blood coagulation 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 one of your close relatives has had a blood clot in a leg, lung or other organ at a young age (e.g. under the age of about 50); or with aging.

How to recognize a blood clot: painful swelling of a leg or a sudden
change in skin color that, for example, becomes pale, red or blue, sudden shortness of breath,
unexplained sudden cough that may cause blood to be coughed up; or sudden chest pain, severe
dizziness or lightheadedness, severe stomach pain, sudden loss of vision.
Consult a doctor immediately if any of these symptoms occur.
If you experience side effects associated with the use of androgens (see “Possible side effects”),
you should stop treatment with Sustanon and, once the disorder has resolved, resume it with a
lower dose.

Children and adolescents
In children of prepubertal age, growth in height and sexual development should be monitored as
androgens in general and Sustanon at high doses can accelerate the fusion of the epiphyses (rounded
ends of the long bones) and sexual maturation.

Other medicines and Sustanon
Tell your doctor or pharmacist if you are taking, have recently taken or may take any
other medicines.
Other medicines can affect the effects of Sustanon or Sustanon can affect the effects of other
medicines. Therefore, it is necessary to inform your doctor or pharmacist if you are taking or are about to
take:

• Insulin and/or other medicines to control blood sugar levels;
• Medicines to reduce blood clotting (anticoagulants).

Enzyme inducers may reduce testosterone levels, while enzyme inhibitors may
increase them, therefore a correction of the dose of Sustanon may be necessary.
Androgens can improve glucose tolerance and reduce the need for insulin or other
antidiabetic medicines in diabetic patients (see “Warnings and precautions”).
High doses of androgens can potentiate the anticoagulant action of coumarin drugs allowing
a reduction of the dose (see “Warnings and precautions”).
Also inform your doctor or pharmacist if you are taking or are about to take ACTH hormone or
corticosteroids (used to treat various conditions, such as rheumatism, arthritis, allergic conditions and
asthma). The administration of androgens such as Sustanon may increase the risk of fluid retention,
especially if your heart and liver are not functioning properly.
Androgens can also affect the results of some laboratory tests (e.g. those of the thyroid gland). Therefore, it is necessary to inform the doctor or laboratory personnel performing the tests that you
are using this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Treatment with Sustanon is intended for use in men only, therefore it should not be used
by women who are pregnant or breastfeeding (see “Do not use Sustanon”). If used during
pregnancy, Sustanon exposes the fetus to the risk of virilization.
Fertility
In men, treatment with Sustanon may lead to fertility problems by suppressing
sperm formation.

Driving and using machines
Sustanon does not impair the ability to drive vehicles or operate machinery.

Sustanon contains:

• Peanut oil. This medicine contains peanut oil. Do not use it if you are allergic to peanuts or soy. (see “Do not use Sustanon”).
• Benzyl alcohol(100 mg per ml of solution). This medicine should not be given to premature or newborn babies. Due to the risk of fatal toxic reactions resulting from exposure to benzyl alcohol in quantities greater than 90 mg/kg/day, this medicine should not be given to children under 3 years of age.

For those who play sports:the use of the drug without therapeutic necessity constitutes doping and may
still result in positive doping tests
Improper use in sport:
Patients participating in competitions regulated by the World Anti-Doping Agency (WADA) must
consult the WADA code before using this medicine as Sustanon may interfere with doping tests.
Improper use of this medicine to improve performance in sport poses serious health risks
and should be discouraged.
Substance abuse and dependence:
Always use this medicine as exactly as your doctor or pharmacist has told you to do. Abuse
of testosterone, especially if you use an excessive amount of this medicine alone or with other anabolic androgenic steroids, can
cause serious health problems to the heart and blood vessels (which can
lead to death), mental health problems and/or liver. People who have abused
testosterone may become addicted and experience withdrawal symptoms when the dosage changes
significantly or is abruptly discontinued. Do not abuse this medicine alone or with
other anabolic androgenic steroids, as this involves serious health risks (see paragraph
4).

3. How to use SUSTANON

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Sustanon must be administered with a deep intramuscular injection.
The recommended dose is one 1 ml injection every three weeks.
In general, the dose should be corrected based on the individual patient's response.

Use in children and adolescents
Safety and efficacy in children have not yet been established.

If you use more SUSTANON than you should
In case of accidental administration of an excessive dose of Sustanon, inform your doctor immediately or
go to the nearest hospital.
The acute toxicity of testosterone is slow.
If symptoms of chronic overdose occur, such as polycythemia (increased red blood cells in the
blood), priapism, treatment should be discontinued and resumed at lower doses until the symptoms disappear.

If you forget to use SUSTANON
If you have forgotten a scheduled injection, inform your doctor or nurse as soon as possible. Do not use a
double dose to compensate for a missed dose.

If you stop using SUSTANON
The effects of this medicine do not disappear immediately after discontinuation, but decrease
gradually.
If treatment with this medicine is stopped, the disorders that occurred before the
treatment may reappear within a few weeks.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are listed the possible side effects in order of frequency of occurrence:

Common frequency

• Increase in red blood cell count, hematocrit (percentage of red blood cells in the blood) and hemoglobin (the component of red blood cells that carries oxygen), detected through periodic blood tests.
• Weight gain

Not known (frequency cannot be estimated from available data)

• Progression of a subclinical prostate carcinoma (worsening of a prostate tumor that had not previously shown symptoms);
• Increase in the number of red blood cells, the cells that carry oxygen in the blood (polycythemia)
• Fluid retention, usually characterized by swelling of the ankles or feet
• Depression, nervousness, mood alteration, changes in sexual desire (increased libido, decreased libido)
• High blood pressure (hypertension)
• Nausea
• Abnormal liver function
• Itching, acne
• Muscle pain (myalgia)
• Feminization (gynecomastia), disorders in sperm formation (oligozoospermia), abnormal, prolonged, painful erection of the penis (priapism),
• Prostate pathologies (Prostate growth up to eugonadal status (increase in prostate size to a size representative for the age group in question))
• Abnormal lipids (changes in cholesterol levels: reduction in serum levels of LDL-C, HDL-C and triglycerides), increase in blood levels of markers associated with prostate cancer (increased PSA).

Hypercalcemia may also occur, especially if you suffer from metastatic breast cancer
(usually a sign of bone metastasis progression) and a possible decrease in PBI (Protein Bound
Iodine) without clinical significance.

Additional side effects in children and adolescents
The following side effects have been reported in prepubertal children using androgens (see
“Warnings and precautions”): precocious sexual development, increased frequency of erections,
penile enlargement and premature epiphyseal closure.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverseReporting side effects can
help provide more information on the safety of this medicine.

5. How to store SUSTANON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to
the product in intact packaging, correctly stored.
Store at a temperature below 30°C.
Do not refrigerate or freeze.
Store in the original packaging and keep the container in the outer packaging to protect the
medicine from light.
Since an opened vial cannot be resealed in a way that further guarantees the sterility of the contents,
the solution must be used immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sustanon contains

• The active ingredients are: testosterone propionate, testosterone phenylpropionate, testosterone isocaproate, testosterone decanoate. One 1 ml vial contains 30 mg of testosterone propionate, 60 mg of testosterone phenylpropionate, 60 mg of testosterone isocaproate, 100 mg of testosterone decanoate.
• The other ingredients are: peanut oil and benzyl alcohol

Description of Sustanon and contents of the pack
Injectable solution for intramuscular use, clear, of light yellow colour.
1 vial of 1 ml.

Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland
Tel: +39 0687 502 429

Manufacturer
Ever Pharma Jena GmbH, Otto-Schott-Str. 15, 07745 Jena, Germany