Deca-durabolin

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Deca-Durabolin

50 mg/ml, solution for injection

Nandrolone decanoate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Deca-Durabolin and what is it used for
• 2. Important information before using Deca-Durabolin
• 3. How to use Deca-Durabolin
• 4. Possible side effects
• 5. How to store Deca-Durabolin
• 6. Contents of the packaging and other information

1. What is Deca-Durabolin and what is it used for

Deca-Durabolin is a clear, yellow, oily solution for injection containing 50 mg/ml of nandrolone decanoate as the active substance.
The active substance of the medicine, nandrolone decanoate, belongs to a group of medicines called anabolic steroids.
Deca-Durabolin is used:

• in the treatment of osteoporosis (bone tissue loss)
• as a supplement to specific treatment and dietary recommendations in disease states characterized by a negative nitrogen balance.

Note: Therapy with Deca-Durabolin does not replace therapy with other medicines.

2. Important information before using Deca-Durabolin

When not to use Deca-Durabolin:

• if the patient is allergic to nandrolone decanoate or any of the other ingredients of this medicine (listed in section 6 "What Deca-Durabolin contains").
• if the patient has a known hypersensitivity to peanuts or soy (see section 2 "Deca-Durabolin contains purified arachis oil (from peanuts) and benzyl alcohol (E 1519)").
• if the patient is pregnant or thinks she may be pregnant (see section 2 "Pregnancy, breastfeeding and fertility").
• if the patient has or has had a tumor of the prostate or breast or if there is a suspicion of these tumors.
• in children under 3 years of age.

Warnings and precautions

Before starting treatment with Deca-Durabolin, the patient should discuss it with their doctor or pharmacist.
The medicine may cause the appearance of male characteristics in women (masculinization) (e.g. deepening of the voice, change in body shape, hair growth on the face and torso, frontal baldness, as well as changes in the external genitalia). If any symptoms of masculinization occur, the patient should immediately contact their doctor.
The use of anabolic steroids may cause prostate enlargement, especially in older men. Therefore, the doctor will regularly perform a digital rectal examination of the prostate and measure the level of prostate-specific antigen (PSA) in the blood.
Additionally, regular blood tests will be performed to measure the substance responsible for carrying oxygen in the body (hemoglobin). In very rare cases, the number of red blood cells increases so much that it causes complications.
Medical examinations may also be necessary in other cases. Therefore, before starting treatment with this medicine, the patient should inform their doctor or pharmacist if they have ever had, are currently experiencing, or suspect:

• breast cancer with bone metastases;
• kidney or lung cancer;
• heart disease;
• kidney disease;
• liver disease (including jaundice);
• high blood pressure;
• diabetes;
• epilepsy;
• migraine, headache;
• prostate problems, such as difficulty urinating.

Children and adolescents

The safety and efficacy of this medicine in children and adolescents have not been established.
Treatment of children before puberty should be carried out under the supervision of a doctor (see section 2 "Warnings and precautions").

Deca-Durabolin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines without a prescription.
Other medicines may affect the action of Deca-Durabolin or Deca-Durabolin may affect the action of other medicines. Therefore, the patient should tell their doctor or pharmacist if they are taking or plan to take:

• insulin and/or other medicines that regulate blood sugar levels;
• erythropoietin (a medicine that reduces the symptoms of anemia);
• medicines used to reduce blood clotting (anticoagulant medicines).

The use of anabolic steroids such as Deca-Durabolin may require a reduction in the doses of these medicines.
The patient should also inform their doctor or pharmacist if they are taking or plan to take hormones ACTH or corticosteroids (used to treat various diseases, such as rheumatic diseases, arthritis, allergic diseases, and asthma). The use of anabolic steroids such as Deca-Durabolin may increase the risk of water retention in the body, especially if heart or liver function is impaired.
Anabolic steroids may also affect the results of some laboratory tests (e.g. thyroid function). For this reason, the patient should tell their doctor or laboratory staff about taking this medicine.

Using Deca-Durabolin with food and drink

Consuming meals and drinks does not affect the action of this medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Deca-Durabolin should not be used during pregnancy and breastfeeding or if there is a suspicion that the patient is pregnant.
In men, the use of Deca-Durabolin may lead to fertility disorders due to a decrease in sperm production.
In women, the use of Deca-Durabolin may lead to irregular menstrual cycles or their absence.

Driving and using machines

According to available knowledge, Deca-Durabolin does not affect the ability to drive vehicles and operate machines.

Deca-Durabolin contains purified arachis oil (from peanuts) and benzyl alcohol (E 1519).

The medicine contains purified arachis oil (from peanuts). Do not use if there is a known hypersensitivity to peanuts or soy.
The medicine contains 100 mg of benzyl alcohol (E 1519) per ml. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to small children is associated with a risk of serious side effects, including breathing disorders (so-called "gasping syndrome"). Do not administer to newborns (up to 4 weeks of age) without a doctor's recommendation.
Do not administer to small children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation.
Pregnant or breastfeeding women should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Using Deca-Durabolin in a way that is not in line with the recommendations

Patients participating in competitions supervised by the World Anti-Doping Agency (WADA) should check before using this medicine whether it is listed in the WADA code, as Deca-Durabolin may affect the results of anti-doping tests.
Using this medicine in a way that is not in line with the recommendations, in order to increase physical performance in sports, is associated with a serious risk to health and is considered reprehensible.

Drug abuse and dependence

This medicine should only be administered by a doctor or nurse and used in accordance with the doctor's recommendations. Abuse of anabolic-androgenic steroids, especially if the patient uses this medicine in too high a dose alone or in combination with testosterone, may lead to serious health problems, including those related to the heart and blood vessels (which can lead to death), mental health, and/or liver problems. In people who abuse anabolic-androgenic steroids, dependence may develop, and withdrawal symptoms may occur in the event of significant dose changes or sudden discontinuation of the medicine. The patient should not abuse this medicine, also in combination with testosterone, as it is associated with a serious risk to health. (See section 4. "Drug abuse and dependence".)

3. How to use Deca-Durabolin

This medicine should only be administered by a doctor or nurse.
This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is injected deep into the muscle (in the buttock, thigh, arm).
The solution should be used immediately, as once the ampoule is opened, it cannot be closed in a way that guarantees the sterility of its contents.
This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
To ensure the proper action of the medicine in rebuilding tissues damaged by disease or injury, it is very important to follow a proper diet recommended by the doctor or dietitian.
The dosage depends on the severity of the disease and the body's response to treatment. The doctor will use the appropriate dose of the medicine.
The recommended dose is:

• In the treatment of osteoporosis: 50 mg every 3 weeks.
• As a supplement to specific treatment and dietary recommendations in disease states characterized by a negative nitrogen balance: 25-50 mg every 2 weeks.

Note: To achieve optimal therapeutic effects, it is necessary to administer adequate amounts of vitamins, minerals, and proteins in a high-calorie diet.
If the patient feels that the action of the medicine is too strong or too weak, they should immediately consult their doctor or nurse.

Using Deca-Durabolin in children and adolescents

The safety and efficacy of this medicine in children and adolescents have not been established. Treatment of children before puberty should be carried out under the supervision of a doctor (see section 2 "Warnings and precautions").

Using a higher dose of Deca-Durabolin than recommended

The medicine will be administered by a doctor or nurse. If the patient feels that the action of the medicine is too strong, they should immediately consult their doctor or nurse.

Missing a dose of Deca-Durabolin

The medicine will be administered by a doctor or nurse. If a scheduled injection is missed, the patient should immediately consult their doctor or nurse. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Deca-Durabolin

The action of the medicine does not stop immediately after its discontinuation, but gradually decreases.
After stopping treatment, the symptoms that occurred before treatment may reappear within a few weeks.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Depending on the doses used, the frequency of use, and the total duration of use of Deca-Durabolin, the following side effects may occur:

• fluid retention in tissues, usually manifested by swelling of the ankles and feet or increased blood pressure
• acne
• rash
• increased sexual desire
• nausea
• itching
• increased hemoglobin levels
• increased lipid levels in the blood
• decreased HDL cholesterol levels
• liver function disorders
• liver peliosis (presence of numerous blood-filled cavities in the liver)
• deepening of the voice
• male-type hair growth in women (on the body or face)
• infrequent menstrual cycles (or complete cessation of menstruation)
• enlargement of the clitoris
• enlargement of the penis
• prostate enlargement with difficulty urinating
• painful erections
• decreased sperm count
• growth retardation
• high blood pressure
• reactions at the injection site
• masculinization (appearance of male characteristics in women).

The patient should consult their doctor if they experience a change in voice or fluid retention, or if the side effects are severe or become more troublesome.
Due to the properties of Deca-Durabolin, after stopping the medicine, side effects may not disappear quickly. Injected medicines may cause reactions at the injection site.

Additional side effects in children and adolescents

In children using anabolic steroids before puberty, the following side effects have been reported:

• premature sexual development
• enlargement of the penis
• increased frequency of erections
• growth retardation (lower growth rate).

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Drug abuse and dependence

Abuse of this medicine may lead to serious health problems, especially if the patient uses too high a dose of anabolic-androgenic steroids, also in combination with testosterone. Some of these health problems include serious side effects related to the heart and blood vessels (which can lead to death), mental health, and/or liver problems. (See section 2. "Drug abuse and dependence".)
The following side effects have been reported in the context of abuse of anabolic-androgenic steroids and/or testosterone. In some cases, these events ended in death (*):

Endocrine disorders:secondary gonadal insufficiency.
Psychiatric disorders:depression, hostility, aggression, perception disorders (psychotic disorders), excessive excitement, euphoria, and lack of restraint (mania), unusual suspicion (paranoia), delusions, and irritability.
Cardiovascular disorders:heart attack (myocardial infarction), heart failure*, chronic heart failure*, cardiac arrest*, sudden cardiac death, hypertrophic cardiomyopathy*, cardiac arrhythmias (ventricular arrhythmia*, ventricular tachycardia), venous and/or arterial thrombosis [including deep vein thrombosis, pulmonary embolism, coronary artery thrombosis*, cerebral venous sinus thrombosis*], cerebrovascular event, ischemic stroke.
Hepatobiliary disorders:cholestasis, liver damage, jaundice, liver failure.
Skin and subcutaneous tissue disorders:hair loss.
Reproductive system and breast disorders:testicular atrophy, azoospermia (complete absence of sperm in the semen), gynecomastia (breast enlargement in men), infertility (in men), breast atrophy (in women).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Deca-Durabolin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store at a temperature below 30°C. Do not store in the refrigerator or freeze.
Store in the original packaging. Store the ampoule in the outer packaging.
The solution should be used immediately, as once the ampoule is opened, it cannot be closed in a way that guarantees the sterility of its contents.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Deca-Durabolin contains

• The active substance of the medicine is nandrolone decanoate. 1 ml of the solution for injection contains 50 mg of nandrolone decanoate.
• The other ingredients are benzyl alcohol (E 1519) and purified arachis oil.

What Deca-Durabolin looks like and what the packaging contains

Deca-Durabolin is a clear, yellow, oily solution.
One ml of the solution in a 1 ml ampoule made of colorless glass type I, in a cardboard box.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the country of export:

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland

Manufacturer:

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

Parallel importer:

TDF SA
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Portugal, the country of export:8027821

Parallel import authorization number: 282/24

Date of leaflet approval: 09.07.2024

[Information about the trademark]