Deca-durabolin

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Deca-Durabolin

50 mg/ml, solution for injection

Nandrolone decanoate

The leaflet should be read carefully before using the medicine, as it contains important information for the patient.

The leaflet should be kept so that it can be re-read if necessary.
In case of any doubts, the doctor or pharmacist should be consulted.
This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
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 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 other component 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 "Important information about some components of Deca-Durabolin").
• if the patient is pregnant or suspects that she is pregnant (see section 2 "Pregnancy, breastfeeding, and fertility").
• if the patient has or has had prostate or breast cancer or if there is a suspicion of these cancers.
• in children under 3 years of age.

Warnings and precautions

Before starting treatment with Deca-Durabolin, the doctor or pharmacist should be consulted.
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 doctor should be contacted immediately.
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.
In addition, regular blood tests will be performed to measure the substance responsible for transporting 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 doctor or pharmacist should be informed if the patient has or has had:

• 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 should be carried out under close medical supervision, as the administration of anabolic steroids may cause premature sexual development and growth retardation (see section 4 "Children and adolescents"). Deca-Durabolin contains benzyl alcohol (see section 2 "Important information before using Deca-Durabolin").

Deca-Durabolin and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 doctor or pharmacist should be informed if the patient is taking or plans 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 (anticoagulants).

The use of anabolic steroids such as Deca-Durabolin may require a reduction in the doses of these medicines.
The doctor or pharmacist should also be informed if the patient is taking or plans 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). Therefore, the doctor or laboratory staff should be informed about the use of 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

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 reduced sperm production.
In women, the use of Deca-Durabolin may lead to irregular menstrual cycles or their absence.
If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

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

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

Arachis oil (from peanuts)- if the patient has a known hypersensitivity to peanuts or soy, they should not use this medicine (see section "When not to use Deca-Durabolin").

Benzyl alcohol (100 mg/ml solution) - products containing benzyl alcohol should not be administered to premature infants or newborns. Benzyl alcohol may cause poisoning and allergic reactions in infants and children under 3 years of age.

Do not administerto premature infants or newborns. Benzyl alcohol may cause poisoning and allergic reactions in infants and children under 3 years of age.

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 related to the heart and blood vessels (which may be fatal), 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 changes in dosage or sudden discontinuation of use. The patient should not abuse this medicine, even 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 doctor or pharmacist should be consulted.
The medicine is injected deeply into a muscle (in the buttock, thigh, or 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 doctor or pharmacist should be consulted.
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 this 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 medical supervision (see section 2 "When to be careful when using Deca-Durabolin").

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 this 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. A double dose should not be used to make up for a missed dose.

Stopping the use of Deca-Durabolin

The action of the medicine does not stop immediately after its discontinuation, but gradually weakens. After stopping treatment, the symptoms that occurred before treatment may reappear within a few weeks.
In case of any further doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

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 spots (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 absence of menstrual cycles)
• 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 doctor should be contacted if the patient experiences 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 discontinuation of 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).
If the patient experiences any side effects, they should inform their doctor or pharmacist. This includes any side effects not listed in this leaflet.

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, even in combination with testosterone. Some of these health problems include serious side effects related to the heart and blood vessels (which may be fatal), 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 were fatal (*):
Endocrine disorders:secondary gonadal insufficiency.
Psychiatric disorders:depression, hostility, aggression, perceptual disorders (psychotic disorders), feelings of excessive excitement, euphoria, and lack of restraint (mania), abnormal 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, thrombosis of the coronary arteries*, cerebral venous sinus thrombosis*], cerebrovascular events.
Hepatobiliary disorders:cholestasis, liver damage, jaundice, liver failure.
Skin and subcutaneous tissue disorders:baldness.
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 not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Deca-Durabolin

The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Store in a temperature below 30°C. Do not store in the refrigerator or freeze.
Store in the original 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 containers. The pharmacist should be asked 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 in a dose of 50 mg in 1 ml of solution.
The other ingredients are: arachis oil and benzyl alcohol (100 mg/ml).

What Deca-Durabolin looks like and what the packaging contains

Deca-Durabolin, solution for injection, is a clear, yellow, oily solution.
One ml of solution in a 1 ml ampoule made of type I glass in a cardboard box.
In case of additional questions or the need to read the full information about the medicine, the doctor or pharmacist should be consulted.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Greece, the country of export:

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

Manufacturer:

Ever Pharma Jena GmbH, Otto-Schott-Strasse 15, 07745 Jena, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export:
52899/30-09-2010
60675/11-11-2014

Parallel import authorization number: 437/17 Date of approval of the leaflet: 24.11.2022

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