Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging is in a foreign language!
Deca-Durabolin
50 mg/ml, solution for injection
Nandroloni decanoas
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Deca-Durabolin is and what it is used for
Important information before using Deca-Durabolin
How to use Deca-Durabolin
Possible side effects
How to store Deca-Durabolin
Contents of the pack and other information

1. What Deca-Durabolin is and what it is 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 in this medicine, nandrolone decanoate, belongs to a group of medicines called anabolic steroids.
Deca-Durabolin is used:

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

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

2. 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 soya (see section 2 “Deca-Durabolin contains purified arachis oil (from peanuts) and benzyl alcohol (E 1519)”).
if the patient is pregnant or suspects she may be pregnant (see section 2 “Pregnancy, breastfeeding and fertility”).
if the patient currently has or has previously had cancer of the prostate gland or breast, or if there is suspicion of such cancers.
in children under 3 years of age.

Warnings and precautions
Before starting treatment with Deca-Durabolin, discuss this with your doctor or pharmacist.
This medicine may cause the development of male characteristics in women (masculinisation) (e.g. lowering of the voice, change in body shape, growth of facial and body hair, frontal baldness, and changes in the external genital organs). If any signs of masculinisation occur, contact your doctor immediately.
The use of anabolic steroids may cause enlargement of the prostate gland, particularly in older men. Therefore, your doctor will regularly perform digital rectal examinations of the prostate gland and measure the level of prostate-specific antigen (PSA) in the blood.
Additionally, regular blood tests will be performed to measure the amount of haemoglobin (the substance in red blood cells responsible for oxygen transport in the body). In very rare cases, the number of red blood cells may increase to such an extent that complications may arise.
Medical examinations may also be necessary in other circumstances. Therefore, before starting treatment with this medicine, inform your doctor or pharmacist if you have ever had, currently have, or are suspected of having:

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

Children and adolescents
The safety and efficacy of this medicine in children and adolescents have not been sufficiently established.
Treatment of children should be carried out under strict medical supervision, as administration of anabolic steroids may cause premature sexual maturation and growth suppression (see section 4 “Additional adverse effects in children and adolescents”).
Deca-Durabolin contains benzyl alcohol (E 1519) (see section 2 “Information before using Deca-Durabolin”).

Deca-Durabolin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you 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, inform your doctor or pharmacist if you are taking or intend to take:

insulin and/or other medicines regulating blood sugar levels;
erythropoietin (a medicine used to reduce symptoms of anaemia);
medicines used to reduce blood clotting (anticoagulants).

Treatment with anabolic steroids such as Deca-Durabolin may require dose adjustments of these medicines.
You should also inform your doctor or pharmacist if you are taking or intend to take ACTH hormones or corticosteroids (used in the treatment of various diseases such as rheumatic diseases, arthritis, allergic conditions and asthma). The use of anabolic steroids such as Deca-Durabolin may increase the risk of fluid retention in the body, especially if heart or liver function is impaired.
Anabolic steroids may also affect the results of certain laboratory tests (e.g. thyroid function).
Therefore, inform your doctor or laboratory staff that you are taking this medicine.

Taking Deca-Durabolin with food and drink
Eating meals and drinking beverages do not affect the action of this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Do not use Deca-Durabolin during pregnancy or breastfeeding, or if pregnancy is suspected.
In men, the use of Deca-Durabolin may lead to fertility disorders due to reduced semen production.
In women, the use of Deca-Durabolin may lead to irregular menstrual periods or absence of menstruation.

Driving and using machines
According to available knowledge, Deca-Durabolin does not affect the ability to drive or operate machinery.

Deca-Durabolin contains purified arachis oil (from peanuts) and benzyl alcohol (E 1519).
This medicine contains purified arachis oil (from peanuts). Do not use if you are hypersensitive to peanuts or soya.
This 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 adverse effects, including respiratory disturbances (so-called “gasping syndrome”). Do not administer to newborns (up to 4 weeks of age) without medical advice.
Do not administer to small children (under 3 years of age) for longer than one week without medical advice from a doctor or pharmacist.
Women who are pregnant or breastfeeding should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (so-called metabolic acidosis).

Use not in accordance with indications
Patients participating in sports events supervised by the World Anti-Doping Agency (WADA) should check whether this medicine is listed in the WADA code before use, as Deca-Durabolin may affect anti-doping test results.
Using this medicine off-label to enhance physical performance in sports is associated with serious health risks and is considered unethical.

Misuse and dependence
This medicine should be administered only by a doctor or nurse and used strictly according to medical instructions. Misuse of anabolic-androgenic steroids, especially when the patient uses this medicine at too high a dose, alone or in combination with testosterone, may lead to serious health problems affecting the heart and blood vessels (which may result in death), mental health, and/or liver problems. In individuals who misuse anabolic-androgenic steroids, dependence may develop, and withdrawal symptoms may occur if the dosage is significantly changed or treatment is suddenly stopped. Patients should not misuse this medicine, including in combination with testosterone, as this poses a serious health risk. (See section 4. “Misuse and dependence”.)

3. How to use Deca-Durabolin

This medicine should only be administered by a doctor or nurse.
You must always use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The medicine is administered by deep intramuscular injection (into the buttock, thigh, or upper arm).
The solution should be used immediately, as once opened, the ampoule cannot be resealed in a way that ensures sterility of its contents.
You must always use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
To ensure proper therapeutic effect in rebuilding tissues damaged by illness or injury, it is very important to follow the diet recommended by your doctor or dietitian.
The dosage depends on the severity of the disease and the body's response to treatment. Your doctor will determine the appropriate dose.
Recommended dosage:

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

Note: To achieve optimal therapeutic effect, adequate intake of vitamins, minerals, and proteins in a high-calorie diet is essential.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or nurse immediately.
Use in children and adolescents
The safety and efficacy of this medicine in children and adolescents have not been sufficiently established. Treatment of children before puberty should be carried out under medical supervision (see section 2 "Warnings and precautions").
Use of a higher than recommended dose of Deca-Durabolin
The medicine will be administered by a doctor or nurse. If you feel that the effect of this medicine is too strong, consult your doctor or nurse immediately.
Missed dose of Deca-Durabolin
The medicine will be administered by a doctor or nurse. If a scheduled injection is missed, consult your doctor or nurse immediately. Do not administer a double dose to make up for a missed dose.
Stopping Deca-Durabolin
The effect of the medicine does not cease immediately after discontinuation, but gradually diminishes.
After stopping treatment, symptoms that were present before treatment may reappear within several weeks.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Depending on the doses used, frequency of administration and total duration of treatment with Deca-Durabolin, the following adverse effects may occur:

fluid retention in tissues, usually manifesting as swelling of ankles and feet or increased blood pressure
acne
rash
increased sexual drive
nausea
itching
increased haemoglobin concentration
increased blood lipid levels
decreased HDL cholesterol concentration
liver function disorders
hepatic peliosis (presence of multiple blood-filled cavities in the liver)
voice changes (lowering of voice pitch)
male-pattern hair growth in women (on body or face)
infrequent menstruation (or complete cessation of menstruation)
clitoral enlargement
penile enlargement
prostate enlargement with difficulty in urination
painful erections
reduced sperm count
growth suppression
hypertension
reactions at the injection site
masculinization (development of male characteristics in women).

You should contact your doctor if you experience voice changes or fluid retention, or if adverse effects are severe or become more bothersome.
Due to the properties of Deca-Durabolin, adverse effects may not resolve quickly after discontinuation of the medicine. Medicines administered by injection may cause reactions at the injection site.

Additional adverse effects in children and adolescents
The following adverse effects have been reported in children receiving anabolic steroids before puberty:

premature sexual maturation
penile enlargement
increased frequency of erections
growth suppression (reduced final height).

If any adverse effects occur in a patient, inform a doctor or pharmacist. This includes any adverse effects not listed in this leaflet.

Misuse and dependence
Misuse of this medicine may lead to serious health problems, especially if the patient uses excessively high doses of anabolic-androgenic steroids, either alone or in combination with testosterone. Some of these health problems include serious adverse effects affecting the heart and blood vessels (which may lead to death), mental health, and/or liver problems. (See section 2. "Misuse and dependence".)

The following adverse effects have been reported in connection with misuse of anabolic-androgenic steroids and/or testosterone. In some cases, these events have resulted in death (*):

Endocrine disorders: secondary gonadal insufficiency.
Mental disorders: depression, hostility, aggression, disturbances in perception of reality (psychotic disorders), feelings of excessive excitement, elation and impulsiveness (mania), unusual suspiciousness (paranoia), delusions and irritability.
Cardiovascular disorders: heart attack (myocardial infarction), heart failure*, chronic heart failure*, cardiac arrest*, sudden cardiac death, cardiac hypertrophy*, cardiomyopathy*, ventricular arrhythmias (ventricular arrhythmia*, ventricular tachycardia), venous and/or arterial thrombosis [including deep vein thrombosis, blood clots in pulmonary arteries (pulmonary embolism), coronary artery thrombosis*, carotid artery occlusion*, intracranial venous sinus thrombosis*], cerebrovascular event, ischaemic stroke.
Hepatic and biliary disorders: cholestasis, liver damage, yellowing of the skin and eyes (jaundice), liver failure.
Skin and subcutaneous tissue disorders: hair loss (alopecia).
Reproductive system and breast disorders: testicular atrophy, azoospermia (complete absence of sperm in semen), gynaecomastia (breast enlargement in males), infertility (in males), atrophy of mammary glands (in females).

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Deca-Durabolin

Keep the medicine out of the 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 stated month.
Store below 30°C. Do not store in the refrigerator or freeze.
Keep in the original packaging. Store the ampoule in the outer packaging.
The solution should be used immediately, as once opened, the ampoule cannot be resealed in a way that ensures sterility of its contents.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Deca-Durabolin contains

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

What Deca-Durabolin looks like and contents of the pack
Deca-Durabolin is a clear, yellow, oily solution.
One ml of solution in a 1 ml ampoule made of colourless type I glass, packed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Portugal, 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
Zbąszyńska 3 Street
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing Authorisation Number in Portugal, country of export: 8027821
Parallel Import Licence Number: 282/24