Deca-durabolin

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Deca-Durabolin is and what it is 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 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 ingredient in Deca-Durabolin, 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 adjunctive therapy to specific treatment and dietary recommendations in disease states characterized by 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 soya (see section 2 "Important information about some ingredients of Deca-Durabolin"),
• 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 prostate or breast cancer, or if there is suspicion of such cancers.

Warnings and precautions
Before starting treatment with Deca-Durabolin, discuss this with your doctor or pharmacist.
The medicine may cause the development of male characteristics in women (masculinization) (e.g. lowered voice tone, change in body shape, facial and body hair growth, frontal baldness, and changes in the external genital organs). If any symptoms of masculinization occur, contact your doctor immediately.
The use of anabolic steroids may cause prostate enlargement, especially in older men. Therefore, your doctor will regularly perform digital rectal examinations of the prostate and measure the level of prostate-specific antigen (PSA) in the blood.
Additionally, regular blood tests will be performed to measure haemoglobin, the substance in red blood cells responsible for oxygen transport throughout the body. In very rare cases, the number of red blood cells may increase significantly, leading to complications.
Medical examinations may also be necessary in other situations. Therefore, before starting 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 urinating.

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 strict medical supervision, as administration of anabolic steroids may cause premature sexual maturation and growth suppression (see section 4 "Children and adolescents").
Deca-Durabolin contains benzyl alcohol (E 1519) (see section 2 "Important 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, tell your doctor or pharmacist if you are taking or plan to take:

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

The use of 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 plan 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 does 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 you suspect you may be pregnant.
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 menstruation or absence of menstruation.

Driving and using machines
Based on 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 have a known hypersensitivity to peanuts or soya.
This medicine contains 100 mg of benzyl alcohol (E 1519) per 1 ml. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with a risk of serious adverse effects, including breathing disorders (so-called "gasping syndrome"). Do not administer to newborns (up to 4 weeks of age) without medical advice.
Do not administer to young children (under 3 years of age) for longer than one week without medical advice from a doctor or pharmacist.
Pregnant or breastfeeding women 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).

Misuse of the medicine
Athletes participating in competitions 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 athletic performance poses serious health risks and is considered unethical.

Abuse and dependence
This medicine should be administered only by a doctor or nurse and used strictly according to medical instructions. Abuse of anabolic-androgenic steroids, especially when this medicine is used at excessive doses 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 abuse anabolic-androgenic steroids, dependence may develop, and withdrawal symptoms may occur if the dosage is significantly changed or treatment is suddenly stopped. You should not abuse this medicine, including in combination with testosterone, as this poses a serious health risk (see section 4 "Abuse and dependence").

3. How to use Deca-Durabolin

This medicine must be administered only by a doctor or nurse.
This medicine should always be used as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
The medicine is injected deeply intramuscularly (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.
This medicine should always be used as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
To ensure the proper tissue-rebuilding effect of the medicine in conditions caused by disease or trauma,
it is very important to follow the 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 determine
the appropriate dose of the medicine.
Recommended dosage:

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

Note: To achieve optimal therapeutic effect, it is essential to consume adequate amounts of vitamins, minerals, and proteins as part of a high-calorie diet.
If you feel that the effect of this medicine is too strong or too weak, contact your doctor or nurse immediately.
Use in children and adolescents
The safety and efficacy of this medicine have not been sufficiently established in children and adolescents.
Treatment of children before puberty should be carried out under medical supervision (see section 2, "When to take special care with Deca-Durabolin").
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, contact 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, contact your doctor or nurse immediately. Do not use a double dose to make up for a missed dose.
Stopping Deca-Durabolin treatment
The effect of the medicine does not stop immediately after discontinuation, but gradually diminishes.
After stopping treatment, symptoms that were present before starting therapy may reappear within a few weeks.
If you have any further questions 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.
Depending on the doses used, frequency of administration and total duration of treatment with
Deca-Durabolin, the following side effects may occur:

• fluid retention in tissues, usually manifested as swelling of the ankles and feet or increased blood pressure,
• acne,
• rash,
• increased sexual desire,
• nausea,
• itching,
• increased hemoglobin concentration,
• increased blood lipid levels,
• decreased HDL cholesterol concentration,
• liver function disorders,
• peliosis hepatis (the presence of numerous blood-filled cavities in the liver),
• voice deepening,
• 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 side effects are severe or become more troublesome.
Due to the properties of Deca-Durabolin, side effects may not resolve quickly after discontinuation of the medicine. Medicines administered by injection may cause reactions at the injection site.

Additional side effects in children and adolescents
In children treated with anabolic steroids before puberty, the following side effects have been reported:

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

If any adverse reactions occur in a patient, inform your doctor or pharmacist. This also applies to any adverse reactions 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, also 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 reactions 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.

Psychiatric disorders: depression, hostility, aggression, disturbances in perception of reality (psychotic disorders), feelings of excessive excitement, euphoria 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, hypertrophy of the heart muscle*, cardiomyopathy*, ventricular rhythm disorders (ventricular arrhythmia*, ventricular tachycardia), venous and/or arterial thrombosis [including deep vein thrombosis, blood clots in the pulmonary arteries (pulmonary embolism), coronary artery thrombosis*, carotid artery occlusion*, intracranial venous sinus thrombosis*], cerebrovascular event, ischemic stroke.

Hepatic and biliary disorders: cholestasis, liver damage, yellowing of the skin and eyes (jaundice), liver failure.

Skin and subcutaneous tissue disorders: alopecia.

Reproductive system and breast disorders: testicular atrophy, azoospermia (complete absence of sperm in semen), gynecomastia (breast enlargement in men), infertility (in men), atrophy of mammary glands (in women).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: +48 22 4921301, Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this 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 to protect from light.
The solution should be used immediately, as an opened 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 required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Deca-Durabolin contains
The active substance is nandrolone decanoate at a dose of 50 mg per 1 ml of solution.
The other components are: purified arachis oil and benzyl alcohol (E 1519).

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.

If you have any further questions or need more information about this medicine,
please consult your doctor or pharmacist.
For more detailed information, please contact the marketing authorisation holder 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
Ever Pharma Jena GmbH, Bruesseler Str. 18, 07747 Jena, Germany

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

Relabelled and/or repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Number in Portugal, country of export: 8027821
Parallel Import Licence Number: 15/21