DECA-DURABOLIN

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Deca-Durabolin
50 mg/ml, solution for injection
Nandroloni decanoas
Please read this leaflet carefully 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 doubts, 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents:

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 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 adjunctive therapy to specific treatment and dietary recommendations in disease states characterized by negative nitrogen balance.

Note: Treatment 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, "Important information about some of the 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.
This medicine may cause the development of male characteristics in women (masculinization), such as lowering of the voice, changes in body shape, facial and body hair growth, frontal baldness, and changes in the external genital organs. If any signs of masculinization occur, contact your doctor immediately.
The use of anabolic steroids may cause enlargement of the prostate gland, especially in older men. Therefore, your doctor will regularly perform digital rectal examinations of the prostate and measure blood levels of prostate-specific antigen (PSA).
In addition, regular blood tests will be performed to monitor the level of haemoglobin – the substance in red blood cells responsible for transporting oxygen 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 treatment with this medicine, inform your doctor or pharmacist if you have ever had, currently have, or are suspected of having:

• breast cancer that has spread to the bones;
• 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 lead to premature sexual development and growth suppression (see section 4, "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, including over-the-counter medicines.
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 plan to take:

• insulin and/or other blood glucose-lowering medicines;
• erythropoietin (a medicine used to reduce symptoms of anaemia);
• medicines used to reduce blood clotting (anticoagulants). The use of anabolic steroids such as Deca-Durabolin may require a reduction in the dose of these medicines.

You should also inform your doctor or pharmacist if you are taking or plan to take ACTH or corticosteroids (used in the treatment of various conditions 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, particularly 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 or drinking beverages does not affect the action of this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think 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 there is suspicion of pregnancy.
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 menstruation or absence of menstruation.

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

Deca-Durabolin contains purified peanut oil and benzyl alcohol (E 1519)
This medicine contains purified peanut oil (from peanuts). Do not use if you are hypersensitive to peanuts or soya.
This medicine contains 104.9 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 breathing disorders (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 or consultation with a pharmacist.
Women who are pregnant or breastfeeding should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies 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 their bodies and cause adverse effects (so-called metabolic acidosis).

Use not in accordance with the indication
Patients participating in sports 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 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 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. In individuals misusing anabolic-androgenic steroids, dependence may develop, and withdrawal symptoms may occur with significant dose reduction or abrupt discontinuation. 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 must be administered only by a doctor or nurse.
You must always use this medicine exactly as prescribed by your doctor. If in doubt, 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 in doubt, consult your
doctor or pharmacist.
To ensure proper tissue rebuilding action in diseases or injuries, 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 doses are:

• In the treatment of osteoporosis: 50 mg every 3 weeks.
• As supportive treatment along with 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, adequate intake of vitamins, minerals, and proteins within 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 “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, consult your doctor or nurse immediately.
Missing a 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 the missed dose.
Stopping Deca-Durabolin treatment
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 a few weeks.
If you have any further doubts regarding 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 hemoglobin concentration
• increased blood lipid levels
• decreased HDL cholesterol concentration
• liver function disorders
• peliosis hepatis (presence of numerous 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 hyperplasia 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, 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 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.
Psychiatric 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, myocardial hypertrophy*, cardiomyopathy*, ventricular arrhythmias (ventricular arrhythmia*, ventricular tachycardia), venous and/or arterial thrombosis [including deep vein thrombosis, pulmonary artery blood clots (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: hair loss.
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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 181 C, 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. 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 to protect it 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 in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Deca-Durabolin contains

• The active substance is nandrolone decanoate. 1 ml of solution for injection contains 50 mg of nandrolone decanoate.
• The other components 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.
1 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, 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
Ever Pharma Jena GmbH
Bruesseler Str. 18
07747 Jena, Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Portugal, the country of export: 8027821
Parallel Import Licence Number: 390/17