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 carefully the entire leaflet before using this 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 another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions 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 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 an adjunct 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 certain 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 had in the past prostate or breast cancer, or if there is suspicion of these cancers.
• in children under 3 years of age.

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 (virilization), such as lowering of the voice, changes in body shape, growth of facial and trunk hair, frontal baldness, and changes in the external genital organs. If any signs of virilization 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).
Regular blood tests will also be performed to monitor the level 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 significantly, leading to complications.
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 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 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 inhibition (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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, 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 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 plan to take ACTH or corticosteroid hormones (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, 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 fluids does not affect the action of this medicine.

Pregnancy, breastfeeding and fertility
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.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, you should consult your doctor or pharmacist before using this medicine.

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

Deca-Durabolin contains peanut oil and benzyl alcohol.
Peanut oil – if the patient has a known hypersensitivity to peanuts or soya, this medicine should not be used (see section “When not to use Deca-Durabolin”).
Benzyl alcohol (100 mg/ml solution) – products containing benzyl alcohol must 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.

Misuse of the medicine
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.
Misuse of this medicine to enhance physical performance in sports is associated with serious health risks and is considered unethical.

Abuse and dependence
This medicine should only be administered by a doctor or nurse and used strictly according to the doctor's instructions. Abuse 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 abuse anabolic-androgenic steroids, dependence may develop and withdrawal symptoms may occur if the dose is significantly changed or treatment is stopped abruptly. Patients should not abuse this medicine, including in combination with testosterone, as this poses serious health risks. (See section 4 “Abuse and dependence”.)

3. How to use Deca-Durabolin

This medicine should only be administered by a doctor or nurse.
This medicine must always be used according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
The medicine is administered by deep intramuscular injection (into the buttock, thigh, or arm).
The solution should be used immediately, as once opened, the ampoule cannot be resealed in a way
that guarantees sterility of its contents.
This medicine must always be used according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
To ensure proper tissue-rebuilding action of the medicine in conditions caused by disease or injury,
it is very important to follow the diet recommended by your doctor or dietitian.
Dosage depends on the severity of the disease and the body's response to treatment. The doctor will
determine the appropriate dose.
Recommended dose:
For the treatment of osteoporosis: 50 mg every 3 weeks.
As supportive treatment alongside specific therapy and dietary recommendations in medical conditions
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 protein within 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 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, the following
adverse effects may occur with Deca-Durabolin:

• fluid retention in tissues, usually manifesting as swelling of the ankles and feet or increased blood pressure
• acne
• rash
• increased sexual desire
• nausea
• itching
• increased haemoglobin concentration
• increased blood lipid concentration
• decreased HDL cholesterol concentration
• liver function disorders
• peliosis hepatis (presence of multiple blood-filled cavities in the liver)
• voice deepening
• male-pattern hair growth in women (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 a change in voice pitch 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:
precocious sexual development;
penile enlargement;
increased frequency of erections;
growth suppression (reduced 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, euphoria and impulsiveness (mania), unusual suspicion
(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, blood clots in pulmonary arteries (pulmonary embolism), coronary artery thrombosis*, carotid artery occlusion*, intracranial venous sinus thrombosis*], cerebrovascular event, ischaemic stroke.

Hepatobiliary and biliary tract 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), gynaecomastia (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, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 adverse effects helps to 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.
The solution should be used immediately, as an opened ampoule cannot be resealed in a way that guarantees 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. This will help protect the environment.

6. Contents of the pack and other information

What Deca-Durabolin contains
The active substance is: nandrolone decanoate 50 mg in 1 ml of solution.
The other ingredients are: arachis (peanut) oil and benzyl alcohol (100 mg/ml).

What Deca-Durabolin looks like and contents of the pack
Deca-Durabolin, solution for injection, is a clear, yellow, oily solution.
One ml of solution in a 1 ml Type I glass ampoule, 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 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, Poland

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

Marketing Authorisation numbers in Greece, the country of export:
52899/30-09-2010
60675/11-11-2014

Parallel Import Authorisation Number: 437/17