Deca-durabolin

Package Leaflet: Information for the Patient

Deca-Durabolin, 50 mg/ml, Solution for Injection

Nandrolone Decanoate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package 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 pack 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, nandrolone decanoate, belongs to a group of medicines called anabolic steroids. Deca-Durabolin is used:

• in the treatment of osteoporosis (bone loss)
• as a supportive treatment for specific medical conditions characterized by a negative nitrogen balance.

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

2. Important information before using Deca-Durabolin

When not to use Deca-Durabolin:

• if you are allergic to nandrolone decanoate or any of the other ingredients of this medicine (listed in section 6 "What Deca-Durabolin contains").
• if you have a known hypersensitivity to peanuts or soya (see section 2 "Important information about some ingredients of Deca-Durabolin").
• if you are pregnant or think you may be pregnant (see section 2 "Pregnancy, breastfeeding, and fertility").
• if you have or have had a tumor of the prostate or breast, or if there is a suspicion of these tumors.

Warnings and precautions

Before starting treatment with Deca-Durabolin, discuss it with your doctor or pharmacist. 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, contact your doctor immediately. The use of anabolic steroids may cause prostate enlargement, especially in older men. Therefore, your doctor will regularly perform a digital rectal examination and measure the level of prostate-specific antigen (PSA) in your blood. Additionally, regular blood tests will be performed to measure the substance responsible for carrying oxygen in the blood (hemoglobin). In very rare cases, the number of red blood cells may increase, causing complications. Medical examinations may also be necessary in other cases. Therefore, before starting treatment with this medicine, inform your doctor or pharmacist if you have or have 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 before puberty should be carried out under close medical supervision, as the administration of anabolic steroids may cause premature sexual development and growth inhibition (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 taking or have recently taken, including those obtained 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 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. You should also inform your doctor or pharmacist if you are taking or plan 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). Therefore, you should tell your doctor or laboratory staff that you are taking 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

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should not use Deca-Durabolin during pregnancy and breastfeeding or if you suspect you are 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.

Driving and using machines

According to current knowledge, Deca-Durabolin does not affect the ability to drive and use machines.

Deca-Durabolin contains arachis oil (peanut oil) and benzyl alcohol (E 1519).

The medicine contains arachis oil (peanut oil). Do not use if you are allergic to peanuts or soya. The medicine contains 104.9 mg of benzyl alcohol (E 1519) per ml. Benzyl alcohol may cause allergic reactions. The administration of benzyl alcohol to newborns is associated with a risk of serious side effects, including respiratory 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 more than a week without medical advice. Pregnant or breastfeeding women should consult their doctor before using this medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). Patients with liver or kidney disease should consult their doctor before using this medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

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 if this medicine is included in the WADA code before using it, as Deca-Durabolin may affect the results of 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, including those related to the heart and blood vessels (which may lead to death), 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 dose changes or sudden discontinuation of use. The patient should not abuse this medicine, also 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. If you have any doubts, consult your doctor or pharmacist. The medicine is injected deep into the 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. If you have any doubts, consult your doctor or pharmacist. 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 your doctor or dietitian. The dosage depends on the severity of the disease and the body's response to treatment. Your 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 supportive treatment for specific medical conditions 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 you feel that the action of this medicine is too strong or too weak, you should immediately consult your 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 you feel that the action of this medicine is too strong, you should immediately consult your doctor or nurse.

Missing a dose of Deca-Durabolin

The medicine will be administered by a doctor or nurse. If you miss a scheduled injection, you should immediately consult your doctor or nurse. Do not use a double dose to make up for the 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. If you have any further doubts about using 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, 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 cessation of menstruation)
• enlargement of the clitoris
• enlargement of the penis
• prostate enlargement with difficulty urinating
• painful erections
• decreased sperm count
• growth inhibition
• high blood pressure
• reactions at the injection site
• masculinization (appearance of male characteristics in women)

You should contact your doctor if you experience 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 inhibition (lower growth)

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. This includes any side effects not listed in this package 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, also in combination with testosterone. Some of these health problems include serious side effects related to the heart and blood vessels (which may lead to death), 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 ended in death (*):

Endocrine disorders:secondary hypogonadism. Psychiatric disorders:depression, hostility, aggression, disorders of perception (psychotic disorders), feelings of excessive excitement, agitation, 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, coronary artery thrombosis*, carotid artery occlusion*, cerebral venous sinus thrombosis*], cerebrovascular events, ischemic stroke. Hepatobiliary disorders:cholestasis, liver damage, jaundice. 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 you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 carton or label after "EXP". The expiry date refers to the last day of the month. Store in a temperature below 30°C. Do not freeze or store in the refrigerator. Store in the original package to protect from light. 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Deca-Durabolin contains

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

What Deca-Durabolin looks like and contents of the pack

Deca-Durabolin is a clear, yellow, oily solution. One ml of the solution in a 1 ml glass ampoule in a cardboard box. If you have any further questions or need to see the full information about this medicine, please ask your doctor or pharmacist.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland, Tel: 0048 22 104 21 00

Manufacturer

Ever Pharma Jena GmbH, Otto-Schott-Str. 15, 07745, Germany

Date of last revision of the package leaflet: