DECA 25 mg /1 Ml Injectable Solution

Зміст інструкції

1. What is Deca-Durabolin and what is it used for
2. What you need to know before you take Deca-Durabolin
3. How to take Deca-Durabolin
4. Possible side effects
5. How to store Deca-Durabolin
6. Contents of the pack and other information

Deca-Durabolin 25 mg/1 ml injectable solution for intramuscular use
nandrolone decanoate

Read this leaflet carefully before you start to use this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Deca-Durabolin is and what it is used for
• 2. What you need to know before you use 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 contains the active ingredient nandrolone decanoate which belongs to a class of
medicines consisting of hormones called “anabolic steroids”.
Deca-Durabolin is used as supportive treatment for bones that have become thin and fragile
(osteoporosis) due to advanced age or as a result of medical treatments (iatrogenic causes).

2. What you need to know before you take Deca-Durabolin

Do not take Deca-Durabolin

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to peanuts or soy (see “Deca-Durabolin contains peanut oil and benzyl alcohol”)
• if you are pregnant or breastfeeding (see “Pregnancy, breastfeeding and fertility”)
• if you have liver problems (hepatic insufficiency, a condition in which the liver fails to perform its functions) (see “Warnings and precautions”)
• if you have a tumor of the prostate (prostatic carcinoma and adenoma) (see “Warnings and precautions”)
• if you are a man with breast cancer (male breast carcinoma)
• if you have had in the past a tumor that started in the liver (primary liver tumor)
• if you have had elevated levels of calcium in your urine and blood for a long time (established hypercalciuria and hypercalcemia) (see “Warnings and precautions)
• if you are not yet sexually developed (prepubertal age, i.e. the age preceding the onset of puberty)
• if you have kidney problems (nephrotic syndrome, a disease that involves a loss of protein in the urine) The medicine contains benzyl alcohol and therefore should not be administered to children under three years of age (see “Deca-Durabolin contains peanut oil and benzyl alcohol”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Deca-Durabolin.
Your doctor may ask you to undergo blood tests or a prostate exam before starting the
treatment, every three months for the first 12 months and subsequently.
Pay particular attention if one of the following occurs:

• If you notice any signs of masculinization (e.g. lowering of the voice or growth of facial hair).
• If, following treatment with Deca-Durabolin, you suspect an increase in the size of a gland present in men called the prostate. In this case, your doctor will have you undergo check-up exams, especially if you are elderly.
• If you are elderly, and have high levels of calcium in your blood (hypercalcemia) and/or conditions that lead to an increase in blood calcium levels such as kidney injury (nephropathies), prostate cancer (prostatic carcinoma and adenoma), breast cancer (male breast carcinoma), other tumors and spread (metastasis) of the tumor to the skeleton (see “Do not take Deca-Durabolin”). Elevated calcium levels can also occur during treatment with Deca-Durabolin.
• If you have other pre-existing diseases such as heart, kidney and liver problems (cardiac, renal or hepatic insufficiency/disease) treatment with Deca-Durabolin may cause complications characterized by fluid retention in the body with or without heart problems (edema with or without congestive heart failure). In these cases, treatment should be discontinued immediately.
• If you have had a heart attack, heart problems, liver, kidneys (cardiac, hepatic or renal insufficiency), high blood pressure (hypertension), epilepsy or headache, you will be monitored by your doctor due to the risk of worsening or recurrence of the disease (relapse). In these cases, treatment should be discontinued immediately.
• If you have diabetes mellitus, Deca-Durabolin may improve sugar tolerance (see “Other medicines and Deca-Durabolin”) and the need for insulin or other antidiabetic medicines may be reduced
• If you are taking medicines that thin the blood (coumarin-type anticoagulants), Deca-Durabolin may enhance their action (see “Other medicines and Deca-Durabolin”).
• If you are a woman with breast cancer that has spread to the bones (breast carcinoma and skeletal metastases), your doctor will regularly check your calcium levels in the blood and urine. If an increase in calcium levels in the blood or urine (hypercalcemia or hypercalciuria) occurs, treatment should be discontinued.
• If you have impaired heart or kidney function, high blood pressure or epilepsy, you will be closely monitored by your doctor, as Deca-Durabolin can cause fluid retention (fluid retention).

For athletes
The use of Deca-Durabolin without therapeutic need constitutes doping and may still
result in a positive doping test.
The improper use of this medicine to improve athletic performance poses serious risks to
health and should be discouraged.
Patients who participate in competitions regulated by the World Anti-Doping Agency (WADA) must
consult the WADA code before using this medicine as Deca-Durabolin may interfere
with doping tests.

Children and adolescents
The medicine is contraindicated under 3 years of age and in general in patients who are not yet sexually developed
(prepubertal age).

Other medicines and Deca-Durabolin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Other medicines can affect the effects of Deca-Durabolin or Deca-Durabolin can affect the effects of other medicines. Therefore, it is necessary to inform your doctor or pharmacist if you are taking or
are about to take:

• Insulin and/or other medicines to control blood sugar levels;
• Erythropoietin (a medicine to reduce anemia);
• Anticoagulants (medicines to thin the blood).

The use of Deca-Durabolin may lead to a reduction in the doses of these medicines.
Also inform your doctor or pharmacist if you are taking or are about to take:

• ACTH hormone or corticosteroids (used to treat various conditions, such as rheumatism, arthritis, allergic conditions and asthma). The administration of Deca-Durabolin may increase the risk of fluid retention, especially if the heart and liver are not functioning properly.

Deca-Durabolin can also affect the results of some laboratory tests (e.g. those of the
thyroid gland). Therefore, it is necessary to inform the doctor or the laboratory personnel performing
the tests that you are using this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Deca-Durabolin should not be used during pregnancy. Treatment with Deca-Durabolin should
be discontinued in case of pregnancy (see “Do not take Deca-Durabolin”).
Breastfeeding
Deca-Durabolin should not be used during breastfeeding (see “Do not take Deca-Durabolin”).
Fertility
In men, treatment with Deca-Durabolin may lead to fertility disorders by suppressing
sperm formation.
In women, treatment with Deca-Durabolin may lead to a reduction in the frequency or suppression
of the menstrual cycle.

Driving and operating machinery
Deca-Durabolin does not affect or has a negligible effect on the ability to drive vehicles or operate
machinery.

Deca-Durabolin contains peanut oil and benzyl alcohol
Do not use Deca-Durabolin if you are allergic to peanuts or soy (see “Do not take Deca-Durabolin”).
Deca-Durabolin should not be administered to children under three years of age as it contains
benzyl alcohol (100 mg per ml of solution) which can cause toxic and allergic reactions.

3. How to take Deca-Durabolin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Deca-Durabolin must be administered by an injection into a muscle
(intramuscular).
The recommended dose is:

• an injection of 25 mg every 3 weeks;
• in severe cases, 50 mg may be administered every 3 weeks, to be practiced deeply intramuscularly.

The duration of treatment depends on the clinical response and the possible occurrence of adverse
effects.

Use in children and adolescents
The medicine is contraindicated in subjects who are not yet sexually developed (prepubertal age).

If you take more Deca-Durabolin than you should
In case of accidental administration of an excessive dose of Deca-Durabolin, inform your
doctor immediately or go to the nearest hospital.
If you feel that the effect of this medicine is too strong, immediately inform your
doctor or nurse.

If you forget to take Deca-Durabolin
If you have forgotten a scheduled injection, inform your doctor or nurse as soon as possible.
Do not take a double dose to make up for the missed dose.

If you stop taking Deca-Durabolin
The effects of Deca-Durabolin do not disappear immediately after discontinuation, but decrease
gradually.
When treatment with Deca-Durabolin is stopped, the disorders that occurred before the
treatment may reappear within a few weeks.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects may not disappear quickly after stopping Deca-Durabolin, due to its class of belonging. Injectable solutions generally can cause a local reaction at the injection site.
Depending on the dose, frequency and total duration of Deca-Durabolin administration, the following side effects may occur:

• masculinization (virilism)
• increased fats in the blood (hyperlipidemia and hypertriglyceridemia)
• reduced glucose tolerance (carbohydrate intolerance)
• increased sexual desire (libido)
• increased blood pressure
• voice disorders (dysphonia)
• nausea
• liver problems (abnormal liver function and peliosis hepatica, a disease characterized by blood-filled cavities distributed throughout the liver)
• boils (acne)
• skin rash
• itching
• abnormal hair growth (hirsutism)
• growth limitation (premature closure of the epiphyses)
• reduced urine output
• benign enlargement of the prostate (benign prostatic hyperplasia)
• persistent and abnormal penile erection (priapism)
• increased penile volume
• increased clitoral volume
• alteration of the menstrual cycle rhythm (oligomenorrhea)
• absence of menstruation (amenorrhea)
• decreased sperm count
• fluid retention (edema)
• reactions at the injection site
• severe, sudden allergic reactions (anaphylactic and hypersensitivity reactions)
• decrease in “good” cholesterol (high-density lipoproteins, i.e. HDL cholesterol)
• increase in a blood component (hemoglobin).

Additional side effects in children and adolescents
In children before sexual development (prepubertal age) who use Deca-Durabolin, the following side effects have been reported:

• precocious sexual development
• increased frequency of erections
• penile enlargement
• growth limitation.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deca-Durabolin

Store at a temperature below 30°C.
Do not refrigerate or freeze. Store in the original package and keep the container
in the outer packaging.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Deca-Durabolin contains

• The active ingredient is nandrolone decanoate. One 1 ml vial contains 25 mg of nandrolone decanoate.
• The other ingredients are benzyl alcohol and peanut oil.

Description of the appearance of Deca-Durabolin and contents of the pack
Injectable solution for intramuscular use.
Pack of 1 glass vial of 1 ml.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24
Ireland

Manufacturer
N.V. Organon, Kloosterstraat 6, 5349 AB Oss (Netherlands)