Label: information for the user

Primobolan Depot 100 mg injectable solution

metenolona enantato

Read this label carefully before starting to use this medication, as it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you and should not be given to others even if they have the same symptoms, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Primobolan Depot and how it is used

2. What you need to know before starting to use Primobolan Depot

3. How to use Primobolan Depot

4. Possible adverse effects

5. Storage of Primobolan Depot

6. Contents of the package and additional informationadditional information

The active ingredient of Primobolan Depot, metenolone enanthate, is an injectable anabolic steroid, indicated for diseases and states that require an increase in protein production to improve the patient's general condition or to prevent damage resulting from catabolic processes (degradation of fats, carbohydrates, and proteins), such as wasting diseases (chronic and degenerative diseases), extreme cachexia (extreme malnutrition), advanced breast or genital organ carcinoma in women.

Anabolic steroids are not indicated for enhancing muscle development in healthy individuals, nor for increasing physical capacity.

Do not use Primobolan Depot

• If you are allergic to nandrolone enanthate or to any of the other components of this medication (including those listed in section 6).
• If you are pregnant or suspect that you may be.
• If you have prostate cancer.
• If you have liver tumors or have had them previously.
• If you have marked sensitivity to androgenic stimuli or anabolic steroids.
• If you have severe liver or kidney insufficiency.
• In case of breast cancer in men.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Primobolan Depot.

Primobolan Depot should be administered exclusively by intramuscular injection. Intravascular injection could cause the patient to develop symptoms of shock. It is recommended to raise the plunger of the syringe before injecting the preparation, to ensure that the needle has not penetrated a blood vessel.

Your doctor should take special precautions and monitor you if you have renal insufficiency, liver insufficiency, congestive heart failure, coronary insufficiency, history of myocardial infarction, high blood pressure, edema, epilepsy, migraine, benign prostatic hypertrophy with urethral obstruction.

- If you have diabetes, it is recommended that you have a closer control of your blood sugar levels, especially at the beginning of treatment.

- If you are a woman, have irregular cycles, and are administered this medication in the first days of the cycle, menstruation may be delayed in rare cases.

Treatment should be suspended if you are a woman and have advanced breast cancer or genital organs that develop hypercalcemia under hormonal treatment.

Infrequently, you may experience isolated episodes of intra-abdominal hemorrhage, with vital risk for you, in the case of benign liver tumors and even less frequently in the case of malignant liver tumors, after administration of hormonal substances such as those contained in Primobolan Depot. In case of intense pain in the upper abdomen, liver enlargement, or signs of intra-abdominal hemorrhage, your doctor should consider the possibility of a liver tumor as a possible cause.

It is recommended to perform regular liver function tests. If your doctor detects a significant increase in liver function parameters or in case of the appearance of gallstones, treatment with Primobolan Depot should be suspended.

- If you are an adolescent, before completing puberty, you should be treated intermittently (see "How to use Primobolan Depot") to avoid signs of virilization and premature bone maturation.

Primobolan Depot should not be used in children.

If you are a man, as a precaution, you may undergo prostate examinations.

Before starting treatment, the possibility of voice changes, especially in women who use it professionally (orators or singers), should be noted.

In case of doubt, consult your doctor.

Use in athletes

This medication contains nandrolone enanthate, which may produce a positive result in doping control tests.

Other medications and Primobolan Depot

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Certain medications may interact with Primobolan Depot, in which case your doctor should adjust the dose or discontinue treatment with one of the medications.

This is especially important in the case of taking:

• oral anticoagulants
• oral hypoglycemic agents or insulin
• ciclosporin
• other androgens

Laboratory tests

This medication may decrease levels of thyroxine-binding globulin.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you suspect that you may be pregnant, consult your doctor or pharmacist before using this medication.

The administration of Primobolan Depot during pregnancy is contraindicated. If you are a fertile woman, it is recommended that you adopt effective contraceptive measures during the entire treatment and, eventually, for some additional time after it.

It is recommended to suspend breastfeeding or avoid administering this medication.

Driving and operating machinery:

No.

Primobolan Depot contains benzyl benzoate

This medication contains 405.4 mg of benzyl benzoate in each 1 ml ampoule equivalent to 405.4 mg/ml.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will determine the duration of your treatment with Primobolan Depot. Do not discontinue treatment prematurely, as the desired therapeutic effect may not be achieved.

Adults

1 vial of Primobolan Depot via intramuscular injection every 2 weeks. After an initial good response, 1 vial every 3-4 weeks.

In very thin women with a weight below that corresponding to their constitutional state, the dose should not exceed half a vial (50 mg) of Primobolan Depot intramuscularly every 2-3 weeks.

The initial dose may be increased or the intervals between injections shortened in case of severe protein deficiency or acute protein loss (severe cachexia or after significant protein loss due to injuries), in order to rapidly achieve an intense anabolic effect:

2 vials of Primobolan Depot intramuscularly initially; afterwards, 1 vial of Primobolan Depot intramuscularly weekly.

For maintenance treatment, the intervals should be extended to 2-4 weeks.

In cases where cachexia is extreme, such as advanced breast or genital organ cancer in women, continuous treatment with 1 vial of Primobolan Depot intramuscularly every 1-2 weeks or 2 vials of Primobolan Depot intramuscularly every 2-3 weeks may be performed.

Adolescents with a body weight above 50 kg (15-18 years)

Half a vial (50 mg) of Primobolan Depot intramuscularly every 2 weeks.

In adolescent patients who have not completed puberty, a treatment-free period of 4-6 weeks should be established after each 4-week treatment cycle.

Primobolan Depot must be injected intramuscularly. The solution must be injected very slowly.

If you estimate that the action of Primobolan Depot is too strong or too weak, inform your doctor or pharmacist.

If you use more Primobolan Depot than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, Primobolan Depot may have adverse effects, although not everyone will experience them.

Adverse reactions are more frequent with high doses and prolonged treatments.

Less Common Adverse Effects

(may affect up to 1 in 100 people)

- Edema.

- Nausea.

- Vomiting.

- Diarrhea.

- Excitement and insomnia.

Rare Adverse Effects

(may affect up to 1 in 1,000 people)

- Hypercholesterolemia (increase in the amount of cholesterol in the blood)

- Hypercalcemia (increase in the amount of calcium in the blood)

- Leucopenia (decrease in the number of leukocytes in the blood)

- Icterus (yellow discoloration of the skin and mucous membranes)

- In adolescents, premature closure of the epiphyses and cessation of growth may occur.

In women sensitive to androgenic stimuli, rare undesirable effects such as acne, hirsutism (excessive hair growth in women) and voice changes may appear. Therefore, a careful assessment should be made before deciding whether treatment with anabolic medications is indicated in women. These symptoms usually disappear when treatment is discontinued. After the first signs of voice changes (fatigue of the voice, aphonia, dysphonia) treatment should be suspended. If it is necessary to continue treatment, voice disorders may become irreversible.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date indicated on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Primobolan Depot

The active principle is metenolone enanthate. Each ampule of Primobolan Depot contains 100mg of metenolone enanthate in injectable solution.

The other components are: benzyl benzoate and castor oil.

Appearance of the product and contents of the packaging

Primobolan Depot is presented as an injectable solution, in colourless glass ampules of 1 ml class hydrolytic I.

It is presented in packaging containing 1 ampule of 1 ml.

Holder of the Marketing Authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Bayer AG

Müllerstrasse 178

13353 Berlin

Germany

Date of the last review of this leaflet:March 2017

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.