PRIMOBOLAN DEPOT 100 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Primobolan Depot 100 mg injectable solution

metenolone enanthate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Primobolan Depot and what is it used for
2. What you need to know before you use Primobolan Depot
3. How to use Primobolan Depot
4. Possible side effects
5. Storage of Primobolan Depot
6. Contents of the pack and further information

1. What is Primobolan Depot and what is it used for

The active substance of Primobolan Depot, metenolone enanthate, is an anabolic steroid for intramuscular injection, indicated for diseases and conditions 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 consumptive diseases (chronic and degenerative diseases), cachexia (extreme malnutrition), advanced breast or genital organ carcinoma in women.

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

Anabolic steroids are not indicated to enhance muscular development in healthy individuals, nor to increase physical capacity.

Do not use Primobolan Depot

• If you are allergic to metenolone enanthate or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you have prostate carcinoma.
• If you have liver tumors or have had them before.
• If you have marked sensitivity to androgenic stimuli or anabolic steroids.
• If you have severe liver or kidney failure.
• In case of breast carcinoma in men.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Primobolan Depot.

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

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

• If you have diabetes, it is recommended that you have closer control of blood glucose, especially at the beginning of treatment.

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

Treatment should be discontinued if you are a woman and have advanced breast or genital organ carcinoma that develops hypercalcemia under hormonal treatment.

Rarely, you may have isolated episodes of intra-abdominal hemorrhage, with vital risk to 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 severe discomfort 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.

Regular liver function tests are recommended. If your doctor detects a significant increase in liver function parameters or in case of the appearance of bile duct stones, treatment with Primobolan Depot should be discontinued.

• 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 changes in the voice, especially in women who use it professionally (speakers or singers), should be indicated.

In case of doubt, consult your doctor.

Use in athletes

This medicine contains metenolone enanthate, which can produce a positive result in doping tests.

Other medicines and Primobolan Depot

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription. Certain medicines may interact with Primobolan Depot, in these cases, your doctor should adjust the dose or interrupt treatment with one of the medicines.

This is especially important when taking:

• oral anticoagulants
• oral hypoglycemics or insulin
• cyclosporin
• other androgens

Laboratory tests

This medicine may decrease thyroxine-binding globulin levels.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Administration of Primobolan Depot during pregnancy is contraindicated. If you are a woman of childbearing age, it is recommended that you use effective contraceptive measures throughout treatment and, if necessary, for some time after treatment.

It is recommended to discontinue breastfeeding or avoid administration of this medicine.

Driving and using machines

Not applicable.

Primobolan Depot contains benzyl benzoate

This medicine contains 405.4 mg of benzyl benzoate per 1 ml ampoule, equivalent to 405.4 mg/ml.

3. How to use Primobolan Depot

Follow exactly the administration instructions of this medicine 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 stop treatment before, as the desired therapeutic effect may not be achieved.

Adults

1 ampoule of Primobolan Depot intramuscularly every 2 weeks. After a good initial response, 1 ampoule every 3-4 weeks.

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

The initial dose may be increased or the intervals between injections shortened in case of acute or severe protein deficiency (severe cachexia or after injuries with significant protein loss), so that an intense anabolic effect can be rapidly achieved:

2 ampoules of Primobolan Depot intramuscularly initially; then, 1 ampoule of Primobolan Depot intramuscularly weekly.

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

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

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

Half an ampoule (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 should be injected intramuscularly. The solution should be injected very slowly.

If you think the action of Primobolan Depot is too strong or too weak, tell 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, Primobolan Depot can cause side effects, although not everybody gets them.

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

Uncommon side effects

(may affect up to 1 in 100 people)

• Edema.
• Nausea.
• Vomiting.
• Diarrhea.
• Excitement and insomnia.

Rare side effects

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

• Hypercholesterolemia (increase in blood cholesterol levels)
• Hypercalcemia (increase in blood calcium levels)
• Leukopenia (decrease in white blood cell count)
• Jaundice (yellowing of skin and mucous membranes)
• In adolescents, premature closure of the epiphyses and growth arrest may occur.

In sensitive women, 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 after treatment is discontinued. After the first signs of voice changes (voice fatigue, hoarseness, dysphonia), treatment should be discontinued. If it is necessary to continue treatment, it is possible that voice disorders may become irreversible.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Primobolan Depot

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

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Primobolan Depot

The active substance is metenolone enanthate. Each 1 ml ampoule of Primobolan Depot contains 100 mg of metenolone enanthate in injectable solution.

The other ingredients are: benzyl benzoate and castor oil.

Appearance of the product and pack contents

Primobolan Depot is presented as an injectable solution in 1 ml colorless glass ampoules of hydrolytic class I.

It is presented in packs containing 1 ampoule of 1 ml.

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer AG

Müllerstrasse 178

13353 Berlin

Germany

Date of last revision of this leaflet:March 2017

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.