Primoteston Depot Consumer Medicine Information

250 mg testosterone enantate for intramuscular injection

What is in this leaflet

Please read this leaflet carefully before you start using PRIMOTESTON DEPOT. It will advise you about how to take PRIMOTESTON DEPOT properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor, professional health care provider or pharmacist.

What is PRIMOTESTON DEPOT used for and how does it work

PRIMOTESTON DEPOT contains a derivative of the natural male sex hormone testosterone (testosterone enanathate).

How does PRIMOTESTON DEPOT work?

PRIMOTESTON DEPOT can be considered an androgenic hormonal preparation that is it induces a masculinising effect such as that produced by the testis, ovaries and adrenal cortex.

After PRIMOTESTON DEPOT is injected into your muscle it is gradually released into the bloodstream thus allowing a time interval between injections. The effect of PRIMOTESTON DEPOT lasts approximately 2- 4 weeks but differs between individuals.

What is PRIMOTESTON DEPOT used for?

PRIMOTESTON DEPOT is used in men for conditions of hypogonadism (abnormal hormone secretion of the gonads); potency disorders; male climacteric (a stage of life similar to that of menopause in females which can lead to symptoms such as: fatigue, diminished sexual desire, erectile impotency) and aplastic anaemia (a condition resulting in an abnormal number of red blood cells).

In woman, PRIMOTESTON DEPOT is used as a supplementary therapy for progressive breast cancer during the postmenopausal period.

Before you use PRIMOTESTON DEPOT

Do not use PRIMOTESTON DEPOT if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use PRIMOTESTON DEPOT.

You must not use PRIMOTESTON DEPOT if:

  • you have prostate cancer
  • you have a previous or existing liver tumor
  • you have breast cancer (except when prescribed for progressive breast cancer in women)
  • you are allergic to any of the ingredients of PRIMOTESTON DEPOT

Tell your doctor if:

If PRIMOTESTON is used in the presence of any of the conditions listed below or they appear for the first time, recur or worsen during treatment, you may need to be kept under close observation. Your doctor can explain this to you. You should tell your doctor if:

  • you have breast cancer (specifically women) and develop hypercalcaemia (increased calcium in the blood) during treatment
  • you have a benign or malignant liver tumor and experience upper abdominal complaints which don't disappear over a short time
  • your haemoglobin levels or haematocrit levels alter over time

What else you should know

PRIMOTESTON DEPOT is not suitable for enhancing muscular development or physical ability.
As a precaution, regular examinations of the prostate are recommended for men. If you are on long-term androgen therapy blood tests should be carried out on a regular basis.

How to use PRIMOTESTON DEPOT properly

Remember that PRIMOTESTON DEPOT has been prescribed for you personally. Do not share it with others.

When and how to administer PRIMOTESTON DEPOT

PRIMOTESTON DEPOT must be injected into the muscle. Short lasting reactions e.g. coughing urges, coughing fits or respiratory distress may occur in rare cases during or immediately after injection. To avoid this PRIMOTESTON DEPOT should be injected extremely slowly.

Dosage and administration for men

Hypogonadism

PRIMOTESTON DEPOT can be used in cases where androgen-dependant target organs (e.g. ovaries, testis and adrenal cortex) are still underdeveloped. This may aid in the development and stimulation of these organs.

250mg PRIMOTESTON DEPOT should be injected into the muscle every 2-3 weeks. To maintain an adequate effect, 250mg PRIMOTESTON DEPOT should be injected into the muscle every 3-4 weeks thereafter. Injection intervals may vary in certain instances.

Potency disorders

Disorders of potency based on an androgen deficiency (a deficiency in hormone which has a masculinising effect) can be eliminated with administration of PRIMOTESTON DEPOT.

1 ampoule PRIMOTESTON DEPOT 250mg should be injected every 4 weeks. (An initial dose of 100mg PRIMOTESTON DEPOT, followed one week later with another 100mg injection can be given).

Male climacteric

In this instance the diminished androgen production (frequent with onset of middle age) and its symptoms e.g. reduced performance, rapid fatigue, diminished memory and ability to concentrate, disorders of libido and potency, depressive moods, irritability, sleep disturbances and general vegetative complaints may be improved with administration of PRIMOTESTON DEPOT.

1 ampoule PRIMOTESTON DEPOT 250mg should be injected every 3-4 weeks. Repeated 6-8 week courses at 2-3 month intervals are recommended.

Aplastic anaemia

This condition results in an abnormal number of red blood cells in the blood. High doses of androgen such as PRIMOTESTON DEPOT promote erythropoiesis (formation of red blood cells).

250mg PRIMOTESTON DEPOT injected into the muscle 2-3 times per week.

Dosage and administration for women

Treatment with androgens such as PRIMOTESTON DEPOT cannot replace surgery or irradiation methods of cancer therapy.

Supplementary therapy of progressive breast cancer in postmenopause

Injection of 250mg PRIMOTESTON DEPOT into the muscle every 2 weeks has led to remissions in some cases. Other benefits of this type of therapy include pain relief, improved condition and mental stimulation.

In particular, PRIMOTESTON DEPOT has frequently shown a positive effect on bone metastases. To maintain this effect it may be necessary to shorten the time intervals between treatments.

Overdosage

PRIMOTESTON DEPOT is classified as non-toxic after single intake. Even in instances which require higher doses of PRIMOTESTON DEPOT no toxicity is to be expected.

When using PRIMOTESTON DEPOT

Tell your doctor immediately if:

You are taking phenobarbital as this medication may decrease the effectiveness of PRIMOTESTON DEPOT.

You develop a blood clot, especially when taking medicines which contain coumarin derivatives at the same time as treatment with PRIMOTESTON DEPOT.

Regular check-ups

When you are using PRIMOTESTON DEPOT, your doctor will tell you to return for regular check-ups.

Side effects

Tell your doctor if you notice any unwanted effect, especially if severe or persistent, or if there is a change in your health that you think might be caused by PRIMOTESTON DEPOT.

The following undesirable side effects have been reported.

  • Water retention and swelling (particularly from high dosed or long term use of PRIMOTESTON DEPOT)
  • jaundice, increased number of red blood cells or abnormal liver function tests
  • gynaecomastia (breast enlargement in men)
  • acne
  • masculinization in women e.g. acne, hirsutism (excessive hair growth), voice changes
  • inhibition of spermatogenesis (sperm production)
  • an increase in haemoglobin and/or haematocrit levels
  • frequent or persistent erections in men
  • various skin and injection site reactions
  • hypersensitivity reactions

Storage

Do not use after the expiry date stated on the package.

Store all drugs properly and keep them out of reach of children.

Further information

PRIMOTESTON DEPOT 250mg contains:

Active substances (per ml)

testosterone enantate 250 mg

Other substances

benzyl benzoate, castor oil

If you have any further questions please consult your doctor or pharmacist.

This leaflet was last revised on 9th February 2004