Androcur Depot 300 mg Solution

ANDROCUR DEPOT is a hormone preparation acting against male sex hormones. (androgens). The active substance is cyproterone acetate. ANDROCUR reduces the testosterone (an androgen) concentration in the blood. This in turn leads to a reduction of sex drive. Androgens encourage the growth of prostate cancer. In these patients, ANDROCUR inhibits this effect.

ANDROCUR DEPOT should not be administered to you: Do not use ANDROCUR DEPOT if you have any of the conditions listed below. If any of these apply to you, tell your doctor before ANDROCUR DEPOT injection is given to you.

• if you have a liver disease
• if you suffer from hereditary disturbances of liver function with impaired excretion of the red blood cell pigment called bilirubin (“Dubin - Johnson Syndrome” or “Rotor - Syndrome”)
• if you have or ever had a benign or malignant liver tumour (only if these are not due to metastases from carcinoma of the prostate).
• if you have a wasting disease (a disease - causing decay or loss of strength, with the exception of inoperable carcinoma of the prostate).
• if you have or ever had a benign brain tumour (meningioma)
• if you suffer from depression
• if you have or have had a disorder affecting the blood circulation: in particular, those conditions relating to thrombosis (the formation of a blood clot) in the blood vessels (thromboembolic process)
• if you have severe diabetes mellitus with blood vessel changes
• if you have sickle cell anaemia
• if you are hypersensitive (allergic) to cyproterone acetate or any of the other ingredients of ANDROCUR DEPOT.

Warning and precautions

Tell your doctor or health care provider before being given the injection if you have or have had any of the following conditions:

• If you suffer from diabetes, since he/she may need to adjust your antidiabetic medication. This requires strict supervision during treatment with ANDROCUR DEPOT (see also section ‘Do not take ANDROCUR’).
• Anemia has been reported during treatment with ANDROCUR. Therefore, your doctor will monitor your red blood cell count during treatment.
• Blood clots
• Liver problems
• Depression
• Breathing problems (shortness of breath)

ANDROCUR may decrease the function of the hormone producing gland attached to the kidneys (adrenal glands). Therefore, your doctor may conduct some tests to monitor this effect during treatment with ANDROCUR.

If you are diagnosed with meningioma, your doctor will stop your treatment with cyproterone acetate (see section ‘Do not use ANDROCUR’).

Blood clots (thromboembolic events) have been reported in patients using ANDROCUR, although a direct link with ANDROCUR has not been established. Patients with a history of blood clots or with advanced tumours have an increased risk of suffering blood clots. Tell your doctor if you have ever had an arterial or venous blood clot, such as a deep vein thrombosis, a clot in the lung (pulmonary embolism), a heart attack (myocardial infarction) or a stroke (cerebrovascular accident).

Do not share medicines prescribed for you with others. Your doctor will inject ANDROCUR very slowly into a muscle avoiding all blood vessels.

Reduction of drive in sexual deviations in males: Your doctor will give you 1 ampoule of ANDROCUR DEPOT as a deep injection into a muscle every 10 to 21 days. Your doctor may increase the dose to 2 ampoules every 10 to 21 days, he/she will give you 1 ampoule each in the right and left buttock. Efficacy can be maintained by injection intervals ranging from 10 to 21 days. When a satisfactory result has been achieved, your doctor will reduce the dosage by gradually increasing the intervals between your injections.

To stabilise the therapeutic effect, it is necessary to use ANDROCUR DEPOT over a long period of time, your doctor may refer you for psychotherapy during this time.

Inoperable carcinoma of the prostate: After orchidectomy: 300 mg (1 ampoule) every 2 weeks as a deep IM injection. Without orchidectomy: 300 mg (1 ampoule) weekly as a deep IM injection. Do not change or interrupt the treatment or dosage prescribed by your doctor once you feel an improvement.

Elderly patients (65 years or older): There are no data suggesting the need for a dosage adjustment in elderly patients.

Patients with impaired liver function: Do not use ANDROCUR if you suffer from impaired liver function (see section ‘Do not use ANDROCUR’).

Patients with impaired kidney function: There are no data suggesting the need for a dosage adjustment in patients with impaired kidney function.

If you take more ANDROCUR DEPOT than you should: Treatment is supportive and symptomatic. Please consult your doctor or pharmacist in the case of accidental overdose. If neither is available, rush the patient to the nearest hospital or poison control centre. Since a health care provider will administer ANDROCUR DEPOT, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to get your ANDROCUR DEPOT injection: Since a health care provider will administer ANDROCUR DEPOT, it is unlikely that the dose will be missed.

If you stop using ANDROCUR DEPOT: Do not stop using ANDROCUR unless your doctor has told you to do so. If you want to stop using ANDROCUR, you should discuss this with your doctor first.

ANDROCUR DEPOT can have side effects. Not all side effects reported for ANDROCUR DEPOT are included in this leaflet. Should your general health worsen while taking ANDROCUR DEPOT, please consult your doctor, pharmacist or other healthcare professional for advice. The most serious undesirable effects associated with the use of ANDROCUR DEPOT are listed in section ‘Take special care with ANDROCUR DEPOT”. Tell your doctor immediately if you notice any of the following symptoms:

• Generally feeling unwell, fever, nausea, vomiting, loss of appetite, itching all over your body, yellowing of your skin and eyes, light coloured bowel movements, dark coloured urine. These symptoms could be signs of liver toxicity, including inflammation of the liver (hepatitis) or liver failure. Disturbances of liver function, some of them severe (jaundice hepatitis and hepatic failure), have been observed in patients with ANDROCUR. At dosages of 100 mg and above also fatal cases have been reported. Most reported fatal cases were in men with advanced prostate cancer. The disturbances of liver function are dose-related and usually develop several months after treatment has begun. Therefore, your doctor will monitor your liver function before treatment and during treatment especially if there are any symptoms or signs suggestive of liver toxicity. If liver toxicity is confirmed, your doctor will stop your treatment with ANDROCUR, unless the liver toxicity can be explained by another cause (e.g. secondary tumours). In this case your doctor may continue your treatment with ANDROCUR if the perceived benefit outweighs the risk.
• Unusual upper abdominal pains which do not disappear spontaneously within a short time. These symptoms could be signs of benign or malignant liver tumours which may lead to life-threatening internal bleeding (intra-abdominal haemorrhage).
• Swelling of the calf or leg, chest pain, being short of breath or suddenly feeling weak. These symptoms could be signs of formation of blood clots (thromboembolic events).

Very common side effects: may affect more than one in 10 people.

• reversible inhibition of sperm production (spermatogenesis)
• reduced sexual drive (libido decreased)
• inability to achieve or maintain an erection (erectile dysfunction)

Common side effects: may affect more than one in 10 people.

• liver toxicity, including jaundice, inflammation of the liver (hepatitis), liver failure
• weight gain
• weight loss
• depressed mood
• temporary restlessness
• enlarged breasts (gynaecomastia)
• tiredness (fatigue)
• hot flushes
• sweating
• shortness of breath

Uncommon side effects: may affect more than one in 10 people.

• rash

Rare side effects: may affect more than one in 10 people.

• allergic reaction (hypersensitivity)

Very rare side effects: may affect more than one in 10 people.

• benign and malignant liver tumours

Side effects for which frequency is not known:

• internal bleeding (intra-abdominal haemorrhage)
• formation of blood clots (thromboembolic events) (see section ‘Take special care with ANDROCUR’)
• pulmonary oil microembolism with symptoms such as cough, shortness of breath (dyspnoea), or chest pain (see section ‘Take special care with ANDROCUR’)
• vasovagal reactions with symptoms such as malaise, increased sweating (hyperhydrosis), dizziness, ‘pins and needles’ (paraesthesia), or fainting (syncope) (see section ‘Take special care with ANDROCUR’)
• benign brain tumours (meningiomas) (see sections ‘Do not use ANDROCUR’ and ‘Take special care with ANDROCUR’)
• osteoporosis
• anaemia

Under treatment with ANDROCUR DEPOT, sexual drive and potency are reduced and the function of the testicles is inhibited. These changes are reversible after ANDROCUR DEPOT treatment has been discontinued. Over the course of several weeks, ANDROCUR DEPOT inhibits the formation of sperms (spermatogenesis) as a result of the antiandrogenic and antigonadotropic actions. Spermatogenesis recovers gradually within a few months of discontinuing the therapy. ANDROCUR DEPOT may lead to swelling of the breast gland (so called gynaecomastia, sometimes combined with tenderness to touch of the mamillae) which usually regresses after ANDROCUR treatment has been discontinued. Permanent enlargement of the mammary glands may occur. Long-term use of ANDROCUR DEPOT may lead to osteoporosis. Benign brain tumours (meningiomas) have been reported in association with long-term use (several years) of ANDROCUR doses of 25 mg and above. (see sections ‘Do not use ANDROCUR’ and ‘Take special care with ANDROCUR’).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects: If you get side effects talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug reaction Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ANDROCUR DEPOT.

Store below 30 °C. Protect from light. Do not use ANDROCUR DEPOT after the expiry date which is stated on the ampoule and the carton. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.