Patient Medication Information: uses, side effects, how to take - Med-Cyproterone
Serious Warnings and Precautions
MED-CYPROTERONE should be prescribed and managed by a doctor experienced with the treatment of prostate cancer. Treatment with MED-CYPROTERONE may cause:
- Liver damage and liver failure
What is MED-CYPROTERONE used for?
MED-CYPROTERONE is used to reduce pain in the treatment of patients with advanced prostate cancer.
How does MED-CYPROTERONE work?
MED-CYPROTERONE contain the medicinal ingredient cyproterone acetate. It is an anti-androgen therapy. It blocks the actions of male sex hormones (androgens). Androgens promote the growth of prostate cancer.
What are the ingredients in MED-CYPROTERONE?
Medicinal ingredients: Cyproterone acetate.
Non-medicinal Ingredients: lactose, cellulose microcrystalline, croscarmellose sodium, povidone, and magnesium stearate.
MED-CYPROTERONE come in the following dosage forms:
MED-CYPROTERONE Tablet: Each tablet contains 50 mg cyproterone acetate.
Do not use MED-CYPROTERONE if you:
- are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of MED-CYPROTERONE;
- have a liver disease or reduced liver function;
- have Dubin-Johnson syndrome or Rotor syndrome. Both syndromes result in an increase in bilirubin (red blood cell pigment);
- have or have had liver tumors that are not due to the spread of prostate cancer;
- have or ever had a benign brain tumor (meningioma);
- have wasting diseases (diseases involving an unintended loss of weight or muscle) that are not related to prostate cancer;
- suffer from severe chronic depression;
- have conditions that increase your risk for developing blood clots (thromboembolic process).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MED-CYPROTERONE. Talk about any health conditions or problems you may have, including if you:
- have a breathing problem. Shortness of breath has been reported in patients taking 300 mg a day of MED-CYPROTERONE.
- have heart disease;
have blood clots. Blood clots have been reported in patients taking cyproterone acetate. Tell your doctor if any of the following apply to you, as you may be at an increased risk of getting a blood clot. If you have:
- a history of blood clots, strokes or heart attacks
- cancer
- abnormal red blood cells (sickle-cell anaemia)
- Severe diabetes that affects your blood circulation
- have liver problem. Severe and fatal liver problems have been reported with MED-CYPROTERONE. Your doctor may conduct regular liver tests before and during treatment to monitor the condition of your liver. Your doctor might decide to end your treatment if necessary;
- have or have had a history of depression;
- have diabetes. Your doctor may need to adjust your antidiabetic medication as taking MED-CYPROTERONE can alter the sugar levels in your blood. Your doctor will check your blood sugars before you begin and during treatment. Strict supervision is required if you are diabetic during your treatment.
- have anemia. Your doctor will monitor your red-blood cell count during treatment. Anaemia has been reported rarely during long term treatment with cyproterone acetate;
- have a history of benign brain tumors (meningiomas).
Other warnings you should know about:
MED-CYPROTERONE is not for use in:
- women
children under the age of 18
- males who have not reached the end of puberty. Using it may have a negative effect on growth and hormonal functions.
Alcohol use:
Consuming alcohol while taking MED-CYPROTERONE may impact the effect of the drug. It is recommended that you avoid the use of alcohol while on treatment.
Use with orchiectomy or GnRH agonist drugs
Your life expectancy may be reduced if you are taking MED-CYPROTERONE for a long period of time if you:
- had an orchiectomy (removal of testicles) or;
- are taking a GnRH agonist (one class of drug that acts against male sex hormones).
Long term treatment in patients with advanced prostate cancer may reduce the life expectancy by 5 years when compared to using surgical castration treatment only.
Driving and using machines:
You may feel tired and weak during treatment. Before you do tasks that require special attention, wait until you know how your body responds to MED-CYPROTERONE.
Liver tumours (benign and malignant)
Using medicines such as MED-CYPROTERONE has very rarely been linked to the development of:
- benign (non-malignant) liver tumours and;
- some forms of liver cancer (malignant liver tumours).
Benign brain tumours (meningiomas)
You may develop meningioma if you take MED-CYPROTERONE for a long duration. Meningioma has been rarely reported in patients with prostate cancer that are taking MED-CYPROTERONE for a shorter duration. Your risk increases especially when you use it for a longer duration (several years) or for a shorter duration with high doses (25 mg per day and above). If you are diagnosed with meningioma, your doctor will stop your treatment.
Antiandrogen Withdrawal Syndrome
Taking MED-CYPROTERONE may increase the risk of the prostate cancer growing, rather than prevent it. Your doctor will stop your treatment immediately and monitor your condition for 6-8 weeks before deciding to proceed with other prostate cancer therapies.
Swelling of breast tissue in males
You may experience swelling of your breasts while on treatment. Your doctor may reduce your dosage or terminate your treatment once assessing your condition.
Adrenal glands
Your adrenal glands may become suppressed during treatment with MED-CYPROTERONE. Your doctor will check the function of your adrenal glands periodically.
Sperm count:
Your sperm count and the amount of ejaculation is reduced when taking 50 mg to 300 mg of MED-CYPROTERONE a day. Your sperm count and ejaculation will usually return to normal after stopping your treatment.
Skin
Treatment with MED-CYPROTERONE may cause the following skin problems:
- Dry skin
- Patchy body hair loss
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with MED-CYPROTERONE:
- Statins (medicines for reducing blood fats)
- Ketoconazole, itraconazole, clotrimazole (for fungal infections)
- Ritonavir (for viral infections)
- Rifampicin (for tuberculosis)
- Phenytoin (for epilepsy)
- St. John’s Wort (herbal remedy for depression)
How to take MED-CYPROTERONE:
- Take exactly as your doctor tells you to take it. Do NOT take more of it than prescribed. Check with your doctor if you are not sure.
- Do not reduce your dose or stop taking your medicine unless your doctor tells you to.
Usual adult dose:
MED-CYPROTERONE Tablet
The recommended starting and maintenance daily dose: 200 mg to 300 mg (4 to 6 tablets) taken in two or three divided doses. Each dose should be taken with liquid after meals.
The maximum daily dose: 300 mg.
Recommended daily dose after orchiectomy (removal of testicles): 100-200 mg (2 to 4 tablets).
Overdose:
| If you think you, or a person you are caring for, have taken too much MED-CYPROTERONE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
MED-CYPROTERONE Tablet
If you missed a dose of MED-CYPROTERONE tablet, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.
What are possible side effects from using MED-CYPROTERONE?
These are not all the possible side effects you may feel when taking MED-CYPROTERONE. If you experience any side effects not listed here, contact your healthcare professional.
Very frequent side effects:
- Swelling of the breast, breast soreness (gynecomastia)
Other side effects:
- Constipation or diarrhea (loose stools)
- Depression
- Dizziness
- Fever or chills
- Frequent urination
- Hair loss or unusual increase in hair growth
- Headache
- Hot flashes
- Indigestion
- Nausea
- Shortness of breath
- Skin rash, blisters
- Skin discoloration
- Tiredness and weakness
- Unusual swelling of the arms, hands, legs, feet and ankles, face
- Vomiting
- Vision change
- Weight gain or weight loss
Serious side effects and what to do about them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Inability to achieve or maintain and erection | ✓ | ||
| Reduced sexual drive | ✓ | ||
| Reversible inhibition of sperm production | ✓ | ||
| RARE | |||
| Liver toxicity, liver inflammation (hepatitis), liver disease, liver failure: generally feeling unwell, fever, nausea, vomiting, loss of appetite, itching all over the body, yellowing of the skin or eyes, light colored bowel movements, dark urine | ✓ | ||
| Blood clots: swelling of the calf or leg (blood clots in the leg), chest pain and being short of breath (blood clots in the lung), suddenly feeling weak, loss of coordination, slurred speech (a stroke or blood clots in the brain), temporary blindness (blood clots in the eye) | ✓ | ||
| Life-threatening internal bleeding (intra-abdominal hemorrhage): unusual upper abdominal pains which do not disappear within a short time | ✓ | ||
| UNKNOWN | |||
| Osteoporosis (thin, fragile bones): broken bones, pain, back pain that gets worse when standing or walking | ✓ | ||
| Pulmonary oil microembolism (oily solution gets into the lung): cough, shortness of breath, or chest pain | ✓ | ||
| General post injection reactions (vasovagal reactions): malaise, increased sweating, dizziness, “pins and needles” sensation or fainting | ✓ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | ✓ | ||
| Benign brain tumors: dull and constant headaches, seizures, sensory deficits (hearing or vision problems, loss of coordination or spatial orientation), cognitive dysfunction (difficulty concentrating, mood or personality problems), and increased intracranial pressure (presents as nausea, headache, papilledema) | ✓ | ||
| Galactorrhea (production of breast milk): nipple discharge in one or both breasts, headaches, vision problems | ✓ | ||
Serious side effects and what to do about them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Benign (not cancer) breast lump: pain, swelling and/or tenderness | ✓ | ||
| in the breast, skin irritation, nipple pain, feeling of a lump through the skin or nipple, redness or scaling on the nipple, and nipple pain or retraction | |||
| Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | ✓ | ||
| Allergic reaction: hypersensitivity, itchiness, rash, swelling, difficulty breathing | ✓ | ||
| Asthma: difficulty breathing and coughing, chest tightness, wheezing or whistling sound when breathing | ✓ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid heartbeat, nausea, vomiting, tenderness when touching the abdomen | ✓ | ||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | ✓ | ||
| Diabetes or increase in blood sugar: with symptoms such as excessive thirst, excessive urination, excessive eating, unexplained weight loss, poor wound healing, infections | ✓ | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at controlled room temperature (15°C to 30°C). Protect from light.
Do not take MED-CYPROTERONE after the expiry date which is stated on the pack.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
Keep out of reach and sight of children.
If you want more information about MED-CYPROTERONE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website ( www.gmprx.com), or by calling Generic Medical Partners Inc. at 1.416.444.4GMP (1.416.444.4467).