Bicalutamide belongs to a group of medicines called non-steroidal anti-androgen. Bicalutamide works by interfering with the actions of male sex hormones (androgens). It is used for the treatment of advanced prostate cancer in combination with hormone therapy or after surgery. Ask your doctor or healthcare professional if you have any questions about why Caloxa has been prescribed for you.
1. What Caloxa is and what it is used for
2. What you need to know before you take Caloxa
Do not take Caloxa if you are hypersensitive (allergic) to bicalutamide or any of the other ingredients of Caloxa (listed in section 6). If you are taking any other medicines, including those available without a prescription, herbal or complementary medicines.
Warnings and precautions
Special care should be taken with Caloxa:
- If you suffer from liver problems.
Other medicines and Caloxa
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your health care provider if you are taking any of the following medicines:
- Ketoconazole and cimetidine
- Warfarin
Driving and using machines
Caloxa can affect your ability to drive, do not drive or use machines until the effects of caloxa subsides.
Caloxa contains Lactose
Caloxa contains lactose monohydrate, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Caloxa.
3. How to take Caloxa
Do not share medicines prescribed for you with any other person. Always take Caloxa exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long your treatment with Caloxa will last. If you have the impression that the effect of Caloxa is too strong or too weak, tell your doctor or pharmacist. The usual dose is one tablet each day. Take your medication exactly as directed by your doctor. Swallow your tablet whole with a drink of water. Take this medicine at the same time each day to avoid missing any doses. If you do miss a dose, take it when you remember unless it is nearly time for your next dose. If your next dose is due, leave out the missed dose and take the next dose on time. Do not take two doses together. Do not stop taking Caloxa without speaking with your doctor first. This medicine is for you. Never give it to others even if their condition appears to be the same as yours. Before taking any 'over-the-counter' medicines, check with your pharmacist which medicines are safe for you to take alongside Caloxa. Keep your regular appointments with your doctor so your progress can be monitored. Caloxa can cause changes to certain blood tests that your doctor may want to check.
Before having any kind of surgery, including dental or emergency treatment, tell your surgeon, dentist or doctor that you are taking Caloxa.
If you take more Caloxa than you should
Never take more than the prescribed dose. In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Where possible take the container with you, even if it is empty.
If you forget to take caloxa
Do not take a double dose to make up for the forgotten individual doses.
4. Possible side effects
Caloxa can have side effects. Not all side effects reported for Caloxa are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Caloxa, please consult your health care provider for advice.
Important: If you experience serious breathlessness, chest infection, swelling of your mouth or face, chest pain, blood in your urine, or yellowing of the skin and whites of your eyes, then contact your doctor straight away or go to the accident and emergency department of your local hospital.
Side effects are:
- Feeling or being sick
- Diarrhoea
These are frequent side effects:
- anaemia
- lack of appetite (anorexia)
- depression
- reduced sex drive
- dizziness
- drowsiness
- sleeplessness
- heart attack
- high blood pressure
- hot flushes
- cough
- sore throat
- sneezing
- fever
- chills
- flu-like symptoms
- abdominal pain
- bloating
- indigestion
- constipation
- nausea
- changes in your liver
- itchy dry skin
- loss of hair
- sweating
- rash
- development of breasts in males
- breast tenderness
- sexual inability
- Weakness
- increased weight
These are less frequent side effects:
- allergic reactions
- nervousness
These side effects have been reported but the frequency is unknown:
- decreased number of white blood cells
- increased blood sugar levels
- increased frequency of urination at night
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 . By reporting side effects you can help provide more information on the safety of Caloxa.
5. How to store caloxa
Store at or below 25 °C. Store in original package. Store all medicines out of reach of children. Do not use after the expiry date stated on the carton. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).