AMITRAZ contains a substance called anastrozole. This belongs to a group of medicines called ‘aromatase inhibitors’. AMITRAZ is used to treat breast cancer in women who have gone through the menopause. AMITRAZ works by cutting down the amount of the hormone called oestrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body called ‘aromatase’.
1. What AMITRAZ is and what it is used for
2. What you need to know before you take AMITRAZ
Do not take AMITRAZ :
• If you are hypersensitive (allergic) to anastrozole or any of the ingredients of AMITRAZ (listed in section 6).
• If you are pregnant or breast-feeding
• If you are pre-menopausal (still have menstrual periods)
• If you have severe kidney disease
• If you have moderate or severe liver disease
If you are not sure, talk to your doctor or pharmacist before taking AMITRAZ .
Warnings and precautions
Tell your doctor, pharmacist or healthcare professional before taking AMITRAZ :
• if you still have menstrual periods and have not yet gone through the menopause.
• if you are taking a medicine that contains tamoxifen or medicines that contain oestrogen (see ‘Other medicines and AMITRAZ ’).
Children and adolescents
AMITRAZ has not been studied in children or adolescents and therefore should not be used in this patient population.
Other medicine and AMITRAZ :
Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines). The use of AMITRAZ with these medicines may cause undesirable interactions. In particular tell your doctor if you are taking:
• Certain medicines used to treat breast cancer, e.g. medicines that contain tamoxifen. This is because these medicines may stop AMITRAZ from working properly.
• Medicines that contain oestrogen, such as hormone replacement therapy (HRT).
Pregnancy, breastfeeding and fertility
Do not take AMITRAZ if you are pregnant or breastfeeding.
3. How to take AMITRAZ
Do not share medicines prescribed for you with any other person. Always take AMITRAZ exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one tablet of AMITRAZ once a day. Your doctor will tell you how long your treatment with AMITRAZ will last. Do not stop any treatment unless your doctor tells you to do so.
If you have the impression that the effect of AMITRAZ is too strong or too weak, tell your doctor or pharmacist.
If you take more AMITRAZ than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.
If you forget to take AMITRAZ
If you forget to take your tablet, just take or next dose as normal. Do not take a double dose to make up for forgotten individual doses.
If you stop taking AMITRAZ
Do not stop taking your tablets unless your doctor tells you to.
4. Possible side effects
AMITRAZ can have side effects. Not all side effects reported for AMITRAZ are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AMITRAZ , please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happens, stop taking AMITRAZ and tell your doctor immediately or go to the casualty department at your nearest hospital:
• Swelling around the eyes or face, tongue or throat, (which may be a serious allergic reaction)
• An extremely severe skin reaction with ulcers or blisters on the skin (this is known as ‘Stevens-Johnson syndrome’).
These are all very serious side effects. If you have them, you may have had a serious reaction to AMITRAZ . You may need urgent medical attention or hospitalisation.
Treatment with AMITRAZ can cause:
• Headache
• Hot flushes
• Feeling sick (nausea)
• Skin rash
• Pain or stiffness in your joints
• Inflammation of the joints (arthritis)
• Feeling weak
Tell your doctor if you notice any of the following:
Frequent side effects:
• Loss of appetite
• Feeling sleepy
• Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand)
• Tickling, tingling or numbness of skin, loss/lack of taste
• Diarrhoea
• Being sick (vomiting)
• Changes in blood tests that show how well your liver is working
• Thinning of your hair (hair loss)
• Bone pain
• Muscle pain and weakness
• Vaginal dryness
Less frequent side effects:
• Changes liver function tests
• Raised or high levels of fatty substance known as cholesterol in your blood. This would be seen in a blood test
• Inflammation of the liver (hepatitis)
• Hives or nettle rash
• Trigger finger (a condition in which your finger or thumb stays in a bent position)
• Increased amounts of calcium in your blood. If you experience nausea, vomiting and thirst, you should tell your doctor, or pharmacist or nurse as you may need to have blood tests
• Inflammation of your skin that may include red patches or blisters
• Skin rash caused by hypersensitivity (this can be from allergic or anaphylactoid reaction)
• Inflammation of the small blood vessels causing red or purple colouring of the skin. Symptoms of joint, stomach, and kidney pain may occur; this is known as ‘HenochSchönlein purpura’.
Effects on your bones
AMITRAZ lowers the amount of the hormone called oestrogen that is in your body. This may lower the mineral content of your bones. Your bones may be less strong and may be more likely to fracture. Your doctor will manage these risks according to treatment guidelines for managing bone health in women who have gone through the menopause. You should talk to your doctor about the risks and treatment options.
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects via https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of AMITRAZ .
5. How to store AMITRAZ
STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
AMITRAZ will be stored in the pharmacy
Store at or below 25 °C.
Keep the container in the outer carton in order to protect from light.
Do not use after the expiry date stated on the blister and the carton.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).