Description

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BRUMIDEX CR belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is needed to make the female sex hormones, oestrogens, especially in postmenopausal women. Reduction in oestrogen levels in the body is a way of treating hormone dependent breast cancer.
BRUMIDEX CR is used to treat hormone dependent early breast cancer in postmenopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen. BRUMIDEX CR is also used to treat hormone dependent advanced breast cancer in postmenopausal women when a different hormonal drug treatment has not worked well enough.

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BEFORE YOU TAKE BRUMIDEX CR

Do not take BRUMIDEX CR
• if you are or have previously been allergic to exemestane (the active ingredient in BRUMIDEX CR) or any of the other ingredients of this medicine (listed in section 6).
• if you have not already been through ‘the menopause’, i.e. you are still having your monthly period.
• if you are pregnant, likely to be pregnant or breast-feeding.

Warnings and precautions
• Before treatment with BRUMIDEX CR, your doctor may want to take blood samples to make sure you have reached the menopause.
• Routine checking of your vitamin D level will also be made before treatment, as your level may be very low in the early stages of breast cancer. You will be given vitamin D supplement if your levels are below normal.
• Before taking BRUMIDEX CR, tell your doctor if you have problems with your liver or kidneys.

• Tell your doctor if you have a history or are suffering from any condition which affects the strength of your bones. Your doctor may want to measure your bone density before and during the treatment of BRUMIDEX CR. This is because drugs of this class lower the levels of female hormones and this may lead to a loss of the mineral content of bones, which might decrease their strength.

Other medicines and BRUMIDEX CR
Please tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
BRUMIDEX CR should not be given at the same time as hormone replacement therapy (HRT).

The following medicines should be used cautiously when taking BRUMIDEX CR. Let your doctor know if you are taking medicines such as:
• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anticonvulsants used to treat epilepsy),
• the herbal remedy St John’s Wort (Hypericum perforatum), or preparations containing it.

Pregnancy and breast-feeding
Do not take BRUMIDEX CR if you are pregnant or breast-feeding.
If you are pregnant or think you might be, tell your doctor.
Discuss contraception with your doctor if there is any possibility that you may become pregnant.

Driving and using machines
If you feel drowsy, dizzy or weak whilst taking BRUMIDEX CR, you should not attempt to drive or operate machinery.

BRUMIDEX CR contains sucrose and methyl parahydroxybenzoate
• If you have previously been told that you have intolerance to some sugars, contact your
doctor before taking this medicine. BRUMIDEX CR tablets contain sucrose (a type of sugar), which may cause a problem in a small number of patients with hereditary intolerance to some sugars (glucose-galactose malabsorption, fructose intolerance or sucrase-isomaltase insufficiency).
• BRUMIDEX CR contains a small amount of methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed), if this should happen please contact your doctor.

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HOW TO TAKE BRUMIDEX CR

Adults and the elderly
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
BRUMIDEX CR tablets should be taken by mouth after a meal at approximately the same time each day. Your doctor will tell you how to take BRUMIDEX CR and for how long. The recommended dose is one 25 mg tablet daily.

If you need to go to the hospital whilst taking BRUMIDEX CR, let the medical staff know what medication you are taking.

Use in children
BRUMIDEX CR is not suitable for use in children.

If you take more BRUMIDEX CR than you should
If too many tablets are taken by accident, contact your doctor at once or go straight to the nearest hospital casualty department. Show them the pack of BRUMIDEX CR tablets.

If you forget to take BRUMIDEX CR
Do not take a double dose to make up for a forgotten tablet.
If you forget to take your tablet, take it as soon as you remember. If it is nearly time for the next dose, take it at the usual time.

If you stop taking BRUMIDEX CR
Do not stop taking your tablets even if you are feeling well, unless your doctor tells you

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POSSIBLE SIDE EFFECTS

Like all medicines, BRUMIDEX CR can cause side effects, although not everybody gets them. In general, BRUMIDEX CR is well tolerated and the following side effects observed in patients treated with BRUMIDEX CR are mainly mild or moderate in nature. Most of the side effects are associated with a shortage of oestrogen (e.g. hot flushes).
Hypersensitivity, inflammation of the liver (hepatitis) and inflammation of the bile ducts of the liver which cause yellowing of the skin (cholestatic hepatitis) may occur. Symptoms include feeling generally unwell, nausea, jaundice (yellowing of the skin and eyes), itching, right sided abdominal pain and loss of appetite. Contact your doctor promptly to seek urgent medical advice if you think you have any of these symptoms.
Very common side effects (may affect more than 1 in 10 people):
• Depression
• Difficulty sleeping
• Headache
• Hot flushes
• Dizziness
• Feeling sick
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis and joint stiffness)
• Tiredness
• A reduction in the number of white blood cells
• Abdominal pain
• Elevated level of liver enzymes
• Elevated level of a hemoglobin breakdown in the blood
• Elevated level of a blood enzyme in the blood due to liver damage
• Pain
Common side effects (may affect up to 1 in 10 people):
• Loss of appetite
• Carpal tunnel syndrome (a combination of pins and needles, numbness and pain affecting all of the hand except the little finger) or tingling/prickling of the skin
• Stomach ache, vomiting (being sick), constipation, indigestion, diarrhoea
• Hair loss
• Skin rash, hives and itchiness
• Thinning of bones which might decrease their strength (osteoporosis), leading to bone fractures (breaks or cracks) in some cases
• Pain, swollen hands and feet
• A reduction in the number of platelets in the blood
• Muscle weakness Uncommon side effects (may affect up to 1 in 100 people):
• Hypersensitivity
Rare side effects (may affect up to 1 in 1,000 people):
• A breakout of small blisters on an area of the skin in a rash
• Drowsiness
• Inflammation of the liver
• Inflammation of the bile ducts of the liver which cause yellowing of the skin
Not known side effect (frequency cannot be estimated from the available data):
• Low level of certain white blood cells in the blood
Changes in the amount of certain blood cells (lymphocytes) and platelets circulating in your blood, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood) may also be seen.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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HOW TO STORE YOUR MEDICINE

• Keep this medicine out of the sight and reach of children.
• Do not use BRUMIDEX CR after the expiry date which is stated on the outer carton and the blister after EXP. The expiry date refers to the last day of the month.
• This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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FURTHER INFORMATION

What BRUMIDEX CR contains
• The active substance is exemestane. Each coated tablet contains 25 mg exemestane.
• The other ingredients are silica colloidal hydrated, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycollate (type A), polysorbate, polyvinyl alcohol, simeticone, macrogol, sucrose, magnesium carbonate light, methyl parahydroxybenzoate (E218), cetyl esters wax, talc, carnauba wax, ethyl alcohol, shellac, titanium oxide (E171) and iron oxides (E172).

What BRUMIDEX CR looks like and contents of the pack
BRUMIDEX CR is a round, biconvex, off-white, coated tablet marked on one side.
BRUMIDEX CR is available in blister packs of 15, 20, 30, 90, 100 and 120 tablets.
Not all pack sizes will be marketed.