Aromaplex tablets belong to a group of medicines known as aromatase inhibitors. These medicines 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.

Aromaplex tablets are used to treat hormone dependent early breast cancer in postmenopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen.

 tablets are also used to treat hormone dependent advanced breast cancer in postmenopausal women when a different hormonal drug treatment has not worked well enough.

Do not take Aromaplex tablets:

·        If you are or have previously been allergic (hypersensitive) to exemestane or any of the other ingredients. See section 6 (‘Further information’) for full list of other ingredients;

·        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 breastfeeding.

Take special care with Aromaplex tablets:

·        Before taking Aromaplex tablets, your doctor may want to take blood samples to make sure you have reached the menopause;

·        Before taking Aromaplex tablets, 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 with Aromaplex tablets. 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.

·        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.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Aromaplex should not be given at the same time as hormone replacement therapy (HRT).

The following medicines should be used cautiously when taking Exemestane tablets. 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. Johns Wort (Hypericum perforatum), or preparations containing it.

Pregnancy and breast-feeding

Do not take Exemestane if you are pregnant or breastfeeding.

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 Aromaplex tablets, you should not attempt to drive or operate machinery.

Always take Aromaplex tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and the elderly

Aromaplex tablets should be taken by mouth after a meal at approximately the same time each day. Your doctor will tell you how to take your medicine and for how long. The recommended dose is one tablet 25mg daily.

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

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

This medicine is not suitable for use in children.

If you take more Exemestane tablets than you should:

If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Exemestane tablets:

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Aromaplex tablets can cause side effects, although not everybody gets them. In general, your medicine is well tolerated and the following side effects have been observed in patients treated with Exemestane tablets and are mainly mild or moderate in nature. Most of the side effects are associated with a shortage of oestrogen (e.g. hot flushes).

Very common side effects, (affecting more than 1 person in 10):

• Difficulty sleeping
• Headache
• Hot flushes
• Feeling sick
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis and joint stiffness)
• Tiredness
• Depression
• Dizziness

•       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, (affecting between 1 to 10 people in 100):

• Loss of appetite
• carpal tunnel syndrome (a combinations of pins and needles, numbness and pain affecting all of the hand except the little finger)
• Stomach ache, vomiting (being sick), constipation, indigestion, diarrhoea
• Skin rash, hair loss
• 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,
• hives and itchiness,
• tingling/prickling of the skin.

Uncommon side effects, (affecting between 1 to 10 people in 1000):

• Hypersensitivity

Rare side effects, (affecting between 1 to 1000 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 effects, (frequency cannot be estimated from the available data):

• Low level of certain white blood cells in the blood”
   
• Drowsiness
• Inflammation of the liver

Hypersensitivity and inflammation of the bile ducts of the liver which cause yellowing of the skin (cholestatic hepatitis) may occur. Symptoms include a general malaise, nausea, vomiting, jaundice (yellowing of the skin and eyes), itching, abdominal pain localized on the right side and loss of appetite. Contact your doctor if you think you have any of these symptoms

If you have any blood tests done, it may be noticed that there are changes in your liver function. Changes in the amount of certain blood cells (lymphocytes) and platelets circulating in your blood may occur, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use Aromaplex tablets after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
• Store the tablets in their original package.
• Your medicine doesn’t require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist

how to dispose of medicines no longer required. These measures will help to protect the environment.