EXEMESTANE 25 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - EXEMESTANE 25 MG FILM-COATED TABLETS

Exemestane 25 mg film-coated tablets

Exemestane

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their symptoms are the same as yours.

- if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

1. What Exemestane is and what it is used for
2. What you need to know before you take Exemestane
3. How to take Exemestane
4. Possible side effects
5. How to store Exemestane
6. Contents of the pack and other information

1. what exemestane is and what it is used for

Your medicine is called Exemestane. Exemestane 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.

Exemestane 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.

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

2. what you need to know before you take exemestane if you are or have previously been allergic to exemestane (the active ingredient in exemestane

tablets) 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 breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Exemestane.
Before treatment with Exemestane, 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 Exemestane, 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 Exemestane. This is because medicines 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 Exemestane

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

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

The following medicines should be used cautiously when taking Exemestane. 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

Ask your doctor or pharmacist for advice before taking any medicine.

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 Exemestane, you should not attempt to drive or operate machinery.

Exemestane contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take exemestanealways take this medicine exactly as your doctor has told you. check with your doctor if you are not sure.

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

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

Use in children

Exemestane tablets are not suitable for use in children.

If you take more Exemestane 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 Exemestane tablets.

If you forget to take Exemestane

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 Exemestane

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

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

In general, Exemestane is well tolerated and the following side effects observed in patients treated with Exemestane 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: 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 haemoglobin breakdown in the blood
Elevated level of a blood enzyme in the blood due to liver damage
Pain

Common: 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
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
Swollen hands and feet
A reduction in the number of platelets in the blood
Feeling of weakness

Uncommon: may affect up to 1 in 100 people

Hypersensitivity

Rare: 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: 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 may occur, 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. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store

5. how to store exemestane

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after {EXP}. The expiry date refers to the last day of that month.

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 to protect the environment.

6. contents of the pack and other information the active substance is exemestane. each film-coated tablet contains 25 mg exemestane.

The other ingredients are: core: povidone K30; maize starch (bleached), starch pregelatinised

(partially), sodium starch glycolate type A, cellulose microcrystalline type 101, talc, silica colloidal anhydrous, magnesium stearate and polysorbate 80; film-coating: polyvinyl alcohol partially hydrolyzed, talc, macrogol 3350 and titanium dioxide (E171).

What Exemestane tablets looks like and contents of the pack

Exemestane 25 mg film-coated tablets are white, round, lenticular, with uniform appearance and intact edges.

Pack sizes:

Blister packs: 10, 30, 40, 60, 90 and 100 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Torrent Pharma (UK) Ltd.

3rd Floor, Nexus Building

4 Gatwick Road

Crawley

West Sussex

RH10 9BG