Patient leaflet - Exemestane 25 mg film-coated tablets
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 hormone, oestrogen, especially in postmenopausal women. Reducing 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.
It 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. BEFORE YOU TAKE EXEMESTANE
Do not take Exemestane
if you are or have previously been allergic
(hypersensitive) to exemestane (the active ingredient in Exemestane or any of the other ingredients of Exemestane (Please see 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 Exemestane, your doctor may
want to take blood samples to make sure you have reached the menopause.
Before taking Exemestane, tell your doctor if you have
problems with your liver or kidneys.
If you have a history or are suffering from any
condition which affects the strength of your bones. 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. You may have to undergo tests to measure your bone density before and during treatment. Your doctor can give you medicines or Vitamin D supplements to prevent or treat the bone loss.
Taking other medicines
Please tell your doctor if you are taking or have recently taken 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 (anti-convulsants used to treat epilepsy),
- the herbal remedy St John’s wort (Hypericum perforatum), or preparations containing it. Pregnancy and breast-feeding
Do not take Exemestane 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 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 EXEMESTANE
Always take Exemestane exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how to take Exemestane and for how long.
Adults and the elderly
The usual dose is one 25 mg film-coated tablet daily. Exemestane film-coated 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 and for how long. Children and adolescents
Exemestane is not suitable for use in children and adolescents.
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 film-coated tablets.
If you forget to take Exemestane
Do not take a double dose to make up for a forgotten dose. If you forget to take your film-coated 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 film-coated 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, Exemestane 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.
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LH : 160 mm x 240 mm Rudipharm Limited / UK
Back
Marketing Authorisation Holder:
Rudipharm Limited
Unit 6, Salbrook Road Industrial Estate
Salbrook Road, Redhill, Surrey, RH1 5GJ, United Kingdom
Manufacturer:
Rudipharm Limited
Oak House, Reeds Crescent,
Watford, WD24 4QP, UK
To listen to or request a copy of this leaflet in Braille, large print or audio please call, 01293 827819 (UK only)
Please be ready to give the following information:
Product name
Exemestane 25mg tablets
Reference number
PL 49565/0147
This leaflet was last revised in November 2025.
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 side effects, (ocurring in more than 1 in 10 people):
- Difficulty sleeping
- Headache
- Hot flushes
- dizziness
- Feeling sick
- Increased sweating
Muscle and joint pain (including osteoarthritis, back
pain, arthritis and joint stiffness)
- Tiredness
- Depression
- Abdominal Pain
- A reduction in the number of white blood cells • 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 side effects, (occuring in more than 1 in 100 but less than 1 in 10 people):
- Loss of appetite
carpal tunnel syndrome (a combinations 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 • Skin rash hives and itchiness
- hair loss
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 side effects, (occurring in more than 1 in 1000 but less than 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 (blood cells which cause clotting) circulating in your blood may occur, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood).
If any side effects gets serious or if you notice any side effect not listed on this leaflet, please tell your doctor or your pharmacist as soon as possible.
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. By reporting side-effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE EXEMESTANE
Keep out of the reach and sight of children.
Do not use Exemestane after the expiry date which is stated on the carton after <EXP>.
The expiry date refers to the last day of that month. This medicine does not 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.
6. FURTHER INFORMATION
What Exemestane contains
The active substance is exemestane. Each film coated tablet contains 25 mg exemestane.
The other ingredients are:
Tablet core:
Mannitol, Copovidone, Crospovidone, Microcrystalline Cellulose, Silica, colloidal anhydrous Sodium Starch Glycolate (Type A), Magnesium Stearate
Film coating:
Hypromellose, Macrogol 400,Titanium Dioxide.
What Exemestane looks like and contents of the pack
White to off-white, round compound cup tablet, with “25” on one side and plain on the reverse.
Exemestane is available in blister packs of:
15, 20, 30, 90, 100, 120 and 200 (Blisters of 10 & 15) film-coated tablets.
Not all pack sizes may be marketed.
Exemestane 25 mg Tablets
Headings: 11pt (Bold)
Sub-Heading: 9pt (Bold)
Normal Text: 9pt (Regular)
Exemestane 25mg tablets - PIL