What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 42357/0210.

Exemestane 25 mg coated tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Exemestane 25 mg 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 signs of illness 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.

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

Exemestane belongs to a group of medicines known as aromatase inhibitors. Aromatase Inhibitors interfere with a substance called aromatase, which is needed to produce the female sex hormones, called 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
  • 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

Do not take Exemestane

  • if you are allergic (hypersensitive) to exemestane 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, or are likely to be pregnant
  • if you are 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 treatment, your Vitamin D level maybe routinely checked as in the early stages of breast cancer this may be very low. If your levels are lower than normal, you will be given a Vitamin D supplement.

Talk to your doctor or pharmacist before taking Exemestane:

  • 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 (e.g. osteoprosis). Your doctor may want to measure your bone density before and during the treatment with Exemestane. 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. Your doctor may give you medicine to prevent or treat bone loss.

Please tell your doctor if one of these conditions applies to you.

Children and adolescents

Exemestane is not suitable for use in children and adolescents.

Anti-doping test

The active substance exemestane contained in this medication can produce a positive analytic result in an anti-doping test.

Other medicines and Exemestane

Please tell your doctor or pharmacist 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 oestrogen-containing medicines, for example hormone replacement therapy (HRT).

The following medicines should be used cautiously when taking Exemestane:

  • rifampicin (an antibiotic),
  • carbamazepine or phenytoin (medicines used to treat epilepsy),
  • the herbal remedy St Johns Wort (Hypericum perforatum), or preparations containing it.

Exemestane with food and drink

You should take Exemestane tablets after a meal.

Pregnancy, breast-feeding and fertility.

Do not take Exemestane if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should discuss contraception with your doctor if there is any possibility that you may become pregnant.

Driving and using machines

If you feel tired, drowsy, dizzy or weak whilst taking Exemestane, you should not drive or operate machinery.

Exemestane tablets contain sucrose (sugar).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Exemestane 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).

3. How to take Exemestane

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

Adults and the elderly

The reccomended dose is one tablet daily after a meal, at approximately the same time each day.

Use in children and adolescents

Exemestane is not suitable for children and adolescents under the age of 18.

Method of administration

You should take Exemestane tablets by mouth. Do not chew the tablets. You can swallow the tablets with some liquid (e.g. a glass of water, 200ml).

Duration of treatment

Your doctor will tell you how long you should take Exemestane tablets.

If you take more Exemestane than you should

If you have taken too many tablets 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 or pharmacist.

4. Possible side effects

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

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).

Hypersensitivity, inflammation of the liver (hepatitis) and inflammation of the bile ducts of the liver sometimes causing 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. Seek urgent medical advice if you think you have any of these symptoms

Seek advice from your doctor immediately if:

  • you have signs of a decreased number of white blood cells called leucocytes. Symptoms can include frequent infections, fatigue, sleepiness, fever and headache.
  • you have signs of a decreased number of blood cells called platelets. Symptoms can include brusing easily, prolonged bleeding from cuts, bleeding gums, nose bleeds, fatigue and yellowing of the skin and/or whites of the eyes (jaundice).
  • your bones seem weaker and/or have been easily fracturered as this may indicate that your bones have thinned and weakend (osteoporosis). Your doctor may decide that you should stop using Exemestane.

Very common side effects (may affect more than 1 in 10 people)

  • Depression
  • Decreased number of white blood cells
  • Headache
  • Nausea (feeling sick)
  • Abdominal pain
  • Dizziness
  • Increased sweating
  • Muscle and joint pain (including inflammation of bones and joints, back pain, pain in limbs and joint stiffness)
  • Hot flushes
  • Tiredness
  • Difficulty sleeping
  • Pain
  • Elevated levels of liver enzyme
  • Elevated levels of haemoglobin breakdown products in the blood
  • Elevated levels of a blood enzyme (due to liver damage)

Common side effects (may affect up to 1 in 10 people)

  • Carpal tunnel syndrome (a combination of pins and needles, numbness and pain affecting all of the hand except the little finger)
  • Stomach ache, vomiting, constipation, indigestion, diarrhoea
  • Skin rash, itchiness, hives
  • Hair loss
  • Thinning of bones which might decrease their strength (osteoporosis), leading to bone fractures (breaks or cracks)
  • Loss of appetite
  • Muscle weakness
  • Pain, swollen hands and feet
  • A reduction of the number of platelets in the blood

Uncommon side effects (may affect up to 1 in 100 people)

  • Hypersensitivity

Rare side effects (may affect up to 1 in 1,000 people)

  • Break out of small blisters on the skin
  • Inflammation of the liver
  • Yellowing of the skin caused by inflammation of the bile ducts in the liver
  • Drowsiness

Not known (frequency cannot be estimated from the available data)

  • Decrease in the level of certain white blood cells in the blood
  • Changes in the levels of certain white blood cells (lymphocytes) and platelets in the blood - especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood) may also be seen

If you get any side effects, talk to your doctor or pharmacist. 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Exemestane

Store below 30°C in a dry place.

Store in the original container in order to protect from light.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the 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 coated tablet contains 25 mg exemestane.

The other ingredients are microcrystalline cellulose,crospovidone, polysorbate 80, mannitol (E421), colloidal anhydrous silica, magnesium stearate, sucrose, spray-dried acacia, purified talc, titanium dioxide (E171), Opaglos (dehydrated ethanol, Shellac, beeswax white, carnauba wax yellow).

What Exemestane looks like and contents of the pack

Exemestane is a round, biconvex, white to off-white, coated tablet.

Pack sizes: 10, 15, 20, 30, 90, 105, 100, 120

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Amneal Pharma Europe Limited
70 Sir John Rogerson‘s Quay
Dublin 2
Ireland

Manufacturer:

TECNlMEDE- Sociedade Técnico-Medicinal S.A.
Qunta de Cerca
Caixaria
2565-187 Dois Portos
Portugal

This leaflet was last revised in February-2017.

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