Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Warnings and precautions
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Reviewed Date: 29-Sep-21
Package leaflet: Information for the patient
Exemestane 25mg 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 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. What is in this leaflet:
Your medicine is called Exemestane 25mg film-coated tablets. Exemestane 25mg film-coated tablets belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with an enzyme 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 25mg film-coated 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. Exemestane 25mg film-coated 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.
• If you are allergic to exemestane or any of 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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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Reviewed Date: 29-Sep-21
Talk to your doctor or pharmacist before taking Exemestane 25 mg film-coated tablets • Before treatment with Exemestane 25mg film-coated tablets, your doctor may want to take blood samples to make sure you have reached the menopause. • if you have problems with your liver or kidneys. • if you have a history of or are suffering from any condition which affects the strength of your bones (e.g. Osteoporosis). Your doctor may want to measure your bone density before and during the treatment of Exemestane 25mg film-coated tablets. This is because drugs of this class lower the levels of female hormones which help in bone growth. This may lead to a loss of the mineral content of bones, which might decrease their strength. • if you know you have low levels of vitamin D (for example you are unable to spend time in natural sunlight). Your doctor may want to check your Vitamin D levels before treatment and, if needed, give you Vitamin D supplements. Other medicines and Exemestane 25 mg film-coated tablets Tell your doctor or pharamcist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Exemestane 25 mg film-coated tablets should not be given at the same time as hormone replacement therapy (HRT) or with any oestrogen-containing medicines (including combined oral contraceptive pills). The following medicines should be used cautiously when taking Exemestane 25 mg film-coated tablets. Let your doctor know if you are taking medicines such as:
• rifampicin (an antibiotic), • (anticonvulsants used to treat epilepsy, (carbamazepine or phenytoin) • herbal remedy St Johns wort (Hypericum perforatum), or preparations containing it. Pregnancy and breast-feeding Do not take Exemestane 25 mg film-coated tablets if you are pregnant, likely to be pregnant or breastfeeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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 25mg film-coated tablets, you should not attempt to drive or operate machinery. Exemestane 25 mg film-coated tablets contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium free".
The following side effects have also been reported
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Reviewed Date: 29-Sep-21
Use in children and adolescents Exemestane 25mg film-coated tablets are not suitable for use in children and adolescents below 18 years. If you take more Exemestane 25 mg film-coated tablets 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 25 mg film-coated tablets tablets. If you forget to take Exemestane 25 mg film-coated tablets 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 25 mg film-coated tablets Do not stop treatment without consulting your doctor. If you stop the treatment your symptoms might reappear. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. In general, Exemestane 25 mg film-coated tablets are well tolerated and the following side effects observed in patients treated with Exemestane 25 mg film-coated tablets are mainly mild or moderate in nature. Most of the side effects are associated with a shortage of oestrogen (e.g. hot flushes). If you experience the following, stop taking the tablets and tell your doctor immediately or go to the casualty department of your nearest hospital: Common side effects (may affect up to 1 in 10 people)
• Thinning of bones which might decrease their strength (osteoporosis), leading to bone fractures (breaks or cracks) in some cases • Carpal tunnel syndrome (a combination of pins and needles, numbness and pain affecting all of the hand except the little finger) Uncommon side effects (may affect up to 1 in 100 people):
• Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath , wheezing or trouble breathing (anaphylaxis) Rare side effects (may affect up to 1 in 1,000 people):
• Inflammation of the liver (hepatitis) may occur or blockage in the bile duct which may cause yellowing of the skin or eyes, feeling generally unwell, nausea, itching, right sided abdominal pain and loss of appetite. • Rapid appearance of skin rash, red and swollen areas or patches of the skin studded with small fluid-filled blisters, skin inflammation, flaking or peeling of the skin over the body which may also be associated with fever.
Very common side effects, (may affect more than 1 in 10 people):
• Loss of appetite, weight loss • Being sick (vomiting), constipation, indigestion, diarrhoea • Skin rash, hives and itching, • Hair loss • Swollen hands and feet • Pins and needles • A reduction in the number of platelets in the blood (thrombocytopenia) • Muscle weakness Rare side effects (may affect up to 1 in 1,000 people):
• Drowsiness
Not known side effect (frequency cannot be estimated from the available data): • Low level of certain white blood cells (lymphocytes) in the blood
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Reviewed Date: 29-Sep-21
• Depression • Difficulty sleeping • Headache • Hot flushes • Dizziness • Feeling sick, nausea • Increased sweating • Muscle and joint pain, including swelling, creaking, stiffness and pain of one or more joints) • Tiredness • A reduction in the number of white blood cells (leucopenia) • Stomach pain • Elevated liver enzymes • Elevated level of haemoglobin breakdown in the blood • Elevated level of a certain blood enzyme due to liver damage • Pain Common side effects, (may affect up to 1 in 10 people):
If you have any blood tests done, it may be noticed that there are changes in your liver function (increase in liver enzymes and bilirubin). Changes in the amount of white blood cells (so-called leucocytes and lymphocytes) and platelets circulating in your blood may occur, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood). You may have increased bruising and bleeding than normal or more easily get infections (with symptoms e.g. sore throat, fever, severe chills). In clinical studies the following side effects have been noted but it has not been established if these are related to the medicine itself:
• changes in vagina and womb, vaginal bleeding, • changes in vision, • blockage of blood vessel due to blood clotting, heart attack, increased blood pressure, heart failure, • changes in or increased levels of cholesterol and other fats in the blood. Reporting of side effects
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Reviewed Date: 29-Sep-21
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.
• This medicine does not require any special storage conditions. • Do not use this medicine 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 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.
The other ingredients are: Tablet Core: Silica, colloidal anhydrous, crospovidone, hypromellose 5cP, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80 and sodium starch glycolate (Type A). Film-coating: hypromellose 5cP, macrogol, talc and titanium dioxide (E171).
What Exemestane 25 mg film-coated tablets look like and contents of the pack Exemestane 25 mg film-coated tablets are white, round biconvex film-coated tablets Exemestane 25 mg film-coated tablets are available in blister packs of 14, 15, 20, 30, 60, 90, 100 and 120 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer Remedica Ltd., Limassol Industrial Estate, P.O. Box 51706, CY-3508 Limassol Cyprus McDermott Laboratories t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin13 Ireland Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary This leaflet was last revised in: September 2021
Exemestane 25 mg film-coated tablets comes as tablet containing 25mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Exemestane 25 mg film-coated tablets is exemestane.
Medicines with the same active substance, strength and form include: EXEMESTANE 25 mg Coated tablets, Exemestane 25 mg film-coated tablets, Exemestane 25 mg film-coated tablets. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Exemestane 25 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Exemestane is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2 – 3 years of initial adjuvant tamoxifen therapy.
Exemestane is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy. Efficacy has not been demonstrated in patients with oestrogen receptor negative status.
Posology
Adults and elderly patients
The recommended dose of exemestane is one 25 mg tablet to be taken orally once a day, preferably after a meal.
In patients with early breast cancer, treatment with exemestane should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by exemestane), or earlier if tumour relapse occurs.
In patients with advanced breast cancer, treatment with exemestane should continue until tumour progression is evident.
No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2).
Paediatric population
Not recommended for use in children and adolescents.
Method of administration
For oral use.
Hypersensitivity to the active substance or to any of the excipient listed in section 6.1.Pre-menopausal women and in pregnant or breast-feeding women.
Exemestane should not be administered to women with pre-menopausal endocrine status. Therefore, whenever clinically appropriate, the post-menopausal status should be ascertained by assessment of LH, FSH and oestradiol levels.
Exemestane should be used with caution in patients with hepatic or renal impairment.
Exemestane is a potent oestrogen lowering agent, and a reduction in bone mineral density and an increased fracture rate has been observed following administration (see section 5.1). At the commencement of adjuvant treatment with exemestane, women with osteoporosis or at risk of osteoporosis should have treatment baseline bone mineral health assessment, based on current clinical guidelines and practice. Patients with advanced disease should have their bone mineral density (BMD) assessed on a case-by-case basis. Although adequate data to show the effects of therapy in the treatment of the bone mineral density loss caused by exemestane are not available, patients treated with exemestane should be carefully monitored and treatment for, or prophylaxis of, osteoporosis should be initiated in at risk patients.
Routine assessment of 25 hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be considered, due to the high prevalence of severe deficiency in women with early breast cancer. Women with Vitamin D deficiency should receive supplementation with Vitamin D.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.
In vitro evidence showed that the drug is metabolised through cytochrome P450 (CYP) 3A4 and aldoketoreductases (see section 5.2) and does not inhibit any of the major CYP isoenzymes. In a clinical pharmacokinetic study, the specific inhibition of CYP 3A4 by ketoconazole showed no significant effects on the pharmacokinetics of exemestane.
In an interaction study with rifampicin, a potent CYP450 inducer, at a dose of 600mg daily and a single dose of exemestane 25mg, the AUC of exemestane was reduced by 54% and Cmax by 41%. Since the clinical relevance of this interaction has not been evaluated, the co-administration of drugs, such as rifampicin, anticonvulsants (e.g. phenytoin and carbamazepine) and herbal preparations containing Hypericum perforatum (St John's wort) known to induce CYP3A4 may reduce the efficacy of exemestane.
Exemestane should be used cautiously with drugs that are metabolised via CYP3A4 and have a narrow therapeutic window. There is no clinical experience of the concomitant use of exemestane with other anticancer drugs.
Exemestane should not be coadministered with oestrogen-containing medicines as these would negate its pharmacological action.
Pregnancy
No clinical data on exposed pregnancies are available with exemestane. Studies on animals have shown reproductive toxicity (see section 5.3). Exemestane is therefore contraindicated in pregnant women.
Breast-feeding
It is not known whether exemestane is excreted into human milk. Exemestane should not be administered to women that are breastfeeding.
Women of perimenopausal status or child-bearing potential
The physician needs to discuss the necessity of adequate contraception with women who have the potential to become pregnant including women who are perimenopausal or who have recently become postmenopausal, until their postmenopausal status is fully established (see sections 4.3 and 4.4).
Drowsiness, somnolence, asthenia and dizziness have been reported with the use of the drug. Patients should be advised that, if these events occur, their physical and/or mental abilities required for operating machinery or driving a car may be impaired.
Exemestane was generally well tolerated across all clinical studies conducted with exemestane at a standard dose of 25 mg/day, and undesirable effects were usually mild to moderate.
The withdrawal rate due to adverse events was 7.4% in patients with early breast cancer receiving adjuvant treatment with exemestane following initial adjuvant tamoxifen therapy. The most commonly reported adverse reactions were hot flushes (22%), arthralgia (18%) and fatigue (16%).
The withdrawal rate due to adverse events was 2.8% in the overall patient population with advanced breast cancer. The most commonly reported adverse reactions were hot flushes (14%) and nausea (12%).
Most adverse reactions can be attributed to the normal pharmacological consequences of oestrogen deprivation (eg hot flushes).
The reported adverse reactions from clinical studies and post-marketing experience are listed below by system organ class and by frequency.
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Blood and lymphatic system disorders
Very common
Leucopenia (**)
Common
Thrombocytopenia (**)
Not known
Lymphocyte count decreased (**)
Immune system disorders
Uncommon
Hypersensitivity
Metabolism and nutrition disorders:
Common
Anorexia
Psychiatric disorders:
Very common
Depression, insomnia
Nervous system disorders:
Very common
Dizziness, headache
Common
Carpal tunnel syndrome, paraesthesia
Rare
Somnolence
Vascular disorders:
Very common
Hot flushes
Gastrointestinal disorders:
Very common
Abdominal pain, nausea
Common
Vomiting, constipation, dyspepsia, diarrhoea
Hepatobiliary disorders
Very common
Hepatic enzyme increased, blood bilirubin increased, blood alkaline phosphatase increased
Rare
Hepatitis(†), cholestatic hepatitis(†)
Skin and subcutaneous tissue disorders:
Very common
Increased sweating
Common
Rash, alopecia, urticaria, pruritus
Rare
Acute generalised exanthematous pustulosis(†)
Musculoskeletal and connective tissue disorders:
Very common
Joint and musculoskeletal pain (*)
Common
Osteoporosis, fracture
General disorders and administration site conditions:
Very common
Pain, fatigue
Common
Peripheral oedema, asthenia
(*) Includes: arthralgia, and less frequently pain in limb, osteoarthritis, back pain, arthritis, myalgia and joint stiffness.
(**) In patients with advanced breast cancer thrombocytopenia and leucopenia have been reported rarely, leucopenia. An occasional decrease in lymphocytes has been observed in approximately 20% of patients receiving exemestane, particularly in patients with pre-existing lymphopenia; however, mean lymphocyte values in these patients did not change significantly over time and no corresponding increase in viral infections was observed. These effects have not been observed in patients treated in early breast cancer studies.
(†) Frequency calculated by rule of 3/X
The table below presents the frequency of pre-specified adverse events and illnesses in the early breast cancer study Intergroup Exemestane Study (IES), irrespective of causality, reported in patients receiving trial therapy and up to 30 days after cessation of trial therapy.
Adverse events and illnesses
Exemestane
(N = 2249)
Tamoxifen
(N = 2279)
Hot flushes
491 (21.8%)
457 (20.1%)
Fatigue
367 (16.3%)
344 (15.1%)
Headache
305 (13.6%)
255 (11.2%)
Insomnia
290 (12.9%)
204 (9.0%)
Sweating increased
270 (12.0%)
242 (10.6%)
Gynaecological
235 (10.5%)
340 (14.9%)
Dizziness
224 (10.0%)
200 (8.8%)
Nausea
200 (8.9%)
208 (9.1%)
Osteoporosis
116 (5.2%)
66 (2.9%)
Vaginal haemorrhage
90 (4.0%)
121 (5.3%)
Other primary cancer
84 (3.6%)
125 (5.3%)
Vomiting
50 (2.2%)
54 (2.4%)
Visual disturbance
45 (2.0%)
53 (2.3%)
Thromboembolism
16 (0.7%)
42 (1.8%)
Osteoporotic fracture
14 (0.6%)
12 (0.5%)
Myocardial infarction
13 (0.6%)
4 (0.2%)
In the IES study, the frequency of ischemic cardiac events in the exemestane and tamoxifen treatment arms was 4.5% versus 4.2%, respectively. No significant difference was noted for any individual cardiovascular event including hypertension (9.9% versus 8.4%), myocardial infarction (0.6% versus 0.2%) and cardiac failure (1.1% versus 0.7%).
In the IES study, exemestane was associated with a greater incidence of hypercholesterolemia compared with tamoxifen (3.7% vs. 2.1%).
In a separate double blinded, randomized study of postmenopausal women with early breast cancer at low risk treated with exemestane (N=73) or placebo (N=73) for 24 months, exemestane was associated with an average 7-9% mean reduction in plasma HDL-cholesterol, versus a 1% increase on placebo. There was also a 5-6% reduction in apolipoprotein A1 in the exemestane group versus 0-2% for placebo. The effect on the other lipid parameters analysed (total cholesterol, LDL cholesterol, triglycerides, apolipoprotein-B and lipoprotein-a) was very similar in the two treatment groups. The clinical significance of these results is unclear.
In the IES study, gastric ulcer was observed at a higher frequency in the exemestane arm compared to tamoxifen (0.7% versus <0.1%). The majority of patients on exemestane with gastric ulcer received concomitant treatment with non-steroidal anti-inflammatory agents and/or had a prior history.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Clinical trials have been conducted with exemestane given up to 800 mg in a single dose to healthy female volunteers and up to 600 mg daily to postmenopausal women with advanced breast cancer; these dosages were well tolerated. The single dose of exemestane that could result in life-threatening symptoms is not known. In rats and dogs, lethality was observed after single oral doses equivalent respectively to 2000 and 4000 times the recommended human dose on a mg/m2 basis. There is no specific antidote to overdosage and treatment must be symptomatic. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
Ask anything about Exemestane 25 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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