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EXEMESTANE 25 MG COATED TABLETS

Active substance(s): EXEMESTANE / EXEMESTANE / EXEMESTANE

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Exemestane 25 mg - UK

Team Leader

Review - 15

Item Code

APPEM11 01

Supersede Code

N/A

Pharma Code: 2415

Printed Colours
Black

Material/File Name APPEM11_01 PIL Exemestane 25 mg Tab (UK-HEL)

Ardhyang U.
Initiator

Substrate / GSM

40 GSM Bible Paper
NON-Printed Colours
Key-Line

Pratik P.
Reason for issue

Market / Pack

New Product Pack

UK

Size & Component 150 x 400 mm, Final folding size: 150 x 40 mm

Prepared By I.O.

Min. Font Size

9 pt (Page 01 of 02)

Initiation Date

23/02/17

Approved By

Checked By
Packaging Development

Country RA

Production

QA

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

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.

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.

400 mm

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 every 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.

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.

150 mm

APPEM11
01

1. What Exemestane is and what it is
used for

Exemestane 25 mg - UK

Team Leader

Review - 15

Item Code

APPEM11 01

Supersede Code

N/A

Pharma Code: 2415

Printed Colours
Black

Material/File Name APPEM11_01 PIL Exemestane 25 mg Tab (UK-HEL)

Ardhyang U.
Initiator

Substrate / GSM

40 GSM Bible Paper
NON-Printed Colours
Key-Line

Pratik P.
Reason for issue

Market / Pack

New Product Pack

UK

Size & Component 150 x 400 mm, Final folding size: 150 x 40 mm

Prepared By I.O.

Min. Font Size

9 pt (Page 02 of 02)

Initiation Date

23/02/17

Approved By

Checked By
Packaging Development

Country RA

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.

Production

QA

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.

Common side effects (may affect up to 1 in 10
people)
• Carpal tunnel syndrome (a combinations 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

What Exemestane looks like and contents of
the pack
Exemestane is a round, biconvex, white to
off-white, coated tablet.
Pack sizes: 10, 15, 30, 90, 105, 100, 20, 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:
TECNIMEDE- Sociedade Técnico-Medicinal S.A.
Qunta de Cerca, Caixaria, 2565-187 Dois Portos
Portugal
This leaflet was last revised in February-2017.

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

150 mm

APPEM11
01

400 mm

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 enzynes
• Elevated level ofs of haemoglobin breakdown
products in the blood
• Elevated levels if a blood enzyme (due to liver
damage)

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).

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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