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EXEMESTANE 25MG FILM COATED TABLETS

Active substance(s): EXEMESTANE / EXEMESTANE

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TEVA UK Ref:

231-30-80005-G LEA EXEMESTANE 25mg TAB TUK
Dimensions Changed:
No
Length:
323 mm
Width:
200 mm
Depth:
Foil Width:
N/A

Version:

1

25 May 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

PAGE 1: FRONT FACE (INSIDE OF REEL)

Package leaflet: Information for the patient

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 illnessare 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

Pharma code 241 (1110010)
First bar is 105mm from the top edge of the leaflet.

1. What Exemestane 25mg Film-Coated Tablets
are and what they are used for
2. What you need know before you take
Exemestane 25mg Film-Coated Tablets
3. How to take Exemestane 25mg Film-Coated
Tablets
4. Possible side effects
5. How to store Exemestane 25mg Film-Coated
Tablets
6. Contents of the pack and other information

1

What Exemestane 25mg Film-Coated
Tablets are and what they are used for

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 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 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 Tablet 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 25mg Film-Coated
Tablets

Do not take Exemestane 25mg Film-Coated
Tablets
if you are or have previously been allergic to
exemestane (the active ingredient in
Exemestane 25mg Film-Coated 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 if
you are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Exemestane 25mg 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.
• 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 25mg Film-Coated

REG0050596

Version 2.4

Approved

Tablets, 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
25mg Film-Coated Tablets. 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.
Children and adolescents
• Exemestane 25mg Film-Coated Tablet is not
suitable for use in children and adolescents.
Other medicines and Exemestane 25mg
Film-Coated Tablets
Tell your doctor if you are taking, have recently
taken or might take any other medicines,
including medicines obtained without a
prescription.
Exemestane 25mg Film-Coated Tablets should
not be given at the same time as hormone
replacement therapy (HRT). The following
medicines should be used cautiously when
taking Exemestane 25mg Film-Coated Tablets .
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 John’s Wort (Hypericum
perforatum), or preparations containing it.
Exemestane 25mg Film-Coated Tablets with
food
Exemestane 25mg Film-Coated Tablets should
be taken once daily, preferably after a meal.
Pregnancy and breast-feeding
Do not take Exemestane 25mg Film-Coated
Tablets 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.
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.

3

How to take Exemestane 25mg
Film-Coated Tablets

Adults and the elderly
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Exemestane 25mg Film-Coated Tablets should
be taken by mouth once daily, preferably after a
meal.
Your doctor will tell you how to take
Exemestane 25mg Film-Coated 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 25mg Film-Coated Tablets, let the
medical staff know what medication you are
taking.
Use in children and adolescents
Exemestane 25mg Film-Coated Tablets are not
suitable for use in children and adolescents.
If you take more Exemestane 25mg 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 25mg
Film-Coated Tablets.

Page 1 of 4

Top of page cut-off to middle of registration mark: 44 mm.

Exemestane
25 mg Film-Coated Tablets

TEVA UK Ref:

231-30-80005-G LEA EXEMESTANE 25mg TAB TUK
Dimensions Changed:
No
Length:
323 mm
Width:
200 mm
Depth:
Foil Width:
N/A

Version:

1

25 May 2016

Colours Used:

BLACK
PANTONE® GREEN C
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you forget to take Exemestane 25mg
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 25mg
Film-Coated Tablets
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 25mg Film-Coated Tablets
are well tolerated and the following side effects
observed in patients treated with Exemestane
25mg 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).
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.
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 hemoglobin breakdown in
the blood
• Elevated level of a blood enzyme in the blood
due to liver damage
• Pain
Common: may affect upto 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
• Stomach ache, 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
• Pain, swollen hands and feet
• A reduction in the number of platelets in the
blood
• Muscle 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 (blood cells which
cause clotting) circulating in your blood,
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 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 25mg
Film-Coated Tablets

• Keep this medicine out of the sight and reach
of children.
• Do not use this medicine after the expiry date
which is stated on the carton and the blister
after .
• The expiry date refers to the last day of that
month.
• This medicine does not require any special
storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away of medicines
you no longer use. These measures will help
protect the environment.

6

Contents of the pack and other
information

What Exemestane 25mg Film-Coated Tablets
contain
The active substance is exemestane. Each
film-coated tablet contains 25 mg exemestane.
The other ingredients are:
Tablet core:
Mannitol, Copovidone, Crospovidone, Silicified
microcrystalline cellulose (containing
Microcrystalline cellulose & Silica, colloidal
anhydrous, Sodium starch glycolate (Type A),
Magnesium stearate
Film coating:
Hypromellose, Macrogol 400,Titanium Dioxide.
What Exemestane 25mg Film-Coated Tablets
looks like and contents of the pack
Exemestane 25mg Film-Coated Tablet is a white
to off-white, round compound cup tablet of
6 mm diameter, debossed with “25” on one side
and plain on the reverse.
Exemestane 25mg Film-Coated Tablets are
available in blister packs of:
10, 14, 20, 30, 50x1, 60, 90, 100 (Blisters of 10 or
14 or 30) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorsiation Holder is
TEVA UK Limited
Brampton Road,
Hampden Park,
Eastbourne,
East Sussex BN22 9AG
United Kingdom
EirGen Pharma Ltd. 64/65 Westside Business
Park, Old Kilmeaden Road, Waterford, Ireland.
This leaflet was last revised in May 2016
PL 00289/1498

80005-G
323 x 200

REG0050596

Version 2.4

Approved

Page 2 of 4

TEVA UK Ref:

231-30-90013-G LEA EXEMESTANE 25mg TAB TUK (PHAR) Dimensions Changed:
No
Length:
300 mm
Width:
180 mm
Depth:
Foil Width:
N/A

Package leaflet: Information for the patient

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 illnessare 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 25mg Film-Coated Tablets are
and what they are used for
2. What you need know before you take Exemestane
25mg Film-Coated Tablets
3. How to take Exemestane 25mg Film-Coated Tablets
4. Possible side effects
5. How to store Exemestane 25mg Film-Coated
Tablets
6. Contents of the pack and other information

What Exemestane 25mg Film-Coated
Tablets are and what they are used for

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 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 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 Tablet 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 25mg Film-Coated Tablets

Do not take Exemestane 25mg Film-Coated Tablets
if you are or have previously been allergic to
exemestane (the active ingredient in Exemestane
25mg Film-Coated 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 if you
are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Exemestane 25mg 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.
• 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 25mg Film-Coated
Tablets, tell your doctor if you have problems with
your liver or kidneys.
• Tell your doctor if you have a history or are

REG0051127

Version 1.4

1

Colours Used:

Exemestane 25 mg
Film-Coated Tablets

1

Version:

Approved

25 May 2016

BLACK
PANTONE® GREEN C
Template

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 25mg Film-Coated
Tablets. 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.
Children and adolescents
• Exemestane 25mg Film-Coated Tablet is not
suitable for use in children and adolescents.
Other medicines and Exemestane 25mg Film-Coated
Tablets
Tell your doctor if you are taking, have recently taken
or might take any other medicines, including
medicines obtained without a prescription.
Exemestane 25mg Film-Coated Tablets should not be
given at the same time as hormone replacement
therapy (HRT). The following medicines should be
used cautiously when taking Exemestane 25mg
Film-Coated Tablets . 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 John’s Wort (Hypericum
perforatum), or preparations containing it.
Exemestane 25mg Film-Coated Tablets with food
Exemestane 25mg Film-Coated Tablets should be
taken once daily, preferably after a meal.
Pregnancy and breast-feeding
Do not take Exemestane 25mg Film-Coated Tablets 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.
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.

3

How to take Exemestane 25mg
Film-Coated Tablets

Adults and the elderly
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Exemestane 25mg Film-Coated Tablets should be
taken by mouth once daily, preferably after a meal.
Your doctor will tell you how to take Exemestane
25mg Film-Coated 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 25mg Film-Coated Tablets, let the
medical staff know what medication you are taking.
Use in children and adolescents
Exemestane 25mg Film-Coated Tablets are not
suitable for use in children and adolescents.
If you take more Exemestane 25mg 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 25mg Film-Coated Tablets.
If you forget to take Exemestane 25mg 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.

Page 2 of 4

TEVA UK Ref:

231-30-90013-G LEA EXEMESTANE 25mg TAB TUK (PHAR) Dimensions Changed:
No
Length:
300 mm
Width:
180 mm
Depth:
Foil Width:
N/A

BLACK

Template

Possible side effects

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.
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 hemoglobin breakdown in the
blood
• Elevated level of a blood enzyme in the blood due
to liver damage
• Pain
Common: may affect upto 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
• Stomach ache, 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
• Pain, swollen hands and feet
• A reduction in the number of platelets in the
blood
• Muscle 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

Version 1.4

25 May 2016

PANTONE® GREEN C

Like all medicines, this medicine can cause side
effects, although not everybody gets them. In
general, Exemestane 25mg Film-Coated Tablets are
well tolerated and the following side effects
observed in patients treated with Exemestane 25mg
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).

REG0051127

1

Colours Used:

If you stop taking Exemestane 25mg Film-Coated
Tablets
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

Version:

Changes in the amount of certain blood cells
(lymphocytes) and platelets (blood cells which
cause clotting) circulating in your blood, 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 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 25mg
Film-Coated Tablets

• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date
which is stated on the carton and the blister after
.
• The expiry date refers to the last day of that
month.
• This medicine does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to
throw away of medicines you no longer use. These
measures will help protect the environment.

6

Contents of the pack and other
information

What Exemestane 25mg Film-Coated Tablets
contain
The active substance is exemestane. Each
film-coated tablet contains 25 mg exemestane.
The other ingredients are:
Tablet core:
Mannitol, Copovidone, Crospovidone, Silicified
microcrystalline cellulose (containing
Microcrystalline cellulose & Silica, colloidal
anhydrous, Sodium starch glycolate (Type A),
Magnesium stearate
Film coating:
Hypromellose, Macrogol 400,Titanium Dioxide.
What Exemestane 25mg Film-Coated Tablets looks
like and contents of the pack
Exemestane 25mg Film-Coated Tablet is a white to
off-white, round compound cup tablet of 6 mm
diameter, debossed with “25” on one side and plain
on the reverse.
Exemestane 25mg Film-Coated Tablets are available
in blister packs of:
10, 14, 20, 30, 50x1, 60, 90, 100 (Blisters of 10 or 14
or 30) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorsiation Holder is
TEVA UK Limited
Brampton Road,
Hampden Park,
Eastbourne,
East Sussex BN22 9AG
United Kingdom
EirGen Pharma Ltd. 64/65 Westside Business Park,
Old Kilmeaden Road, Waterford, Ireland.
This leaflet was last revised in May 2016
PL 00289/1498

Approved

90013-G
0000000000
000000

Page 3 of 4

Expand view ⇕

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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