EXEMESTANE 25MG FILM COATED TABLETS

Active substance: EXEMESTANE

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EXEMESTANE
25 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you
start taking this medicine.
• 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:

1. What Exemestane 25 mg Film-Coated
Tablets are and what they are used for
2.Before you take Exemestane 25 mg
Film-Coated Tablets
3.How to take Exemestane 25 mg
Film-Coated Tablets
4.Possible side effects
5.How to store Exemestane 25 mg
Film-Coated Tablets
6.Further information

1

WHAT EXEMESTANE 25 mg
FILM-COATED TABLETS ARE AND
WHAT THEY ARE USED FOR

Your medicine is called Exemestane 25 mg
Film-Coated Tablets.
Exemestane 25 mg Film-Coated Tablets
belong 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 25 mg 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.
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
25 mg FILM-COATED TABLETS

Do not take Exemestane 25 mg Film-Coated
Tablets
if you are or have previously been allergic
(hypersensitive) to exemestane (the active
ingredient in Exemestane 25 mg Film-Coated
Tablets or any of the other ingredients of
Exemestane 25 mg Film-Coated Tablets
(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
if you are breast-feeding.

Take special care with Exemestane 25 mg
Film-Coated Tablets
• Before treatment with Exemestane 25 mg
Film-Coated Tablets, your doctor may want
to take blood samples to make sure you
have reached the menopause.
• Before taking Exemestane 25 mg
Film-Coated Tablets, 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 medicine 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 25 mg 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 25 mg
Film-Coated Tablets. 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 25 mg Film-Coated
Tablets 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 25 mg Film-Coated Tablets, you
should not attempt to drive or operate
machinery.

3

HOW TO TAKE EXEMESTANE 25 mg
FILM-COATED TABLETS

Always take Exemestane 25 mg Film-Coated
Tablets 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 25 mg
Film-Coated Tablets and for how long.
Adults and the elderly
The usual dose is one 25 mg film-coated
tablet daily.
Exemestane 25 mg Film-Coated Tablets
should be taken by mouth after a meal at
approximately the same time each day.
Children and adolescents
Exemestane 25 mg Film-Coated Tablets are not
suitable for use in children and adolescents.

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.
If you forget to take Exemestane 25 mg
Film-Coated Tablets
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 25 mg
Film-Coated Tablets
Do not stop taking your film-coated tablets
even if you are feeling well, unless your
doctor tells you.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Exemestane 25 mg
Film-Coated Tablets 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).
Very common side effects, (occurring in more
than 1 in 10 people):
• Difficulty sleeping
• Headache
• Hot flushes
• Feeling sick
• Increased sweating
• Muscle and joint pain (including
osteoarthritis, back pain, arthritis and joint
stiffness)
• Tiredness.
Common side effects, (occuring in more than
1 in 100 but less than 1 in 10 people):
• Loss of appetite
• Depression
• Dizziness, carpal tunnel syndrome (a
combination of pins and needles,
numbness and pain affecting all of the hand
except the little finger)
• Stomach ache, vomiting (being sick),
constipation, indigestion, diarrhoea
• Skin rash, hair loss
• Thinning of bones which might decrease
their strength (osteoporosis), leading to
bone fractures (breaks or cracks) in some
cases
• Pain, swollen hands and feet.
Uncommon side effects, (occurring in more
than 1 in 1000 but less than 1 in 100 people):
• Drowsiness
• Muscle weakness.
Inflammation of the liver (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 if you think you have any of these
symptoms.

If you have any blood tests done, it may be
noticed that there are changes in your liver
function. 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.

5

HOW TO STORE EXEMESTANE 25 mg
FILM-COATED TABLETS

Keep out of the reach and sight of children.
Do not use Exemestane 25 mg Film-Coated
Tablets after the expiry date which is stated
on the carton after .
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 25 mg 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, Sodium
Starch Glycolate (Type A), Magnesium
Stearate.
Film coating:
Hypromellose, Macrogol 400,Titanium
Dioxide.
What Exemestane 25 mg Film-Coated Tablets
look like and contents of the pack
White to off-white, round compound cup
tablet, debossed with “25” on one side and
plain on the reverse.
Exemestane 25 mg Film-Coated Tablets are
available in blister packs of:
10, 14, 20, 30, 50x1, 60, 90, 100 (Blisters of 10
or 14) 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.
Manufacturer is Siegfried Generics (Malta) Ltd
HHF070 Hal Far Industrial Estate, Hal Far
BBG3000 Malta.
This leaflet was last revised in March 2010.
PL 00289/1498
90013-A

0000000000
000000

EXEMESTANE
25 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you
start taking this medicine.
• 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:

1. What Exemestane 25 mg Film-Coated
Tablets are and what they are used for
2.Before you take Exemestane 25 mg
Film-Coated Tablets
3.How to take Exemestane 25 mg
Film-Coated Tablets
4.Possible side effects
5.How to store Exemestane 25 mg
Film-Coated Tablets
6.Further information

1

WHAT EXEMESTANE 25 mg
FILM-COATED TABLETS ARE AND
WHAT THEY ARE USED FOR

Your medicine is called Exemestane 25 mg
Film-Coated Tablets.
Exemestane 25 mg Film-Coated Tablets
belong 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 25 mg 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.
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
25 mg FILM-COATED TABLETS

Do not take Exemestane 25 mg Film-Coated
Tablets
if you are or have previously been allergic
(hypersensitive) to exemestane (the active
ingredient in Exemestane 25 mg Film-Coated
Tablets or any of the other ingredients of
Exemestane 25 mg Film-Coated Tablets
(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
if you are breast-feeding.

Take special care with Exemestane 25 mg
Film-Coated Tablets
• Before treatment with Exemestane 25 mg
Film-Coated Tablets, your doctor may want
to take blood samples to make sure you
have reached the menopause.
• Before taking Exemestane 25 mg
Film-Coated Tablets, 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 medicine 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 25 mg 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 25 mg
Film-Coated Tablets. 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 25 mg Film-Coated
Tablets 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 25 mg Film-Coated Tablets, you
should not attempt to drive or operate
machinery.

3

HOW TO TAKE EXEMESTANE 25 mg
FILM-COATED TABLETS

Always take Exemestane 25 mg Film-Coated
Tablets 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 25 mg
Film-Coated Tablets and for how long.
Adults and the elderly
The usual dose is one 25 mg film-coated
tablet daily.
Exemestane 25 mg Film-Coated Tablets
should be taken by mouth after a meal at
approximately the same time each day.
Children and adolescents
Exemestane 25 mg Film-Coated Tablets are not
suitable for use in children and adolescents.

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.
If you forget to take Exemestane 25 mg
Film-Coated Tablets
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 25 mg
Film-Coated Tablets
Do not stop taking your film-coated tablets
even if you are feeling well, unless your
doctor tells you.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Exemestane 25 mg
Film-Coated Tablets 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).
Very common side effects, (occurring in more
than 1 in 10 people):
• Difficulty sleeping
• Headache
• Hot flushes
• Feeling sick
• Increased sweating
• Muscle and joint pain (including
osteoarthritis, back pain, arthritis and joint
stiffness)
• Tiredness.
Common side effects, (occuring in more than
1 in 100 but less than 1 in 10 people):
• Loss of appetite
• Depression
• Dizziness, carpal tunnel syndrome (a
combination of pins and needles,
numbness and pain affecting all of the hand
except the little finger)
• Stomach ache, vomiting (being sick),
constipation, indigestion, diarrhoea
• Skin rash, hair loss
• Thinning of bones which might decrease
their strength (osteoporosis), leading to
bone fractures (breaks or cracks) in some
cases
• Pain, swollen hands and feet.
Uncommon side effects, (occurring in more
than 1 in 1000 but less than 1 in 100 people):
• Drowsiness
• Muscle weakness.
Inflammation of the liver (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 if you think you have any of these
symptoms.

If you have any blood tests done, it may be
noticed that there are changes in your liver
function. 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.

5

HOW TO STORE EXEMESTANE 25 mg
FILM-COATED TABLETS

Keep out of the reach and sight of children.
Do not use Exemestane 25 mg Film-Coated
Tablets after the expiry date which is stated
on the carton after .
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 25 mg 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, Sodium
Starch Glycolate (Type A), Magnesium
Stearate.
Film coating:
Hypromellose, Macrogol 400,Titanium
Dioxide.
What Exemestane 25 mg Film-Coated Tablets
look like and contents of the pack
White to off-white, round compound cup
tablet, debossed with “25” on one side and
plain on the reverse.
Exemestane 25 mg Film-Coated Tablets are
available in blister packs of:
10, 14, 20, 30, 50x1, 60, 90, 100 (Blisters of 10
or 14) 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.
Manufacturer is EirGen Pharma Ltd. 64/65
Westside Business Park, Old Kilmeaden Road,
Waterford, Ireland.
This leaflet was last revised in August 2011.
PL 00289/1498
90013-B

0000000000
000000

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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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