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FEMARA 2.5MG FILM-COATED TABLETS

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FEMARA® 2.5mg Filmcoated Tablets

1. What Femara is and what it is
used for

(letrozole)

What Femara is and how it works

Package leaflet: Information for
the user

Femara contains an active
substance called letrozole. It
belongs to a group of medicines
called aromatase inhibitors. It is a
hormonal (or “endocrine”) breast
cancer treatment. Growth of breast
cancer is frequently stimulated by
oestrogens which are female sex
hormones. Femara reduces the
amount of oestrogen by blocking an
enzyme (“aromatase”) involved in
the production of oestrogens and
therefore may block the growth of
breast cancer that needs oestrogens
to grow. As a consequence tumour
cells slow or stop growing and/or
spreading to other parts of the body.

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.
What is in this leaflet
1. What Femara is and what it is
used for
2. What you need to know before
you take Femara
3. How to take Femara
4. Possible side effects
5. How to store Femara
6. Contents of the pack and other
information

What Femara is used for
Femara is used to treat breast
cancer in women who have gone
through menopause i.e cessation of
periods.
It is used to prevent cancer from
happening again. It can be used as
first treatment before breast cancer
surgery in case immediate surgery is
not suitable or it can be used as first
treatment after breast cancer
surgery or following five years
treatment with tamixofen. Femara is
also used to prevent breast tumour
spreading to other parts of the body
in patients with advanced breast
cancer.

If you have any questions about how
Femara works or why this medicine
has been prescribed for you, ask
your doctor.
2. What you need to know before
you take Femara
Follow all the doctor’s instructions
carefully. They may differ from the
general information in this leaflet.
Do not take Femara
 if you are allergic to letrozole or to
any of the other ingredients of this
medicine (listed in section 6),
 if you still have periods, i.e. if you
have not yet gone through the
menopause,
 if you are pregnant,
 if you are breast-feeding.
If any of these conditions apply to
you, do not take this medicine and
talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Femara
 if you have a severe kidney
disease,
 if you have a severe liver disease,
 if you have a history of
osteoporosis or bone fractures
(see also “Follow-up during
Femara treatment” in section 3).
If any of these conditions apply to
you, tell your doctor. Your doctor

will take this into account during
your treatment with Femara.
Children and adolescents (below
18 years)
Children and adolescents should not
use this medicine.
Older people (age 65 years and
over)
People aged 65 years and over can
use this medicine at the same dose
as for other adults.

Driving and using machines
If you feel dizzy, tired, drowsy or
generally unwell, do not drive or
operate any tools or machines until
you feel normal again.
Femara contains lactose
Femara contains lactose (milk
sugar). If you have been told by your
doctor that you have an intolerance
to some sugars, contact your doctor
before taking this medicine.
3. How to take Femara

Other medicines and Femara
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines,
including medicines obtained without
a prescription.
Pregnancy, breast-feeding and
fertility
 You should only take Femara
when you have gone through the
menopause. However, your doctor
should discuss with you the use of
effective contraception, as you
may still have the potential to
become pregnant during treatment
with Femara.
 You must not take Femara if you
are pregnant or breast feeding as
it may harm your baby.

Always take this medicine exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.
The usual dose is one tablet of
Femara to be taken once a day.
Taking Femara at the same time
each day will help you remember
when to take your tablet.
The tablet can be taken with or
without food and should be
swallowed whole with a glass of
water or another liquid.
How long to take Femara
Continue taking Femara every day
for as long as your doctor tells you.
You may need to take it for months
or even years. If you have any
questions about how long to keep
taking Femara, talk to your doctor.

Follow-up during Femara
treatment
You should only take this medicine
under strict medical supervision.
Your doctor will regularly monitor
your condition to check whether the
treatment is having the right effect.
Femara may cause thinning or
wasting of your bones
(osteoporosis) due to the reduction
of oestrogens in your body. Your
doctor may decide to measure your
bone density (a way of monitoring
for osteoporosis) before, during and
after treatment.
If you take more Femara than you
should
If you have taken too much Femara,
or if someone else accidentally
takes your tablets, contact a doctor
or hospital for advice immediately.
Show them the pack of tablets.
Medical treatment may be
necessary.
If you forget to take Femara
 If it is almost time for your next
dose (e.g. within 2 or 3 hours), skip
the dose you missed and take your
next dose when you are meant to.
 Otherwise, take the dose as soon
as your remember, and then take
the next tablet as you would
normally.
 Do not take a double dose to make
up for the one that you missed.

If you stop taking Femara
Do not stop taking Femara unless
your doctor tells you to. See also the
section above “How long to take
Femara”.
4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
Most of the side effects are mild to
moderate and will generally
disappear after a few days to a few
weeks of treatment.
Some of these side effects, such as
hot flushes, hair loss or vaginal
bleeding, may be due to the lack of
oestrogens in your body.
Do not be alarmed by this list of
possible side effects. You may not
experience any of them.
Some side effects could be
serious:
Rare or uncommon side effects
(i.e. they may affect between 1 to
100 in every 10,000 patients):
 Weakness, paralysis or loss of
feeling in any part of the body
(particularly arm or leg), loss of
coordination, nausea, or difficulty
speaking or breathing (sign of a
brain disorder, e.g. stroke).
 Sudden oppressive chest pain
(sign of a heart disorder).

 Difficulty breathing, chest pain,
fainting, rapid heart rate, bluish
skin discoloration, or sudden arm,
leg or foot pain (signs that a blood
clot may have formed).
 Swelling and redness along a vein
which is extremely tender and
possibly painful when touched.
 Severe fever, chills or mouth
ulcers due to infections (lack of
white blood cells).
 Severe persistent blurred vision.
If any of the above occurs, tell
your doctor straight away.
You should also inform the doctor
straight away if you experience any
of the following symptoms during
treatment with Femara:
 Swelling mainly of the face and
throat (signs of allergic reaction).
 Yellow skin and eyes, nausea, loss
of appetite, dark-coloured urine
(signs of hepatitis).
 Rash, red skin, blistering of the
lips, eyes or mouth, skin peeling,
fever (signs of skin disorder).
Some side effects are very
common. These side effects may
affect more than 10 in every 100
patients.
 Hot flushes
 Increased level of cholesterol
(hypercholesterolaemia)
 Fatigue
 Increased sweating
 Pain in bones and joints
(arthralgia)

If any of these affects you severely,
tell your doctor.
Some side effects are common.
These side effects may affect
between 1 to 10 in every 100
patients.
 Skin rash
 Headache
 Dizziness
 Malaise (generally feeling unwell)
 Gastrointestinal disorders such as
nausea, vomiting, indigestion,
constipation, diarrhoea
 Increase in or loss of appetite
 Pain in muscles
 Thinning or wasting of your bones
(osteoporosis), leading to bone
fractures in some cases (see also
“Follow-up during Femara
treatment” in section 3)
 Swelling of arms, hands, feet,
ankles (oedema)
 Depression
 Weight increase
 Hair loss
 Raised blood pressure
(hypertension)
 Abdominal pain
 Dry skin
 Vaginal bleeding
If any of these affects you severely,
tell your doctor.
Other side effects are uncommon.
These side effects may affect
between 1 to 10 in every 1,000
patients.

 Nervous disorders such as anxiety,
nervousness, irritability,
drowsiness, memory problems,
somnolence, insomnia
 Impairment of sensation,
especially that of touch
 Eye disorders such as blurred
vision, eye irritation
 Palpitations, rapid heart rate
 Skin disorders such as itching
(urticaria)
 Vaginal discharge or dryness
 Joint stiffness (arthritis)
 Breast pain
 Fever
 Thirst, taste disorder, dry mouth
 Dryness of mucous membranes
 Weight decrease
 Urinary tract infection, increased
frequency of urination
 Cough
 Increased level of enzymes
If any of these affects you severely,
tell your doctor.
If you get any side effects, talk to
your doctor or pharmacist. This
includes any side effects not listed in
this leaflet.
5. How to store Femara
Do not store above 30ºC. Store in
the original package in order to
protect from moisture.
Keep all medicines out of the sight
and reach of children.

Do not take the tablets after their
expiry date which is printed on the
outside of the pack.
If your doctor tells you to stop taking
Femara Tablets, please take any
unused tablets back to your
pharmacist to be destroyed. Only
keep the tablets if the doctor tells
you to. Do not throw them away with
your normal household water or
waste. This will help to protect the
environment.

Product Licence Holder and
Manufacturer
This product is procured from within
the EU by the Product Licence
Holder: IMED Healthcare Ltd, New
Road, Buncrana, Co. Donegal,
Ireland.

6. Contents of the pack and other
information

Repackager
IMED Pharma Ltd, Unit 625
Kilshane Avenue, Northwest
Business Park, Ballycoolin, Dublin
15, Ireland.

What Femara contains
 The active substance is letrozole.
Each film-coated tablet contains
2.5 mg letrozole.
 The other ingredients are lactose
monohydrate, cellulose
microcrystalline, maize starch,
sodium starch glycolate,
magnesium stearate and silica
colloidal anhydrous. The coating
is composed of hypromellose,
talc, macrogol 8000, titanium
dioxide (E171) and iron oxide
yellow (E172).
What Femara looks like and
contents of the pack
Femara Tablets are round, dark
yellow tablets marked FV on one
side and CG on the other.
They come in blister packs of 30.

Manufacturer
Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West
Sussex RH12 5AB, United Kingdom.

This leaflet was last revised in
27/06/2013
PL: 40854/0015

POM

FEMARA is a registered trademark.
Copyright Novartis Pharmaceuticals
UK Limited.

FEMARA® 2.5mg Filmcoated Tablets

1. What Femara is and what it is
used for

(letrozole)

What Femara is and how it works

Package leaflet: Information for
the user

Femara contains an active
substance called letrozole. It
belongs to a group of medicines
called aromatase inhibitors. It is a
hormonal (or “endocrine”) breast
cancer treatment. Growth of breast
cancer is frequently stimulated by
oestrogens which are female sex
hormones. Femara reduces the
amount of oestrogen by blocking an
enzyme (“aromatase”) involved in
the production of oestrogens and
therefore may block the growth of
breast cancer that needs oestrogens
to grow. As a consequence tumour
cells slow or stop growing and/or
spreading to other parts of the body.

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.
What is in this leaflet
1. What Femara is and what it is
used for
2. What you need to know before
you take Femara
3. How to take Femara
4. Possible side effects
5. How to store Femara
6. Contents of the pack and other
information

What Femara is used for
Femara is used to treat breast
cancer in women who have gone
through menopause i.e cessation of
periods.
It is used to prevent cancer from
happening again. It can be used as
first treatment before breast cancer
surgery in case immediate surgery is
not suitable or it can be used as first
treatment after breast cancer
surgery or following five years
treatment with tamixofen. Femara is
also used to prevent breast tumour
spreading to other parts of the body
in patients with advanced breast
cancer.

If you have any questions about how
Femara works or why this medicine
has been prescribed for you, ask
your doctor.
2. What you need to know before
you take Femara
Follow all the doctor’s instructions
carefully. They may differ from the
general information in this leaflet.
Do not take Femara
 if you are allergic to letrozole or to
any of the other ingredients of this
medicine (listed in section 6),
 if you still have periods, i.e. if you
have not yet gone through the
menopause,
 if you are pregnant,
 if you are breast-feeding.
If any of these conditions apply to
you, do not take this medicine and
talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Femara
 if you have a severe kidney
disease,
 if you have a severe liver disease,
 if you have a history of
osteoporosis or bone fractures
(see also “Follow-up during
Femara treatment” in section 3).
If any of these conditions apply to
you, tell your doctor. Your doctor

will take this into account during
your treatment with Femara.
Children and adolescents (below
18 years)
Children and adolescents should not
use this medicine.
Older people (age 65 years and
over)
People aged 65 years and over can
use this medicine at the same dose
as for other adults.

Driving and using machines
If you feel dizzy, tired, drowsy or
generally unwell, do not drive or
operate any tools or machines until
you feel normal again.
Femara contains lactose
Femara contains lactose (milk
sugar). If you have been told by your
doctor that you have an intolerance
to some sugars, contact your doctor
before taking this medicine.
3. How to take Femara

Other medicines and Femara
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines,
including medicines obtained without
a prescription.
Pregnancy, breast-feeding and
fertility
 You should only take Femara
when you have gone through the
menopause. However, your doctor
should discuss with you the use of
effective contraception, as you
may still have the potential to
become pregnant during treatment
with Femara.
 You must not take Femara if you
are pregnant or breast feeding as
it may harm your baby.

Always take this medicine exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.
The usual dose is one tablet of
Femara to be taken once a day.
Taking Femara at the same time
each day will help you remember
when to take your tablet.
The tablet can be taken with or
without food and should be
swallowed whole with a glass of
water or another liquid.
How long to take Femara
Continue taking Femara every day
for as long as your doctor tells you.
You may need to take it for months
or even years. If you have any
questions about how long to keep
taking Femara, talk to your doctor.

Follow-up during Femara
treatment
You should only take this medicine
under strict medical supervision.
Your doctor will regularly monitor
your condition to check whether the
treatment is having the right effect.
Femara may cause thinning or
wasting of your bones
(osteoporosis) due to the reduction
of oestrogens in your body. Your
doctor may decide to measure your
bone density (a way of monitoring
for osteoporosis) before, during and
after treatment.
If you take more Femara than you
should
If you have taken too much Femara,
or if someone else accidentally
takes your tablets, contact a doctor
or hospital for advice immediately.
Show them the pack of tablets.
Medical treatment may be
necessary.
If you forget to take Femara
 If it is almost time for your next
dose (e.g. within 2 or 3 hours), skip
the dose you missed and take your
next dose when you are meant to.
 Otherwise, take the dose as soon
as your remember, and then take
the next tablet as you would
normally.
 Do not take a double dose to make
up for the one that you missed.

If you stop taking Femara
Do not stop taking Femara unless
your doctor tells you to. See also the
section above “How long to take
Femara”.
4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
Most of the side effects are mild to
moderate and will generally
disappear after a few days to a few
weeks of treatment.
Some of these side effects, such as
hot flushes, hair loss or vaginal
bleeding, may be due to the lack of
oestrogens in your body.
Do not be alarmed by this list of
possible side effects. You may not
experience any of them.
Some side effects could be
serious:
Rare or uncommon side effects
(i.e. they may affect between 1 to
100 in every 10,000 patients):
 Weakness, paralysis or loss of
feeling in any part of the body
(particularly arm or leg), loss of
coordination, nausea, or difficulty
speaking or breathing (sign of a
brain disorder, e.g. stroke).
 Sudden oppressive chest pain
(sign of a heart disorder).

 Difficulty breathing, chest pain,
fainting, rapid heart rate, bluish
skin discoloration, or sudden arm,
leg or foot pain (signs that a blood
clot may have formed).
 Swelling and redness along a vein
which is extremely tender and
possibly painful when touched.
 Severe fever, chills or mouth
ulcers due to infections (lack of
white blood cells).
 Severe persistent blurred vision.
If any of the above occurs, tell
your doctor straight away.
You should also inform the doctor
straight away if you experience any
of the following symptoms during
treatment with Femara:
 Swelling mainly of the face and
throat (signs of allergic reaction).
 Yellow skin and eyes, nausea, loss
of appetite, dark-coloured urine
(signs of hepatitis).
 Rash, red skin, blistering of the
lips, eyes or mouth, skin peeling,
fever (signs of skin disorder).
Some side effects are very
common. These side effects may
affect more than 10 in every 100
patients.
 Hot flushes
 Increased level of cholesterol
(hypercholesterolaemia)
 Fatigue
 Increased sweating
 Pain in bones and joints
(arthralgia)

If any of these affects you severely,
tell your doctor.
Some side effects are common.
These side effects may affect
between 1 to 10 in every 100
patients.
 Skin rash
 Headache
 Dizziness
 Malaise (generally feeling unwell)
 Gastrointestinal disorders such as
nausea, vomiting, indigestion,
constipation, diarrhoea
 Increase in or loss of appetite
 Pain in muscles
 Thinning or wasting of your bones
(osteoporosis), leading to bone
fractures in some cases (see also
“Follow-up during Femara
treatment” in section 3)
 Swelling of arms, hands, feet,
ankles (oedema)
 Depression
 Weight increase
 Hair loss
 Raised blood pressure
(hypertension)
 Abdominal pain
 Dry skin
 Vaginal bleeding
If any of these affects you severely,
tell your doctor.
Other side effects are uncommon.
These side effects may affect
between 1 to 10 in every 1,000
patients.

 Nervous disorders such as anxiety,
nervousness, irritability,
drowsiness, memory problems,
somnolence, insomnia
 Impairment of sensation,
especially that of touch
 Eye disorders such as blurred
vision, eye irritation
 Palpitations, rapid heart rate
 Skin disorders such as itching
(urticaria)
 Vaginal discharge or dryness
 Joint stiffness (arthritis)
 Breast pain
 Fever
 Thirst, taste disorder, dry mouth
 Dryness of mucous membranes
 Weight decrease
 Urinary tract infection, increased
frequency of urination
 Cough
 Increased level of enzymes
If any of these affects you severely,
tell your doctor.
If you get any side effects, talk to
your doctor or pharmacist. This
includes any side effects not listed in
this leaflet.
5. How to store Femara
Do not store above 30ºC. Store in
the original package in order to
protect from moisture.
Keep all medicines out of the sight
and reach of children.

Do not take the tablets after their
expiry date which is printed on the
outside of the pack.
If your doctor tells you to stop taking
Femara Tablets, please take any
unused tablets back to your
pharmacist to be destroyed. Only
keep the tablets if the doctor tells
you to. Do not throw them away with
your normal household water or
waste. This will help to protect the
environment.

Product Licence Holder and
Manufacturer
This product is procured from within
the EU by the Product Licence
Holder: IMED Healthcare Ltd, New
Road, Buncrana, Co. Donegal,
Ireland.

6. Contents of the pack and other
information

Repackager
Cross Healthcare Ltd, Unit 2A
Bandeath Industrial Estate, Throsk,
Stirlingshire, FK7 7NP, UK

What Femara contains
 The active substance is letrozole.
Each film-coated tablet contains
2.5 mg letrozole.
 The other ingredients are lactose
monohydrate, cellulose
microcrystalline, maize starch,
sodium starch glycolate,
magnesium stearate and silica
colloidal anhydrous. The coating
is composed of hypromellose,
talc, macrogol 8000, titanium
dioxide (E171) and iron oxide
yellow (E172).
What Femara looks like and
contents of the pack
Femara Tablets are round, dark
yellow tablets marked FV on one
side and CG on the other.
They come in blister packs of 30.

Manufacturer
Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West
Sussex RH12 5AB, United Kingdom.

This leaflet was last revised in
27/06/2013
PL: 40854/0015

POM

FEMARA is a registered trademark.
Copyright Novartis Pharmaceuticals
UK Limited.

FEMARA® 2.5mg Filmcoated Tablets

1. What Femara is and what it is
used for

(letrozole)

What Femara is and how it works

Package leaflet: Information for
the user

Femara contains an active
substance called letrozole. It
belongs to a group of medicines
called aromatase inhibitors. It is a
hormonal (or “endocrine”) breast
cancer treatment. Growth of breast
cancer is frequently stimulated by
oestrogens which are female sex
hormones. Femara reduces the
amount of oestrogen by blocking an
enzyme (“aromatase”) involved in
the production of oestrogens and
therefore may block the growth of
breast cancer that needs oestrogens
to grow. As a consequence tumour
cells slow or stop growing and/or
spreading to other parts of the body.

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.
What is in this leaflet
1. What Femara is and what it is
used for
2. What you need to know before
you take Femara
3. How to take Femara
4. Possible side effects
5. How to store Femara
6. Contents of the pack and other
information

What Femara is used for
Femara is used to treat breast
cancer in women who have gone
through menopause i.e cessation of
periods.
It is used to prevent cancer from
happening again. It can be used as
first treatment before breast cancer
surgery in case immediate surgery is
not suitable or it can be used as first
treatment after breast cancer
surgery or following five years
treatment with tamixofen. Femara is
also used to prevent breast tumour
spreading to other parts of the body
in patients with advanced breast
cancer.

If you have any questions about how
Femara works or why this medicine
has been prescribed for you, ask
your doctor.
2. What you need to know before
you take Femara
Follow all the doctor’s instructions
carefully. They may differ from the
general information in this leaflet.
Do not take Femara
 if you are allergic to letrozole or to
any of the other ingredients of this
medicine (listed in section 6),
 if you still have periods, i.e. if you
have not yet gone through the
menopause,
 if you are pregnant,
 if you are breast-feeding.
If any of these conditions apply to
you, do not take this medicine and
talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Femara
 if you have a severe kidney
disease,
 if you have a severe liver disease,
 if you have a history of
osteoporosis or bone fractures
(see also “Follow-up during
Femara treatment” in section 3).
If any of these conditions apply to
you, tell your doctor. Your doctor

will take this into account during
your treatment with Femara.
Children and adolescents (below
18 years)
Children and adolescents should not
use this medicine.
Older people (age 65 years and
over)
People aged 65 years and over can
use this medicine at the same dose
as for other adults.

Driving and using machines
If you feel dizzy, tired, drowsy or
generally unwell, do not drive or
operate any tools or machines until
you feel normal again.
Femara contains lactose
Femara contains lactose (milk
sugar). If you have been told by your
doctor that you have an intolerance
to some sugars, contact your doctor
before taking this medicine.
3. How to take Femara

Other medicines and Femara
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines,
including medicines obtained without
a prescription.
Pregnancy, breast-feeding and
fertility
 You should only take Femara
when you have gone through the
menopause. However, your doctor
should discuss with you the use of
effective contraception, as you
may still have the potential to
become pregnant during treatment
with Femara.
 You must not take Femara if you
are pregnant or breast feeding as
it may harm your baby.

Always take this medicine exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.
The usual dose is one tablet of
Femara to be taken once a day.
Taking Femara at the same time
each day will help you remember
when to take your tablet.
The tablet can be taken with or
without food and should be
swallowed whole with a glass of
water or another liquid.
How long to take Femara
Continue taking Femara every day
for as long as your doctor tells you.
You may need to take it for months
or even years. If you have any
questions about how long to keep
taking Femara, talk to your doctor.

Follow-up during Femara
treatment
You should only take this medicine
under strict medical supervision.
Your doctor will regularly monitor
your condition to check whether the
treatment is having the right effect.
Femara may cause thinning or
wasting of your bones
(osteoporosis) due to the reduction
of oestrogens in your body. Your
doctor may decide to measure your
bone density (a way of monitoring
for osteoporosis) before, during and
after treatment.
If you take more Femara than you
should
If you have taken too much Femara,
or if someone else accidentally
takes your tablets, contact a doctor
or hospital for advice immediately.
Show them the pack of tablets.
Medical treatment may be
necessary.
If you forget to take Femara
 If it is almost time for your next
dose (e.g. within 2 or 3 hours), skip
the dose you missed and take your
next dose when you are meant to.
 Otherwise, take the dose as soon
as your remember, and then take
the next tablet as you would
normally.
 Do not take a double dose to make
up for the one that you missed.

If you stop taking Femara
Do not stop taking Femara unless
your doctor tells you to. See also the
section above “How long to take
Femara”.
4. Possible side effects
Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
Most of the side effects are mild to
moderate and will generally
disappear after a few days to a few
weeks of treatment.
Some of these side effects, such as
hot flushes, hair loss or vaginal
bleeding, may be due to the lack of
oestrogens in your body.
Do not be alarmed by this list of
possible side effects. You may not
experience any of them.
Some side effects could be
serious:
Rare or uncommon side effects
(i.e. they may affect between 1 to
100 in every 10,000 patients):
 Weakness, paralysis or loss of
feeling in any part of the body
(particularly arm or leg), loss of
coordination, nausea, or difficulty
speaking or breathing (sign of a
brain disorder, e.g. stroke).
 Sudden oppressive chest pain
(sign of a heart disorder).

 Difficulty breathing, chest pain,
fainting, rapid heart rate, bluish
skin discoloration, or sudden arm,
leg or foot pain (signs that a blood
clot may have formed).
 Swelling and redness along a vein
which is extremely tender and
possibly painful when touched.
 Severe fever, chills or mouth
ulcers due to infections (lack of
white blood cells).
 Severe persistent blurred vision.
If any of the above occurs, tell
your doctor straight away.
You should also inform the doctor
straight away if you experience any
of the following symptoms during
treatment with Femara:
 Swelling mainly of the face and
throat (signs of allergic reaction).
 Yellow skin and eyes, nausea, loss
of appetite, dark-coloured urine
(signs of hepatitis).
 Rash, red skin, blistering of the
lips, eyes or mouth, skin peeling,
fever (signs of skin disorder).
Some side effects are very
common. These side effects may
affect more than 10 in every 100
patients.
 Hot flushes
 Increased level of cholesterol
(hypercholesterolaemia)
 Fatigue
 Increased sweating
 Pain in bones and joints
(arthralgia)

If any of these affects you severely,
tell your doctor.
Some side effects are common.
These side effects may affect
between 1 to 10 in every 100
patients.
 Skin rash
 Headache
 Dizziness
 Malaise (generally feeling unwell)
 Gastrointestinal disorders such as
nausea, vomiting, indigestion,
constipation, diarrhoea
 Increase in or loss of appetite
 Pain in muscles
 Thinning or wasting of your bones
(osteoporosis), leading to bone
fractures in some cases (see also
“Follow-up during Femara
treatment” in section 3)
 Swelling of arms, hands, feet,
ankles (oedema)
 Depression
 Weight increase
 Hair loss
 Raised blood pressure
(hypertension)
 Abdominal pain
 Dry skin
 Vaginal bleeding
If any of these affects you severely,
tell your doctor.
Other side effects are uncommon.
These side effects may affect
between 1 to 10 in every 1,000
patients.

 Nervous disorders such as anxiety,
nervousness, irritability,
drowsiness, memory problems,
somnolence, insomnia
 Impairment of sensation,
especially that of touch
 Eye disorders such as blurred
vision, eye irritation
 Palpitations, rapid heart rate
 Skin disorders such as itching
(urticaria)
 Vaginal discharge or dryness
 Joint stiffness (arthritis)
 Breast pain
 Fever
 Thirst, taste disorder, dry mouth
 Dryness of mucous membranes
 Weight decrease
 Urinary tract infection, increased
frequency of urination
 Cough
 Increased level of enzymes
If any of these affects you severely,
tell your doctor.
If you get any side effects, talk to
your doctor or pharmacist. This
includes any side effects not listed in
this leaflet.
5. How to store Femara
Do not store above 30ºC. Store in
the original package in order to
protect from moisture.
Keep all medicines out of the sight
and reach of children.

Do not take the tablets after their
expiry date which is printed on the
outside of the pack.
If your doctor tells you to stop taking
Femara Tablets, please take any
unused tablets back to your
pharmacist to be destroyed. Only
keep the tablets if the doctor tells
you to. Do not throw them away with
your normal household water or
waste. This will help to protect the
environment.

Product Licence Holder and
Manufacturer
This product is procured from within
the EU by the Product Licence
Holder: IMED Healthcare Ltd, New
Road, Buncrana, Co. Donegal,
Ireland.

6. Contents of the pack and other
information

Repackager
Cast Healthcare Ltd, Unit B6 The
Business Centre, 5-7 Tobermore
Road, Draperstown,
Northern Ireland, BT45 7AG, UK

What Femara contains
 The active substance is letrozole.
Each film-coated tablet contains
2.5 mg letrozole.
 The other ingredients are lactose
monohydrate, cellulose
microcrystalline, maize starch,
sodium starch glycolate,
magnesium stearate and silica
colloidal anhydrous. The coating
is composed of hypromellose,
talc, macrogol 8000, titanium
dioxide (E171) and iron oxide
yellow (E172).
What Femara looks like and
contents of the pack
Femara Tablets are round, dark
yellow tablets marked FV on one
side and CG on the other.
They come in blister packs of 30.

Manufacturer
Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West
Sussex RH12 5AB, United Kingdom.

This leaflet was last revised in
27/06/2013
PL: 40854/0015

POM

FEMARA is a registered trademark.
Copyright Novartis Pharmaceuticals
UK Limited.

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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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