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Active substance: LETROZOLE

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Package leaflet: Information for the user

2.5mg Tablets

Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
– 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

2. What you need to know before
you take Femara

What Femara is and how it works
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.

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
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.
Other medicines and Femara
Tell your doctor or pharmacist if you are
taking, have recently taken or might

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 tamoxifen.
Femara is also used to prevent breast
tumour spreading to other parts of the
body in patients with advanced breast
If you have any questions about how
Femara works or why this medicine
has been prescribed for you, ask your

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
– You must not take Femara if you are
pregnant or breast feeding as it may
harm your baby.
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

3. How to take Femara
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
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
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
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
– Do not take a double dose to make up
for the one that you missed.
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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
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
– 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
– 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
– 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,
– Pain or burning sensation in the hands
or wrist (carpal tunnel syndrome)
– Impairment of sensation, especially
that of touch
– Eye disorders such as blurred vision,
eye irritation
– Palpitations, rapid heart rate
– Skin disorders such as itching
– 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
Side effects with frequency not known
Trigger finger, a condition in which
your finger or thumb catches in a bent
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
– Keep out of the reach and sight of
– Do not use Femara after the expiry
date which is stated on the carton
after EXP. The expiry date refers to the
last day of that month.
– Do not store above 30ºC.
– Store in the original package in order
to protect from moisture.
– Do not use any pack that is damaged
or shows signs of tampering.

6. Contents of the pack and other
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 ­ oating is composed of hypromelc
lose, talc, macrogol 8000, titanium
dioxide (E 171) and iron oxide yellow
(E 172).
What Femara looks like and contents of
the pack
– Femara is supplied as film-coated
tablets. The film-coated tablets are
dark-yellow and round. They are
marked with “FV” on one side and
“CG” on the other side.
– Each blister pack contains 10, 14, 28,
30 or 100 tablets. Not all pack sizes
may be available in your country.
Marketing Authorisation Holder and
Marketing Authorisation Holder
Novartis Pharmaceuticals UK Limited,
Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, United Kingdom.
Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West
Sussex RH12 5AB, United Kingdom.
Novartis Pharmaceuticals UK Limited,
Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, United Kingdom.
This leaflet was last revised in 03/2014.
If you would like any more information,
or would like the leaflet in a different
format, please contact Medical
­nformation at Novartis Pharmaceuticals
UK Ltd, telephone number 01276
FEMARA is a registered trademark.
Copyright Novartis Pharmaceuticals UK
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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.