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FEMARA 2.5 MG TABLETS

Active substance(s): LETROZOLE

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Package leaflet: Information for the user

2.5mg Tablets
(letrozole)

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.
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

1. What Femara is and what it is used
for

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.

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 cancer.
If you have any questions about how
Femara works or why this medicine has
been prescribed for you, ask your doctor.

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.

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.
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

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.

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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).
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– 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
– 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 (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
Side effects with frequency not known
Trigger finger, a condition in which
your finger or thumb catches in a bent
position.
If any of these affects you severely, tell your
doctor.
Reporting of side effects
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.

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– Keep out of the reach and sight of
children.
– 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
information
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 (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
Manufacturer
Marketing Authorisation Holder
Novartis Pharmaceuticals UK Limited,
Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, United Kingdom.
Manufacturer
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
November 2014.
If you would like any more information, or
would like the leaflet in a different format,
please contact Medical Information at
Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.
FEMARA is a registered trademark.
Copyright Novartis Pharmaceuticals UK
Limited.

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5. How to store Femara

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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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