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LETROZOLE 2.5M TABLETS

Active substance(s): LETROZOLE

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Package leaflet: Information for the user

Femara® 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.

The name of your medicine is Femara 2.5mg
Tablets but will be referred to as Femara
throughout 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

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

Follow all the doctor’s instructions carefully. They
may differ from the general information in this
leaflet.

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.
What Femara is used for

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.

Femara is used to treat breast cancer in women
who have gone through menopause i.e.
cessation of periods.

Warnings and precautions

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

Talk to your doctor or pharmacist before taking
Femara

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

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.

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.

How long to take Femara

If you stop taking 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.

Do not stop taking Femara unless your doctor
tells you to. See also the section above ‘How
long to take Femara’.

Follow-up during Femara treatment

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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

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.

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.

Children and adolescents (below 18 years)

3. How to take Femara

If you forget to take Femara

Children and adolescents should not use this
medicine.

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

-

If any of these conditions apply to you, tell your
doctor. Your doctor will take this into account
during your treatment with Femara.

The usual dose is one tablet of Femara to be
taken once a day. Taking Femara at the same

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.

4. Possible side effects

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).

If any of these affects you severely, tell your
doctor.

-

Swelling and redness along a vein which is
extremely tender and possibly painful when
touched.

Some side effects are common. These side
effects may affect between 1 to 10 in every 100
patients.

-

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).

Some side effects are very common. These
side effects may affect more than 10 in every 100
patients.

-

Impairment of sensation, especially that of
touch

-

Eye disorders such as blurred vision, eye
irritation

Reporting 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

-

Skin rash

-

Headache

-

Dizziness

-

Malaise (generally feeling unwell)

-

Palpitations, rapid heart rate

-

Gastrointestinal disorders such as nausea,
vomiting, indigestion, constipation, diarrhoea

-

Skin disorders such as itching (urticaria)

Store the tablets in their original pack. Do not
store above 30°C.

-

Vaginal discharge or dryness

-

Increase in or loss of appetite

Keep out of the sight and reach of children.

-

Joint stiffness (arthritis)

-

Pain in muscles

-

Breast pain

-

Thinning or wasting of your bones
(osteoporosis), leading to bone fractures in
some cases (see also ‘Follow-up during
Femara treatment’ in section 3)

-

Fever

Do not take your tablets after the expiry date
which is stated on the box label after ‘Exp’. The
expiry date refers to the last day of that month

-

Thirst, taste disorder, dry mouth
Dryness of mucous membranes
Weight decrease

-

-

Swelling of arms, hands, feet, ankles
(oedema)
Depression

-

Urinary tract infection, increased frequency
of urination

-

Weight increase

-

Cough

-

Hair loss

-

Increased level of enzymes

-

Raised blood pressure (hypertension)

-

Abdominal pain

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).

Nervous disorders such as anxiety,
nervousness, irritability, drowsiness, memory
problems, somnolence, insomnia
Pain or burning sensation in the hands or
wrist (carpal tunnel syndrome)

-

-

Hot flushes

-

Dry skin

-

Increased level of cholesterol
(hypercholesterolaemia)

-

Vaginal bleeding

-

Fatigue

-

Increased sweating

-

Pain in bones and joints (arthralgia)

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.

By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Femara

Remember if your doctor tells you to stop taking
this medicine; return any unused tablets to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
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. Contents of the pack and other
information
What Femara contains
They contain 2.5mg of the active ingredient,
letrozole. They also contain the inactive
ingredients colloidal anhydrous silica,
microcrystalline cellulose, lactose, magnesium
stearate, maize starch, sodium carboxymethyl
starch, hydroxypropyl methylcellulose,
polyethylene glycol, talc, titanium dioxide(E171)
and iron oxide yellow (E172).
What Femara looks like and contents of the
pack
Femara are dark yellow, round, film-coated
tablets, with markings ‘FV’ on one side and ‘CG’
on reverse.
The tablets come in blister packs of 30.
Manufactured by: Novartis Pharma GmbH,
Roonstrasse 25, D-90429, Nurnberg, Germany.
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.

Side effects with frequency not known
Trigger finger, a condition in which your finger or
thumb catches in a bent position.

Femara® 2.5mg Tablets

If any of these affects you severely, tell your
doctor.

Femara is a registered trademark of Novartis
Pharmaceuticals UK Limited.

PL: 18799/1882
Leaflet date: 16.11.2015

POM

Package leaflet: Information for the user

Letrozole 2.5mg Tablets
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.

The name of your medicine is Letrozole 2.5mg
Tablets but will be referred to as Letrozole
throughout this leaflet.
What is in this leaflet
1. What Letrozole is and what it is used for
2. What you need to know before you take
Letrozole
3. How to take Letrozole
4. Possible side effects
5. How to store Letrozole
6. Contents of the pack and other information

1. What Letrozole is and what it is
used for

2. What you need to know before you
take Letrozole

What Letrozole is and how it works

Follow all the doctor’s instructions carefully. They
may differ from the general information in this
leaflet.

Letrozole 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.
Letrozole 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.
What Letrozole is used for

Do not take Letrozole
-

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.

Letrozole is used to treat breast cancer in women
who have gone through menopause i.e.
cessation of periods.

Warnings and precautions

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. Letrozole is also used
to prevent breast tumour spreading to other parts
of the body in patients with advanced breast
cancer.

-

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
Letrozole treatment’ in section 3).

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

Talk to your doctor or pharmacist before taking
Letrozole

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 Letrozole
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 Letrozole 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 Letrozole.
You must not take Letrozole 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.
Letrozole contains lactose

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.

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.

How long to take Letrozole

If you stop taking Letrozole

Continue taking Letrozole 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
Letrozole, talk to your doctor.

Do not stop taking Letrozole unless your doctor
tells you to. See also the section above ‘How
long to take Letrozole’.

Follow-up during Letrozole treatment

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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.
Letrozole 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 Letrozole than you should

Letrozole 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.

If you have taken too much Letrozole, 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.

Children and adolescents (below 18 years)

3. How to take Letrozole

If you forget to take Letrozole

Children and adolescents should not use this
medicine.

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

-

If any of these conditions apply to you, tell your
doctor. Your doctor will take this into account
during your treatment with Letrozole.

The usual dose is one tablet of Letrozole to be
taken once a day. Taking Letrozole at the same

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.

4. Possible side effects

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).

If any of these affects you severely, tell your
doctor.

-

Swelling and redness along a vein which is
extremely tender and possibly painful when
touched.

Some side effects are common. These side
effects may affect between 1 to 10 in every 100
patients.

-

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 Letrozole:
-

-

Swelling mainly of the face and throat (signs
of allergic reaction).

Some side effects are very common. These
side effects may affect more than 10 in every 100
patients.

-

Impairment of sensation, especially that of
touch

-

Eye disorders such as blurred vision, eye
irritation

Reporting 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

-

Skin rash

-

Headache

-

Dizziness

-

Malaise (generally feeling unwell)

-

Palpitations, rapid heart rate

-

Gastrointestinal disorders such as nausea,
vomiting, indigestion, constipation, diarrhoea

-

Skin disorders such as itching (urticaria)

Store the tablets in their original pack. Do not
store above 30°C.

-

Vaginal discharge or dryness

-

Increase in or loss of appetite

Keep out of the sight and reach of children.

-

Joint stiffness (arthritis)

-

Pain in muscles

-

Breast pain

-

Thinning or wasting of your bones
(osteoporosis), leading to bone fractures in
some cases (see also ‘Follow-up during
Letrozole treatment’ in section 3)

-

Fever

Do not take your tablets after the expiry date
which is stated on the box label after ‘Exp’. The
expiry date refers to the last day of that month

-

Thirst, taste disorder, dry mouth
Dryness of mucous membranes
Weight decrease

-

-

Swelling of arms, hands, feet, ankles
(oedema)
Depression

-

Urinary tract infection, increased frequency
of urination

-

Weight increase

-

Cough

-

Hair loss

-

Increased level of enzymes

-

Raised blood pressure (hypertension)

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).

Nervous disorders such as anxiety,
nervousness, irritability, drowsiness, memory
problems, somnolence, insomnia
Pain or burning sensation in the hands or
wrist (carpal tunnel syndrome)

-

-

Abdominal pain

-

Hot flushes

-

Dry skin

-

Increased level of cholesterol
(hypercholesterolaemia)

-

Vaginal bleeding

-

Fatigue

-

Increased sweating

-

Pain in bones and joints (arthralgia)

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.

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.

By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Letrozole

Remember if your doctor tells you to stop taking
this medicine; return any unused tablets to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
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. Contents of the pack and other
information
What Letrozole contains
They contain 2.5mg of the active ingredient,
letrozole. They also contain the inactive
ingredients colloidal anhydrous silica,
microcrystalline cellulose, lactose, magnesium
stearate, maize starch, sodium carboxymethyl
starch, hydroxypropyl methylcellulose,
polyethylene glycol, talc, titanium dioxide(E171)
and iron oxide yellow (E172).
What Letrozole looks like and contents of the
pack
Letrozole are dark yellow, round, film-coated
tablets, with markings ‘FV’ on one side and ‘CG’
on reverse.
The tablets come in blister packs of 30.
Manufactured by: Novartis Pharma GmbH,
Roonstrasse 25, D-90429, Nurnberg, Germany.
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Letrozole 2.5mg Tablets
PL: 18799/1882
Leaflet date: 16.11.2015

POM

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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