LETROZOLE 2.5M TABLETS

Active substance: LETROZOLE

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Femara® 2.5mg Tablets
(letrozole)

1. What Femara is and what it is used
for

2. What you need to know before you
take Femara

Package leaflet: Information for the user

What Femara is and how it works

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

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.

-

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.

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

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.

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,

-

3. How to take Femara

If you forget to take Femara

People aged 65 years and over can use this
medicine at the same dose as for other adults.

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 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.

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.

-

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.

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

if you are pregnant,

-

Older people (age 65 years and over)

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.

-

-

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.

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 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).

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

-

-

-

Depression

-

Dryness of mucous membranes

-

Weight increase

-

Weight decrease

-

Hair loss

-

-

Raised blood pressure (hypertension)

Urinary tract infection, increased frequency
of urination

-

Abdominal pain

-

Cough
Increased level of enzymes

-

Hot flushes

-

Increased level of cholesterol
(hypercholesterolaemia)

-

Fatigue

-

Dry skin

-

Sudden oppressive chest pain (sign of a
heart disorder).

-

Increased sweating

-

Vaginal bleeding

-

Pain in bones and joints (arthralgia)

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.

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

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.

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

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

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 Tablets are dark yellow, round, filmcoated tablets, with markings „FV‟ on one side
and „CG‟ on reverse.

-

Skin rash

Severe fever, chills or mouth ulcers due to
infections (lack of white blood cells).

-

Headache

-

Dizziness

Severe persistent blurred vision.

-

Malaise (generally feeling unwell)

-

If any of the above occurs, tell your doctor
straight away.

-

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

Eye disorders such as blurred vision, eye
irritation

-

Palpitations, rapid heart rate

You should also inform the doctor straight away if
you experience any of the following symptoms
during treatment with Femara:

-

Increase in or loss of appetite

-

Skin disorders such as itching (urticaria)

-

Pain in muscles

-

Vaginal discharge or dryness

-

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

-

Joint stiffness (arthritis)

-

Breast pain

-

Fever

Leaflet date: 04.02.2013

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

-

Thirst, taste disorder, dry mouth

FEMARA is a registered trademark of Novartis
Pharmaceuticals UK Limited.

-

-

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).

-

Keep all medicines out of the sight and reach of
children.

The tablets come in blister packs of 30.

Do not take the tablets after their expiry date
which is printed on the outside of the pack.

Manufactured by: Novartis Pharma GmbH,
Roonstrasse 25, D-90429, Nurnberg, Germany.

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.

Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK
Femara® 2.5mg Tablets

POM

PL No: 18799/1882

Letrozole 2.5mg Tablets

1. What Letrozole is and what it is
used for

2. What you need to know before you
take Letrozole

Package leaflet: Information for the user

What Letrozole is and how it works

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

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.

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

-

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.

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

What Letrozole is used for
Letrozole 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. Letrozole 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 Letrozole
works or why this medicine has been prescribed
for you, ask your doctor.

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,

-

3. How to take Letrozole

If you forget to take Letrozole

People aged 65 years and over can use this
medicine at the same dose as for other adults.

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 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.

The usual dose is one tablet of Letrozole to be
taken once a day. Taking Letrozole at the same
time each day will help you remember when to
take your tablet.

-

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.

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

if you are pregnant,

-

Older people (age 65 years and over)

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
Letrozole
-

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 any of these conditions apply to you, tell your
doctor. Your doctor will take this into account
during your treatment with Letrozole.
Children and adolescents (below 18 years)
Children and adolescents should not use this
medicine.

-

-

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
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.

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 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.
Follow-up during Letrozole 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. 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
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.

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

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):

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

-

Hot flushes

-

Increased level of cholesterol
(hypercholesterolaemia)

-

-

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.

-

Depression

-

Dryness of mucous membranes

-

Weight increase

-

Weight decrease

-

Hair loss

-

-

Raised blood pressure (hypertension)

Urinary tract infection, increased frequency
of urination

-

Abdominal pain

-

Cough

Fatigue

-

Dry skin

-

Increased level of enzymes

-

Increased sweating

-

Vaginal bleeding

-

Pain in bones and joints (arthralgia)

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

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.

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

-

Skin rash

Severe fever, chills or mouth ulcers due to
infections (lack of white blood cells).

-

Headache

-

Dizziness

Severe persistent blurred vision.

-

Malaise (generally feeling unwell)

-

If any of the above occurs, tell your doctor
straight away.

-

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

Eye disorders such as blurred vision, eye
irritation

-

Palpitations, rapid heart rate

You should also inform the doctor straight away if
you experience any of the following symptoms
during treatment with Letrozole:

-

Increase in or loss of appetite

-

Skin disorders such as itching (urticaria)

-

Pain in muscles

-

Vaginal discharge or dryness

-

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

-

Joint stiffness (arthritis)

-

Breast pain

-

Fever

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

-

Thirst, taste disorder, dry mouth

-

-

-

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).

-

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 Letrozole
Store the tablets in their original pack. Do not
store above 30°C.
Keep all medicines out of the sight and reach of
children.

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 Tablets are dark yellow, round, filmcoated tablets, with markings „FV‟ on one side
and „CG‟ on reverse.
The tablets come in blister packs of 30.

Do not take the tablets after their expiry date
which is printed on the outside of the pack.

Manufactured by: Novartis Pharma GmbH,
Roonstrasse 25, D-90429, Nurnberg, Germany.

If your doctor tells you to stop taking Letrozole
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.

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 No: 18799/1882
Leaflet date: 04.02.2013

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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