LETROZOLE 2.5MG TABLETS

Active substance: LETROZOLE

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Assessed against the UK PIL May
2012 (pharmacovigilance inc.)
S1693 LEAFLET Femara 20131113.doc

PACKAGE LEAFLET: INFORMATION FOR USER

FEMARA 2.5mg TABLETS
(letrozole)
Your medicine is known as Femara 2.5mg Tablets but will be
referred to as Femara throughout the following leaflet.
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

Children and adolescents (below 18 years)

By Caroline McDermott at

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

1. What Femara is and what it is used for

If you feel dizzy, tired, drowsy or generally unwell, do not drive or
operate any tools or machines until you feel normal again.

2. What you need to know before you take Femara

Femara contains lactose

3. How to take Femara

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.

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
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.
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

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
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.



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,

Otherwise, take the dose as soon as you remember, and then
take the next tablet as you would normally.





if you are pregnant,

Do not take a double dose to make up for the one that you
missed.

 if you are breast-feeding.
If any of these conditions apply to you, do not take this medicine
and talk to your doctor.

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”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Femara

4. POSSIBLE SIDE EFFECTS



if you have a severe kidney disease,



if you have a severe liver disease,

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



if you have a history of osteoporosis or bone fractures (see also
“Follow-up during Femara treatment” in section 3).

Most of the side effects are mild to moderate and will generally
disappear after a few days to a few weeks of treatment.

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

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:



Thirst, taste disorder, dry mouth

Rare or uncommon side effects (i.e. they may affect between 1 to
100 in every 10,000 patients):



Dryness of mucous membranes



Weight decrease

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).



Urinary tract infection, increased frequency of urination



Cough



Increased level of enzymes



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

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



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 you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.



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.

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

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

5. HOW TO STORE FEMARA





KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Store in the original package to
protect from moisture.



If your doctor stops your treatment, take any leftover tablets
back to the pharmacy for safe disposal.



Do not use after the expiry date printed on the carton label or
blister strip.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.





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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Femara contains



Skin rash



Headache



Dizziness



Malaise (generally feeling unwell)



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



Increase in or loss of appetite



What Femara looks like and contents of the pack

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)

Femara Tablets are round, yellow tablets marked “FV” on one
side and “CG” on the other.



Femara tablets are available as blister packs of 30 tablets.



The active substance is letrozole. Each film-coated tablet
contains 2.5 mg letrozole.



The other ingredients are silica colloidal anhydrous,
microcrystalline cellulose, lactose monohydrate, magnesium
stearate, maize starch, sodium starch glycollate, hypromellose,
macrogol 8000, talc, titanium dioxide (E171) and iron oxide
yellow (E172).



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



Depression



Weight increase



Hair loss



Raised blood pressure (hypertension)



Abdominal pain

Manufacturer



Dry skin



Vaginal bleeding

This product is manufactured by Novartis Farma S.p.A., Via
Provinciale Schito 131, Torre Annunziata (Na), Italy.

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.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

POM

PL No: 19488/1693



Nervous disorders such as anxiety, nervousness, irritability,
drowsiness, memory problems, somnolence, insomnia

Leaflet revision date: 13 November 2013



Impairment of sensation, especially that of touch



Eye disorders such as blurred vision, eye irritation

Femara is a registered trademark of Novartis Pharmaceuticals UK
Ltd.



Palpitations, rapid heart rate



Skin disorders such as itching (urticaria)



Vaginal discharge or dryness



Joint stiffness (arthritis)



Breast pain



Fever

S1693 LEAFLET Femara 20131113.doc

S1693 LEAFLET Letrozole 20131113.doc

PACKAGE LEAFLET: INFORMATION FOR USER

LETROZOLE 2.5mg TABLETS

Children and adolescents (below 18 years)
Children and adolescents should not use this medicine.
Older people (age 65 years and over)

Your medicine is known as Letrozole 2.5mg Tablets but will be
referred to as Letrozole Tablets throughout the following leaflet.

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

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

Other medicines and Letrozole Tablets



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 Letrozole Tablets are and what they are used for
2. What you need to know before you take Letrozole Tablets
3. How to take Letrozole Tablets
4. Possible side effects
5. How to store Letrozole Tablets
6. Contents of the pack and other information

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 Tablets 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 Tablets.



You must not take Letrozole Tablets 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 Tablets contain lactose
Letrozole Tablets contain 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.

1. WHAT LETROZOLE TABLETS ARE AND WHAT THEY ARE
USED FOR

3. HOW TO TAKE LETROZOLE TABLETS

What Letrozole Tablets are and how they work

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

Letrozole Tablets contain 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 Tablets reduce 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 Tablets are used for
Letrozole Tablets are 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 Tablets are 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 Tablets work or why
this medicine has been prescribed for you, ask your doctor.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LETROZOLE TABLETS
Follow all the doctor’s instructions carefully. They may differ from
the general information in this leaflet.

The usual dose is one tablet of Letrozole Tablets to be taken once a
day. Taking Letrozole Tablets 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 Letrozole Tablets
Continue taking Letrozole Tablets 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
Tablets, talk to your doctor.
Follow-up during Letrozole Tablets 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 Tablets 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 Tablets than you should
If you have taken too much Letrozole Tablets, 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 Letrozole Tablets


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 you 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.

Do not take Letrozole Tablets


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 stop taking Letrozole Tablets

 if you are breast-feeding.
If any of these conditions apply to you, do not take this medicine
and talk to your doctor.

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

Warnings and precautions

4. POSSIBLE SIDE EFFECTS

Talk to your doctor or pharmacist before taking Letrozole Tablets

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



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 Tablets 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 Tablets.

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:



Fever

Rare or uncommon side effects (i.e. they may affect between 1 to
100 in every 10,000 patients):



Thirst, taste disorder, dry mouth



Dryness of mucous membranes

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).



Weight decrease



Urinary tract infection, increased frequency of urination



Cough



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



Increased level of enzymes



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.



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
Tablets:

If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
Reporting of 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.
By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE LETROZOLE TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Store in the original package to
protect from moisture.



Rash, red skin, blistering of the lips, eyes or mouth, skin
peeling, fever (signs of skin disorder).

If your doctor stops your treatment, take any leftover tablets
back to the pharmacy for safe disposal.



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

Do not use after the expiry date printed on the carton label or
blister strip.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.



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).





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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Letrozole Tablets contain


The active substance is letrozole. Each film-coated tablet
contains 2.5 mg letrozole.



The other ingredients are colloidal anhydrous silica,
microcrystalline cellulose, lactose monohydrate, magnesium
stearate, maize starch, sodium starch glycollate, hypromellose,
macrogol 8000, talc, titanium dioxide (E171) and iron oxide
yellow (E172).



Skin rash



Headache



Dizziness



Malaise (generally feeling unwell)



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



Increase in or loss of appetite

What Letrozole Tablets look like and contents of the pack



Pain in muscles





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

Letrozole Tablets are round, yellow tablets marked “FV” on one
side and “CG” on the other.



Letrozole tablets are available as blister packs of 30 tablets.



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

Product Licence holder



Depression



Weight increase



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

Hair loss



Raised blood pressure (hypertension)



Manufacturer

Abdominal pain



Dry skin

This product is manufactured by Novartis Farma S.p.A., Via
Provinciale Schito 131, Torre Annunziata (Na), Italy



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

POM

PL No: 19488/1693

Leaflet revision date: 13 November 2013
S1693 LEAFLET Letrozole 20131113.doc

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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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