FEMARA 2.5 MG TABLETS

Active substance: LETROZOLE

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Package leaflet: Information for the user

Femara® 2.5 mg Tablets

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)

(letrozole)

Children and adolescents should not use this medicine.

This medicine is called Femara 2.5 mg Tablets but will be
referred to as Femara throughout this leaflet.

Older people (age 65 years and over)

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
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
What Femara is and how it works

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.

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.

3) HOW TO TAKE FEMARA

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.

Taking Femara at the same time each day will help you
remember when to take your tablet.

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.

How long to take Femara

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





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).

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.

The tablet can be taken with or without food and should be
swallowed whole with a glass of water or another liquid.
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).

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, darkcoloured 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

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
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









Do not store above 30ºC.
Store in the original package.
Protect from moisture.
Keep out of the sight and reach of children.
Do not take the tablets after their expiry date which is
printed on the outside of the pack.
If your doctor tells you to stop taking Femara, 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.
If the tablets show any signs of deterioration seek the
advice of your pharmacist.

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

What Femara looks like and contents of the pack
Coated tablet, dark yellow, round, slightly biconvex with
bevelled edges. One side bears the imprint FV, the other CG.
They come in blister packs of 30 tablets.
Manufacturer
Novartis Farma S.p.A.
Via Proviniciale Schito 131,
Torre Annunziata (Na),
Italy.
It is procured from within the EU and repackaged by
Mediwin Limited, PL Holder: Mediport Limited,
13 Martello Enterprise Centre,
Courtwick Lane,
Littlehampton,
West Sussex,
BN17 7PA,
United Kingdom.
POM

PL: 18980/0852

Femara® is a registered Trademark of Novartis AG
Date of Leaflet Preparation: 24/06/2013
REF:
MCP-0852v1

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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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