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LETROZOLE 2.5MG FILM COATED TABLETS

Active substance(s): LETROZOLE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Letrozole
Package leaflet: Information for the user

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 Letrozole 2.5 mg Film-Coated Tablet is and what it
is used for
2. What you need to know before you take Letrozole 2.5 mg
Film-Coated Tablet
3. How to take Letrozole 2.5 mg Film-Coated Tablet
4. Possible side effects
5. How to store Letrozole 2.5 mg Film-Coated Tablet
6. Contents of the pack and other information
Pharma code 584

1

What Letrozole 2.5 mg Film-Coated Tablet is and
what it is used for

What Letrozole 2.5 mg Film-Coated Tablet is and how it
works
Letrozole 2.5 mg Film-Coated Tablets 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
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.

2

What you need to know before you take Letrozole
2.5 mg Film-Coated Tablet

Follow all the doctor's instructions carefully. They may
differ from the general information in this leaflet.
Do not take Letrozole 2.5 mg Film-Coated Tablet
• If you are allergic to letrozole or 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 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 2.5 mg Film-Coated Tablets.

Children and adolescents
Children or adolescents should not use this medicine.
Older people
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.
Pregnancy, breast-feeding and fertility
You should only take Letrozole when you have gone
through the menopause. However, your doctor should
discuss with you about using effective contraceptive, 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 2.5 mg Film-Coated Tablets contains lactose and
tartrazine aluminium lake
This medicinal product 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.
This medicinal product contains tartrazine aluminium lake
(E102) and may cause allergic reactions.

3

How to take Letrozole 2.5 mg Film-Coated Tablets

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 recommended dose is one tablet of Letrozole 2.5 mg
Film-Coated Tablets to be taken once a day. Taking
Letrozole 2.5 mg Film-Coated 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 2.5 mg Film-Coated Tablets
Continue taking Letrozole 2.5 mg Film-Coated 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 2.5 mg
Film-Coated Tablets, 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 2.5 mg Film-Coated Tablets
than you should
If you have taken too many Letrozole 2.5 mg Film-Coated
Tablets or if someone else accidentally takes your tablets,
contact your doctor or hospital for advice immediately.
Show them the pack of tablets. Medical treatment may be
necessary.
If you forget to take Letrozole 2.5 mg Film-Coated 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 a forgotten
dose.

Top of page cut-off to middle of registration mark: 44 mm.

Letrozole 2.5 mg
Film-coated Tablets

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you stop taking Letrozole 2.5 mg Film-Coated Tablets
Do not stop taking Letrozole 2.5 mg Film-Coated Tablets
unless your doctor tells you to. See also the section
above, "How long to take Letrozole 2.5 mg Film-Coated
Tablets".
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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.

Other side effects are uncommon (may affect up to 1 in
100 people):.
• 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.

Do not be alarmed by this list of possible side effects. You Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
may not experience any of them.
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
Some side effects could be serious:
the Yellow Card Scheme at:
Rare (may affect up to 1 in 1,000 people) or uncommon
www.mhra.gov.uk/yellowcard
(may affect up to 1 in 100 people):
By reporting side effects you can help provide more
• weakness, paralysis or loss of feeling in an arm or leg
information on the safety of this medicine.
or any other part of the body, loss of coordination,
nausea, or difficulty in speaking or breathing (sign of a
brain disorder, e.g. stroke)
5 How to store Letrozole 2.5 mg Film-Coated Tablets
• sudden oppressive chest pain (sign of a heart disorder)

Keep this medicine out of the sight and reach of
• difficulty in breathing, chest pain, fainting, rapid heart
children.
rate, bluish skin discolouration, or sudden arm or leg
• Do not use this medicine after the expiry date which is
(foot) pain (signs that a blood clot may have formed)
stated on the blister and carton after ‘EXP’. The expiry
• swelling and redness along a vein which is extremely
date refers to the last day of that month.
tender and possibly painful when touched

This medicinal product does not require any special
• severe fever, chills or mouth ulcers due to infections
storage conditions.
(lack of white blood cells)
• Do not use this medicine if you notice visible signs of
• severe persistent blurred vision
deterioration.
If any of the above occurs, tell your doctor straight away.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
You should also inform the doctor straight away if you
away medicines you no longer use. These measures will
experience any of the following symptoms during
help protect the environment.
treatment with Letrozole:
• Swelling mainly of the face and throat (signs of an
allergic reaction)
6 Contents of the pack and other information
• Yellow skin and eyes, nausea, loss of appetite,
What Letrozole 2.5 mg Film-Coated Tablets contain
dark-coloured urine (signs of hepatitis)
• Rash, red skin, blistering of the lips, eyes or mouth, skin • The active substance is letrozole. Each film-coated tablet
contains 2.5 mg letrozole.
peeling, fever (signs of skin disorder)
• The other ingredients are cellulose microcrystalline,
starch (maize), magnesium stearate, lactose
Some side effects are very common (may affect more
monohydrate, silica colloidal anhydrous, sodium starch
than 1 in 10 people):
glycollate (type A) and Opadry II 85F32723 Yellow which
• Hot flushes
consists of iron oxide yellow (E172), macrogol 3350,
• Increased level of cholesterol (hypercholesterolaemia)
titanium dioxide (E171), talc, indigo carmine aluminium
• Fatigue
lake (E132), poly(vinyl alcohol) and tartrazine aluminium
• Increased sweating
lake (E102).
• Pain in bones and joints (arthralgia)
If any of these affects you severely, tell your doctor.
What Letrozole 2.5 mg Film-Coated Tablets look like and
contents of the pack
Some side effects are common (may affect up to 1 in 10
• Letrozole 2.5 mg Film-Coated Tablets are dark yellow,
people.)
standard convex round, film-coated tablets debossed
• Skin rash
with “93” on one side and “B1” on the other side.
• Headache
• Letrozole 2.5 mg Film-Coated Tablets are available in
• Dizziness
pack sizes of 1, 10, 14, 15, 20, 28, 30, 60, 90, 98 and 100
• Malaise (generally feeling unwell)
film-coated tablets; hospital pack of 50 film-coated
• Gastrointestinal disorders such as nausea, vomiting,
tablets are also available.
indigestion, constipation, diarrhoea
Not all pack sizes may be marketed.
• Increase in or loss of appetite
• Pain in muscles
Marketing
Authorisation Holder and Manufacturer
• Thinning or wasting of your bones (osteoporosis),
TEVA UK Limited, Eastbourne, BN22 9AG
leading to bone fractures in some cases (see also
“Follow-up during Letrozole treatment” in section 3)
This leaflet was last revised in June 2015.
• Swelling of arms, hands, feet, ankles (oedema)
• Sad mood (depression)
PL
00289/1168
• Weight increase
• Hair loss
• Raised blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
If any of these affects you severely, tell your doctor.
95402-D
323 x 200

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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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