LETROZOLE 2.5MG FILM COATED TABLETS

Active substance: LETROZOLE

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TEVA UK Ref:

Version:

231-30-95402-C LEA LETROZOLE TAB 2.5MG TUK

1

17 June 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

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. Do not pass it on to
others. It may harm them, even if their symptoms 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.

Other medicines and letrozole
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Pregnancy, breast-feeding and fertility
You should only take Letrozole 2.5 mg Film-Coated Tablet 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 2.5 mg Film-Coated Tablet.
You must not take Letrozole 2.5 mg Film-Coated Tablet if you are
pregnant or breast-feeding as it may harm your baby.

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

1

WHAT LETROZOLE 2.5 mg FILM-COATED TABLET IS AND
WHAT IT IS USED FOR

Pharma code 584

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 2.5 mg
Film-Coated Tablets 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.

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 Tablet contains lactose
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
TABLET

Always take Letrozole 2.5 mg Film-Coated Tablets exactly as your
doctor or pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual 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.

What Letrozole 2.5 mg Film-Coated Tablet is used for
Letrozole 2.5 mg Film-Coated Tablet is used to treat breast cancer in
The tablet can be taken with or without food and should be
women who have gone through menopause i.e. cessation of periods. swallowed whole with a glass of water or another liquid.
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 2.5 mg Film-Coated Tablet is also used to
prevent breast tumour spreading to other parts of the body in
patients with advanced breast cancer.

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 2.5 mg Film-Coated Tablets treatment
If you have any questions about how Letrozole 2.5 mg Film-Coated You should only take this medicine under strict medical
Tablet works or why this medicine has been prescribed for you, ask supervision. Your doctor will regularly monitor your condition to
your doctor.
check whether the treatment is having the right effect.

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.

Letrozole 2.5 mg Film-Coated Tablet 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.

Do NOT take Letrozole 2.5 mg Film-Coated Tablet
If you are allergic (hypersensitive) to letrozole or any of the other
ingredients of this medicine listed in section 6 of this leaflet
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 you take more Letrozole 2.5 mg Film-Coated Tablets than you
should

If any of these conditions apply to you, do not take this medicine
and talk to your doctor.

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 the one that you
missed.

Warnings and precautions
Talk to your doctor or pharmacist before taking Letrozole 2.5 mg
Film-Coated Tablet
If you have a severe kidney disease
If you have a severe liver disease
If you have a history of osteoperosis or bone fractures (see also
“Follow-up during Letrozole 2.5 mg Film-Coated Tablet
treatment” in section 3).

If you have taken too much 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 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. See also the section above, "How long to
If any of these conditions apply to you, tell your doctor. Your doctor take Letrozole 2.5 mg Film-Coated Tablets".
will take this into account during your treatment with Letrozole
2.5 mg Film-Coated Tablet.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
Children and adolescents (below 18 years)
Children or 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.

REG0083112

Version 2.2

Approved

Page 2 of 4

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

LETROZOLE 2.5 mg
FILM-COATED TABLETS

TEVA UK Ref:

Version:

231-30-95402-C LEA LETROZOLE TAB 2.5MG TUK

1

17 June 2014

PAGE 2: REAR FACE (OUTSIDE OF REEL)

4

POSSIBLE SIDE EFFECTS

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

Like all medicines, Letrozole 2.5 mg Film-Coated Tablets 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 (i.e. they may affect between 1 to 100 in every
10,000):
weakness, paralysis or loss of feeling in an arm or leg 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)
sudden oppressive chest pain (sign of a heart disorder)
difficulty in breathing, chest pain, fainting, rapid heart rate, bluish
skin discolouration, or sudden arm or leg (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.

5

HOW TO STORE LETROZOLE 2.5 MG FILM-COATED
TABLETS

Keep out of the reach and sight of children
Do not use Letrozole after the expiry date which is stated on the
blister and carton after ‘EXP’. The expiry date refers to the last day
of that month
This medicinal product does not require any special storage
conditions
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 2.5 mg Film-Coated Tablets contain
The active ingredient is letrozole. Each film-coated tablet contains
2.5 mg letrozole.
The other ingredients are cellulose microcrystalline, starch
(maize), magnesium stearate, lactose monohydrate, silica
colloidal anhydrous, sodium starch glycollate (type A) and
Opadry II 85F32723 Yellow which consists of iron oxide yellow
(E172), macrogol 3350, titanium dioxide (E171), talc, indigo
carmine aluminium lake (E132), poly (vinyl alcohol) and tartrazine
aluminium lake (E102).

What Letrozole 2.5 mg Film-Coated Tablets look like and contents of
You should also inform the doctor straight away if you experience any the pack
Letrozole 2.5 mg Film-Coated Tablets are dark yellow, standard
of the following symptoms during treatment with {Letrozole 2.5 mg
convex round, film-coated tablets debossed with “93” on one
Film-Coated Tablets}:
side and “B1” on the other side.
Swelling mainly of the face and throat (signs of an allergic reaction)
Letrozole 2.5 mg Film-Coated Tablets are available in pack sizes of
Yellow skin and eyes, nausea, loss of appetite, dark-coloured urine
1, 10, 14, 15, 20, 28, 30, 60, 90, 98 and 100 film-coated tablets;
(signs of hepatitis)
hospital pack of 50 film-coated tablets are also available.
Rash, red skin, blistering of the lips, eyes or mouth, skin peeling,
Not all pack sizes may be marketed.
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.

Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in 06/2014.
PL 00289/1168

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 {Letrozole 2.5 mg
Film-Coated Tablets} treatment” in section 3)
Swelling of arms, hands, feet, ankles (oedema)
Sad mood (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.
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

REG0083112

Version 2.2

Approved

95402-C

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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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