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LETROZOLE 2.5 MG FILM COATED TABLETS

Active substance(s): LETROZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER



Letrozole 2.5 mg film-coated tablets



letrozole
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.

In this leaflet:
1. What Letrozole 2.5 mg is and what it is used for
2. What you need to know before you take Letrozole 2.5 mg
3. How to take Letrozole 2.5 mg
4. Possible side effects
5. How to store Letrozole 2.5 mg
6. Contents of the pack and other information

1. What Letrozole 2.5 mg is and what
it is used for
What Letrozole 2.5 mg is and how it works
Letrozole 2.5 mg 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 2.5 mg is used for
Letrozole is used to treat breast cancer in women who have
gone through menopause i.e. cessation of periods.

recently taken or might take any other medicines, including
medicines obtained without a prescription.
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.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
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 contains lactose
Letrozole 2.5 mg 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.

3. How to take Letrozole 2.5 mg

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 surgery or following five years
treatment with tamoxifen. Letrozole is also used to prevent
breast tumour spreading to other parts of the body in patients
with advanced breast cancer.

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 you have any questions about how letrozole works or why
this medicine has been prescribed for you, ask your doctor.

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

2. What you need to know before you
take Letrozole 2.5 mg

How long to take Letrozole 2.5 mg
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 all the doctor’s instructions carefully. They may differ
from the general information in this leaflet.
Do not take Letrozole 2.5 mg
• 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 Letrozole
2.5 mg
• 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 section 3, “Follow-up during Letrozole 2.5 mg
treatment”).
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.
Children and adolescents (below 18 years)
Children or adolescents should not use this medicine.
Older people (aged 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 Letrozole 2.5 mg
Tell your doctor or pharmacist if you are taking, have

The usual dose is one tablet of Letrozole 2.5 mg to be taken
once a day Taking Letrozole 2.5 mg at the same time each
day will help you remember when to take your tablet.

Follow-up during Letrozole 2.5 mg 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 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 forget to take Letrozole 2.5 mg
• 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 Letrozole 2.5 mg
Do not stop taking letrozole unless your doctor tells you to. See
also the section above “How long to take Letrozole 2.5 mg”.

If you have any further questions on the use of this product,
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.
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 in 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 letrozole:
• 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)
Very common side effects (may affect more than 1 in 10
people)
• 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.
Common side effects (may affect up to 1 in 10 people)
• 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 section 3, ”Followup during Letrozole 2.5 mg treatment”)
• 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.
Uncommon side effects (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
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.
• skin

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet.
You can also report side effects directly via the national
reporting system: Yellow Card Scheme
Website: 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 2.5 mg
Keep out of the reach and sight of children.
This medicinal product does not require any special storage
conditions.
Do not use letrozole after the expiry date which is stated on
the blister and carton after EXP. The first two digits indicate
the month and the last four digits indicate the year. The
expiry date refers to the last day of that month.
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 contains
• The active substance is letrozole. Each film-coated tablet
contains 2.5 mg letrozole.
• The other ingredients are lactose monohydrate, cellulose
microcrystalline (E460), maize starch pregelatinised,
sodium starch glycolate, magnesium stearate (E572),
silica, colloidal anhydrous (E551).
The ingredients in the tablet coating are macrogol, talc
(E553b), hypromellose (E464), titanium dioxide (E171), iron
oxide yellow (E172).
What Letrozole 2.5 mg looks like and contents of the
pack
Letrozole is a yellow film-coated round tablet, inscripted with
L9OO at one side and 2.5 on the other side.
Letrozole is available in blisters of 10, 14, 20, 28, 30, 50,
56, 60, 84, 90, 98 or 100 tablets per box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Manufacturer:
Synthon BV,
Microweg 22, 6545 CM Nijmegen, The Netherlands.
Manufacturer
Synthon Hispania S.L.
Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat, Spain.
Distributed by:
Consilient Health (UK) Ltd,
No.1 Church Road, Richmond upon Thames, Surrey.
TW9 2QE
This leaflet was last approved in December 2014

PL 14048/0072

P0424

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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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