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LETROZOLE 2.5 MG FILM COATED TABLETS

Active substance(s): LETROZOLE

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Common Technical Document
Letrozole 2.5 mg
Film-coated tablets

1.3.1

Package Leaflet 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.
What is in this leaflet
1.
2.
3.
4.
5.
6.
1.

What Letrozole 2.5 mg is and what it is used for
What you need to know before you take Letrozole 2.5 mg
How to take Letrozole 2.5 mg
Possible side effects
How to store Letrozole 2.5 mg
Contents of the pack and other information
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.
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.
If you have any questions about how letrozole works or why this medicine has been prescribed for
you, ask your doctor.
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Common Technical Document
Letrozole 2.5 mg
Film-coated tablets

2.

What you need to know before you take Letrozole 2.5 mg

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 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.
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Film-coated tablets

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

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 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.
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
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-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.

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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, dark-coloured 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
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Common Technical Document
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Film-coated tablets




pain in muscles
thinning or wasting of your bones (osteoporosis), leading to bone fractures in some cases (see also
section 3, ”Follow-up 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
 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 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.
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Common Technical Document
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Film-coated tablets

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,
500 Chiswick High Road, London, W4 5RG.
PL 14048/0072
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany
France
The Netherlands
United Kingdom

Letroblock 2,5 mg Filmtabletten
Letroman 2,5 mg, comprimé pelliculé
Letroman 2,5 mg, filmomhulde tabletten
Letrozole 2.5 mg, Film-coated Tablets

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Common Technical Document
Letrozole 2.5 mg
Film-coated tablets

This leaflet was last approved in
December 2014

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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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