LETROZOLE 2.5 MG FILM-COATED TABLET

Active substance: LETROZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.
What Letrozole is and what it is used for
2.
What you need to know before you take Letrozole
3.
How to take Letrozole
4.
Possible side effects
5.
How to store Letrozole
6.
Contents of the pack and other information

1.

WHAT LETROZOLE IS AND WHAT IT IS USED FOR

What Letrozole is and how it works
Letrozole 2.5 mg Film-coated Tablets contain 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 often caused 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
tumours 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.

1

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE LETROZOLE

Follow all the doctor´s instructions carefully. They may differ from the general information in this
leaflet.
Do not take Letrozole:
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:
if you have severe kidney disease
if you have 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.
Children and adolescents (below 18 years)
Children and 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.
Other medicines and Letrozole
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.
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 contains lactose

2

Letrozole 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

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 to be taken once a day. Taking Letrozole 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
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 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 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
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
Do not stop taking Letrozole unless your doctor tells you to. See also the section above “How long to
take Letrozole”.

4.

POSSIBLE SIDE EFFECTS

3

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 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).
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

4

-

Thinning or wasting of your bones (osteoporosis), leading to bone fractures in some cases (see
also “Follow-up during Letrozole 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 LETROZOLE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The
expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

5

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Letrozole contains
-

-

The active substance is letrozole. Each film-coated tablet contains 2.5 mg letrozole.
The other ingredients in the tablet core are: lactose monohydrate, microcrystalline cellulose,
maize starch, hypromellose, silica, colloidal anhydrous, sodium starch glycolate (Type A) and
magnesium stearate.
The Film-coating (Opadry Yellow) contains: hypromellose, titanium dioxide (E 171), iron oxide
yellow (E 172) and macrogols.

What Letrozole looks like and contents of the pack
Letrozole 2.5 mg film-coated tablets are yellow, circular, biconvex film-coated tablets, debossed with

‘DB03’ on one side and plain on the other side.
Letrozole 2.5 mg film-coated tablets are available in packs of 30 and 100 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
This medicinal product is authorised in the Member States of the EEA under the following
names:
Name of the
Member State

Name of the medicinal product

Czech Republic

Letrozol Orion 2,5 mg potahované tablety

Denmark

Letrozol Orion 2,5 mg filmovertrukne tabletter

6

Finland

Letrozol Orion 2,5 mg kalvopäällysteiset tabletit
Letrozol Orion 2,5 mg filmdragerade tabletter

Norway

Letrozol Orion 2,5 mg filmdrasjerte tabletter

Poland

Letrozol Orion 2,5 mg tabletki powlekane

Slovak Republic

Letrozol Orion 2,5 mg filmom obalené tablety

Sweden

Letrozol Orion 2,5 mg filmdragerade tabletter

United Kingdom

Letrozole 2.5 mg film-coated tablets

This leaflet was last revised in
02/2013

7

Expand view ⇕

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.

Hide
(web4)