Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking FEMARA?
FEMARA contains the active ingredient letrozole. FEMARA is used to treat breast cancer
in post-menopausal women.
For more information, see Section
1. Why am I taking FEMARA? in the full CMI.
2. What should I know before I take FEMARA?
Do not use if you have ever had an allergic reaction to letrozole or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. Your doctor will
want to check your hormone levels to ensure you are no longer having periods. Your
doctor may also send you for tests to check on your heart, liver, kidneys, and bones.
For more information, see Section
2. What should I know before I take FEMARA? in the full CMI.
3. What if I am taking other medicines?
4. How do I take FEMARA?
The usual dose is one (1) FEMARA tablet a day, ideally at the same time each day to
help you remember to take it.
Swallow your tablet whole with a glass of water or other liquid.
5. What should I know while taking FEMARA?
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Things you should do
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Remind any doctor, dentist, or pharmacist you visit that you are taking FEMARA.
Keep all your doctor's appointments so that your progress can be checked.
Promptly get all blood tests, bone tests and any other tests on your liver, heart
or kidneys done.
Use effective contraception (birth control) to avoid becoming pregnant.
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Things you should not do
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Do not stop taking this medicine suddenly.
Do not give this medicine to someone else.
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Driving or using machines
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FEMARA may make you feel tired or dizzy and may impair your driving.
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Drinking alcohol
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FEMARA may make you feel tired or dizzy. Alcohol may increase this effect.
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Looking after your medicine
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Store it in a cool dry place below 30°C (room temperature) away from moisture, heat,
or sunlight.
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6. Are there any side effects?
More common side effects include muscle/joints/back/breast pain, raised blood pressure/cholesterol,
feeling tired, sick, annoyed, anxious, nervous, dizzy; headache, vertigo, hot flush,
vomiting, cough, tummy pain, diarrhoea, frequent wee, constipation, sweating, hair
loss, weight change, vaginal bleeding/discharge. More serious side effects include
allergic reaction i.e. wheezing, difficulty breathing, swelling of lips, tongue/face,
blisters/spreading rash on eyes, lips, face; yellow eyes/skin, unable to wee; loss
of vision, balance, co-ordination; difficulty speaking, confusion, constant flu-like
symptoms i.e. fever, chills, sore throat; bluish/pale skin, heart palpitations, irregular/fast
heartbeat, crushing chest pain, numb/tingling limbs, bone fracture, tendonitis, pain
or swelling around joints, tendon tears.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
letrozole (leh-TRO-zole)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking FEMARA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking FEMARA.
Where to find information in this leaflet:
1. Why am I taking FEMARA?
FEMARA contains the active ingredient letrozole. FEMARA belongs to a class of medicines called 'aromatase inhibitors'. It is also
commonly referred to as an "antioestrogen."
FEMARA is used to treat breast cancer in women who no longer have a period (post-menopause)
because of natural aging, surgery or by some other means. FEMARA reduces the amount
of a hormone (chemical) known as 'oestrogen' that your body produces naturally to
reduce the spread of cancer.
2. What should I know before I take FEMARA?
Warnings
Do not take FEMARA if:
you are allergic to letrozole, or any of the ingredients listed at the end of this
leaflet.
you are still having your period (pre-menopause).
you are pregnant or are breast-feeding.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have a liver condition.
have a problem with your kidneys.
have a history of bone fractures or brittle bones from reduced bone mass ('osteoporosis').
are allergic to any other medicines, dyes, or preservatives.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Screening
FEMARA can only be taken in women who are no longer having periods.
Your doctor may send you for a blood test to check your hormone levels and confirm
this.
Monitoring during treatment
Your doctor may want to check on your bones during treatment using a bone density
test or may send you for an X-ray.
Your doctor may also send you for blood tests from time to time to check how your
heart, liver and kidneys are doing while taking FEMARA, especially if you have a known
condition affecting these. Your doctor may alter your treatment plan or ask you to
stop taking it depending on the results.
Birth control
If you have recently entered menopause or are in the early stages of menopause, your
doctor will discuss contraception options with you if you are able to become pregnant.
You should not become pregnant while taking FEMARA as it might harm your unborn baby.
Male patients
FEMARA may reduce fertility in men.
Pregnancy and breastfeeding
Tell your doctor straight away if you are pregnant or intend to become pregnant. There
are reports of abnormalities in babies born to mothers who took FEMARA during pregnancy.
You must not take FEMARA if you are breastfeeding or intend to breastfeed. It may
pass into your breast milk and harm your baby.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you buy without a prescription from your
pharmacy, supermarket, or health food shop.
Some medicines may interfere with FEMARA and affect how it works. They include:
Medicines that may affect FEMARA include:
Anti-fungal medicines such as ketoconazole, itraconazole, voriconazole
Medicines for HIV such as ritonavir
Antibiotics such as clarithromycin, and telithromycin
Methoxsalen used for some skin conditions
Medicines for seizures (fits) such as phenytoin or phenobarbital
Clopidogrel which you may be taking if you have had previously had a heart attack
or a stroke.
Some antibiotics like rifampicin.
Some other breast cancer medicines such as carbamazepine or tamoxifen.
St. John's wort (a herbal extract) used in a variety of conditions.
Other medicines that contain oestrogen or affect the amount of oestrogen in your body.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FEMARA.
Your doctor may consider your treatment carefully if you are taking any of these medicines.
4. How do I take FEMARA?
How much to take
The usual dose is one (1) FEMARA tablet a day.
Follow the instructions provided by your doctor and take FEMARA until your doctor
tells you to stop.
How to take FEMARA
Swallow the tablet whole with a glass or water or other liquid.
If your tummy is upset after you take the tablet you can take FEMARA with a meal or
after a snack.
When to take FEMARA
FEMARA should be used regularly at the same time each day to help you remember to
take it.
How long to take FEMARA
Take FEMARA for as long as your doctor tells you to.
If you forget to take FEMARA
If you miss your dose at the usual time and it is almost time for your next tablet
(in the next 2-3 hours), skip the dose you missed and take your next dose when you
are meant to. Otherwise, take your tablet as soon as you remember and then go back
to taking the tablet as you normally would.
Do not take two tablets to make up for the dose you missed.
If you take too much FEMARA
If you think that you have used too much FEMARA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking FEMARA?
Things you should do
Remind any doctor, dentist, or pharmacist you visit that you are taking FEMARA.
Keep all your doctor's appointments so that your progress can be checked.
Promptly get all blood tests, bone tests and any other tests on your liver, heart
or kidneys done so that your doctor can check these.
Use birth control to avoid becoming pregnant.
Call your doctor straight away if you:
Become pregnant or think you may be pregnant.
Are experiencing an allergic reaction to the medicine.
Some of the symptoms of an allergic reaction may include rash, itching or hives on
the skin; swelling of the face, lips, tongue, or other parts of the body; shortness
of breath, wheezing or trouble breathing.
Things you should not do
Do not stop taking this medicine suddenly.
Do not give FEMARA to someone else.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how FEMARA
affects you.
FEMARA can make you feel tired or dizzy. You must not drive or operate machinery if
you are experiencing this.
Drinking alcohol
Tell your doctor if you drink alcohol.
FEMARA can make you feel tired or dizzy. Alcohol may increase the effect.
Looking after your medicine
Keep FEMARA tablets inside the original packaging until it is time to take them.
Store it in a cool dry place below 30°C (room temperature) away from moisture, heat,
or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Keep it where young children cannot reach it.
When to discard your medicine
You must only discard your medicine if your doctor has told you to stop taking it
or the expiry date on the packaging has passed.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date or if the packaging is torn or shows
signs of tampering.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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Heart problems:
Fast or irregular heartbeat
Increased blood pressure
Crushing chest pain or sudden shooting arm or leg (foot) pain (signs of a heart attack)
Signs of an allergic reaction:
Trouble breathing, wheezing
Spreading rash, red skin, blistering of the lips, eyes or mouth, skin peeling (signs
of skin disorder)
Swelling of the face and throat.
Liver and kidney problems:
Yellow skin or eyes (jaundice)
Very dark wee or unable to wee
Vision problems:
Blurry vision (cataract) or blindness
Blood or circulation problems:
Weakness or being unable to move limbs or face, difficulty speaking/slurred speech,
problems balancing or moving properly (signs of stroke)
Swelling and redness along a vein which is extremely tender, painful to touch
Numbness or painful swelling/ tingling in hands or feet, limbs
Bluish skin, coughing up blood, fainting
Swelling of the feet, ankles, or other parts of the body due to fluid build-up (signs
of oedema)
Infections
Flu-like symptoms including fever, chills, sore throat, general lack of energy or
tiredness
Feeling constantly sick, sores in mouth
Bone and connective tissue problems:
Thinning of bones (osteoporosis), bone fractures
Tendon disorders including tendonitis (inflammation of the tendon) and tenosynovitis
(inflammation of the tissue surrounding the tendon): pain, swelling and tenderness
near a joint.
Tendon tears: feel a snap or pop when the tear happens, severe pain, swelling.
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Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
FEMARA is available in tablets containing 2.5 mg of the active ingredient, letrozole.
What FEMARA contains
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Active ingredient
(main ingredient)
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letrozole
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Other ingredients
(inactive ingredients)
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silica - colloidal anhydrous
cellulose - microcrystalline
lactose
magnesium stearate
starch-maize
sodium starch glycollate
hypromellose
iron oxide yellow
macrogol 8000
talc - purified
titanium dioxide
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Potential allergens
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Contains lactose, galactose, and sulfites.
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Femara does not contain sucrose, gluten, tartrazine, or any other azo dyes.
Do not take this medicine if you are allergic to any of these ingredients.
What FEMARA looks like
FEMARA 2.5 mg tablets: dark yellow, round, coated tablet, marked 'CG' on one side
and 'FV' on the other; supplied in blister packs in a cardboard carton of 30 tablets
(AUST R 60605).
Who distributes FEMARA
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113 Australia
Telephone 1-800-671-203
This leaflet was prepared in August 2024.
® = Registered trademark
Internal document code: fem140824c is based on PI fem140824i.