FEMARA 2.5mg Tablets
(letrozole)
What you need to know about Femara Tablets
Your doctor has decided that you need this medicine to help treat your condition.
Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place bacause you may want to read it again.
If you have any other questions, or if there is something you don't understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Femara Tablets are and what they are used for
- 2. Things to consider before you start to take Femara Tablets
- 3. How to take Femara Tablets
- 4. Possible side effects
- 5. How to store Femara Tablets
- 6. Further information
What Femara Tablets are and what they are used for
Letrozole, the active ingredient in Femara Tablets, is one of a group of medicines called aromatase inhibitors. These block the production of oestrogens.
Femara Tablets are used to treat breast cancer in post-menopausal women. They can be used either before surgery to reduce the size of the tumour, or after surgery to help prevent the tumour from returning.
They can also be used in patients with advanced breast cancer to help stop the tumour spreading to other parts of the body.
Things to consider before you start to take Femara Tablets
Some people MUST NOT take Femara Tablets. Talk to your doctor if:
- You think you may be allergic to letrozole or to any of the other ingredients of Femara Tablets. (These are listed in section 6.)
- You have not yet gone through the menopause.
- There is a possibility that you might be pregnant.
- You are breast-feeding.
- You have a serious liver disease.
You should also ask yourself these questions before taking Femara Tablets:
- Do you suffer from any serious kidney disease?
- Do you have an inherited intolerance to some sugars such as lactose? The tablets contain a small amount of lactose.
If the answer to these questions is YES, tell your doctor or pharmacist because Femara Tablets might not be the right medicine for you.
Femara Tablets are not suitable for either children or men.
Are you taking other medicines?
No special problems have been reported but you should always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
Will there be any problems with driving or using machinery?
If you feel dizzy, tired or drowsy when you start to take Femara Tablets, do not drive or work with machinery.
Is there anything else you need to know before taking your medicine?
- Your doctor may want to measure your bone density before and during your treatment. Drugs like Femara Tablets reduce the levels of female hormones. This can lead to a loss of minerals in bones and cause osteoporosis (decrease in bone density and strength).
How to take Femara Tablets
The doctor will decide what dose of Femara Tablets you should take. Always take the tablets exactly as your doctor has told you to. The dose will be on the pharmacist's label. Check the label carefully. It should tell you how many tablets to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking the tablets for as long as you have been told unless you have any problems. In that case, check with your doctor.
The usual dose of Femara is 1 tablet once a day. You will probably continue to take Femara Tablets for a number of years.
What if you forget to take a dose?
If you forget to take a dose, take it as soon as you remember. Then go on as before.
What if you take too many tablets?
If you accidentally take too many Femara Tablets, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.
Possible side effects
Femara Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects. Any side effects are usually mild or moderate and may wear off after a few day's treatment. However, if they are severe or last for more than a few days, tell your doctor.
Some of these side effects may also be caused by your illness.
Some side effects can be serious
Severe skin and/or allergic reactions, angina, heart attack, thrombosis, pulmonary embolism or stroke have occasionally been reported as side effects.
Stop taking the tablets and tell your doctor or go to the emergency department at your nearest hospital IMMEDIATELY if you get any of the following symptoms:
- Heavy or tight chest or pain in the chest, spreading to your arms or shoulders, neck, teeth or jaw, abdomen or back
- Coughing blood
- Unusual pains or swelling of your arms or legs
- Sudden shortness of breath, difficulty in speaking or breathing
- Fainting
- Numbness or weakness in your arm or leg or any part of your body
- Loss of co-ordination
- Vision changes
- Sudden severe headache
- Severe rash or redness, which might include blistering and peeling and be accompanied by fever
- Itching, swollen throat, face, eyelids or lips, difficulty breathing.
There have been reports of hepatitis, possibly with yellow skin and eyes, nausea, loss of appetite and dark-coloured urine. If you notice any of these symptoms, please go and see your doctor straightaway.
The side effects listed below have also been reported:
The most common side effects experienced by more than 10% of people are:
- Hot flushes
- Pains in the joints (arthralgia).
Up to 1 in 10 people have experienced:
- Loss of appetite or increased appetite
- Feeling or being sick, indigestion, constipation, diarrhoea
- Weight gain
- Raised cholesterol levels
- Depression
- Headache
- Dizziness
- Hair loss
- Increased sweating
- Skin rash
- Muscle pain
- Bone problems (pain, bone thinning (osteoporosis), fractures)
- Feeling tired
- Swelling in the legs or feet due to fluid retention.
Up to 1 in 100 people have experienced:
- Urinary tract infections, urinating more often
- Pain in the breast including in the tumour or in the stomach
- General swelling due to fluid retention
- Decreased white blood cells which can lead to infections (leucopenia)
- Mental problems (anxiety, nervousness, irritability, loss of memory)
- Sleep problems (sleepiness or difficulty in sleeping)
- Changes in sensation, including touch sensation (pins and needles), taste changes
- Eye problems such as cataract (loss of transparency of the lens of the eye), eye irritation, blurred vision, dry eyes
- Heart problems such as palpitations, fast heart beat (tachycardia) irregular heart beat (arrhythmia), angina and heart attack (ischemic cardiovascular disease)
- Inflamed blood vessels
- Hypertension (raised blood pressure)
- Breathlessness
- Dry mouth or mouth ulcers
- Liver problems
- Dry or itchy skin or raised wheals
- Arthritis (inflammation of the joints)
- Vaginal bleeding, vaginal discharge, vaginal dryness
- Fever
- Thirst
- Weight loss
- Cough.
Up to 1 in 1,000 people have experienced:
- Thrombosis (clotting in the blood vessels e.g. legs)
- Pulmonary embolism (a blood clot in the lungs).
If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.
How to store Femara Tablets
Store tablets in their original pack. Do not store above 30°C.
Keep all medicines out of the reach and sight of children.
Do not take the tablets after their expiry date which is printed on the outside of the pack.
If your doctor tells you to stop taking Femara Tablets, please take any unused tablets back to your pharmacist to be destroyed. Only keep the tablets if the doctor tells you to. Do not throw them away with your normal household water or waste. This will help to protect the environment.
Further information
Femara Tablets are round, yellow tablets marked FV on one side and CG on the other. They contain 2.5mg of the active ingredient, letrozole. They also contain the inactive ingredients silica aerogel, cellulose, lactose, magnesium stearate, maize starch, sodium carboxymethyl starch, hydroxypropyl methylcellulose, polyethylene glycol, talc, titanium dioxide (E171) and iron yellow (E172).
They come in blister packs of 14 or 28.
The product licence holder is
The manufacturer responsible for release on to the market is
This leaflet was approved in March 2009
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.
Femara is a registered trademark.
Copyright Novartis Pharmaceuticals UK Limited
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