Letrozole 2.5mg film coated tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about LETROZOLE-GA.
It does not contain all the information that is known about LETROZOLE-GA. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of taking LETROZOLE-GA against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What LETROZOLE-GA is used for
LETROZOLE-GA is used for the treatment of breast cancer in post-menopausal women i.e. women who no longer have periods, either because of their natural age or following surgery or chemotherapy.
LETROZOLE-GA contains the active ingredient, 2.5mg of letrozole and is presented in tablets.
Letrozole is an aromatase inhibitor – this family of medicines, which can be referred to also as “antioestrogens”, function by decreasing the production of oestrogen in your body.
The growth of certain types of breast cancer is promoted by oestrogen.
These cancers are known as “oestrogen-dependent”. Decreasing the production of oestrogen may aid to prevent the cancer from growing.
This might be the first time you are taking an “antioestrogen” such as LETROZOLE-GA or you might have taken another “antioestrogen” such as tamoxifen in the past.
If you have any questions about why LETROZOLE-GA has been prescribed for you, ask your doctor.
You may have been prescribed LETROZOLE-GA by your doctor for another reason. LETROZOLE-GA is only obtainable with a doctor’s prescription.
LETROZOLE-GA is also not addictive.
Before you take LETROZOLE-GA
When you must not use it
Do not take LETROZOLE-GA if you are allergic to:
- Letrozole, the active ingredient in this medicine
- Any of the other ingredients of LETROZOLE-GA as mentioned at the end of this Consumer Medicine Information leaflet
If you get an allergic reaction, symptoms 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 troubled breathing
Do not take LETROZOLE-GA if you have not yet experienced menopause. This medicine is intended only to be used in post-menopausal women (ie. women who no longer have periods).
Women of child-bearing age who have recently become postmenopausal or perimenopausal are advised to use a proven method of birth control to avoid pregnancy until your postmenopausal status is fully determined.
Do not use LETROZOLE-GA if you are pregnant or breastfeeding as it may affect your baby.
Do not use LETROZOLE-GA after the expiry date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.
Do not use LETROZOLE-GA if the packaging is torn or shows signs of tampering. In such case, please return it to your pharmacist.
Do not use it to treat any other complaints unless your doctor says it is safe.
Do not give this medicine to anyone else.
Before you start to use it
If you have severe kidney or liver disease, you must tell your doctor. Your doctor might take special precautions while you are taking this medication.
If you are allergic to any other medicines, foods, dyes or preservatives, you must tell your doctor. Your doctor will need to know if you are allergy prone.
If you have not told your doctor any of the above things, please tell them before you begin taking LETROZOLE-GA.
Taking other medicines
If you are on any other medicine, including medicine from a chemist, supermarket or health shop that you bought without a prescription, you must tell your doctor. These medicines may affect the way LETROZOLE-GA works.
Your doctor or pharmacist can tell you what to do if you are taking LETROZOLE-GA with any other medicine.
How to take LETROZOLE-GA
When taking LETROZOLE-GA, follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, you must ask your doctor or pharmacist for help.
How much to take
The usual dose is one LETROZOLE-GA tablet taken per day.
How to take it:
LETROZOLE-GA tablets should be swallowed whole with a glass of water or other liquid.
If you get an upset stomach after the taking the tablet, take it with a meal or after a snack.
How long to take it
Continue taking LETROZOLE-GA for as long as your doctor or pharmacist tells you.
Your progress will be checked by your doctor to ensure this medicine is working. Your doctor will make a decision on how long your treatment should continue.
Talk to your doctor if you are unsure.
If you forget to take it
If it is close to your next dose (e.g. within 2 or 3 hours), then skip the dose you have missed and take your next dose when you are meant to.
Otherwise, take the dose as soon as you remember, then go back to taking your LETROZOLE-GA tablets as per normal.
Do not take extra tablets to make up for a missed dose.
Ask your doctor or pharmacist for more hints if you have trouble remembering to take LETROZOLE-GA.
If you take too much – Overdose
Immediately, telephone your doctor or the Poisons Information Centre (telephone 13 11 26) or go to the Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much LETROZOLE-GA. Do this even if there are no signs of discomfit or poisoning.
Please keep these telephone numbers handy.
While you are using LETROZOLE-GA
Things you must do
Tell your doctor immediately, if you become pregnant while taking LETROZOLE-GA. This medicine should not be taken while you are pregnant
Your doctor’s instructions should be followed carefully. If you do not, your treatment may not be helpful or you may have unwanted side effects.
Make sure you go to all of your doctor’s appointments so that your progress can be checked. Your doctor may ask you to have blood tests from time to time to check on your progress and pick up any unwanted side effects. Furthermore, your doctor may decide to assess the health of your bones as this medicine may cause thinning or wasting of your bones (osteoporosis).
Tell your doctor, dentist or pharmacist that you are on LETROZOLE-GA if you are about to start taking any other new medicine.
Tell any other doctor, dentist or pharmacist who treats you that you are using LETROZOLE-GA.
Things you must not do
Do not use LETROZOLE-GA to treat any other complaints unless your doctor says it is safe.
Do not give this medicine to anyone else, even if they have the same symptoms as you.
Things to be careful of
Be careful driving or operating machinery or doing other jobs which require you to be alert while you are taking LETROZOLE-GA until you know how LETROZOLE-GA affects you. This medicine might cause dizziness or tiredness in some people. If you think that you have any of these symptoms, please do not drive or do anything else that could be dangerous.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LETROZOLE-GA. LETROZOLE-GA helps most people, but it may have unwanted side effects in some people. All medicines have side effects. Sometimes they are serious but most of the time they are not. You may require medical treatment if you get some of the side effects.
Do not be worried by the list of possible side effects. You may not even experience any of them.
Ask your doctor or pharmacist to answer any questions that you may have.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you have any of the following:
- signs that blood clots could have formed, such as sudden severe headache, sudden loss of coordination, blurred vision or sudden loss of vision, slurred speech, numbness or tingling in an arm or leg, painful swelling in the thighs or calves, chest pain, difficulty in breathing, coughing blood.
- continuous “flu-like” symptoms such as chills, fever, sore throat, sores in mouth, swollen glands, tiredness or lack of energy, which could be signs of blood problems
The above are all serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor if you have any of the following side effects and they worry you:
- swelling of the feet, ankles or other parts of the body due to a build up of fluid
- skin rash, itching or dry skin
- pain in the muscles, joints or bones; joint stiffness, arthritis
- vaginal spotting or bleeding
- whitish, thick vaginal discharge, vaginal dryness
- headache
- fever
- tiredness, sleepiness, weakness or dizziness
- difficulty sleeping
- numbness or tingling in hands or feet
- mood changes such as anxiety, nervousness, irritability and depression (sad mood)
- forgetfulness
- change in sense of taste
- blurred vision or eye irritation
- upset stomach, nausea (feeling sick) or vomiting, abdomen pain
- constipation
- diarrhoea
- dry mouth, sore mouth, mouth ulcers and cold sores
- increased thirst
- breast pain
- hot flushes
- increased sweating
- appetite or weight changes
- hair thinning
- urgent need to urinate (pass water)
- pain or burning sensation when urinating, which may be a sign of an infection
- fast or irregular heartbeats
- thinning of bones (osteoporosis), leading to bone fractures in some cases
Tell your doctor if you have anything else that is making you unwell. Other side effects not listed above may occur in some people.
Some of these can be found only through laboratory testing.
After taking LETROZOLE-GA
Storage
- Keep your LETROZOLE-GA tablets in the blister pack until it is time to take them
- Keep the LETROZOLE-GA tablets in a cool dry place where the temperature stays below 30°C
- Do not keep LETROZOLE-GA or any other medicine in the bathroom or any other place that is hot or steamy
- Do not keep the tablets on window sills or in the car.
Both heat and dampness can destroy some medicines. LETROZOLE-GA tablets will keep well if it is cool and dry.
Keep LETROZOLE-GA tablets where children cannot reach them. A good place to store medicines is in a locked cupboard at least one-and-a-half metres above the ground.
Disposal
Ask your pharmacist what to do with any tablets you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.
Product description
What it looks like:
LETROZOLE-GA 2.5 mg tablets are yellow to dark yellow round, film coated, biconvex tablet, engraved with ‘L’ on one face and plain on the other.
Ingredients:
Each LETROZOLE-GA contains 2.5mg of the active ingredient, letrozole, plus the following ingredients:
Excipient
- colloidal anhydrous silica
- microcrystalline cellulose
- lactose monohydrate
- magnesium stearate
- maize starch
- sodium starch glycollate
- hypromellose
- macrogol 400
- titanium dioxide
- iron oxide yellow (CI77492)
Supplier
Actavis Pty Ltd
Level 5, 117 Harrington Street
The Rocks NSW 2000
This leaflet was prepared in February 2014.
AUST R 174638
Published by MIMS August 2014