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Information for Consumers

Revised: 11 June 2015

Consumer Medicine Information

LETARA

Letrozole, 2.5 mg Film coated tablets

What is in this leaflet

This leaflet answers some of the common questions about LETARA.

It does not contain all the information that is known about LETARA.

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 LETARA 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 LETARA is for

LETARA 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.

LETARA contains the active ingredient, 2.5 mg of letrozole and is presented in tablets.

Letrozole is an aromatase inhibitor - this family of medicines, which can be referred, 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 LETARA or you might have taken another "antioestrogen" such as tamoxifen in the past.

If you have any questions about why LETARA has been prescribed for you, ask your doctor.

You may have been prescribed LETARA by your doctor for another reason.

LETARA is only accessible with a doctor's prescription.

LETARA is also not addictive.

Before you use LETARA

When you must not use it

Do not take LETARA if you are allergic to:

If you get an allergic reaction, symptoms may include:

Do not take LETARA if you have not yet experienced menopause. This medicine is intended only to be used in post-menopausal women i.e. women who no longer have periods.

Do not use LETARA if you are pregnant or breastfeeding unless your doctor says that it is safe.

Do not use LETARA 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 LETARA 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 LETARA.

Taking other medicines

These medicines may affect the way LETARA works.

Your doctor or pharmacist can tell you what to do if you are taking LETARA with any other medicine.

Using LETARA

Taking LETARA, 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 LETARA tablet taken per day.

How to take it:

LETARA 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 LETARA 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 you miss a dose, do not take an extra dose.

Just resume your normal schedule. For example, if you forget to take Monday's tablet leave the tablet allocated to Monday. Then on Tuesday resume as normal by taking the tablet allocated to Tuesday.

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 LETARA.

Overdose

Immediately, telephone your doctor or the National Poisons and Hazardous Chemicals Information Centre (0800 POISON - 0800 764 766) 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 LETARA. Do this even if there are no signs of discomfit or poisoning.

Please keep these telephone numbers handy.

While you are using LETARA

Things you must do:

Tell your doctor immediately, if you become pregnant while taking LETARA. 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.

Tell your doctor, dentist or pharmacist that you are on LETARA 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 LETARA.

Things you must not do:

Do not use LETARA 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 LETARA until you know how LETARA 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 LETARA.

LETARA 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 worry 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:

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:

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 using LETARA

Storage

Both heat and dampness can destroy some medicines. LETARA tablets will keep well if it is cool and dry.

Keep LETARA 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:

LETARA 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 LETARA contains 2.5 mg of the active ingredient, letrozole, plus the following ingredients:

Excipients - colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, sodium starch glycollate, hydroxypropyl methylcellulose, polyethylene glycol 8000, talc, titanium dioxide (E 171), iron oxide yellow (E 172).

Manufacturer

Douglas Pharmaceuticals Ltd
P O Box 45 027
Auckland 0651
New Zealand

Phone: (09) 835 0660
Fax: (09) 835 0665

Date of preparation

This leaflet was prepared in May 2009.

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