Tarceva®
Erlotinib hydrochloride
25 mg, 100 mg and 150 mg film-coated tablets
What is in this leaflet
This leaflet answers some common questions about TARCEVA tablets.
It does not contain all the available information.
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 you taking TARCEVA 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 TARCEVA is used for
TARCEVA contains the active ingredient erlotinib hydrochloride.
TARCEVA is used for the treatment of advanced or metastatic (spreading) non-small cell lung cancer (NSCLC) after previous treatment with chemotherapy.
TARCEVA belongs to a group of medicines called anti-neoplastic agents which are used to treat cancer.
TARCEVA prevents the activity of a protein called epidermal growth factor receptor. This protein is known to be involved in the growth and spread of cancer cells.
Your doctor, however, may have prescribed TARCEVA for another purpose.
Ask your doctor if you have any questions why TARCEVA has been prescribed for you.
This medicine is available only with a doctor's prescription.
Before you take TARCEVA
When you must not take it
Do not take TARCEVA if:
- you have had an allergic reaction to TARCEVA or any ingredients listed at the end of this leaflet
- the package is torn or shows signs of tampering
- the expiry date printed on the pack has passed
If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure if you should be taking TARCEVA, talk to your doctor.
Use in children
Do not give TARCEVA to children.
Safety and effectiveness in patients less than 18 years of age have not been established.
Before you start to take it
Tell your doctor if:
- you are pregnant or plan to become pregnant
TARCEVA may be harmful to an unborn baby when taken by a pregnant woman.
If you are a woman who could become pregnant use adequate contraception during treatment, and continue contraception for at least 2 weeks after taking the last tablet.
If you become pregnant while you are being treated with TARCEVA, immediately inform your doctor. TARCEVA is not generally recommended for use in pregnant women unless the benefits of treatment outweigh the risk to the unborn baby. - you are breast-feeding or plan to breast-feed
It is not known whether TARCEVA passes into breast milk. It is not recommended that you breast-feed while taking TARCEVA. - you have liver problems
- you are a smoker
- you are allergic to any other medicines, foods, dyes or preservatives
If you have not told your doctor about any of the above, tell them before you start taking TARCEVA.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or healthfood shop.
Some medicines may interfere with TARCEVA. These medicines include:
- ketoconazole (Nizoral® ), a medicine used to treat fungal infections
- rifampicin (Rifadin®, Rifinah®), a medicine used to treat infections
- warfarin (Coumadin®, Marevan®), a medicine used to thin the blood
- ciprofloxacin (Cipflox®, Ciproxen®), a medicine used to treat bacterial infections
- omeprazole (Losec®, Omezol®), a medicine used to treat gastric reflux and stomach ulcers.
These medicines may be affected by TARCEVA, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking TARCEVA.
Ask your doctor or pharmacist if you are not sure about this list of medicines.
How to take TARCEVA
Follow all directions given to you by your doctor or pharmacist.
They may differ from the information contained in this leaflet.
How much to take
Take TARCEVA exactly as your doctor has prescribed.
Your doctor will tell you how many TARCEVA tablets to take each day.
The usual dose is one 150 mg TARCEVA tablet each day.
Your doctor may adjust your dose if necessary.
How to take it
Swallow tablets whole with a glass of water.
Do not chew the tablets.
When to take it
Take TARCEVA on an empty stomach. For example, one hour before food or two hours after food.
Food can interfere with the absorption of TARCEVA.
How long to take it
How long you will be treated with TARCEVA will depend on your cancer and how well you respond to the medicine.
Continue taking TARCEVA until your doctor tells you to stop.
If you forget to take it
Do not take an extra dose. Wait until the next dose and take your normal dose then.
Do not try to make up for the dose that you missed by taking more than one dose at a time.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering your dose, ask your pharmacist for some hints.
In case of an overdose
Immediately telephone your doctor or National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) for advice, or go to your nearest Accident and Emergency Centre, if you think you or anyone else may have taken too much TARCEVA. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking TARCEVA
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking TARCEVA.
Tell your doctor if you become pregnant while taking TARCEVA.
If you are a smoker, try not to smoke while you are taking TARCEVA.
Smoking can interfere with how well TARCEVA will work and reduce the effectiveness of the medicine.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you feel the tablets are not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can be checked.
Things you must not do
Do not stop taking TARCEVA or change the dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give TARCEVA to anyone else even if they have the same condition as you.
Do not use TARCEVA to treat other complaints unless your doctor says to.
Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.
Things to be careful of
Be careful driving or operating machinery until you know how TARCEVA affects you.
However, TARCEVA is not expected to affect your ability to drive or operate machinery.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TARCEVA.
TARCEVA can help people with non-small cell lung cancer but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- rash
- diarrhoea
- your doctor may need to treat you with an anti-diarrhoeal (e.g. loperamide) - tiredness
- loss of appetite
- shortness of breath/difficulty in breathing
- cough
- infection, fever, chills
- nausea, vomiting
- pain, redness, swelling or sores in the mouth
- itching
- dry skin
- eye irritation, discharge with itching of the eyes and crusty eyelids
- stomach pain
- nose bleeds
- unusual hair loss or thinning
- swelling around the nails
These are the more common side effects of TARCEVA. Your doctor will tell you more about them. Your doctor may also recommend that you change the dose of TARCEVA if you experience any of the above side effects.
Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any of the following:
- severe or persistent diarrhoea, nausea, loss of appetite or vomiting
- bleeding from the stomach or intestines
Signs and symptoms may include severe stomach pain, vomiting blood or material that looks like coffee grounds, bleeding from your rectum, black sticky bowel motions, bloody diarrhoea. - sudden onset of new or progressively worsening breathing difficulties, associated with cough or fever
These symptoms may indicate interstitial lung disease.
- nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine
These may be serious side effects. You may need urgent medical attention.
This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After taking TARCEVA
Storage
Keep your tablets in their container until it is time to take them.
If you take the tablets out of their container they may not keep well.
Keep TARCEVA in a cool dry place where the temperature stays below 30°C.
Do not store it, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep TARCEVA where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking TARCEVA, or the medication has passed its expiry date, ask your pharmacist what to do with any tablets that are left over.
Product description
Availability
TARCEVA is available in three strengths, 25 mg, 100 mg and 150 mg.
Each tablet strength comes in packs of 30 tablets.
What TARCEVA looks like
- TARCEVA 25 mg tablets are white to yellowish, round tablets with "TARCEVA 25" and a logo printed in brownish yellow on one side.
- TARCEVA 100 mg tablets are white to yellowish, round tablets with "TARCEVA 100" and a logo printed in grey on one side.
- TARCEVA 150 mg tablets are white to yellowish, round tablets with "TARCEVA 150" and a logo printed in brown on one side.
Ingredients
Active ingredient
erlotinib hydrochloride
Inactive ingredients
Lactose monohydrate, microcrystalline cellulose, sodium starch glycollate, sodium lauryl sulphate, magnesium stearate
The tablets have a film-coating which contains:
hydroxypropyl cellulose, titanium dioxide, polyethylene glycol, hydroxypropyl methylcellulose
The printing ink contains:
Shellac, iron oxide yellow, anhydrous ethanol, N-butyl alcohol, isopropy alcohol, ethyl acetate. The 100 mg tablet also contains titanium dioxide and iron oxide black. The 150 mg tablet also contains iron oxide black and iron oxide red.
TARCEVA tablets are gluten free.