TARCEVA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tarceva 25mg film-coated tablets

Tarceva 100mg film-coated tablets

Tarceva 150mg film-coated tablets

erlotinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

? Keep this leaflet, you may need to read it again.

? If you have any further questions, ask your doctor or pharmacist.

? This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

? If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Tarceva and what is it used for
2. What you need to know before you take Tarceva
3. How to take Tarceva
4. Possible side effects
5. Storage of Tarceva
6. Contents of the pack and further information

1. What is Tarceva and what is it used for

Tarceva contains the active substance erlotinib. Tarceva is a medicine used to treat cancer and works by preventing the activity of a protein called epidermal growth factor receptor (EGFR). This protein is known to be involved in the growth and spread of cancer cells.

Tarceva is indicated for adults. You may be prescribed this medicine if you have advanced non-small cell lung cancer. It may be prescribed as initial treatment or as treatment if your disease remains virtually unchanged after initial chemotherapy, since your cancer cells have specific mutations in the EGFR. It may also be prescribed if previous chemotherapy has not helped to control your disease.

You may also be prescribed this medicine in combination with another treatment called gemcitabine if you have metastatic pancreatic cancer.

2. What you need to know before you take Tarceva

Do not take Tarceva

? if you are allergic to erlotinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

? if you are taking other medicines that may increase or decrease the amount of erlotinib in your blood or affect its action (e.g. antifungals such as ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John's Wort or proteasome inhibitors), consult your doctor. In some cases, these medicines may reduce the efficacy or increase the side effects of Tarceva, and your doctor may need to adjust your treatment. Your doctor should avoid treating you with these medicines while you are taking Tarceva.

? if you take anticoagulants (medicines that help prevent the formation of blood clots, e.g. warfarin) as Tarceva may make you more prone to bleeding. Consult your doctor, he will need to have regular blood tests done.

? if you are taking statins (medicines that lower blood cholesterol levels), as Tarceva may increase the risk of muscle problems associated with statins, which can rarely lead to muscle breakdown (rhabdomyolysis) causing kidney damage. Consult your doctor.

? if you wear contact lenses and/or have a history of eye problems such as very dry eyes, inflammation of the front part of the eye (cornea) or ulcers that affect the front part of the eye, inform your doctor.

See also "Using Tarceva with other medicines" below.

You should tell your doctor:

? if you suddenly have difficulty breathing associated with cough or fever, as your doctor may need to give you other medicines and interrupt your treatment with Tarceva.

? if you have diarrhea, as your doctor may need to give you an anti-diarrheal (e.g. loperamide).

? immediately if you have persistent or severe diarrhea, nausea, loss of appetite or vomiting, as your doctor may need to interrupt Tarceva administration and treat you in the hospital.

• ? if you have ever had liver problems. Tarceva can cause serious liver problems, and some cases have been fatal. Your doctor may perform blood tests while you are taking this medicine to check if your liver is working properly.

? if you have severe abdominal pain, blisters, or severe skin peeling. Your doctor may need to interrupt or stop your treatment.

? if you experience worsening or acute redness and pain in the eye, increased tearing, blurred vision, and/or sensitivity to light, please inform your doctor or nurse immediately, as you may need urgent treatment (see also section 4 "Possible side effects").

? if you are also taking a statin and experience unexplained muscle pain, pain when touched, weakness, or cramps. Your doctor may need to interrupt or stop your treatment.

See also section 4 "Possible side effects".

Liver or kidney disease:

It is not known if Tarceva has a different effect in case of abnormal liver or kidney function. Treatment with this medicine is not recommended if you have severe liver or kidney disease.

Glucuronidation disorder, such as Gilbert's syndrome

If you have a glucuronidation disorder, such as Gilbert's syndrome, your doctor should administer Tarceva treatment with caution.

Smokers

It is recommended that you stop smoking if you are being treated with Tarceva, as smoking may decrease the amount of this medicine in your blood.

Children and adolescents

Tarceva has not been studied in patients under 18 years of age. Treatment with this medicine is not recommended in children and adolescents.

Other medicines and Tarceva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Tarceva with food and drinks

Do not take Tarceva with food. See also section 3 "How to take Tarceva".

Pregnancy and breastfeeding

Avoid becoming pregnant while taking Tarceva. If you can become pregnant, use adequate contraceptive methods during treatment and for at least 2 weeks after taking the last Tarceva tablet.

If you become pregnant while taking Tarceva, inform your doctor immediately, as he will decide whether or not to continue treatment.

Do not breastfeed your baby if you are taking Tarceva, for at least 2 weeks after taking the last Tarceva tablet.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

The possible effects of Tarceva on the ability to drive and use machines have not been studied, but it is unlikely that your treatment will affect this ability.

Tarceva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

Tarceva contains a sugar called lactose monohydrate.

If your doctor has told you that you have an intolerance to some sugars, consult him before taking Tarceva.

3. How to take Tarceva

Follow exactly the instructions of administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The tablet should be taken at least one hour before or two hours after food intake.

The recommended dose is one Tarceva 150 mg tablet per day if you have non-small cell lung cancer.

The recommended dose is one Tarceva 100 mg tablet per day if you have metastatic pancreatic cancer. Tarceva is used in combination with gemcitabine.

Your doctor may adjust your dose in 50 mg intervals. For this reason, Tarceva is available in 25 mg, 100 mg, and 150 mg doses to adjust to different dosing regimens.

If you take more Tarceva than you should

Contact your doctor or pharmacist immediately.

You may experience an increased risk of side effects, and your doctor may need to interrupt your treatment.

If you forget to take Tarceva

If you forget to take one or more doses of Tarceva, contact your doctor or pharmacist as soon as possible.

Do not take a double dose to make up for forgotten doses.

If you stop taking Tarceva

It is important to take Tarceva every day and for the entire duration prescribed by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the side effects mentioned, contact your doctor as soon as possible. In some cases, your doctor may need to reduce your dose or interrupt your treatment with Tarceva.

• Diarrhea and vomiting (very common: may affect more than 1 in 10 people). Severe and persistent diarrhea can lead to decreased potassium levels in the blood and decreased kidney function, especially if you are being treated with other chemotherapeutic treatments at the same time. If your diarrhea worsens or becomes persistent, contact your doctor immediately, as your doctor may need to administer hospital treatment.

? Eye irritation due to keratoconjunctivitis (very common: may affect more than 1 in 10 people), conjunctivitis, and keratitis (common: may affect up to 1 in 10 people).

? A form of lung irritation called interstitial lung disease (uncommon in European patients; common in Japanese patients: may affect up to 1 in 100 people in Europe and up to 1 in 10 people in Japan). This disease can also be related to the natural progression of your disease, and in some cases, it can be fatal. If you suddenly experience symptoms such as difficulty breathing associated with cough or fever, contact your doctor immediately, as you may have this disease. Your doctor may decide to permanently interrupt your treatment with Tarceva.

? Gastrointestinal perforations have been observed (uncommon: may affect up to 1 in 100 people). If you experience severe abdominal pain, inform your doctor. Also, inform your doctor if you have previously had a peptic ulcer or diverticular disease, as this may increase the risk of gastrointestinal perforations.

? In rare cases, liver inflammation (hepatitis) has been observed (may affect up to 1 in 1,000 people). Symptoms may include a general feeling of discomfort, with or without possible jaundice (yellowing of the skin and eyes), dark urine, nausea, vomiting, and abdominal pain. In rare cases, liver failure has been observed. This can be potentially fatal. If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment.

Very common side effects(may affect more than 1 in 10 people):

? Rashes that may appear or worsen in sun-exposed areas. If you are exposed to the sun, it is recommended that you use protective clothing and/or sunscreen (e.g. containing minerals)

? Infection

? Loss of appetite, weight loss

? Depression

? Headache, sensation of alteration in the skin or numbness in the limbs

? Difficulty breathing, cough

? Nausea

? Mouth irritation

? Stomach pain, indigestion, and flatulence

? Abnormal blood test results for liver function

? Itching

? Fatigue, fever, stiffness

Common side effects(may affect up to 1 in 10 people):

? Dry skin

? Hair loss

? Nosebleeds

? Bleeding in the stomach or intestine

? Inflammatory reactions around the nail

? Infection of the hair follicles

? Acne

? Skin cracks (fissures in the skin)

? Reduced kidney function (when given off-label in combination with chemotherapy)

Uncommon side effects(may affect up to 1 in 100 people):

? Kidney inflammation (nephritis)

? Excess protein in the urine (proteinuria)

? Change in eyelashes

? Excessive body and facial hair with a male distribution pattern.

? Excessive skin pigmentation

? Changes in eyebrows

? Brittle and loose nails

Rare side effects(may affect up to 1 in 1,000 people):

? Pain and redness or tingling of the hands and/or feet (palmar-plantar erythrodysesthesia syndrome).

Very rare side effects(may affect up to 1 in 10,000 people):

? Cases of corneal ulcers or perforation

? Blisters or severe skin peeling (indicative of Stevens-Johnson syndrome)

? Inflammation of the colored part of the eye (iris)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tarceva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP or CAD. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition of Tarceva

? The active ingredientof Tarceva is erlotinib. Each film-coated tablet contains 25, 100 or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the dose.

? The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, magnesium stearate (see also section 2 for lactose monohydrate).

Tablet coating: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.

Appearance of the Product and Container Contents

Tarceva 25 mg is presented in the form of a film-coated tablet, round, white to yellowish in color with the engraving “T 25” on one side and is available in packs of 30 tablets.

Tarceva 100 mg is presented in the form of a film-coated tablet, round, white to yellowish in color with the engraving “T 100” on one side and is available in packs of 30 tablets.

Tarceva 150 mg is presented in the form of a film-coated tablet, round, white to yellowish in color with the engraving “T 150” on one side and is available in packs of 30 tablets.

Marketing Authorization Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barrell-Str. 1

D-79639 Grenzach-Wyhlen

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.