Prospect: information for the user

Tarceva 25mg film-coated tablets

Tarceva 100mg film-coated tablets

Tarceva 150mg film-coated tablets

erlotinib

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

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

?If you have any doubts, consult your doctor or pharmacist.

?This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.

?If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Tarceva and what it is used for

2.What you need to know before taking Tarceva

3.How to take Tarceva

4.Possible adverse effects

5.Storage of Tarceva

6.Contents of the pack and additional information

Tarceva contains the active ingredient erlotinib. Tarceva is a medication used to treat cancer and works by preventing the activity of a protein called the epidermal growth factor receptor (EGFR). It is known that this protein is involved in the growth and spread of tumor cells.

Tarceva is indicated for adults. Your doctor may prescribe this medication if you have non-small cell lung cancer in an advanced state. They may prescribe it as initial treatment or as treatment if your disease remains practically unchanged after initial chemotherapy, since your cancer cells present specific mutations in the EGFR. They may also prescribe it if previous chemotherapy has not helped to slow your disease.

Your doctor may also prescribe this medication in combination with another treatment called gemcitabina if you have pancreatic cancer in a metastatic state.

Do not take Tarceva

?if you are allergic to erlotinib or any of the other ingredients in 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 effect (for example, 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 decrease the effectiveness or increase the adverse effects of Tarceva and, therefore, your doctor may need to adjust your treatment. Your doctor should avoid treating you with these medicines while you are taking Tarceva.

?if you are taking anticoagulants (medicines that help prevent the formation of blood clots or thrombi, for example, warfarin) as Tarceva may make you more prone to bleeding. Consult your doctor, who will need to perform regular blood tests.

?if you are taking statins (medicines that decrease the level of cholesterol in the blood), as Tarceva may increase the risk of muscle-related problems associated with statin use, which, in rare cases, may lead to muscle degradation (rhabdomyolysis) causing kidney damage, consult your doctor.

?if you use 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 involve the front part of the eye, inform your doctor.

See also below “Tarceva use with other medicines”.

You must inform your doctor:

?if you havesuddendifficulty breathing associated with cough or fever as, if so, 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 (for example, loperamide).

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

• if you have ever had liver problems. Tarceva may cause severe liver problems and some cases have been fatal. Your doctor may perform blood tests while you are taking this medicine to control whether your liver is functioning correctly.

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

?if you experience acute worsening or redness and pain in the eye, increased tearing, blurred vision and/or light sensitivity, please inform your doctor or nurse immediately as you may need urgent treatment (see below Possible Adverse Effects).

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

See also section 4 “Possible adverse effects”.

Liver or kidney disease:

Tarceva has not been studied in patients with liver or kidney disease. It is not recommended to treat patients with severe liver disease or severe kidney disease.

Glucuronidation disorder, such as Gilbert's syndrome

If you have a glucuronidation disorder, such as Gilbert's syndrome, your doctor will need to administer Tarceva 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 the blood.

Children and adolescents

Tarceva has not been studied in patients under 18 years of age. It is not recommended to treat children and adolescents.

Other medicines and Tarceva

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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 appropriate 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 they will decide whether to continue or discontinue treatment.

You should not breastfeed your baby while 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 intend to become pregnant, consult your doctor or pharmacist before using 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 highly 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 certain sugars, consult with them before taking Tarceva.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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 doses of 25 mg, 100 mg, and 150 mg to adjust different dosing regimens.

If you take more Tarceva than you should

Contact your doctor or pharmacist immediately.

You may experience an increase in adverse effects, and your doctor may have 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 compensate for the missed doses.

If you interrupt treatment with Tarceva

It is essential to take Tarceva every day and for the entire time your doctor prescribes it.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 stop treatment with Tarceva.

• Diarrhea and vomiting (very common: may affect more than 1 in 10 people). Severe and persistent diarrhea can cause a decrease in blood potassium levels and kidney function, especially if you are being treated with other chemotherapy treatments at the same time. If your diarrhea worsens or persists, contact your doctor immediately, as your doctor may need to administer hospital treatment.contact your doctor immediatelysince 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 (rare 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 may also be related to the natural progression of your disease and, in some cases, may be fatal. If you suddenly experience symptoms such as difficulty breathing associated with cough or fever, contact your doctor immediately, as you may be suffering from this disease. Your doctor may decide to permanently stop your treatment with Tarceva.

?Gastrointestinal perforations (rare: may affect up to 1 in 100 people). If you have intense 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) (may affect up to 1 in 1,000 people) has been observed. 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 may be potentially fatal. If your blood tests indicate severe changes in your liver function, your doctor may need to stop 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 wear protective clothing and/or use sunscreen (e.g. containing minerals).

?Infection

?Loss of appetite, weight loss

?Depression

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

?Difficulty breathing, cough

?Nausea

?Mouth irritation

?Abdominal pain, indigestion, and flatulence

?Abnormal results in blood tests performed to check liver function

?Itching

?Fatigue, fever, stiffness

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

?Dry skin

?Hair loss

?Nasal bleeding

?Gastrointestinal bleeding

?Inflammatory reactions around the nail

?Folliculitis

?Acne

?Cracks in the skin (skin fissures)

?Reduced kidney function (when given outside approved indications in combination with chemotherapy)

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

?Kidney inflammation (nephritis)

?Excessive protein in urine (proteinuria)

?Changes 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 (erythromelalgia).

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

?Cases of corneal ulceration or perforation

?Severe blistering or peeling of the skin (indicative of Stevens-Johnson syndrome)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after EXP or CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Tarceva

? The active ingredient of 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 glycolate starch, 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 contents of the pack

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

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

Tarceva 150 mg is presented as a film-coated tablet, round, white to yellowish with the imprint “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

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics

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