Tarceva 25 mg film-coated tablets

Tarceva is a medicine used to treat cancer by preventing 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.

This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage. It can be prescribed either if your disease remains largely unchanged after initial chemotherapy, or if previous chemotherapy has not helped to stop your disease.

This medicine can also be prescribed to you in combination with another treatment called gemcitabine if you have cancer of the pancreas at a metastatic stage.

You should not take Tarceva:

• if you are allergic (hypersensitive) to erlotinib or to any of the ingredients of Tarceva.

Take special care during treatment with Tarceva:

• if you are taking other medicines that may increase or decrease the amount of erlotinib in your blood (for example antifungals like ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine or St. John?s Wort). 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 might avoid treating you with these medicines while you are receiving Tarceva.
• if you are taking anticoagulants (a medicine which helps to prevent thrombosis or blood clotting e.g. warfarin), Tarceva may increase your tendency to bleed and your doctor will need to regularly monitor you with some blood tests.
• if you are taking statins (medicines to lower your blood cholesterol), Tarceva may increase the risk of statin related muscle problems, which on rare occasions can lead to serious muscle breakdown (rhabdomyolysis) resulting in kidney damage.

See also below ?Taking other medicines?.

You should tell your doctor:

• if you have sudden difficulty in breathing associated with cough or fever because your doctor may need to treat you with other medicines and interrupt your Tarceva treatment;
• if you have diarrhoea because your doctor may need to treat you with anti-diarrhoeal (for example loperamide);
• immediately, if you have severe or persistent diarrhoea, nausea, loss of appetite, or vomiting because your doctor may need to interrupt your Tarceva treatment and may need to treat you inthe hospital;
• if you have severe pain in the abdomen, severe blistering or peeling of skin, or acute or worsening eye problems (for example eye pain). Your doctor may need to interrupt or stop your treatment.
• if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness or cramps. Your doctor may need to interrupt or stop your treatment.

See also section 4 ?Possible side effects?.

It is not known whether Tarceva has a different effect if your liver or kidneys are not functioning normally. The treatment with this medicine is not recommended if you have a severe liver disease or severe kidney disease.
Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert?s syndrome.
You are advised to stop smoking if you are treated with Tarceva as smoking could decrease the amount of your medicine in the blood.

Children and adolescents
Tarceva has not been studied in patients under the age of 18 years. The treatment with this medicine is not recommended for children and adolescents.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Tarceva with food and drink
Do not take Tarceva with food.

Pregnancy and breast-feeding

Avoid pregnancy while being treated with Tarceva. If you could become pregnant, use adequate contraception during treatment, and 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 who will decide if the treatment should be continued.
Ask your doctor or pharmacist for advice before taking any medicine.
Do not breast-feed if you are being treated with Tarceva.

Driving and using machines
Tarceva has not been studied for its possible effects on the ability to drive and use machines but it is very unlikely that your treatment will affect this ability.

Important information about some of the ingredients of Tarceva

Tarceva contains a sugar called lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tarceva.

Always take Tarceva exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

The usual dose is one tablet of Tarceva 150 mg each day if you have non-small cell lung cancer. The usual dose is one tablet of Tarceva 100 mg each day if you have metastatic pancreatic cancer. Tarceva is given in combination with gemcitabine treatment.

Your doctor may adjust your dose in 50 mg steps. For the different dose regimens Tarceva is available in strengths of 25 mg, 100 mg or 150 mg.

If you take more Tarceva than you should
Contact your doctor or pharmacist immediately.
You may have increased side effects and your doctor may interrupt your treatment.

If you forget to take Tarceva
If you miss 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 a forgotten dose.

If you stop taking Tarceva
It is important to keep taking Tarceva every day, as long as your doctor prescribes it for you. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Tarceva can cause side effects.

These side effects may occur with certain frequencies, which are defined as follows:

• very common: occurring in more than 1 out of 10 patients
• common: occurring in less than 1 out of 10 patients
• uncommon: occurring in less than 1 out of 100 patients
• rare: occurring in less than 1 out of 1000 patients
• very rare: occuring in less than 1 out of 10,000 patients

Contact your doctor as soon as possible if you suffer from any of the below side effects. In some cases your doctor may need to reduce your dose of Tarceva or interrupt treatment:

• Diarrhoea and vomiting (very common). Persistent and severe diarrhoea may lead to low blood potassium and kidney failure, particularly if you receive other chemotherapy treatments at the same time. If you experience more severe or persistent diarrhoea contact your doctor immediately as your doctor may need to treat you in the hospital.
• Eye irritation due to conjunctivitis/keratoconjunctivitis (very common) and keratitis (common).
• Rare form of lung irritation called interstitial lung disease (uncommon). This disease can also be linked to the natural progression of your medical condition and can have a fatal outcome in some cases. If you develop symptoms such as sudden difficulty in breathing associated with cough or fever contact your doctor immediately as you could suffer from this disease. Your doctor may decide to permanently stop your treatment with Tarceva.
• Gastrointestinal perforations (uncommon) have been observed. Tell your doctor if you have severe pain in your abdomen. Also, tell your doctor if you had peptic ulcers or diverticular disease in the past, as this may increase this risk.
• In rare cases liver failure was observed (rare). If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment

Very common side effects (occurring in more than 1 out of 10 patients):

• Rash which may occur or worsen in sun exposed areas. If you are exposed to sun, protective clothing, and/or use of sun screen (e.g. mineral-containing) may be advisable
• Infection
• Loss of appetite, decreased weight
• Depression
• Headache, altered skin sensation or numbness in the extremities
• Difficulty in breathing, cough
• Nausea
• Mouth irritation
• Stomach pain, indigestion and flatulence
• Abnormal blood tests for the liver function
• Itching, dry skin and loss of hair
• Tiredness, fever, rigors

Common side effects (occurring in less than 1 out of 10 patients):

• Bleeding from the nose
• Bleeding from the stomach or the intestines
• Inflammatory reactions around the fingernail
• Cracked skin (skin fissures)

Uncommon side effects (occurring in less than 1 out of 100 patients)

• Eyelash changes
• Excess body and facial hair of a male distribution pattern
• Eyebrow changes
• Brittle and loose nails

Very rare side effects (in less than 1 out of 10,000 patients):

• Cases of perforation or ulceration of the cornea
• Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Tarceva after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.

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 to protect the environment.

What Tarceva contains:

• The active substance of Tarceva is erlotinib. Each film-coated tablet contains 25 mg, 100 mg or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the strength.
• The other ingredients are: Tablet core: lactose monohydrate, cellulose microcrystalline, sodium starch glycolate type A, sodium laurilsulfate, magnesium stearate. Tablet coat:hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol. Printing ink: Tarceva 25 mg: shellac, iron oxide yellow Tarceva 100 mg: shellac, iron oxide yellow, iron oxide black, titanium dioxide Tarceva 150 mg: shellac, iron oxide red

What Tarceva looks like and contents of the pack:

Tarceva 25 mg is supplied as a white to yellowish, round, film-coated tablet with ?Tarceva 25? and logo printed in brownish yellow on one side and is available in pack sizes of 30 tablets. Tarceva 100 mg is supplied as a white to yellowish, round, film-coated tablet with ?Tarceva 100? and logo printed in grey on one side and is available in pack sizes of 30 tablets.
Tarceva 150 mg is supplied as a white to yellowish, round, film-coated tablet with ?Tarceva 150? and logo printed in brown on one side and is available in pack sizes of 30 tablets.

Marketing Authorisation Holder
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturer

Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

LuxembourgLuxemburg Voirsiehe BelgiqueBelgien BelgiëBelgiqueBelgien N.V. Roche S.A. TélTel 32 0 2 525 82 11

359 2 818 44 44 Magyarország Roche Magyarország Kft. Tel 36 - 23 446 800

Malta See United Kingdom eská republika Roche s. r. o. Tel 420 - 2 20382111

Danmark Roche as Tlf 45 - 36 39 99 99 Nederland Roche Nederland B.V. Tel 31 0 348 438050

Deutschland Roche Pharma AG Tel 49 0 7624 140 Norge Roche Norge AS Tlf 47 - 22 78 90 00

Eesti Roche Eesti OÜ Tel 372 - 6 177 380 Österreich Roche Austria GmbH Tel 43 0 1 27739

Roche Hellas A.E. 30 210 61 66 100 Polska Roche Polska Sp.z o.o. Tel 48 - 22 345 18 88

España Roche Farma S.A. Tel 34 - 91 324 81 00 Portugal Roche Farmacêutica Química, Lda Tel 351 - 21 425 70 00

France Roche Tél 33 0 1 46 40 50 00 România Roche România S.R.L. Tel 40 21 206 47 01

Ireland Roche Products Ireland Ltd. Tel 353 0 1 469 0700 Slovenija Roche farmacevtska druba d.o.o. Tel 386 - 1 360 26 00

Slovenská republika Roche Slovensko, s.r.o. Tel 421 - 2 52638201 Ísland Roche as co Icepharma hf Sími 354 540 8000

Italia Roche S.p.A. Tel 39 - 039 2471 SuomiFinland Roche Oy PuhTel 358 0 10 554 500

K .. . 357 - 22 76 62 76 Sverige Roche AB Tel 46 0 8 726 1200

Latvija Roche Latvija SIA Tel 371 - 6 7 039831 United Kingdom Roche Products Ltd. Tel 44 0 1707 366000

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Tel: +370 5 2546799

This leaflet was last approved in.