Tarceva 100 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tarceva 25 mg film-coated tablets

Tarceva 100 mg film-coated tablets

Tarceva 150 mg 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you get 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 this leaflet:

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

1. What Tarceva is and what it is used for

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

Tarceva is indicated for adults. Your doctor may prescribe this medicine if you have advanced non-small cell lung cancer. It may be prescribed as initial treatment or as a subsequent treatment if your disease has remained essentially unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations. It may also be prescribed if previous chemotherapy has not helped to control your disease.

Your doctor may also prescribe this medicine in combination with another treatment called gemcitabine if you have metastatic pancreatic cancer.

2. What you need to know before starting to take Tarceva

Do not take Tarceva

• if you are allergic to erlotinib or to 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., antifungal agents such as ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John’s wort (Hypericum perforatum), or proteasome inhibitors), consult your doctor. In some cases, these medicines may reduce the effectiveness or increase the adverse effects of Tarceva, so 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 thrombosis or blood clots, e.g., 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 lower blood cholesterol levels), as Tarceva may increase the risk of statin-related muscle problems, which in rare cases may lead to muscle breakdown (rhabdomyolysis) and cause 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 affecting the front part of the eye, inform your doctor.

See also below “Use of Tarceva with other medicines”.

You should discuss with your doctor:

• if you suddenly develop difficulty breathing associated with cough or fever, as your doctor may need to prescribe other medicines and interrupt your treatment with Tarceva.
• if you have diarrhoea, as your doctor may prescribe an antidiarrhoeal (e.g., loperamide).
• immediately if you experience persistent or severe diarrhoea, nausea, loss of appetite, or vomiting, as your doctor may need to interrupt Tarceva treatment and hospitalize you for treatment.
• 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 monitor liver function.
• if you experience sudden abdominal pain, severe blistering or peeling of the skin. Your doctor may need to interrupt or stop your treatment.
• if you experience worsening or sudden redness and pain in the eye, excessive tearing, blurred vision, and/or sensitivity to light, please inform your doctor or nurse immediately, as you may require urgent treatment (see section 4 “Possible side effects” below).
• if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness, or cramps. Your doctor may need to interrupt or discontinue your treatment.

See also section 4 “Possible side effects”.

Liver or kidney disease:

It is not known whether Tarceva has a different effect if your liver or kidneys are not functioning normally. Treatment with this medicine is not recommended if you have severe liver disease or severe kidney disease.

Disorders of glucuronidation, such as Gilbert’s syndrome:

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

Smoking:

It is advisable to stop smoking if you are being treated with Tarceva, as smoking may reduce the amount of this medicine in the 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:

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

Taking Tarceva with food and drink:

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 are able to become pregnant, use effective contraception during treatment and for at least 2 weeks after taking the last tablet of Tarceva.

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

You must not breastfeed while taking Tarceva, and for at least 2 weeks after taking the last tablet of Tarceva.

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 very 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 informed you of an intolerance to certain sugars, consult them before taking Tarceva.

3. How to take Tarceva

Follow exactly the instructions for using this medicine as 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 eating food.

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

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

Your doctor may adjust your dose in 50 mg increments. For this reason, Tarceva is available in 25 mg, 100 mg, and 150 mg tablets to allow for 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 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 as long as your doctor prescribes it.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the adverse effects listed below, contact your doctor as soon as possible. In some cases, your doctor may need to reduce your dose or stop your treatment with Tarceva.

• Diarrhea and vomiting (very common: may affect more than 1 in 10 people). Severe and persistent diarrhea may lead to low potassium levels in the blood and reduced kidney function, especially if you are receiving other chemotherapy treatments at the same time. If your diarrhea worsens or becomes persistent, contact your doctor immediately, as you may require 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 type of lung irritation called interstitial lung disease (uncommon in European patients; common in patients of Japanese origin: may affect up to 1 in 100 people in Europe and up to 1 in 10 people in Japan). This condition may also be related to the natural progression of your disease and, in some cases, may be fatal. If you suddenly develop symptoms such as difficulty breathing associated with cough or fever, contact your doctor immediately, as you may be experiencing this condition. Your doctor may decide to permanently discontinue 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 your risk of gastrointestinal perforation.

• Rarely, liver inflammation (hepatitis) has been observed (may affect up to 1 in 1,000 people). Symptoms may include a general feeling of being unwell, 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 serious changes in liver function, your doctor may need to discontinue your treatment.

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

• Skin rashes that may appear or worsen in sun-exposed areas. If you are exposed to sunlight, it is advisable to wear protective clothing and/or use sunscreen (e.g. containing mineral-based ingredients)
• Infection
• Loss of appetite, weight loss
• Depression
• Headache, skin tingling or numbness in the limbs
• Difficulty breathing, cough
• Nausea
• Mouth irritation
• Stomach pain, indigestion, flatulence
• Abnormal blood test results used to monitor liver function
• Itching
• Fatigue, fever, stiffness

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

• Dry skin
• Hair loss
• Nosebleeds
• Stomach or intestinal bleeding
• Inflammatory reactions around the nails
• Hair follicle infection
• Acne
• Skin cracks (skin fissures)
• Reduced kidney function (when used outside approved indications in combination with chemotherapy)

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

• Inflammation of the kidneys (nephritis)
• Excess protein in the urine (proteinuria)
• Changes in eyelashes
• Excessive body and facial hair with a male pattern distribution
• Excessive skin pigmentation
• Changes in eyebrows
• Brittle or loose nails

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

• Pain, redness, or tingling in the hands and/or feet (palmar-plantar erythrodysesthesia syndrome).

Very rare adverse 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 adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 stated on the carton after EXP or CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tarceva

• The active substance in 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 regarding 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 in colour, engraved with “T 25” on one side, and available in packs of 30 tablets.

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

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

Marketing Authorisation Holder

CHEPLAPHARM Registration GmbH
Weiler Straße 5e
79540 Lörrach
Germany

Manufacturer

Delpharm Milano S.r.l.
Via Carnevale 1
20054 Segrate
Italy

CHEPLAPHARM Registration GmbH
Weiler Straße 5e
79540 Lörrach
Germany

Date of the most recent revision of this leaflet:

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