Tarceva

Package leaflet: Information for the user

Tarceva 25 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets

erlotinib
Please 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. 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 inhibiting the activity of a protein called epidermal growth factor receptor (EGFR); this protein is involved in the growth and spread of cancer cells.
Tarceva is indicated for adults. This medicine may be prescribed to you if you have advanced non-small cell lung cancer. It may be prescribed as initial therapy or as a therapy if the disease has remained largely unchanged after initial chemotherapy, provided that the tumour cells have specific EGFR mutations. It may also be prescribed if previous chemotherapy has failed to stop the disease.
This medicine may also be prescribed in combination with another treatment called gemcitabine if you have metastatic pancreatic cancer.

2. What you should know before taking Tarceva

Do not take Tarceva

• if you are allergic to erlotinib or to any of the excipients of this medicine (listed in section 6).

Warnings and precautions

• if you are taking other medicines that may increase or reduce the amount of erlotinib in your blood or affect its efficacy (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 reduce the efficacy or increase the side effects of Tarceva, and your doctor may need to adjust your treatment. Your doctor may decide that you should not take these medicines during treatment with Tarceva.
• if you are taking anticoagulants (medicines that help prevent thrombosis or blood clotting, e.g. warfarin), Tarceva may increase your tendency to bleed. Consult your doctor, who will need to monitor you and periodically prescribe blood tests.
• if you are taking statins (medicines to lower blood cholesterol), Tarceva may increase the risk of statin-related muscle problems, which in rare cases may lead to severe muscle breakdown (rhabdomyolysis) and subsequent kidney damage. Consult your doctor.
• if you wear contact lenses and/or have previously had eye problems such as severe dry eyes, inflammation of the surface of the eye (cornea), or ulcers affecting the front of the eye, consult your doctor.

See also “Other medicines and Tarceva”.
You must inform your doctor:

• if you experience sudden difficulty breathing associated with cough or fever, as your doctor may need to prescribe other medicines and interrupt treatment with Tarceva;
• if you have diarrhoea, as your doctor may need to prescribe anti-diarrhoeal medicines (e.g. loperamide);
• immediately if you have severe or persistent diarrhoea, nausea, loss of appetite or vomiting, as your doctor may need to interrupt treatment with Tarceva and hospital treatment may be required;
• 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 whether your liver is functioning properly;
• if you have severe abdominal pain or serious skin reactions such as blistering or peeling. Your doctor may consider it necessary to interrupt or stop treatment.
• if you develop sudden redness of the eyes or worsening of existing redness accompanied by pain, increased tearing, blurred vision and/or sensitivity to light, discuss this immediately with your doctor or nurse, as urgent treatment may be required (see section 4 “Possible side effects”).
• if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness or cramps. Your doctor may consider it necessary to interrupt or stop treatment.

See also section 4 “Possible side effects”.
Liver and kidney disorders
It is not known whether the effects of Tarceva change if the liver or kidneys are not functioning normally. Treatment with this medicine is not recommended if you have severe liver or kidney disease.
Glucuronidation disorders such as Gilbert’s syndrome
If you have a glucuronidation disorder such as Gilbert’s syndrome, your doctor should treat you with caution.
Smoking
If you are taking Tarceva, you must stop smoking, as smoking can reduce the amount of 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
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 during treatment with Tarceva. If you think you might become pregnant, use an adequate method of contraception during treatment and for at least 2 weeks after taking the last tablet.
If you become pregnant during treatment with Tarceva, inform your doctor immediately. Your doctor will decide whether it is appropriate to continue treatment.
Do not breastfeed during treatment with Tarceva and for at least 2 weeks after taking the last tablet.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No studies have been conducted on the possible effects of Tarceva on the ability to drive and use machines, but it is very unlikely that the treatment will impair this ability.
Tarceva contains sodium
This medicine contains less than 1 mmol (less than 23 mg) of sodium per tablet, i.e. Tarceva 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, contact your doctor before taking Tarceva.

3. How to take Tarceva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The tablet should be taken at least one hour before or two hours after eating food.
The usual dose is one 150 mg Tarceva tablet daily if you have non-small cell lung cancer.
The usual dose is one 100 mg Tarceva tablet daily if you have metastatic pancreatic cancer. Tarceva is administered in combination with gemcitabine.
Your doctor may adjust the dose in increments of 50 mg. For different dosage regimens, Tarceva is available in 25 mg, 100 mg, or 150 mg tablets.
If you take more Tarceva than you should
Contact your doctor or pharmacist immediately.
Side effects may worsen, and your doctor may instruct you to stop 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 the missed dose.
If you stop taking Tarceva
It is important to continue taking Tarceva every day for the full duration prescribed by your doctor.
If you have any questions about using this medicine, consult 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 listed below, contact your doctor as soon as possible. In some cases, your doctor may need to reduce the dose of Tarceva or stop treatment.

• Diarrhoea and vomiting (very common, may affect more than 1 in 10 people). Persistent and severe diarrhoea may lead to low potassium levels in the blood and kidney failure, especially if you are also receiving other chemotherapy drugs. If you have severe or persistent diarrhoea, contact your doctor immediately, as you may require treatment in hospital.
• 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 inflammation called interstitial lung disease (uncommon in European patients, common in Japanese patients: may affect up to 1 in 100 patients in Europe and up to 1 in 10 in Japan). This condition may also be related to the natural progression of your underlying medical condition and, in some cases, may be fatal. If you experience symptoms such as sudden difficulty in breathing associated with cough or fever, seek immediate medical advice, as you may have this condition. Your doctor may decide to permanently discontinue Tarceva treatment.
• Cases of gastrointestinal perforation have been observed (uncommon, may affect up to 1 in 100 people). Inform your doctor if you experience severe abdominal pain. Also inform your doctor if you have previously had peptic ulcer or diverticular disease, as these may increase the risk of perforation.
• In rare cases (may affect up to 1 in 1,000 people), liver inflammation (hepatitis) has been observed. Symptoms may include general malaise, with or without possible jaundice (yellowing of the skin and eyes), dark urine, nausea, vomiting, and abdominal pain. In rare cases, liver failure has occurred, which may be potentially fatal. If your blood tests indicate severe abnormalities in liver function, your doctor may decide to stop treatment.

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

• Skin rash, which may appear or worsen in sun-exposed areas. If you go out in the sun, it is advisable to wear protective clothing and/or use sunscreens (e.g. based on mineral substances)
• Infection
• Loss of appetite, weight loss
• Depression
• Headache, altered skin sensation or numbness of the extremities
• Difficulty breathing, cough
• Nausea
• Mouth irritation
• Stomach pain, indigestion and flatulence
• Changes in blood tests relating to liver function
• Itching
• Tiredness, fever, chills

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

• Dry skin
• Hair loss
• Nosebleeds
• Bleeding from the stomach or intestine
• Inflammatory reactions around the nails
• Infection of hair follicles
• Acne
• Cracked skin (skin fissures)
• Reduced kidney function (when administered outside the approved indications in combination with chemotherapy)

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

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

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

• Redness or pain on the palms of the hands or soles of the feet (palmar-plantar erythrodysesthesia syndrome)

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

• Cases of corneal ulceration or perforation
• Severe skin reactions such as blistering or peeling (indicative of Stevens-Johnson syndrome)
• Inflammation of the coloured part of the eye (uveitis)

Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 blister and carton after
EXP/Scad. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tarceva contains:

• The active substance in Tarceva is erlotinib. Each film-coated tablet contains 25 mg, 100 mg or 150 mg of erlotinib (as erlotinib hydrochloride), depending on the dosage.
• The excipients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate type A, sodium lauryl sulfate, magnesium stearate (see section 2 regarding lactose monohydrate and sodium). Tablet coating: hypromellose, hydroxypropylcellulose, titanium dioxide, macrogol.

Description of the appearance of Tarceva and contents of the pack:
Tarceva 25 mg is supplied as a yellowish-white, round, film-coated tablet, with the inscription “T 25” engraved on one side, and is available in packs of 30 tablets.
Tarceva 100 mg is supplied as a yellowish-white, round, film-coated tablet, with the inscription “T 100” engraved on one side, and is available in packs of 30 tablets.
Tarceva 150 mg is supplied as a yellowish-white, round, film-coated tablet, with the inscription “T 150” engraved on one side, and is available in packs of 30 tablets.
Marketing Authorisation Holder
CHEPLAPHARM Registration GmbH
Weiler Straße 5 E
79540 Lörrach
Germany
Manufacturer
Roche Pharma AG
Emil-Barell-Straße 1
D-79639 Grenzach-Wyhlen
Germany
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.