Tarceva
erlotinib
Keep this leaflet. You may need to read it again.
If you have 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Tarceva is and what it is used for
What you need to know before you take Tarceva
How to take Tarceva
Possible side effects
How to store Tarceva
Contents of the pack and other information
Tarceva contains the active substance erlotinib. Tarceva is a medicine used to treat cancer 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. This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage. It can be prescribed as initial therapy or as therapy if your disease remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations. It can also be prescribed 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.
if you are allergic to erlotinib or any of the ingredients of this medicine (listed in section 6).
if you are taking other medicines that may increase or decrease the amount of erlotinib in your blood or influence its effect (for example antifungals like ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John’s Wort or proteasome inhibitors), talk to 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 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. Talk to your doctor, he 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, talk to your doctor.
if you use contact lenses and/or have a history of eye problems such as severe dry eyes, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye, tell your doctor.
See also below “Other medicines and Tarceva” 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 in the hospital;
if you have severe pain in the abdomen, severe blistering or peeling of skin. Your doctor may need to interrupt or stop your treatment;
if you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light, please tell your doctor or nurse immediately as you may need urgent treatment (see 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 stop 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. The treatment with this medicine is not recommended if you have a severe liver disease or severe kidney disease.
Glucuronidation disorder like Gilbert’s syndrome
Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert’s syndrome.
Smoking
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.
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines or might take
any other medicines.
Do not take Tarceva with food. See also section 3 ‘How to take Tarceva’
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.
Do not breast-feed if you are being treated with Tarceva, and for at least 2 weeks after taking the last tablet.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
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.
Tarceva contains sodium
This medicine contains less than 1 mmol sodium (less than 23 mg) per tablet, that is to say Tarceva is essentially ‘sodium -free’.
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 this medicine 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.
Contact your doctor or pharmacist immediately.
You may have increased side effects and your doctor may interrupt your treatment.
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.
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, this medicine can cause side effects, although not everybody gets them.
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: may affect more than 1 out of 10 people).
Persistent and severe diarrhoea may lead to low blood potassium and impairment of your kidney function, particularly if you receive other chemotherapy treatments at the same
time. If you experience more severe or persistent diarrhoea contact your doctor
Eye irritation due to conjunctivitis/keratoconjunctivitis (very common: may affect more than 1 out of 10 people) and keratitis (common: may affect up to 1 in 10 people).
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 in Japan). 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 have been observed (uncommon: may affect up to 1 in 100 people). 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: may affect up to 1 in 1,000 people). If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment.
Rash which may occur or worsen in sun exposed areas. If you are exposed to sun, protective clothing, and/or use of sunscreen (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
Bleeding from the nose
Bleeding from the stomach or the intestines
Inflammatory reactions around the fingernail
Infection of hair follicles
Acne
Cracked skin (skin fissures)
Reduced kidney function (when given outside the approved indications in combination with chemotherapy)
Eyelash changes
Excess body and facial hair of a male distribution pattern
Eyebrow changes
Brittle and loose nails
Flushed or painful palms or soles (Palmar plantar erythrodysaesthesia syndrome)
Cases of perforation or ulceration of the cornea
Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome)
Inflammation of the coloured part of the eye
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Tablet core: lactose monohydrate, cellulose microcrystalline, sodium starch glycolate type A, sodium laurilsulfate, magnesium stearate (see also section 2 for lactose monohydrate and
sodium).
Tablet coat: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.
Tarceva 25 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 25’ engraved 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 ‘T 100’ engraved 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 ‘T 150’ engraved
on one side and is available in pack sizes of 30 tablets.
Roche Registration GmbH Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen Germany
D-79639 Grenzach-Wyhlen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
N.V. Roche S.A.
Tél/Tel: +32 (0) 2 525 82 11
UAB “Roche Lietuva”
Tel: +370 5 2546799
Рош България ЕООД Тел: +359 2 818 44 44
(Voir/siehe Belgique/Belgien)
Roche s. r. o.
Tel: +420 - 2 20382111
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500
Roche a/s
Tlf: +45 - 36 39 99 99
(See Ireland)
Roche Pharma AG Tel: +49 (0) 7624 140
Roche Nederland B.V. Tel: +31 (0) 348 438050
Roche Eesti OÜ
Tel: + 372 - 6 177 380
Roche Norge AS
Tlf: +47 - 22 78 90 00
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100
Roche Austria GmbH Tel: +43 (0) 1 27739
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88
Roche
Tél: +33 (0) 1 47 61 40 00
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00
Roche d.o.o.
Tel: +385 1 4722 333
Roche România S.R.L. Tel: +40 21 206 47 01
Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700
Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
Roche a/s
c/o Icepharma hf Sími: +354 540 8000
Roche S.p.A.
Tel: +39 - 039 2471
Roche Oy
Puh/Tel: +358 (0) 10 554 500
Γ.Α.Σταμάτης & Σια Λτδ.
Τηλ: +357 - 22 76 62 76
Roche AB
Tel: +46 (0) 8 726 1200
Roche Latvija SIA Tel: +371 - 6 7 039831
Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366000
