Tarceva. 100 mg. 30 tablets

What is Tarceva and what it is used?
Tarceva contains erlotinib active substance . Tarceva is a drug that is used for treating cancer by preventing the activity of a protein called epidermal growth factor (EGFR). It is known that this protein is involved in the growth and spread of cancer cells.
Tarceva is indicated in adults . This medicine may be prescribed to you if you have non-small cell lung cancer in an advanced stage . It may be administered as an initial treatment , if your cancer cells having specific EGFR mutations. It may also be prescribed if your disease remains largely unchanged after initial chemotherapy , or if prior chemotherapy has not helped to stop your disease.
This medicine may also be prescribed to you in combination with another treatment called gemcitabine if you have pancreatic cancer metastasis.

2 . What you should know before taking Tarceva?
Do not take Tarceva
• if you are allergic to erlotinib or any of the other ingredients of this medicine (listed in Section 6) .
Warnings and Precautions
• Talk to your doctor if you are taking other medicines that may increase or decrease the amount of erlotinib in your blood or influence its effects (eg, antifungals like ketoconazole , protease inhibitors, erythromycin , clarithromycin , phenytoin , carbamazepine , barbiturates , rifampicin, ciprofloxacin , omeprazole , ranitidine or St. John's wort or proteasome inhibitors). In some cases, these drugs may reduce the efficacy or increase the side effects of Tarceva and may be necessary for your doctor to adjust your treatment . Your doctor can avoid your treatment with these medicines while taking Tarceva.
• if you are taking anticoagulants ( medicine that helps to prevent thrombosis or blood clotting such as warfarin ), Tarceva may increase your tendency to bleed . Talk to your doctor , he will have to perform some regular blood tests .
• If you are being treated with statins (drugs that lower cholesterol in your blood ), Tarceva may increase the risk of muscle problems with statins , in rare cases it can lead to serious muscle disorder (rhabdomyolysis ) leading to kidney damage . Talk to your doctor.
• If you wear contact lenses and / or have a history of eye problems , eg . pronounced dry eyes , inflammation of the front part of the eye ( cornea) or ulcers affecting the front of the eye , tell your doctor.
See also below under " Other medicines and Tarceva".

You should tell your doctor :
if you have sudden difficulty in breathing associated with cough or fever, as may be necessary for your doctor to treat you with other medicines and interrupt your treatment with Tarceva;
if you have diarrhea, because you may need your doctor to treat you with anti-diarrheal medicines (eg loperamide ) ;
immediately if you experience severe or persistent diarrhea , nausea, loss of appetite or vomiting, because you may need your doctor may interrupt your treatment with Tarceva and may need to take you to hospital treatment .
if you have severe abdominal pain , severe blistering or peeling of the skin. You may need your doctor to interrupt or stop your treatment if you get redness or acute worsening of redness and eye pain , increased lacrimation , blurred vision and / or sensitivity to light, please tell your doctor immediately or nurse because 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. You may need your doctor 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 . Not be treated with this medicine if you have severe liver disease or severe kidney disease.

Violation of glucuronidation as Gilbert's syndrome
Your doctor should treat you with caution if you have a breach of glucuronidation Syndrome Gilbert.
smoking
You are advised to stop smoking if you are treated with Tarceva as smoking can reduce the amount of drug in your blood.

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

Other medicines and Tarceva
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines.

Tarceva with food and drink
Do not take Tarceva with food. See also section 3 " How to take Tarceva". Pregnancy
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 during treatment with Tarceva, tell your doctor who will decide whether to continue treatment. Do not breastfeed if you are taking Tarceva.
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine.

Driving and using machines

Possible effects of Tarceva on ability to drive and use machines have not been studied , but it is very likely that your treatment will affect this ability.

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

3 . How to take Tarceva?
Always take this medicine exactly as advised by your doctor. If you are not sure, ask your doctor or pharmacist.
The tablet should be taken at least one hour before or two hours after food intake .
The usual dose is one tablet of Tarceva 150 mg each day , if you have a non-small cell lung cancer .
The usual dose is one tablet of Tarceva 100 mg each day if you have pancreatic cancer metastasis. Tarceva is given in combination with gemcitabine treatment .
Your doctor may adjust the dose by 50 mg at once. For the different dosage regimens Tarceva tablets of 25 mg, 100 mg or 150 mg.

If you take more than the dose of Tarceva
Contact your doctor or pharmacist.
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 quickly.
Do not take a double dose to make up for a missed dose. If you stop taking Tarceva
It is important to take Tarceva every day until your doctor prescribes it .
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Contact your doctor as soon as possible if you experience any of the side effects below. In some cases it may be necessary for your doctor to reduce the dose of Tarceva or interrupt treatment :
• Diarrhea and vomiting (very common may affect more than 1 in 10 people). Prolonged and severe diarrhea may lead to a decrease in blood potassium and renal function, especially if you receive other types of chemotherapy at the same time . If you get severe or persistent diarrhea, contact your doctor immediately as you may need your doctor to treat you in the hospital.
• Eye irritation due to conjunctivitis / keratoconjunctivitis (very common may affect more than 1 in 10 people) and keratitis ( common: may affect up to 1 in 10 people).
• forms of pulmonary inflammation called interstitial lung disease ( uncommon in Europeans , common in Japanese patients : may affect up to 1 in 100 people in Europe and 1 in 10 in Japan) . This disease may also be associated with the natural development of your health and in some cases can be fatal . If you develop symptoms such as sudden difficulty in breathing associated with cough or fever, contact your doctor immediately as you may suffer from this disease. Your doctor may decide to permanently terminate your treatment with Tarceva.
• There have perforations of the gastrointestinal tract ( uncommon may affect up to 1 in 100 people). Tell your doctor if you have severe stomach pain . Also tell your doctor if you have peptic ulcers or diverticular disease in the past, as this may increase this risk .
• In rare cases liver failure ( rare: may affect up to 1 in 1000 people). If your blood tests show major changes in your liver function may need your doctor may interrupt your treatment .

Very common side effects (may affect more than 1 in 10 people):
• rash that may appear or worsen on areas exposed to the sun . If you are exposed to the sun , can be recommended protective clothing and / or use of sun screen ( eg mineral - containing )
• Infection
• loss of appetite , weight loss
• Depression
• Headache , altered skin sensation or numbness
• Difficulty in breathing, coughing
• Nausea
• Inflammation of the mouth
• Stomach pain , indigestion and flatulence
• Abnormal blood tests for liver function
• Itchy , dry skin and hair loss
• Fatigue , fever , chills

Common side effects (may affect up to 1 in 10 people):
• Nosebleeds
• Bleeding from the stomach or intestines
• inflammation around nails
• infection of hair follicles
• Acne
• Flaking skin ( fissures on the skin)
• Reduced renal function ( when used outside the approved indications in combination with chemotherapy)

Uncommon side effects (may affect up to 1 in 100 people):
• Eyelash changes
• Enhanced male pattern hair from body and face
• Changes eyebrows
• fragility and loss of nails

Rare side effects (may affect up to 1 in 1000 people)
• Red and painful hands or feet ( Palmar -plantar erythrodysaesthesia )

Very rare side effects (may affect up to 1 in 10,000 people):
• Cases of perforation or ulceration of the cornea
• Increased blistering or peeling of the skin ( indicative syndrome Stevens-Johnson)

Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet . You can also report side effects directly through the national system of notification referred to in Annex V. As reported side effects , you can do your bit to get more information on the safety of this medicine.

5 . How to store Tarceva?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the blister and 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 dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Tarceva?
• The active substance of Tarceva is erlotinib. Each tablet contains 25 mg, 100 mg or 150 mg of erlotinib ( as erlotinib hydrochloride) according to the quantity of active agent.
• The other ingredients are:
Tablet core : lactose monohydrate, microcrystalline cellulose , sodium starch glycolate type A , sodium lauryl sulfate , magnesium stearate ( see also section 2 of lactose monohydrate).
Tablet coat : hypromellose, hydroxypropyl cellulose , titanium dioxide , macrogol .

Tarceva looks like and contents of the pack ?
Tarceva 25 mg is a white to yellowish , round, film-coated tablet engraved with 'T 25 ' on one side and is available in packs of 30 tablets .
Tarceva 100 mg is a white to yellowish , round, film-coated tablet engraved with 'T100' on one side and is available in packs of 30 tablets .
Tarceva 150 mg is a white to yellowish , round, film-coated tablet engraved with 'T 150 ' on one side and is available in packs of 30 tablets .

Marketing Authorisation Holder
Roche