Erlotinib zentiva

Package leaflet: Information for the user

Erlotinib Zentiva, 25 mg, film-coated tablets
Erlotinib Zentiva, 100 mg, film-coated tablets
Erlotinib Zentiva, 150 mg, film-coated tablets
Erlotinibum
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Erlotinib Zentiva is and what it is used for
2. Before you take Erlotinib Zentiva
3. How to take Erlotinib Zentiva
4. Possible side effects
5. How to store Erlotinib Zentiva
6. Contents of the pack and other information

1. What Erlotinib Zentiva is and what it is used for

Erlotinib Zentiva contains the active substance erlotinib. Erlotinib Zentiva is a medicine used
in the treatment of cancer. The mechanism of action of this medicine is based on inhibition of
a protein called epidermal growth factor receptor (EGFR). This protein is involved in the
growth and spread of cancer cells.
Erlotinib Zentiva is indicated for use in adult patients. This medicine may be prescribed to
patients with advanced non-small cell lung cancer. It may be used as first-line treatment or
when the disease has remained substantially unchanged after first-line chemotherapy,
provided that tumour cells show specific EGFR mutations. The medicine may also be used
when previous chemotherapy has failed to halt disease progression.
This medicine may also be prescribed in combination with another medicine called gemcitabine
for patients with metastatic pancreatic cancer.

2. Important information before using Erlotinib Zentiva

When not to use Erlotinib Zentiva

• if the patient is allergic to erlotinib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Tell your doctor before taking Erlotinib Zentiva:

• if the patient is taking other medicines that may increase or decrease erlotinib blood levels, or otherwise affect its action (for example antifungal medicines such as
  ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine,
  barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St John's wort, or proteasome inhibitors). Please consult your doctor. In some cases, these medicines may reduce the effectiveness or increase the severity of adverse reactions of Erlotinib Zentiva.
  In such cases, the doctor must modify the treatment. The doctor may advise avoiding the use of these medicines during treatment with Erlotinib Zentiva.

• if the patient is taking anticoagulants (a medicine that helps prevent blood clots or thrombosis, e.g. warfarin). Erlotinib Zentiva may increase the tendency to bleed. In such cases, consult your doctor, who will need to regularly monitor blood tests.

• consult your doctor if the patient is taking statins (medicines used to lower blood cholesterol levels), as Erlotinib Zentiva may increase the risk of statin-induced muscle disease (rhabdomyolysis), which in rare cases may lead to severe muscle damage causing kidney injury.

• if the patient wears contact lenses and (or) has previously experienced eye problems such as severe dry eye, inflammation of the front part of the eye (cornea), or ulceration in the front part of the eye.

See also below "Other medicines and Erlotinib Zentiva".
Tell your doctor

• if sudden breathing difficulties occur, accompanied by cough or fever, as other medicines may be needed and treatment with Erlotinib Zentiva may need to be interrupted;
• if diarrhoea occurs, as an antidiarrhoeal medicine (e.g. loperamide) may be needed;
• immediately if the patient develops severe or persistent diarrhoea, nausea, loss of appetite, or vomiting, as treatment with Erlotinib Zentiva may need to be stopped and hospital treatment may be required;
• if the patient has ever had liver problems. Erlotinib Zentiva may cause serious liver problems, and some cases may be fatal. The doctor may perform blood tests during treatment with this medicine to monitor whether the liver is functioning properly;
• if the patient experiences severe abdominal pain, widespread blistering or peeling of the skin, temporary interruption or complete discontinuation of treatment may be necessary;
• if the patient develops acute or worsening eye redness and pain, increased tearing, blurred vision and (or) light sensitivity, tell the doctor or nurse immediately, as urgent treatment may be required (see below: "Possible side effects");
• if the patient is also taking statins and develops unexplained muscle pain, tenderness, weakness, or muscle cramps. In such cases, the doctor may temporarily interrupt or completely discontinue treatment. See also section 4 "Possible side effects".

Liver or kidney disease
It is not known whether the effect of Erlotinib Zentiva may be altered in case of impaired liver or kidney function. Use of this medicine is not recommended in patients with severe liver disease or severe kidney disease.
Glucuronidation disorders, such as Gilbert's syndrome
The doctor must exercise caution in patients with glucuronidation disorders, e.g. patients with Gilbert's syndrome.
Smoking
Patients being treated with Erlotinib Zentiva are advised to stop smoking, as smoking may reduce blood levels of the medicine.
Children and adolescents
Erlotinib Zentiva has not been studied in patients under 18 years of age. Use of this medicine is not recommended in children and adolescents.
Other medicines and Erlotinib Zentiva
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Erlotinib Zentiva with food and drink
Do not take Erlotinib Zentiva with food. See also section 3. "How to take Erlotinib Zentiva".
Pregnancy and breastfeeding
Avoid becoming pregnant while taking Erlotinib Zentiva. Women who could become pregnant should use appropriate contraceptive methods during treatment and for at least 2 weeks after taking the last tablet.
If the patient becomes pregnant while taking Erlotinib Zentiva, she should inform her doctor immediately. The doctor will decide whether treatment may continue.
Do not breastfeed during treatment with Erlotinib Zentiva and for at least 2 weeks after taking the last tablet.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Erlotinib Zentiva has not been studied with regard to its potential effect on the ability to drive and operate machinery. It is very unlikely that this treatment would adversely affect the ability to drive and operate machinery.
Erlotinib Zentiva contains lactose and sodium
If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per coated tablet, i.e. the medicine is considered "sodium-free".
3. How to take Erlotinib Zentiva
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist again.
The tablet should be taken at least one hour before a meal or at least two hours after a meal.
The usual dose of Erlotinib Zentiva is 150 mg once daily in non-small cell lung cancer.
In metastatic pancreatic cancer, the usual dose of Erlotinib Zentiva is 100 mg once daily. Erlotinib Zentiva is given in combination with gemcitabine.
The doctor may recommend reducing the dose in steps of 50 mg. To allow for different dosing regimens, Erlotinib Zentiva is available in 25 mg, 100 mg and 150 mg tablets.
The 100 mg Erlotinib Zentiva tablet may be divided into equal doses.
Taking more Erlotinib Zentiva than prescribed
Contact your doctor or pharmacist immediately. Adverse reactions may worsen and the doctor may discontinue the medicine.
If a dose of Erlotinib Zentiva is missed
If one or more doses of Erlotinib Zentiva are missed, contact your doctor or pharmacist as soon as possible.
Do not take a double dose to make up for a missed dose.
Stopping Erlotinib Zentiva
It is important to take Erlotinib Zentiva every day for as long as your doctor recommends.
If in doubt about using the medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the adverse reactions listed below occur, contact your doctor as soon as possible. In some cases, your doctor may reduce the dose of Erlotinib Zentiva or discontinue treatment:

• Diarrhoea and vomiting (very common: affects more than 1 in 10 patients). Persistent and severe diarrhoea may lead to low blood potassium levels and kidney dysfunction, particularly if the patient is receiving other types of chemotherapy at the same time. If diarrhoea becomes more severe or persistent, you must contact your doctor immediately, as hospital treatment may be necessary.
• Eye irritation due to conjunctivitis/corneal inflammation (very common: affects more than 1 in 10 patients), conjunctivitis, and corneal inflammation (common: affects less than 1 in 10 patients).
• Lung tissue irritation, known as interstitial lung disease (not common in European patients; common in Japanese patients: affects less than 1 in 100 European patients and 1 in 10 Japanese patients). This condition may also be related to the natural progression of the underlying disease and, in some cases, may be fatal. If symptoms such as sudden breathing difficulties accompanied by cough or fever occur, contact your doctor immediately, as these may be signs of this disease. Your doctor may decide to permanently discontinue treatment with Erlotinib Zentiva.
• Gastrointestinal perforation (not common: affects less than 1 in 100 patients). Inform your doctor if the patient experiences severe abdominal pain. Also inform your doctor if the patient has a history of peptic ulcers or diverticular disease, as these conditions may increase the risk of gastrointestinal perforation.
• In rare cases, hepatitis has been observed (may affect up to 1 in 1,000 people). 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 been observed, which may lead to death. If blood test results indicate severe liver function abnormalities, your doctor may decide to discontinue treatment.

Very common adverse reactions (affect more than 1 in 10 patients):

• Skin rash, which may appear or worsen on skin exposed to sunlight. Patients exposed to sunlight may be advised to wear protective clothing and/or use sunscreens (e.g. mineral-based).
• Infections.
• Loss of appetite, weight loss.
• Depression.
• Headache, skin sensory disturbances, or limb numbness.
• Breathing difficulties, cough.
• Nausea.
• Mouth irritation.
• Abdominal pain, indigestion, bloating.
• Abnormal blood test results assessing liver function.
• Itching.
• Fatigue, fever, chills.

Common adverse reactions (affect no more than 1 in 10 patients):

• Dry skin.
• Hair loss.
• Nosebleeds.
• Bleeding from the stomach or intestines.
• Inflammatory reactions around the nails.
• Folliculitis.
• Acne.
• Skin cracking.
• Kidney function disorders (when used outside registered indications in combination with chemotherapy).

Uncommon adverse reactions (affect no more than 1 in 100 patients):

• Kidney inflammation.
• Excess protein in the urine (proteinuria).
• Changes in eyelashes.
• Excessive male-pattern body and facial hair growth.
• Increased skin pigmentation.
• Changes in eyebrows.
• Nail fragility and loss.

Rare adverse reactions (affect no more than 1 in 1,000 patients):

• Redness or pain in the palms of the hands or soles of the feet (hand-foot syndrome).

Very rare adverse reactions (affect no more than 1 in 10,000 patients):

• Cases of corneal ulceration or perforation.
• Severe blistering or skin peeling (resembling Stevens-Johnson syndrome).
• Inflammation of the coloured part of the eye.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Erlotinib Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer
carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the packaging and other information

What Erlotinib Zentiva contains

• The active substance is erlotinib. Each coated tablet contains 25 mg, 100 mg or 150 mg of erlotinib (as erlotinib hydrochloride), depending on the dose.
• The other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl starch type A, colloidal anhydrous silica, sodium lauryl sulphate, magnesium stearate.
  Tablet coating: hypromellose (2910), 6 mPas, hydroxypropylcellulose, titanium dioxide (E171), polyethylene glycol 400.

What Erlotinib Zentiva looks like and contents of the pack
Erlotinib Zentiva 25 mg, coated tablets are white, round, biconvex tablets, embossed on one side with the code "E9OB" and "25" on the other side, with a diameter of approximately 6 mm.
Erlotinib Zentiva 100 mg, coated tablets are white, round, biconvex tablets with a breakline on both sides, embossed on one side of the tablet with the code "E9OB" above the breakline and "100" below the breakline, with a diameter of approximately 10 mm.
Erlotinib Zentiva 150 mg, coated tablets are white, round, biconvex tablets, embossed on one side with the code "E9OB" and "150" on the other side, with a diameter of approximately 10.4 mm.
Erlotinib Zentiva is available in packs containing 30 coated tablets.

Marketing Authorisation Holder
Zentiva k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer/Importer
Synthon Hispania, S.L., Calle Castello 1, Pol. Las Salinas, Sant Boi De Llobregat
08830 Barcelona, Spain
Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Netherlands, Germany, Portugal, France, Latvia, Poland, United Kingdom (Northern Ireland), Sweden, Slovakia, Czech Republic: Erlotinib Zentiva

For more detailed information about this medicine, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00