Erlotinib krka

Package leaflet: Information for the patient

Erlotinib Krka, 25 mg, film-coated tablets
Erlotinib Krka, 100 mg, film-coated tablets
Erlotinib Krka, 150 mg, film-coated tablets
erlotinibum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• 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 effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Erlotinib Krka contains the active substance erlotinib. Erlotinib Krka is a medicine used in the treatment of cancer. The mechanism of action of this medicine is based on inhibition of the activity of a protein called epidermal growth factor receptor (EGFR). This protein is involved in the growth and spread of cancer cells.
Erlotinib Krka is indicated for use in adult patients. It 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 the tumour cells show specific EGFR mutations.
Erlotinib Krka 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 Krka

When not to use Erlotinib Krka

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

Warnings and precautions

• if the patient is taking other medicines that may increase or decrease the blood concentration of erlotinib 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), consult the doctor. In some cases, these medicines may

reduce the effectiveness or increase the adverse effects of Erlotinib Krka. In such
cases, the doctor must modify the treatment. The doctor may advise avoiding the
use of the mentioned medicines during treatment with Erlotinib Krka.

• if the patient is taking anticoagulant medicines (medicines that help prevent blood clots or thrombosis, e.g. warfarin), Erlotinib Krka may increase the tendency to bleed. In such cases, consult the doctor, who will need to carry out regular blood tests.
• if the patient is taking statins (medicines used to lower blood cholesterol levels), Erlotinib Krka may increase the risk of statin-induced muscle disease, which in rare cases may lead to severe muscle damage (rhabdomyolysis) causing kidney damage. Consult the doctor.
• 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 ulcers in the front part of the eye, inform the doctor.

See also below "Other medicines and Erlotinib Krka".
The patient should inform the doctor:

• if sudden breathing difficulties occur accompanied by cough or fever, as other medicines may be needed and treatment with Erlotinib Krka may need to be interrupted;
• if diarrhoea occurs, as an antidiarrhoeal medicine (e.g. loperamide) may be required;
• immediately, if severe or persistent diarrhoea, nausea, loss of appetite, or vomiting occur, as treatment with Erlotinib Krka may need to be interrupted and hospital treatment may be necessary;
• if the patient has ever had liver problems. Erlotinib 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 severe abdominal pain, worsening acne-like rash, or skin peeling occurs. Temporary interruption or complete discontinuation of treatment may be necessary;
• if acute or worsening eye redness and pain, increased tearing, blurred vision and/or sensitivity to light occur, inform the doctor or nurse immediately, as urgent treatment may be required (see "Possible side effects");
• if the patient is also taking statins and experiences unexplained muscle pain, tenderness, weakness, or 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 Krka may be altered in patients with impaired liver or kidney function. Use of this medicine is not recommended in patients with severe liver disease or severe kidney disease.
Disorders of glucuronidation reactions, such as Gilbert's syndrome
The doctor must exercise caution in patients with disorders of glucuronidation reactions, e.g. in patients with Gilbert's syndrome.
Smoking
Patients treated with Erlotinib Krka are advised to stop smoking, as smoking may reduce the blood concentration of the medicine.
Children and adolescents
Erlotinib Krka has not been studied in patients under 18 years of age. Use of this medicine in children and adolescents is not recommended.
Other medicines and Erlotinib Krka
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Erlotinib Krka with food and drink
Do not take Erlotinib Krka with food. See also section 3 "How to take Erlotinib Krka".
Pregnancy and breastfeeding
Avoid becoming pregnant during treatment with Erlotinib Krka. Female patients who could become pregnant should use effective contraception during treatment and for at least 2 weeks after taking the last tablet.
If a patient becomes pregnant while taking Erlotinib Krka, she should inform her doctor immediately. The doctor will decide whether treatment may continue.
Do not breastfeed during treatment with Erlotinib Krka and for at least 2 weeks after taking the last tablet.
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Erlotinib Krka has not been studied with regard to possible effects on the ability to drive or use machines. It is very unlikely that this treatment would affect the ability to drive or use machines.
Erlotinib Krka contains lactose and sodium
If the patient has been diagnosed with intolerance to certain sugars, consult the doctor before taking Erlotinib Krka.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Erlotinib Krka

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
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 Krka is 150 mg once daily in the case of non-small cell lung cancer.
In the case of metastatic pancreatic cancer, the usual dose of Erlotinib Krka is 100 mg once daily. Erlotinib Krka is administered in combination with another medicine – gemcitabine.
Your doctor may adjust the dose of the medicine in increments of 50 mg. To allow for different dosing regimens, Erlotinib Krka is available in tablets of 25 mg, 100 mg, and 150 mg.
Taking more Erlotinib Krka than prescribed
Contact your doctor or pharmacist immediately.
An increase in adverse effects may occur, and your doctor may discontinue the treatment.
Missed dose of Erlotinib Krka
If you miss one or more doses of Erlotinib Krka, contact your doctor or pharmacist as soon as possible.
Do not take a double dose to make up for a missed dose.
Stopping Erlotinib Krka
Erlotinib Krka should be taken daily for as long as your doctor prescribes.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• Diarrhoea and vomiting (very common: may affect more than 1 in 10 people). Persistent and severe diarrhoea may lead to low blood potassium levels and kidney dysfunction, particularly if the patient is receiving another type 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 inflammation of the conjunctiva and cornea (very common: may affect more than 1 in 10 people), conjunctivitis, and keratitis (common: may affect up to 1 in 10 people).
• Lung tissue irritation, known as interstitial lung disease (uncommon in European population and common in Japanese population: may affect up to 1 in 100 people in the European population and up to 1 in 10 people in the Japanese population). 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 shortness of breath 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 Krka.
• Gastrointestinal perforation (uncommon: may affect up to 1 in 100 people). Inform your doctor if the patient experiences severe abdominal pain. You should 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 tests indicate severe liver function abnormalities, your doctor may recommend discontinuing treatment.

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

• 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
• Difficulty breathing, cough
• Nausea
• Mouth irritation
• Abdominal pain, indigestion and bloating
• Abnormal blood test results assessing liver function
• Itching
• Fatigue, fever, chills

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

• Dry skin
• Hair loss
• Nosebleeds
• Bleeding from the stomach or intestines
• Inflammatory reactions around the nails
• Folliculitis
• Acne
• Skin fissures
• Kidney failure (when Erlotinib Krka is used outside registered indications in combination with chemotherapy)

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

• Kidney inflammation
• Excessive protein in the urine (proteinuria)
• Eyelash changes
• Excessive body and facial hair growth (male pattern)
• Excessive skin pigmentation
• Eyebrow changes
• Brittle and soft nails

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

• Redness or pain in the palms of the hands or soles of the feet (hand-foot syndrome, also known as palmar-plantar erythrodysesthesia)

Very rare adverse reactions (may affect up to 1 in 10,000 people):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Erlotinib Krka

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
Store in the original blister pack to protect from moisture.
There are no special storage temperature requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Package contents and other information

What Erlotinib Krka contains

• The active substance is erlotinib. Erlotinib Krka 25 mg, film-coated tablets: Each film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Krka 100 mg, film-coated tablets: Each film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Krka 150 mg, film-coated tablets: Each film-coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
• Other ingredients are: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose 240 mPas, sodium lauryl sulfate, sodium carboxymethyl starch (type A), calcium silicate, magnesium stearate in the tablet core, and in the tablet coating: hypromellose 6 mPas, type 2910, propylene glycol, titanium dioxide (E 171), talc, iron oxide red (E 172) (only for 100 mg tablets), and iron oxide yellow (E 172) (only for 25 mg and 100 mg tablets). See section 2, "Erlotinib Krka contains lactose and sodium".

What Erlotinib Krka looks like and contents of the pack
Erlotinib Krka 25 mg, film-coated tablets (tablets)
Light yellow, round, slightly biconvex film-coated tablets with bevelled edges, embossed with the number "25" on one side. Tablet dimensions: approximately 6 mm in diameter.
Erlotinib Krka 100 mg, film-coated tablets (tablets)
Light orange-pink, round, slightly biconvex film-coated tablets with bevelled edges, embossed with the number "100" on one side. Tablet dimensions: approximately 11 mm in diameter.
Erlotinib Krka 150 mg, film-coated tablets (tablets)
White to almost white, round, biconvex film-coated tablets with bevelled edges, embossed with the number "150" on one side. Tablet dimensions: approximately 12 mm in diameter.
Erlotinib Krka is available in blister packs containing 30 film-coated tablets, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturers:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

For further information, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500