Erlotinib Krka

Package Leaflet: Information for the Patient

Erlotinib Krka, 25 mg, Coated Tablets

Erlotinib Krka, 100 mg, Coated Tablets

Erlotinib Krka, 150 mg, Coated Tablets

Erlotinib

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

Erlotinib Krka contains the active substance erlotinib. Erlotinib Krka is a medicine used to treat patients with cancer. The mechanism of action of the medicine involves inhibiting the activity of a protein called epidermal growth factor receptor (EGFR). This protein is involved in the process of growth and spread of cancer cells. Erlotinib Krka 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 a first-line treatment or when the disease has not progressed significantly after first-line chemotherapy, provided that the tumor cells have specific EGFR mutations. Erlotinib Krka may also be used when previous chemotherapy has not stopped the progression of the disease. This medicine may also be prescribed in combination with another medicine called gemcitabine to patients with pancreatic cancer with metastases.

2. Important information before taking Erlotinib Krka

When not to take Erlotinib Krka

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

Warnings and precautions

• -if you are taking other medicines that may increase or decrease the levels of erlotinib in your blood, or affect its action (e.g., antifungal medicines such as ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John's Wort, or proteasome inhibitors), you should consult your doctor. In some cases, these medicines may reduce the effectiveness or increase the side effects of Erlotinib Krka. In such cases, your doctor may need to modify your treatment. Your doctor may advise you to stop taking these medicines while taking Erlotinib Krka.

if you are taking anticoagulant medicines (medicines that help prevent blood clots or thrombosis, e.g., warfarin), Erlotinib Krka may increase the risk of bleeding. In such cases, you should consult your doctor, who will need to regularly perform blood tests to monitor your condition.

• -if you are taking statins (medicines used to lower cholesterol levels in the blood), Erlotinib Krka may increase the risk of muscle disease caused by statins, which can rarely lead to severe muscle damage (rhabdomyolysis) causing kidney damage. You should consult your doctor.
• -if you wear contact lenses and (or) have previously had eye problems, such as severe dry eye, inflammation of the front part of the eye (keratitis), or ulcers in the front part of the eye, you should tell your doctor.

See also "Other medicines and Erlotinib Krka" below. You should inform your doctor:

• -if you experience sudden difficulty breathing with accompanying cough or fever, as it may be necessary to use other medicines and interrupt treatment with Erlotinib Krka;
• -if you experience diarrhea, as it may be necessary to use an anti-diarrheal medicine (e.g., loperamide);
• -immediately, if you experience severe or persistent diarrhea, nausea, loss of appetite, or vomiting, as it may be necessary to interrupt treatment with Erlotinib Krka and possibly hospitalize you;
• -if you have ever had liver problems. Erlotinib may cause serious liver problems, and some cases may be fatal. Your doctor may perform blood tests while you are taking this medicine to monitor liver function;
• -if you experience severe abdominal pain, increased formation of pimples on the skin, or skin peeling. It may be necessary to temporarily interrupt or completely stop treatment;
• -if you experience acute or worsening redness and eye pain, increased tearing, blurred vision, and (or) sensitivity to light, you should immediately tell your doctor or nurse, as urgent treatment may be necessary (see "Possible side effects");
• -if you are taking statins and experience muscle pain of unknown cause, sensitivity, weakness, or muscle cramps. In such cases, your doctor may temporarily interrupt or completely stop treatment.

See also section 4 "Possible side effects". Liver or kidney disease It is not known whether the action of Erlotinib Krka may change in case of impaired liver or kidney function. The use of this medicine is not recommended in patients with severe liver or kidney disease. Glucuronidation reaction disorders, such as Gilbert's syndrome Your doctor should exercise caution in patients with glucuronidation reaction disorders, e.g., patients with Gilbert's syndrome. Smoking Patients treated with Erlotinib Krka are advised to stop smoking, as smoking may decrease the levels of the medicine in the blood.

Children and adolescents

Erlotinib Krka has not been studied in patients under 18 years of age. The use of this medicine is not recommended in children and adolescents.

Other medicines and Erlotinib Krka

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Erlotinib Krka with food and drink

You should not take Erlotinib Krka with food. See also section 3 "How to take Erlotinib Krka".

Pregnancy and breastfeeding

You should avoid becoming pregnant while taking Erlotinib Krka. Female patients who may become pregnant should use appropriate contraceptive methods during treatment and for at least 2 weeks after taking the last tablet. If you become pregnant while taking Erlotinib Krka, you should immediately inform your doctor, who will decide whether treatment can be continued. You should not breastfeed while taking Erlotinib Krka and for at least 2 weeks after taking the last tablet. If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Erlotinib Krka has not been studied for its potential impact on the ability to drive or operate machines. It is very unlikely that this treatment will affect your ability to drive or operate machines.

Erlotinib Krka contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking Erlotinib Krka. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Erlotinib Krka

Take this medicine always as directed by your doctor. If you are not sure, ask 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 for non-small cell lung cancer. For pancreatic cancer with metastases, the usual dose of Erlotinib Krka is 100 mg once daily. Erlotinib Krka is given in combination with another medicine called gemcitabine. Your doctor may adjust the dose of the medicine in 50 mg increments. To allow for different dosing schedules, Erlotinib Krka is available in 25 mg, 100 mg, and 150 mg tablets.

Taking a higher dose of Erlotinib Krka than recommended

Contact your doctor or pharmacist immediately. There may be an increased risk of side effects, and your doctor may interrupt treatment.

Missing a 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 treatment with Erlotinib Krka

Take Erlotinib Krka every day for as long as your doctor tells you to. If you have any doubts about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Erlotinib Krka can cause side effects, although not everybody gets them. If you experience any of the following side effects, tell your doctor as soon as possible. In some cases, your doctor may reduce the dose of Erlotinib Krka or interrupt treatment:

• -Diarrhea and vomiting (very common: may affect more than 1 in 10 people). Persistent and severe diarrhea may lead to low potassium levels in the blood and kidney problems, especially if you are receiving other types of chemotherapy at the same time. If you experience more severe or persistent diarrhea, you should contact your doctor immediately, as hospital treatment may be necessary.
• -Eye irritation due to conjunctivitis and keratitis (very common: may affect more than 1 in 10 people), conjunctivitis, and keratitis (common: may affect up to 1 in 10 people).
• -Irritation of the lung tissue, called interstitial lung disease (uncommon in the European population and common in the 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 disease may also be related to the natural progression of the underlying disease and in some cases may be fatal. If you experience symptoms such as sudden difficulty breathing with accompanying cough or fever, you should contact your doctor immediately, as these may be signs of this disease. Your doctor may decide to permanently stop treatment with Erlotinib Krka.
• -Perforation of the digestive tract (uncommon: may affect up to 1 in 100 people). You should tell your doctor if you experience severe abdominal pain. You should also tell your doctor if you have a history of stomach ulcers or diverticulitis, as these conditions may increase the risk of perforation of the digestive tract.
• -In rare cases, liver inflammation 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. It can lead to death. If blood tests indicate severe changes in liver function, your doctor may advise you to stop treatment.

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

• -Rash, which may appear or worsen on skin exposed to sunlight. Patients who are exposed to sunlight may be advised to use protective clothing and (or) sunscreens (e.g., containing minerals)
• -Infections
• -Loss of appetite, weight loss
• -Depression
• -Headache, sensation disorders, or numbness of the limbs
• -Difficulty breathing, cough
• -Nausea
• -Mouth irritation
• -Abdominal pain, indigestion, and bloating
• -Abnormal liver function test results
• -Itching
• -Fatigue, fever, chills

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

• -Dry skin
• -Hair loss
• -Nosebleeds
• -Gastrointestinal bleeding
• -Inflammatory reactions around the nails
• -Folliculitis
• -Acne
• -Skin cracking
• -Kidney failure (when taking Erlotinib Krka off-label in combination with chemotherapy)

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

• -Kidney inflammation
• -Excessive protein in the urine (proteinuria)
• -Eyelash changes
• -Excessive hair growth on the body and face of male type
• -Excessive skin pigmentation
• -Eyebrow changes
• -Brittle and fragile nails

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 perforation or ulceration of the cornea
• -Severe skin reactions with blistering or peeling of the skin (resembling Stevens-Johnson syndrome)
• -Inflammation of the colored part of the eye

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Erlotinib Krka

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 packaging after "EXP". The expiry date refers to the last day of that month. Store in the original blister pack to protect from moisture. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Erlotinib Krka contains

• -The active substance of the medicine is erlotinib. Erlotinib Krka, 25 mg, coated tablets Each coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Krka, 100 mg, coated tablets Each coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Krka, 150 mg, coated tablets Each coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
• -The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, hypromellose 240 mPas, sodium lauryl sulfate, croscarmellose sodium (type A), calcium silicate, magnesium stearate in the tablet core, and 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) in the tablet coating. See section 2 "Erlotinib Krka contains lactose and sodium".

What Erlotinib Krka looks like and contents of the pack

Erlotinib Krka, 25 mg, coated tablets (tablets) Light yellow, round, slightly convex coated tablets with beveled edges, with "25" engraved on one side. Tablet diameter: approximately 6 mm. Erlotinib Krka, 100 mg, coated tablets (tablets) Light orange-pink, round, slightly convex coated tablets with beveled edges, with "100" engraved on one side. Tablet diameter: approximately 11 mm. Erlotinib Krka, 150 mg, coated tablets (tablets) White to almost white, round, convex coated tablets with beveled edges, with "150" engraved on one side. Tablet diameter: approximately 12 mm. Erlotinib Krka is available in blisters containing 30 coated tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Manufacturer: 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, contact the marketing authorization holder's representative: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warsaw Tel. 22 57 37 500 Date of last revision of the leaflet:01.08.2024