Erlotinib Zentiva

See also below "Other medicines and Erlotinib Zentiva".

Tell your doctor:

Liver or kidney disease

The effect of Erlotinib Zentiva in patients with impaired liver or kidney function is not known. The use of this medicine is not recommended in patients with severe liver or kidney disease.

Glucuronyl transferase deficiency, such as Gilbert's syndrome

Your doctor should exercise caution when treating patients with glucuronyl transferase deficiency, such as those with Gilbert's syndrome.

Smokers

Patients treated with Erlotinib Zentiva are advised to stop smoking, as smoking may decrease the levels of the medicine in the blood.

Children and adolescents

Erlotinib Zentiva 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 Zentiva

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan 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

It is recommended to avoid becoming pregnant while taking Erlotinib Zentiva. 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 a female patient becomes pregnant while taking Erlotinib Zentiva, she should immediately inform her doctor, who will decide whether treatment can be continued.

Do not breastfeed while taking Erlotinib Zentiva and for at least 2 weeks after taking the last tablet.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Erlotinib Zentiva has not been studied for its potential to affect the ability to drive or operate machines. It is unlikely that this treatment will adversely affect the ability to drive or operate machines.

Erlotinib Zentiva contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which is essentially sodium-free.

3. How to take Erlotinib Zentiva

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The tablet should be taken at least 1 hour before a meal or at least 2 hours after a meal.

The usual dose of Erlotinib Zentiva is 150 mg once daily for non-small cell lung cancer.

For pancreatic cancer with metastases, the usual dose of Erlotinib Zentiva is 100 mg once daily. Erlotinib Zentiva is given in combination with gemcitabine.

Your doctor may reduce the dose of Erlotinib Zentiva in increments of 50 mg. To allow for different dosing schedules, Erlotinib Zentiva is available in 25 mg, 100 mg, and 150 mg tablets.

The 100 mg tablet of Erlotinib Zentiva can be divided into equal doses.

Take more than the recommended dose of Erlotinib Zentiva

Contact your doctor or pharmacist immediately. You may experience increased side effects, and your doctor may stop your treatment.

Miss a dose of Erlotinib Zentiva

If you miss one or more doses of Erlotinib Zentiva, contact your doctor or pharmacist as soon as possible.

Do not take a double dose to make up for a missed dose.

Stop taking Erlotinib Zentiva

It is important to take Erlotinib Zentiva every day for as long as your doctor prescribes it.

If you have any questions about your treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Erlotinib Zentiva can cause side effects, although not everybody gets them.

If you experience any of the following side effects, contact your doctor as soon as possible. In some cases, your doctor may reduce the dose of Erlotinib Zentiva or stop your treatment:

• Diarrhea and vomiting (very common: affects 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 immediately contact your doctor, as you may need hospital treatment.
• Eye irritation due to conjunctivitis/keratitis (very common; affects more than 1 in 10 people), conjunctivitis, and keratitis (common: affects less than 1 in 10 people).
• Lung tissue irritation, called interstitial lung disease (uncommon in the European population; common in the Japanese population: affects less than 1 in 100 people in the European population and 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 cough or fever, you should immediately contact your doctor, as these may be signs of this disease. Your doctor may decide to permanently stop your treatment with Erlotinib Zentiva.
• Gastrointestinal perforation (uncommon: affects less than 1 in 100 people). You should inform your doctor if you experience severe abdominal pain. You should also inform your doctor if you have previously had stomach ulcers or diverticulitis, as these conditions may increase the risk of gastrointestinal perforation.
• In rare cases, liver inflammation (may affect up to 1 in 1000 people) has been observed. 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 test results indicate severe liver function changes, your doctor may decide to stop your treatment.

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

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

Common side effects(affects less than 1 in 10 people):

• Dry skin.
• Hair loss.
• Nosebleeds.
• Bleeding from the stomach or intestines.
• Inflammatory reactions around the nails.
• Folliculitis.
• Acne.
• Skin cracking.
• Kidney problems (when used off-label in combination with chemotherapy).

Uncommon side effects(affects less than 1 in 100 people):

• Kidney inflammation.
• Excessive protein in the urine (proteinuria).
• Changes in eyelashes.
• Excessive hair growth on the body and face.
• Excessive skin pigmentation.
• Changes in eyebrows.
• Brittle or broken nails.

Rare side effects(affects less than 1 in 1000 people):

• Redness or pain on the palms of the hands or soles of the feet (palmar-plantar erythrodysesthesia syndrome).

Very rare side effects(affects less than 1 in 10,000 people):

• Corneal ulcers or perforation.
• Severe skin blistering or peeling (similar to Stevens-Johnson syndrome).
• Iritis.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety, 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 or its representative in Poland.

By reporting side effects, you can help provide more information on the safety of this 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 and carton after "EXP". The expiry date refers to the last day of the month.

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 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: lactose monohydrate, microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethylcellulose type A, colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate. Tablet coating: hypromellose (2910), 6 mPas, hydroxypropylcellulose, titanium dioxide (E171), macrogol 400.

What Erlotinib Zentiva looks like and contents of the pack

Erlotinib Zentiva, 25 mg, coated tablets are white, round, biconvex tablets with "E9OB" engraved on one side and "25" on the other, with a diameter of approximately 6 mm.

Erlotinib Zentiva, 100 mg, coated tablets are white, round, biconvex tablets with a score line on both sides, "E9OB" engraved above the score line and "100" below the score line on one side, with a diameter of approximately 10 mm.

Erlotinib Zentiva, 150 mg, coated tablets are white, round, biconvex tablets with "E9OB" engraved on one side and "150" on the other, with a diameter of approximately 10.4 mm.

Erlotinib Zentiva is available in packs of 30 coated tablets.

Marketing authorization 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 medicine is authorized in the Member States of 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 further information on this medicine, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

tel.: +48 22 375 92 00

Date of last revision of the package leaflet:December 2023