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Erlotinib Zentiva

Erlotinib Zentiva

About the medicine

How to use 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

Erlotinib

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

  • Keep this package leaflet, you may need to read it again.
  • Ask your doctor or pharmacist if you have any further questions.
  • 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 the package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

  • 1. What is Erlotinib Zentiva and what is it used for
  • 2. Important information before taking 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 is Erlotinib Zentiva and what is it used for

Erlotinib Zentiva contains the active substance erlotinib. Erlotinib Zentiva is a medicine used to treat cancer. The mechanism of action of the medicine involves inhibiting the activity of a protein called the epidermal growth factor receptor (EGFR). This protein is involved in the process of 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 a first-line treatment or when the disease has not progressed significantly after first-line chemotherapy and provided that the tumor cells have specific EGFR mutations. The medicine 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 Zentiva

When not to take Erlotinib Zentiva

Warnings and precautions

Tell your doctor before taking Erlotinib Zentiva:

See also below "Other medicines and Erlotinib Zentiva". You should tell your doctor

Liver or kidney disease It is not known whether the action of Erlotinib Zentiva may be affected in cases of impaired liver or kidney function. The use of this medicine is not recommended in patients with severe liver or kidney disease. Glucuronyl transferase conjugation disorders, such as Gilbert's syndrome Your doctor should exercise caution when treating patients with glucuronyl transferase conjugation disorders, 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

You should 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 you become pregnant while taking Erlotinib Zentiva, you should immediately inform your doctor, who will decide whether treatment can be continued. You should 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Erlotinib Zentiva has not been studied for its ability to affect your ability to drive or use machines. It is unlikely that this treatment will affect your ability to drive or use machines.

Erlotinib Zentiva contains lactose and sodium

3. How to take Erlotinib Zentiva

Always 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 one hour before a meal or at least two 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 advise you to reduce the dose of Erlotinib Zentiva, in steps of 50 mg. To allow for different dosing schedules, Erlotinib Zentiva is available in tablets of 25 mg, 100 mg and 150 mg. The 100 mg tablet can be divided into equal doses.

Taking a higher dose of Erlotinib Zentiva than recommended

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

Missing a dose of Erlotinib Zentiva

Stopping treatment with Erlotinib Zentiva

It is important to take Erlotinib Zentiva every day for as long as your doctor prescribes it. If you have any doubts 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, tell 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 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).
  • Pulmonary 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 accompanying 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 the presence of 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
  • -Excess protein in the urine (proteinuria)
  • Changes in eyelashes.
  • Excessive hair growth on the body and face.
  • Excessive skin pigmentation
  • Changes in eyebrows.
  • Brittleness and loss of 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):

  • Cases of corneal ulceration or perforation.
  • Severe skin blistering or peeling (resembling Stevens-Johnson syndrome).
  • Iritis.

Reporting side effects

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 which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month. There are no special storage requirements 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 film-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, film-coated tablets are white, round, biconvex tablets with "E9OB" engraved on one side and "25" on the other, approximately 6 mm in diameter. Erlotinib Zentiva, 100 mg, film-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, approximately 10 mm in diameter. Erlotinib Zentiva, 150 mg, film-coated tablets are white, round, biconvex tablets with "E9OB" engraved on one side and "150" on the other, approximately 10.4 mm in diameter. Erlotinib Zentiva is available in packs of 30 film-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

  • Country of registration
  • Active substance
  • Prescription required
    Yes
  • Manufacturer
  • Importer
    Synthon B.V. Synthon Hispania S.L.

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