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