Effects of this medicine

Before using this medicine, tell your doctor/pharmacist

• If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
  If you are a patient with interstitial lung disease (interstitial pneumonia, pneumonitis, irradiation pneumonitis, organized pneumonia, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltration, alveolitis, etc.), lung infection, gastrointestinal ulcer, or diverticulum of large intestine.
  If you ever had any of those diseases mentioned above.
  If you are a patient with hepatic disorder.

• If you are pregnant or breastfeeding.

• If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)

Dosage regimen (proper use of this medicine)

• Your dosage regimen is:(order of your doctor)

• General dosage regimen: For treatment of non-small cell lung cancer which is unresectable, recurrent and progressive, and got worse after cancer chemotherapy: For adults, take 150mg of erlotinib once a day, either over 1 hour before meal or over 2 hours after meal. The dose may be decreased according to your symptoms.
  For treatment of pancreatic cancer not amenable to curative resection: It is used along with gemcitabin. For adults, take 100mg of erlotinib once a day, either over 1 hour before meal or over 2 hours after meal. The dose may be decreased according to your symptoms.
  1 tablet contains 25mg of erlotinib. Strictly follow the instructions of your doctor/pharmacist.
• Avoid taking the medicine from just 1 hour before the meal to 2 hours after meal. Otherwise, you may have serious side effects.

• Missed dose: Take the missed dose on an empty stomach. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.

• Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. You may have serious diarrhea, rash, or elevation of ALT(GPT)/AST(GOT).

• Others: Do not stop taking the medicine without the instructions of your doctor.

Precautions while using this medicine

• You may have serious side effects by taking the medicine. You need to be informed of precautions and so on until you fully understand them.
• The medicine may cause side effects such as interstitial lung disease, rash, diarrhea, and corneal perforation/ulcer. If you have symptoms such as shortness of breath, breathing difficulty, cough, fever, rash, diarrhea, and ocular pain, or if you feel that those symptoms get worse, go and see a doctor immediately.
• Avoid pregnancy if you have the possibility of it.
• Avoid breastfeeding.
• Grapefruit juice, hypericum perforatum-contained food and tobacco (smoking) affect the medicine. Avoid them while taking the medicine.

Side effects of this medicine

• shortness of breath, breathing difficulty, labored and frequent breathing, cough, dry cough, fever, weight loss, phlegm, loss of appetite, bluish lips and finger/toe nails.[interstitial lung disease (interstitial pneumonia, pneumonitis, irradiation pneumonitis, organized pneumonia, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltration, alveolitis, etc.)]
• lassitude, loss of appetite, nausea, vomiting, itch, yellowness in the skin and/or the white of the eye, dark urine, flapping tremor in hands[hepatitis, hepatic failure, hepatic function disorder]
• muddy/watery stool, severe abdominal pain, nausea, sweating[serious diarrhea]
• decreased consciousness, swollen body/eyes, easy fatigability, decreased urinary volume, urinary retention, headache, lassitude, breathlessness[acute renal failure]
• lassitude, loss of appetite, fever, high fever, joint pain, red rash with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, rash and blister, inflamed eyelid/eye, conjunctival sore, severe stomatitis, lip/intraoral sore, pain in the genitalia[mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (TEN), erythema multiforme]
• nausea, vomiting, stomachache, vomiting of blood, abdominal pain, severe abdominal pain, bloody/black stool[perforation of the digestive tract, gastrointestinal ulcer, gastrointestinal bleeding]
• sensitive to light, blurred vision, irritation in the eyes, ocular pain, teary eyes[corneal perforation, corneal ulcer]

Storage and other information

• Keep out of the reach of children. Store at room temperature (1-30℃), away from direct sunlight and moisture.
• Discard the remainder. Do not store them. Ask the pharmacist how to discard.