Erlotinib Vipharm

Leaflet attached to the packaging: information for the user

Erlotinib Vipharm, 25 mg, coated tablets

Erlotinib Vipharm, 100 mg, coated tablets

Erlotinib Vipharm, 150 mg, coated tablets

Erlotinib

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Erlotinib Vipharm and what is it used for
• 2. Important information before taking Erlotinib Vipharm
• 3. How to take Erlotinib Vipharm
• 4. Possible side effects
• 5. How to store Erlotinib Vipharm
• 6. Contents of the packaging and other information

1. What is Erlotinib Vipharm and what is it used for

Erlotinib Vipharm contains the active substance erlotinib. Erlotinib Vipharm is a medicine used in the treatment of 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 Vipharm 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 changed significantly after first-line chemotherapy and provided that the cancer cells have specific EGFR mutations. Erlotinib Vipharm 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 Vipharm

When not to take Erlotinib Vipharm:

Warnings and precautions:

Before starting treatment with Erlotinib Vipharm, the patient should discuss it with their doctor.

See also below "Erlotinib Vipharm and other medicines".
The patient should inform their doctor:

See also section 4 "Possible side effects".
Liver or kidney disease
The effect of Erlotinib Vipharm 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.
Disorders of glucuronidation reactions, such as Gilbert's syndrome
The doctor should exercise caution in patients with disorders of glucuronidation reactions, such as those with Gilbert's syndrome.
Smokers
Patients treated with Erlotinib Vipharm are advised to quit smoking, as smoking may decrease the levels of the medicine in the blood.

Children and adolescents

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

Erlotinib Vipharm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Erlotinib Vipharm with food and drink

Erlotinib Vipharm should not be taken with food.
See also section 3 "How to take Erlotinib Vipharm".

Pregnancy and breastfeeding

Pregnancy should be avoided during treatment with Erlotinib Vipharm. 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 patient becomes pregnant during treatment with Erlotinib Vipharm, they should immediately inform their doctor, who will decide whether treatment can be continued. Breastfeeding should not be done during treatment with Erlotinib Vipharm and for at least 2 weeks after taking the last tablet.
In pregnancy, during breastfeeding, or if there is a suspicion of pregnancy, or if the patient is planning to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Erlotinib has not been studied for its potential to affect the ability to drive or use machines. It is very unlikely that such treatment would have a negative impact on the ability to drive or use machines.

Erlotinib Vipharm contains lactose.

If the patient has been diagnosed with intolerance to certain sugars, they should contact their doctor before taking Erlotinib Vipharm.

Erlotinib Vipharm contains sodium.

Each tablet contains less than 1 mmol (23 mg) of sodium, which means the medicine is considered "sodium-free".

3. How to take Erlotinib Vipharm

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their 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 Vipharm is 150 mg once daily in the case of non-small cell lung cancer.
In the case of pancreatic cancer with metastases, the usual dose of Erlotinib Vipharm is 100 mg once daily. Erlotinib Vipharm is given in combination with another medicine - gemcitabine.
The doctor may recommend reducing the dose of the medicine, gradually by 50 mg. To enable different dosing schedules, Erlotinib Vipharm is available in tablets of 25 mg, 100 mg, and 150 mg.
The 100 mg coated tablets of Erlotinib Vipharm can be divided into equal doses.

Taking a higher dose of Erlotinib Vipharm than recommended

The patient should immediately contact their doctor or pharmacist.
There may be an increase in side effects, and the doctor may discontinue treatment.

Missing a dose of Erlotinib Vipharm

If the patient misses one or more doses of Erlotinib Vipharm, they should contact their doctor or pharmacist as soon as possible.
The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Erlotinib Vipharm

Erlotinib Vipharm should be taken daily for as long as the doctor recommends. If the patient has any doubts about taking the medicine, they should consult their doctor or pharmacist.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Erlotinib Vipharm can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should contact their doctor as soon as possible. In some cases, the doctor may reduce the dose of Erlotinib Vipharm or discontinue treatment:

• Diarrhea and vomiting (very common: affects more than 1 in 10 patients). Persistent and severe diarrhea may lead to low potassium levels in the blood and kidney dysfunction, especially if the patient is receiving other chemotherapy at the same time. If severe or persistent diarrhea occurs, the patient should immediately contact their doctor, as hospital treatment may be necessary.
• Eye irritation due to conjunctivitis/keratitis and conjunctivitis (very common: affects more than 1 in 10 patients) and keratitis (common: affects no more than 1 in 10 patients).
• Lung tissue irritation, called interstitial lung disease (uncommon in the European population and common in the Japanese population: affects no more than 1 in 100 patients in the European population and 1 in 10 patients 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 symptoms such as sudden difficulty breathing with accompanying cough or fever occur, the patient should immediately contact their doctor, as these may be signs of this disease. The doctor may decide to permanently discontinue Erlotinib Vipharm treatment.
• Gastrointestinal perforation (uncommon: affects no more than 1 in 100 patients). The patient should inform their doctor if they experience severe abdominal pain. The patient should also inform their doctor if they have a history of stomach ulcers or diverticulitis, as the presence of these conditions may increase the risk of gastrointestinal perforation.
• In rare cases, liver inflammation (may affect no more than 1 in 1000 patients) 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 may lead to death. If blood tests indicate severe changes in liver function, the doctor may recommend discontinuing treatment.

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

• 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, sensory disturbances, or numbness of the limbs
• Breathing difficulties, cough
• Nausea
• Mouth irritation
• Abdominal pain, indigestion, bloating
• Abnormal liver function test results
• Itching, dry skin, hair loss
• Fatigue, fever, chills

Common side effects(affects no more than 1 in 10 patients):

• Nosebleeds
• Bleeding from the stomach or intestines
• Inflammatory reactions around the nails
• Folliculitis
• Acne
• Skin cracking
• Kidney failure (when erlotinib is taken off-label in combination with chemotherapy)

Uncommon side effects(affects no more than 1 in 100 patients):

• Changes in eyelashes
• Excessive hair growth on the body and face of male type
• Changes in eyebrows
• Brittle and fragile nails

Rare side effects(affects no more than 1 in 1000 patients):

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

Very rare side effects(affects no more than 1 in 10,000 patients):

• Cases of corneal ulcers or perforation
• Severe skin rash or skin peeling (resembling Stevens-Johnson syndrome)
• Uveitis

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse.
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:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: 22 49-21-301
fax: 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, more information can be collected on the safety of the medicine.

5. How to store Erlotinib Vipharm

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Erlotinib Vipharm contains

• The active substance of the medicine is erlotinib. Erlotinib Vipharm 25 mg coated tablets: One coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Vipharm 100 mg coated tablets: One coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Vipharm 150 mg coated tablets: One coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
• The other ingredients are: Tablet core:lactose monohydrate, microcrystalline cellulose, and calcium hydrogen phosphate, sodium carboxymethyl cellulose (type A), colloidal silicon dioxide, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Tablet coating:hypromellose (E 464), hydroxypropyl cellulose (E 463), titanium dioxide (E 171), macrogol.

What Erlotinib Vipharm looks like and contents of the pack

Erlotinib Vipharm 25 mg coated tablets:
white, round, biconvex coated tablets with a diameter of about 6 mm, with the inscription "E9OB" on one side and "25" on the other side.
Erlotinib Vipharm 100 mg coated tablets:
white, round, biconvex coated tablets with a diameter of about 10 mm, with a dividing line on both sides, with the inscription "E9OB" above the dividing line and "100" below the dividing line. The tablet can be divided into equal doses.
Erlotinib Vipharm 150 mg coated tablets:
white, round, biconvex coated tablets with a diameter of about 10.4 mm, with the inscription "E9OB" on one side and "150" on the other side.
A carton box with blisters containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Vipharm S.A.
A. and F. Radziwiłłów Street 9
05-850 Ożarów Mazowiecki

Manufacturer

Synthon BV
Microweg 22
6545 CM Nijmegen,
Netherlands
Synthon Hispania SL
C/ Castelló n 1, Pol. Las Salinas, Sant Boi de Llobregat, Barcelona, 08830
Spain

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

NL
Erlotinib Vipharm 25 film-coated tablets
Erlotinib Vipharm 100 film-coated tablets
Erlotinib Vipharm 150 film-coated tablets
CZ
Erlotinib Vipharm
HU
Erlotinib Vipharm 25 mg film-coated tablets
Erlotinib Vipharm 100 mg film-coated tablets
Erlotinib Vipharm 150 mg film-coated tablets
PL
Erlotinib Vipharm
SK
Erlotinib Vipharm 25 mg
Erlotinib Vipharm 100 mg
Erlotinib Vipharm 150 mg

Date of last revision of the leaflet:

November 2022