Erlotinib Vipharm

Package Leaflet: Information for the User

Erlotinib Vipharm, 25 mg, film-coated tablets

Erlotinib Vipharm, 100 mg, film-coated tablets

Erlotinib Vipharm, 150 mg, film-coated tablets

Erlotinib

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Erlotinib Vipharm contains the active substance erlotinib. Erlotinib Vipharm is a medicine used to treat cancer. Its mechanism of action involves inhibiting the activity of a protein called epidermal growth factor receptor (EGFR). This protein is involved in the 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 progressed significantly after first-line chemotherapy and provided that the tumor 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 that has spread.

2. Before you take Erlotinib Vipharm

When not to take Erlotinib Vipharm:

Warnings and precautions:

Before taking Erlotinib Vipharm, discuss this with your doctor.

See also below "Erlotinib Vipharm and other medicines".
You should tell your 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 severe kidney disease.
Glucuronyl transferase conjugation disorders, such as Gilbert's syndrome
The doctor should exercise caution in patients with glucuronyl transferase conjugation disorders, 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

Erlotinib Vipharm with food and drink

Do not take Erlotinib Vipharm with food.
See also section 3 "How to take Erlotinib Vipharm".

Pregnancy and breastfeeding

Avoid becoming pregnant while taking Erlotinib Vipharm. Women who may become pregnant should use appropriate contraception during treatment and for at least 2 weeks after taking the last tablet.
If you become pregnant while taking Erlotinib Vipharm, tell your doctor immediately, who will decide whether treatment can be continued. Do not breastfeed while taking Erlotinib Vipharm 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 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 Vipharm contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Erlotinib Vipharm.

Erlotinib Vipharm contains sodium

Each tablet contains less than 1 mmol (23 mg) of sodium, i.e., the medicine is essentially 'sodium-free'.

3. How to take Erlotinib Vipharm

Always take this medicine exactly as your doctor has told you. If you are not sure, check with 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 Vipharm is 150 mg once daily for non-small cell lung cancer.
For pancreatic cancer with metastases, the usual dose of Erlotinib Vipharm is 100 mg once daily. Erlotinib Vipharm is given in combination with another medicine called gemcitabine.
Your doctor may reduce the dose of Erlotinib Vipharm in increments of 50 mg. To allow for different dosing schedules, Erlotinib Vipharm is available in 25 mg, 100 mg, and 150 mg film-coated tablets.
The 100 mg film-coated tablets of Erlotinib Vipharm can be divided into equal doses.

If you take more Erlotinib Vipharm than you should

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

If you forget to take Erlotinib Vipharm

If you miss one or more doses of Erlotinib Vipharm, contact your doctor or pharmacist as soon as possible.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Erlotinib Vipharm

Erlotinib Vipharm should be taken daily for as long as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 Vipharm or discontinue 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, contact your doctor immediately, as hospital treatment may be necessary.
• Eye irritation due to conjunctivitis/keratitis and conjunctiva (very common: affects more than 1 in 10 people) and keratitis (common: affects no more than 1 in 10 people).
• 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 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, contact your doctor immediately, as these may be signs of this disease. Your doctor may decide to permanently discontinue Erlotinib Vipharm treatment.
• Gastrointestinal perforation (uncommon: affects no more than 1 in 100 people). Tell your doctor if you experience severe abdominal pain. You should also tell 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 tests indicate severe liver function changes, your doctor may advise discontinuing 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 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 blood test results
• Itching, dry skin, hair loss
• Fatigue, fever, chills

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

• 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 people):

• 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 people):

• 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 people):

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

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or 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:
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, you can help provide more information on the safety of this medicine.

5. How to store Erlotinib Vipharm

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 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Erlotinib Vipharm contains

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

What Erlotinib Vipharm looks like and contents of the pack

Erlotinib Vipharm 25 mg film-coated tablets:
White, round, biconvex film-coated tablets with a diameter of about 6 mm, with "E9OB" engraved on one side and "25" on the other side.
Erlotinib Vipharm 100 mg film-coated tablets:
White, round, biconvex film-coated tablets with a diameter of about 10 mm, with a score line on both sides and "E9OB" engraved above the score line and "100" below the score line. The tablet can be divided into equal doses.
Erlotinib Vipharm 150 mg film-coated tablets:
White, round, biconvex film-coated tablets with a diameter of about 10.4 mm, with "E9OB" engraved on one side and "150" on the other side.
Carton containing blisters with 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Vipharm S.A.
A. and F. Radziwiłłów 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 filmomhulde tabletten
Erlotinib Vipharm 100 filmomhulde tabletten
Erlotinib Vipharm 150 filmomhulde tabletten
CZ
Erlotinib Vipharm
HU
Erlotinib Vipharm 25 mg filmtabletta
Erlotinib Vipharm 100 mg filmtabletta
Erlotinib Vipharm 150 mg filmtabletta
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