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. It may be prescribed for patients with advanced non-small cell lung cancer. It can be used as a first-line treatment or when the disease has not progressed significantly after first-line chemotherapy, 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.

It can also be prescribed in combination with another medicine called gemcitabine for 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.

• tell your doctor if you are taking statins (medicines used to lower cholesterol levels in the blood). Erlotinib Vipharm may increase the risk of muscle disease caused by statins (rhabdomyolysis), which can rarely lead to severe muscle damage causing kidney damage.

See also "Erlotinib Vipharm with other medicines" below.

Tell your doctor:

• immediately, if you experience severe or persistent diarrhea, nausea, loss of appetite, or vomiting, as you may need to stop taking Erlotinib Vipharm and may need to be treated in a hospital;

See also section 4 "Possible side effects".

Liver or kidney disease

It is not known whether Erlotinib Vipharm may affect people with abnormal liver or kidney function. This medicine is not recommended for patients with severe liver or kidney disease.

Glucuronidation reaction disorders, such as Gilbert's syndrome

Your doctor should exercise caution when treating patients with glucuronidation reaction disorders, such as those with Gilbert's syndrome.

Smokers

Patients taking 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. It is not recommended for use in children and adolescents.

Erlotinib Vipharm with 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 effective contraception during treatment and for at least 2 weeks after 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 the last tablet.

In pregnancy and breastfeeding, or if you 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 very 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 your dose by 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 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 stop your 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 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, tell your doctor as soon as possible:

• Diarrhea and vomiting (very common: may affect 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, tell your doctor immediately, as you may need hospital treatment.
• Eye irritation due to conjunctivitis/keratitis and conjunctivitis (very common: may affect more than 1 in 10 people) and keratitis (common: may affect up to 1 in 10 people).
• Lung tissue irritation, called interstitial lung disease (uncommon in the European population and common in the Japanese population: may affect up to 1 in 100 people in the European population and up to 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 cough or fever, tell your doctor immediately, as these may be signs of this disease. Your doctor may decide to stop your Erlotinib Vipharm treatment permanently.
• Gastrointestinal perforation (uncommon: may affect up to 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 (which 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. This can lead to death. If blood tests indicate severe changes in liver function, your doctor may advise you to stop treatment.

Very common side effects(may affect 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, 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(may affect up to 1 in 10 people):

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

Uncommon side effects(may affect up to 1 in 100 people):

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

Rare side effects(may affect up to 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(may affect up to 1 in 10,000 people):

• Cases of corneal ulcers or perforation
• Severe skin rash and blistering, resembling Stevens-Johnson syndrome
• Iritis

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects directly via the national reporting system listed in the "Contact" section below.

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.

No special storage precautions are required.

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 anhydrous silica, 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 30 film-coated tablets in blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Vipharm S.A.
ul. A. i 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 is authorised 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