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
Erlotinibum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Erlotinib Vipharm is and what it is used for
2. What you need to know before taking 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 in the treatment of cancer. The mechanism of action of this medicine is based on inhibition
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 to patients
with advanced non-small cell lung cancer. It can be used as first-line treatment or when the
disease has remained substantially unchanged after first-line chemotherapy, provided that
tumour cells show specific EGFR mutations. Erlotinib Vipharm may also be used when previous
chemotherapy has failed to halt disease progression.
This medicine may also be prescribed in combination with another medicine called gemcitabine
for patients with metastatic pancreatic cancer.

2. Important information before using Erlotinib Vipharm

When not to use Erlotinib Vipharm:

• if the patient is allergic to erlotinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:
Before starting treatment with Erlotinib Vipharm, discuss this with your doctor.

• if the patient has ever had liver problems. Erlotinib may cause serious liver problems, and some cases may be fatal. Your doctor may perform blood tests during treatment to monitor whether the liver is functioning properly.
• if the patient is taking other medicines that may increase or decrease the blood concentration of erlotinib – the active substance in Erlotinib Vipharm – or affect its action (e.g. antifungal medicines such as ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St John's wort, or proteasome inhibitors), consult your doctor. In some cases, these medicines may reduce the effectiveness or increase the severity of adverse effects of Erlotinib Vipharm. In such cases, the doctor must adjust the treatment. Your doctor may advise avoiding the use of the mentioned medicines during treatment with Erlotinib Vipharm.
• if the patient is taking anticoagulant medicines (a medicine that helps prevent blood clots or thrombosis, e.g. warfarin). Erlotinib Vipharm may increase the tendency to bleed. In such cases, consult your doctor, who will need to perform regular blood tests.
• consult your doctor if the patient is taking statins (medicines used to lower blood cholesterol levels). Erlotinib Vipharm may increase the risk of statin-induced muscle disease (rhabdomyolysis), which in rare cases may lead to severe muscle damage causing kidney injury.
• if the patient wears contact lenses and/or has previously experienced eye problems such as severe dry eye, inflammation of the front part of the eye (cornea), or corneal ulceration.

See also below "Erlotinib Vipharm with other medicines".
The patient should inform the doctor:

• if sudden breathing difficulties occur, accompanied by cough or fever, as other medicines may be needed and treatment with Erlotinib Vipharm may need to be interrupted;
• if diarrhoea occurs, as an antidiarrhoeal medicine (e.g. loperamide) may be required;
• immediately, if severe or persistent diarrhoea, nausea, loss of appetite, or vomiting occur, as treatment with Erlotinib Vipharm may need to be interrupted and hospital treatment may be necessary;
• if severe abdominal pain, increased acne-like skin rash, or skin peeling occur. Temporary interruption or complete discontinuation of treatment may be necessary;
• immediately, if acute or worsening eye redness and pain, increased tearing, blurred vision, and/or photophobia occur, inform the doctor or nurse immediately, as urgent treatment may be required (see below: Possible side effects);
• if the patient is also taking statins and experiences unexplained muscle pain, tenderness, weakness, or cramps. In such cases, the doctor may temporarily interrupt or completely discontinue treatment.

See also section 4 "Possible side effects".
Liver or kidney disease
It is not known whether the effect of Erlotinib Vipharm may be altered in patients with impaired liver or kidney function. The use of this medicine is not recommended in patients with severe liver or severe kidney disease.
Impaired glucuronidation reactions, such as Gilbert's syndrome
The doctor must exercise caution in patients with impaired glucuronidation reactions, e.g. patients with Gilbert's syndrome.
Smoking
Patients treated with Erlotinib Vipharm are advised to stop smoking, as smoking may reduce blood concentrations of the medicine.
Children and adolescents
Erlotinib Vipharm has not been studied in patients under 18 years of age. This medicine is not recommended for use in children and adolescents.
Erlotinib Vipharm with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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. Female patients who could 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 while taking Erlotinib Vipharm, she should inform her doctor immediately. The doctor will decide whether treatment may continue. Do not breastfeed during treatment with Erlotinib Vipharm and for at least 2 weeks after taking the last tablet.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
The effect of erlotinib on the ability to drive and use machines has not been specifically studied. It is very unlikely that this treatment would adversely affect the ability to drive and use machines.
Erlotinib Vipharm contains lactose.
If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before taking Erlotinib Vipharm.
Erlotinib Vipharm contains sodium.
Each tablet contains less than 1 mmol (23 mg) of sodium, meaning the medicine is considered "sodium-free".

3. How to take Erlotinib Vipharm

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.
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 metastatic pancreatic cancer, the usual dose of Erlotinib Vipharm is 100 mg once daily. Erlotinib Vipharm is administered in combination with another medicine – gemcitabine.
Your doctor may recommend reducing the dose of the medicine gradually by 50 mg. To allow for various dosing regimens, Erlotinib Vipharm is available in tablets of 25 mg, 100 mg, and 150 mg.
Erlotinib Vipharm 100 mg coated tablets may be divided into equal doses.
Taking more Erlotinib Vipharm than prescribed
Contact your doctor or pharmacist immediately.
An increase in adverse reactions may occur, and your doctor may discontinue the treatment.
Missing a dose of 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 missed dose.
Stopping Erlotinib Vipharm treatment
Erlotinib Vipharm should be taken daily for as long as your doctor recommends. If you have any concerns about taking this medicine, consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions listed below occur, contact your doctor as soon as possible. In some cases, your doctor may reduce the dose of Erlotinib Vipharm or discontinue treatment:

• Diarrhoea and vomiting (very common: affects more than 1 in 10 patients). Persistent and severe diarrhoea may lead to low potassium levels in the blood and kidney dysfunction, especially if the patient is receiving another type of chemotherapy at the same time. If diarrhoea becomes more severe or persistent, contact your doctor immediately, as hospital treatment may be necessary.
• Eye irritation due to conjunctivitis/corneal and conjunctival inflammation (very common; affects more than 1 in 10 patients) and keratitis (common: affects up to 1 in 10 patients).
• Lung tissue irritation, known as interstitial lung disease (not common in European (Caucasian) populations and common in Japanese populations: affects up to 1 in 100 European patients and 1 in 10 Japanese patients). This condition may also be related to the natural progression of the underlying disease and, in some cases, may result in death. If symptoms such as sudden breathing difficulties accompanied by cough or fever occur, contact your doctor immediately, as these may be signs of this disease. Your doctor may decide to permanently discontinue treatment with Erlotinib Vipharm.
• Gastrointestinal perforations (not common: affects up to 1 in 100 patients). Inform your doctor if the patient experiences severe abdominal pain. Also inform your doctor if the patient has previously had peptic ulcers or diverticular disease, as having these conditions may increase the risk of gastrointestinal perforation.
• In rare cases, hepatitis has been observed (may affect up to 1 in 1000 people). 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, which may lead to death. If blood tests indicate severe liver function abnormalities, your doctor may recommend discontinuing treatment.

Very common adverse reactions (affects more than 1 in 10 patients):

• Rash, which may appear or worsen on skin exposed to sunlight. Patients exposed to sunlight may be advised to use protective clothing and/or sunscreens (e.g. mineral-based)
• Infections
• Loss of appetite, weight loss
• Depression
• Headache, skin sensory disturbances or limb numbness
• Breathing difficulties, cough
• Nausea
• Oral mucositis
• Abdominal pain, indigestion, bloating
• Abnormal blood test results assessing liver function
• Itching, dry skin, hair loss
• Fatigue, fever, chills

Common adverse reactions (affects up to 1 in 10 patients):

• Nosebleeds
• Bleeding from the stomach or intestines
• Inflammatory reactions around the nails
• Folliculitis
• Acne
• Skin fissures
• Kidney failure (when erlotinib is taken outside registered indications in combination with chemotherapy)

Uncommon adverse reactions (affects up to 1 in 100 patients):

• Eyelash changes
• Excessive body and facial hair growth (male pattern)
• Eyebrow changes
• Brittle and soft nails

Rare adverse reactions (affects up to 1 in 1000 patients):

• Redness or pain in the palms of the hands or soles of the feet (hand-foot skin reaction)

Very rare adverse reactions (affects up to 1 in 10,000 patients):

• Cases of corneal ulceration or perforation
• Severe blistering or peeling of the skin (resembling Stevens-Johnson syndrome)
• Inflammation of the coloured part of the eye

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the blister pack and the cardboard
box after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must 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: One film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Vipharm 100 mg film-coated tablets: One film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride). Erlotinib Vipharm 150 mg film-coated tablets: One film-coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
• Other ingredients are: Tablet core: monohydrate lactose, microcrystalline cellulose and calcium hydrogen phosphate, sodium carboxymethyl starch (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 approximately 6 mm, embossed with
the mark “E9OB” on one side and “25” on the other.
Erlotinib Vipharm 100 mg film-coated tablets:
White, round, biconvex film-coated tablets with a diameter of approximately 10 mm, with a break line on both sides, embossed with the mark “E9OB” above the break line and “100” below the break 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 approximately 10.4 mm, embossed with the mark “E9OB” on one side and “150” on the other.
Carton box with blisters containing 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland

Manufacturer
Synthon BV
Microweg 22
6545 CM Nijmegen,
The 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

November 2022