ERLOTINIB SANDOZ 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Erlotinib Sandoz 25 mg Film-Coated Tablets EFG

Erlotinib Sandoz 100 mg Film-Coated Tablets EFG

Erlotinib Sandoz 150 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Erlotinib Sandoz and what is it used for
2. What you need to know before you take Erlotinib Sandoz
3. How to take Erlotinib Sandoz
4. Possible side effects
5. Storage of Erlotinib Sandoz
6. Contents of the pack and other information

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

Erlotinib Sandoz contains the active substance erlotinib. This medicine is used to treat cancer and works by preventing the activity of a protein called epidermal growth factor receptor (EGFR). It is known that this protein is involved in the growth and spread of tumor cells.

Erlotinib is indicated for adults. You may be prescribed this medicine if you have advanced non-small cell lung cancer. It may be prescribed as initial treatment or as treatment if your disease remains virtually unchanged after initial chemotherapy, since your cancer cells have specific mutations in the EGFR. It may also be prescribed if previous chemotherapy has not helped to control your disease.

You may also be prescribed this medicine in combination with another treatment called gemcitabine if you have metastatic pancreatic cancer.

2. What you need to know before you take Erlotinib Sandoz

Do not take Erlotinib Sandoz

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

Warnings and precautions

• if you are taking other medicines that may increase or decrease the amount of erlotinib in your blood or affect its effect (e.g., antifungals 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 efficacy or increase the effects of erlotinib, and your doctor may need to adjust your treatment. Your doctor should avoid treating you with these medicines while you are taking erlotinib,
• if you are taking anticoagulants (medicines that help prevent the formation of blood clots or thrombosis, e.g., warfarin) since erlotinib may make you more prone to bleeding. Consult your doctor, he will need to have you undergo regular blood tests,
• if you are taking statins (medicines that lower blood cholesterol levels), as erlotinib may increase the risk of muscle problems related to statins, which can rarely lead to muscle breakdown (rhabdomyolysis) causing kidney damage, consult your doctor,
• if you wear contact lenses and/or have a history of eye problems such as very dry eyes, inflammation of the front part of the eye (cornea), or ulcers that affect the front part of the eye, inform your doctor.

See also below “Other medicines and Erlotinib Sandoz”.

You should consult your doctor:

• if you suddenly have difficulty breathing associated with cough or fever, as your doctor may need to give you other medicines and interrupt your treatment with erlotinib;
• if you have diarrhea, as your doctor may need to give you an anti-diarrheal (e.g., loperamide);
• immediately if you have persistent or severe diarrhea, nausea, loss of appetite, or vomiting, as your doctor may need to interrupt the administration of erlotinib and have you treated in the hospital;
• if you have ever had liver problems. Erlotinib may cause serious liver problems, and some cases have been fatal. Your doctor may perform blood tests while you are taking this medicine to check if your liver is working properly;
• if you have severe abdominal pain, blisters, or severe skin peeling. Your doctor may need to interrupt or discontinue your treatment;
• if you experience worsening or acute redness and pain in the eye, increased tearing, blurred vision, and/or sensitivity to light, please inform your doctor or nurse immediately, as you may need urgent treatment (see also below Possible side effects);
• if you are also taking a statin and experience unexplained muscle pain, pain when touched, weakness, or cramps. Your doctor may need to interrupt or discontinue your treatment.

See also section 4 “Possible side effects”.

Liver or kidney disease

It is not known if this erlotinib has a different effect in case of abnormal liver or kidney function. Treatment with this medicine is not recommended if you have severe liver or kidney disease.

Glucuronidation disorder, such as Gilbert's syndrome

If you have a glucuronidation disorder, such as Gilbert's syndrome, your doctor should administer erlotinib treatment with caution.

Smokers

It is recommended that you stop smoking if you are being treated with erlotinib, as smoking may decrease the amount of this medicine in your blood.

Children and adolescents

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

Other medicines and Erlotinib Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Erlotinib Sandoz with food and drinks

Do not take this medicine with food. See also section 3 “How to take Erlotinib Sandoz”.

Pregnancy and breast-feeding

Avoid becoming pregnant while taking erlotinib. If you can become pregnant, use adequate contraceptive methods during treatment and for at least 2 weeks after taking the last erlotinib tablet.

If you become pregnant while taking erlotinib, inform your doctor immediately, as he will decide whether you should continue treatment.

Do not breast-feed your baby if you are taking erlotinib and for at least 2 weeks after taking the last erlotinib tablet.

If you are pregnant or breast-feeding, 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

The possible effects of Erlotinib Sandoz on the ability to drive and use machines have not been studied, but it is unlikely that your treatment will affect this ability.

Erlotinib Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

Erlotinib Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with him before taking this medicine.

3. How to take Erlotinib Sandoz

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The tablet should be taken at least one hour before or two hours after food intake.

The recommended dose is one 150 mg erlotinib tablet per day if you have non-small cell lung cancer.

The recommended dose is one 100 mg erlotinib tablet per day if you have metastatic pancreatic cancer. Erlotinib is used in combination with gemcitabine.

Your doctor may adjust your dose in 50 mg intervals.

For this reason, Erlotinib Sandoz is available in 25 mg, 100 mg, and 150 mg doses to adjust to different dosing regimens.

If you take more Erlotinib Sandoz than you should

Contact your doctor or pharmacist immediately.

You may experience an increased risk of side effects, and your doctor may need to interrupt your treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Erlotinib Sandoz

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

If you stop taking Erlotinib Sandoz

It is important to take this medicine every day and for the entire time your doctor prescribes it.

If you have any other questions about the use of this medicine, 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 side effects mentioned, contact your doctor as soon as possible. In some cases, your doctor may need to reduce your dose or interrupt treatment with erlotinib:

• Diarrhea and vomiting (very common: may affect more than 1 in 10 people). Severe and persistent diarrhea can lead to decreased potassium levels in the blood and decreased kidney function, especially if you are receiving other chemotherapeutic treatments at the same time. If your diarrhea worsens or becomes persistent, contact your doctor immediately, as your doctor may need to have you treated in the hospital.

• Irritation of the eyes due to keratoconjunctivitis (very common: may affect more than 1 in 10 people), conjunctivitis, and keratitis (common: may affect up to 1 in 10 people).

• A form of lung irritation called interstitial lung disease (uncommon in European patients; common in Japanese patients: may affect up to 1 in 100 people in Europe and up to 1 in 10 people in Japan). This disease can also be related to the natural progression of your disease, and in some cases, it can be fatal. If you suddenly experience symptoms such as difficulty breathing associated with cough or fever, contact your doctor immediately, as you may have this disease. Your doctor may decide to permanently discontinue your treatment with this medicine.

• Gastrointestinal perforations have been observed (uncommon: may affect up to 1 in 100 people). If you experience severe abdominal pain, inform your doctor. Also, inform your doctor if you have previously had a peptic ulcer or diverticular disease, as this may increase the risk of gastrointestinal perforations.

• In rare cases, liver inflammation (hepatitis) has been observed (may affect up to 1 in 1,000 people). Symptoms may include a general feeling of discomfort, 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 be potentially fatal. If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment.

Very common side effects (may affect more than 1 in 10 people):

• Rashes that may appear or worsen in sun-exposed areas. If you are exposed to the sun, it is recommended that you use protective clothing and/or sunscreen (e.g., containing minerals),
• infection
• loss of appetite, weight loss,
• depression,
• headache, sensation of alteration in the skin or numbness in the extremities,
• difficulty breathing, cough,
• nausea,
• mouth irritation,
• stomach pain, indigestion, and flatulence,
• abnormal blood test results to check liver function,
• itching,
• fatigue, fever, stiffness.

Common side effects (may affect up to 1 in 10 people):

• Dry skin,
• hair loss,
• nosebleeds,
• bleeding in the stomach or intestine,
• inflammatory reactions around the nail,
• infection of the hair follicles,
• acne,
• skin cracks (fissures in the skin),
• reduced kidney function (when given outside approved indications in combination with chemotherapy).

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

• Kidney inflammation (nephritis),
• excess protein in the urine (proteinuria),
• changes in the eyelashes,
• excessive body and facial hair with a male distribution pattern,
• excessive skin pigmentation,
• changes in the eyebrows,
• brittle and loose nails.

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

• Pain or redness of the palms or soles (palmar-plantar erythrodysesthesia syndrome).

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

• Cases of corneal ulceration or perforation,
• blisters or severe skin peeling (indicative of Stevens-Johnson syndrome),
• inflammation of the colored part of the eye.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Erlotinib Sandoz

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 is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Erlotinib Sandoz

• The active substance is erlotinib.

Erlotinib Sandoz 25 mg film-coated tablets

Each tablet contains 25 mg of erlotinib (as hydrochloride).

Erlotinib Sandoz 100 mg film-coated tablets

Each tablet contains 100 mg of erlotinib (as hydrochloride).

Erlotinib Sandoz 150 mg film-coated tablets

Each tablet contains 150 mg of erlotinib (as hydrochloride).

• The other ingredients are:

core: lactose monohydrate, microcrystalline cellulose (E460), sodium carboxymethyl starch type A, magnesium stearate (E470b).

coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), methacrylic acid - ethyl acrylate copolymer (1:1) type A, sodium hydrogen carbonate.

Appearance of the product and contents of the pack

Erlotinib Sandoz 25 mg film-coated tablets:white to yellowish, round, biconvex tablet with “25” engraved on one side. The diameter of the tablet is 6.1 mm ± 5%.

Erlotinib Sandoz 100 mg film-coated tablets:white to yellowish, round, biconvex tablet with “100” engraved on one side. The diameter of the tablet is 8.9 mm ± 5%.

Erlotinib Sandoz 150 mg film-coated tablets:white to yellowish, round, biconvex tablet with “150” engraved on one side. The diameter of the tablet is 10.5 mm ± 5%.

The tablets are packaged in aluminum-OPA/Alu/PVC blisters, packed in a cardboard box.

Package sizes:

30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

or

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

Date of last revision of this leaflet:July 2024.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)