Erlotinib Sandoz 150 mg film-coated tablets EFG

Package Leaflet: Information for the User

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 the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

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

Erlotinib is indicated for adults. Your doctor may prescribe this medicine if you have advanced non-small cell lung cancer. It may be prescribed as initial treatment or as maintenance treatment when your disease has remained essentially stable after initial chemotherapy, provided that your cancer cells have specific EGFR mutations. It may also be prescribed if previous chemotherapy has not helped to control your disease.

Your doctor may also prescribe this medicine in combination with another treatment called gemcitabine if you have metastatic pancreatic cancer.

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

Do not take Erlotinib Sandoz

• if you are allergic to erlotinib or to 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 action (e.g., antifungal agents 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 effects of erlotinib, and therefore 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 thrombosis or blood clots, e.g., warfarin), as erlotinib may make you more prone to bleeding. Consult your doctor; he will need to perform regular blood tests;
• if you are taking statins (medicines that lower blood cholesterol levels), as erlotinib may increase the risk of muscle-related problems associated with statins, which in rare cases may 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 involving 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 develop difficulty breathing associated with cough or fever, as your doctor may need to prescribe other medicines and interrupt your treatment with erlotinib;
• if you have diarrhoea, as your doctor may need to prescribe an antidiarrhoeal (e.g., loperamide);
• immediately if you have persistent or severe diarrhoea, nausea, loss of appetite, or vomiting, as your doctor may need to interrupt the administration of erlotinib and treat you in hospital;
• if you have ever had liver problems. Erlotinib can cause serious liver problems, and some cases have been fatal. Your doctor may perform blood tests while you are taking this medicine to monitor whether your liver is functioning properly;
• if you have sudden severe abdominal pain, or severe blistering or peeling of the skin. Your doctor may need to interrupt or stop your treatment;
• immediately if you experience worsening or sudden 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 require urgent treatment (see below Possible adverse effects);
• if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness, or cramps. Your doctor may need to interrupt or discontinue your treatment.

See also section 4 “Possible adverse effects”.

Liver or kidney disease

It is not known whether erlotinib has a different effect if your liver or kidneys are not functioning normally. Treatment with this medicine is not recommended if you have severe liver disease or severe kidney disease.

Glucuronidation disorders, such as Gilbert’s syndrome

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

Smoking

It is advisable to stop smoking if you are being treated with erlotinib, as smoking may reduce the amount of this medicine in the 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

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

Taking Erlotinib Sandoz with food and drink

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

Pregnancy and breastfeeding

Avoid becoming pregnant while taking erlotinib. If you are able to become pregnant, use effective contraception during treatment and for at least 2 weeks after taking the last tablet of erlotinib.

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

You must not breastfeed while taking erlotinib and for at least 2 weeks after taking the last tablet.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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 very 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 informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Erlotinib Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

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

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

Your doctor may adjust your dose in 50 mg increments.

For this reason, Erlotinib Sandoz is available in 25 mg, 100 mg, and 150 mg strengths to allow for different dosing regimens.

If you take more Erlotinib Sandoz than you should

Contact your doctor or pharmacist immediately.

You may experience an increase in adverse effects, and your doctor may need to discontinue your treatment.

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

If you forget to take Erlotinib Sandoz

If you miss 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 missed doses.

If you stop taking Erlotinib Sandoz

It is important to take this medicine every day and for as long as your doctor prescribes it.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the adverse effects listed below, contact your doctor as soon as possible. In some cases, your doctor may need to reduce your dose or stop treatment with erlotinib:

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

• Eye irritation 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 type of lung irritation called interstitial lung disease (uncommon in European patients; common in patients of Japanese origin: may affect up to 1 in 100 people in Europe and up to 1 in 10 people in Japan). This condition may also be related to the natural progression of your disease and, in some cases, may be fatal. If you suddenly develop symptoms such as difficulty breathing associated with cough or fever, contact your doctor immediately, as you may be experiencing this condition. Your doctor may decide to permanently discontinue 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 your risk of gastrointestinal perforation.

• Rarely, liver inflammation (hepatitis) has been observed (may affect up to 1 in 1,000 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 occurred, which may be potentially fatal. If blood tests show significant changes in liver function, your doctor may need to discontinue your treatment.

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

• Skin rashes that may appear or worsen in sun-exposed areas. If you are exposed to sunlight, it is advisable to wear protective clothing and/or use sunscreen (e.g., containing mineral filters),
• infection,
• loss of appetite, weight loss,
• depression,
• headache, skin irritation or numbness in the limbs,
• difficulty breathing, cough,
• nausea,
• mouth irritation,
• stomach pain, indigestion, and flatulence,
• abnormal results in blood tests performed to check liver function,
• itching,
• fatigue, fever, stiffness.

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

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

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

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

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

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

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Erlotinib Sandoz Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and the outer carton after EXP/CAD. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 components are:

core: monohydrate lactose, 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 and ethyl acrylate copolymer Type A (1:1), 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 aluminium-OPA/Alu/PVC blisters, packed into a cardboard container.

Pack sizes:

30 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

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 the most recent revision of this leaflet: July 2024.

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