Prospect: information for the patient

Erlotinib Sandoz 25 mg film-coated tablets

Erlotinib Sandoz 100 mg film-coated tablets

Erlotinib Sandoz 150 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

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

3. How to take Erlotinib Sandoz

4. Possible adverse effects

5. Storage of Erlotinib Sandoz

6. Contents of the pack and additional information

Erlotinib Sandoz contains the active ingredient erlotinib. This medication is used to treat cancer and works by preventing the activity of a protein called the 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 medication if you have non-small cell lung cancer in an advanced state. You may be prescribed this medication as initial treatment or as treatment if your disease remains practically unchanged after initial chemotherapy, as your cancer cells present specific mutations in the EGFR. You may also be prescribed this medication if previous chemotherapy has not helped to slow your disease.

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

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 decrease the effectiveness 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 thrombi, e.g., warfarin) as erlotinib may make you more prone to bleeding. Consult your doctor, he will need to do regular blood tests,
• if you are taking statins (medicines that decrease the level of cholesterol in the blood), as erlotinib may increase the risk of muscle-related problems associated with statin that, in rare cases, may lead to muscle degradation (rhabdomyolysis) causing kidney damage, consult your doctor,
• if you use 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 include the front part of the eye, inform your doctor.

See also below “Other medicines and Erlotinib Sandoz”.

You should consult your doctor:

• if you havesuddendifficulty breathing associated with cough or fever as, if so, 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 treat you in the hospital;
• if you have ever had liver problems. Erlotinib may cause severe liver problems and some cases have been fatal. Your doctor may perform blood tests while you are taking this medicine to monitor if your liver is functioning correctly;
• if you have acute abdominal pain, blisters or severe skin peeling. Your doctor may need to interrupt or discontinue your treatment;
• if you experience worsening or acute and painful redness 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 below Possible side 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 side effects”.

Liver or kidney disease

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

Glucuronidation disorder, such as Gilbert's syndrome

If you have a glucuronidation disorder, such as Gilbert's syndrome, your doctor should administer the treatment with erlotinib 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 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 aretaking, havetakenrecentlyor may need to take any other medicine.

Taking Erlotinib Sandoz with food and drinks

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

Pregnancy andbreastfeeding

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

If you become pregnant while takingerlotinib, inform your doctor immediately as he will decide if you should continue treatment.

You should not breastfeed your baby if you are takingerlotiniband for at least 2 weeks after taking the last tablet.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating 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 indicated that you have a certain sugar intolerance, consult with him before taking this medicine.

Follow exactly the administration instructions for this medication as indicated 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 having eaten food.

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

The recommended dose is one Erlotinib 100 mg 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 doses of 25 mg, 100 mg, and 150 mg to adjust 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 interrupt your treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication 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 compensate for the missed doses.

If you interrupt treatment with Erlotinib Sandoz

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

If you have 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 stop treatment with erlotinib:

• Diarrhea and vomiting (very common: can affect more than 1 in 10 people). Severe and persistent diarrhea can cause a decrease in blood potassium and kidney function, especially if you are receiving other chemotherapy treatments at the same time. If your diarrhea worsens or persists, contact your doctor immediatelyas your doctor may need to administer hospital treatment.

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

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

• Gastrointestinal perforations have been observed (rare: can affect up to 1 in 100 people). If you have 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 (can 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 stop your treatment.

Very common side effects (can 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 wear protective clothing and/or use sunscreen (e.g. containing minerals),
• infection
• loss of appetite, weight loss,
• depression,
• headache, sensation of skin alteration or numbness in the extremities,
• 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 side effects (can affect up to 1 in 10 people):

• Skin dryness,
• hair loss,
• nosebleeds,
• bleeding in the stomach or intestines,
• 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).

Rare side effects (can affect up to 1 in 100 people):

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

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

• Palmar-plantar erythrodysaesthesia syndrome (pain or redness of the palms or soles).

Very rare side effects (can 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the blister pack and on the box after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofErlotinib Sandoz

• The active ingredient 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: 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), copolymer of methacrylic acid and ethyl acrylate Type A (1:1), sodium hydrogen carbonate.

Appearance of the product and contents of the package

Erlotinib Sandoz 25 mg film-coated tablets:white to yellowish, round, biconvex tablet with a “25” engraved on one face. 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 face. The diameter of the tablet is 8.9 mm ± 5 %.

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

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

Package sizes:

30 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

or

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

Last review date of this leaflet:July 2024.

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