ERLOTINIB TARBIS 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Erlotinib Tarbis 25 mg film-coated tablets EFG

Erlotinib Tarbis 100 mg film-coated tablets EFG

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

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

Erlotinib Tarbis 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 slow down your disease.

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

2. Before taking Erlotinib Tarbis

Do not take Erlotinib Tarbis

• 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 this medicine, and therefore your doctor may need to adjust your treatment. Your doctor should avoid treating you with these medicines while you are taking Erlotinib Tarbis.
• if you are taking anticoagulants (medicines that help prevent the formation of blood clots or thrombosis, e.g. warfarin) since Erlotinib Tarbis may make you more prone to bleeding. Consult your doctor, he will need to have some blood tests done regularly.
• if you are taking statins (medicines that lower blood cholesterol levels), as Erlotinib Tarbis 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 “Taking Erlotinib Tarbis with other medicines”.

You must tell 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 Tarbis;
• 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 Tarbis and treat you in the 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 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 stop 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 on palpation, weakness or cramps. Your doctor may need to interrupt or suspend your treatment.

See also section 4 “Possible side effects”.

Liver or kidney disease

It is not known if this medicine has a different effect in case of liver or kidney dysfunction. 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 treatment with caution.

Smokers

It is recommended that you stop smoking if you are being treated with this medicine, as smoking can 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 Tarbis

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

Taking Erlotinib Tarbis with food and drinks

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

Pregnancy and breast-feeding

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

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

You should not breast-feed if you are taking Erlotinib Tarbis.

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 Tarbis on the ability to drive and use machines have not been studied, but it is unlikely that your treatment will affect this ability.

Erlotinib Tarbis contains lactose.

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

Erlotinib Tarbis contains sodium

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

3. How to take Erlotinib Tarbis

Follow exactly the instructions of administration of this medicine 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 ingested food.

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

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

Your doctor may adjust your dose in intervals of 50 mg. For this reason, Erlotinib Tarbis is available in doses of 25 mg, 100 mg and 150 mg to adjust the different dosing regimens.

If you take more Erlotinib Tarbis 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 Tarbis

If you forget to take one or more doses of Erlotinib Tarbis, 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 Tarbis

It is important to take Erlotinib Tarbis every day and for as long as 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 Tarbis:

• 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 administer treatment 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 patients of Japanese origin: may 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, 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 interrupt 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 failure has been observed (rare: may affect up to 1 in 1,000 people). If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment.

• 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 limbs
• Difficulty breathing, cough
• Nausea
• Irritation of the mouth
• Stomach pain, indigestion and flatulence
• Abnormal results in blood tests 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
• Cracks in the skin (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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Erlotinib Tarbis

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 on the carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Erlotinib Tarbis

• The active substance of Erlotinib Tarbis is erlotinib. Each film-coated tablet contains 25, 100 or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the dose.

The other ingredients are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate type A, sodium lauryl sulfate, magnesium stearate (see also section 2 for lactose monohydrate).

Tablet coating: hypromellose, hydroxypropyl cellulose, titanium dioxide, macrogol.

Appearance of the product and pack contents

Erlotinib Tarbis 25 mg is presented in the form of film-coated tablets, round, white, with the engraving “H” on one side and “28” on the other, and is available in packs of 30 tablets.

Erlotinib Tarbis 100 mg is presented in the form of film-coated tablets, round, white, with the engraving “H” on one side and “21” on the other, and is available in packs of 30 tablets.

Erlotinib Tarbis 150 mg is presented in the form of film-coated tablets, round, white, with the engraving “H” on one side and “22” on the other, and is available in packs of 30 tablets.

Marketing authorization holder:

TARBIS FARMA, S.L.U.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

PLA 3000 Paola

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Germany: Erlotinib Amarox 25, 100, 150 mg film-coated tablets

Spain: Erlotinib Tarbis 25, 100, 150 mg film-coated tablets EFG

Netherlands: Erlotinib Amarox 25, 100, 150 mg film-coated tablets

United Kingdom: Erlotinib Amarox 25, 100, 150 mg film-coated tablets

Date of last revision of this leaflet: January 2025

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