Prospect: information for the user

Erlotinib Tarbis 25 mg film-coated tablets

Erlotinib Tarbis 100 mg film-coated tablets

Erlotinib Tarbis 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 doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must 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 or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3. How to take Erlotinib Tarbis

4. Possible adverse effects

5. Storage of Erlotinib Tarbis

6. Contents of the pack and additional information

Erlotinib Tarbis 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 pancreatic cancer in a metastatic state.

Do not take Erlotinib Tarbis

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

Warnings and precautions

• if you are taking other medications that may increase or decrease the amount of erlotinib in your blood or affect its effect (for example, 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 medications may decrease the effectiveness or increase the effects of this medication and your doctor may need to adjust your treatment. Your doctor should avoid treating you with these medications while you are taking Erlotinib Tarbis.
• if you are taking anticoagulants (medications that help prevent the formation of blood clots or coagulation, for example, warfarin) as Erlotinib Tarbis may make you more prone to bleeding. Consult your doctor, who will need to perform regular blood tests.
• if you are taking statins (medications that decrease the level of cholesterol in the blood), as Erlotinib Tarbis may increase the risk of muscle-related problems associated with statin use, which, 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 involve the front part of the eye, inform your doctor.

See also below “Taking Erlotinib Tarbis with other medications”.

You must inform your doctor:

• if you havesuddendifficulty breathing associated with cough or fever, as your doctor may need to give you other medications and interrupt your treatment with Erlotinib Tarbis;
• if you have diarrhea, as your doctor may need to give you an anti-diarrheal (for example, 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 severe liver problems and some cases have been fatal. Your doctor may perform blood tests while you are taking this medication 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 acute worsening or 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 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

We do not know if this medication has a different effect if your liver or kidneys do not function normally. We do not recommend treatment with this medication 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 will need to administer the treatment with caution.

Smokers

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

Children and adolescents

Erlotinib has not been studied in patients under 18 years of age. We do not recommend treatment with this medication in children and adolescents.

Other medications and Erlotinib Tarbis

Inform your doctor or pharmacist if you aretaking, havetakenrecentlyor may need to take any other medication.

Taking Erlotinib Tarbis with food and drinks

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

Pregnancy and lactation

Avoid becoming pregnant while taking Erlotinib Tarbis. If you can become pregnant, use suitable 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 they will decide whether to continue treatment.

You should not breastfeed your baby if you are taking Erlotinib Tarbis.

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

Driving and operating machinery

We have not studied the possible effects of Erlotinib Tarbis on the ability to drive and operate machinery, but it is very unlikely that your treatment will affect this ability.

Erlotinib Tarbis contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Erlotinib Tarbis contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor.If in 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 Tarbis 150 mg tablet per day if you have non-small cell lung cancer.

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

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

If you take more Erlotinib Tarbis 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, 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 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 compensate for the missed doses.

If you interrupt treatment with Erlotinib Tarbis

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

If you have any other questions 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 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 discontinue treatment with Erlotinib Tarbis:

• Diarrhea and vomiting (very common: may affect more than 1 in 10 people). Severe and persistent diarrhea can cause a decrease in blood potassium levels 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: may affect more than 1 in 10 people), conjunctivitis, and keratitis (common: may affect up to 1 in 10 people).

• A lung condition called interstitial lung disease (rare 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 condition may also be related to the natural progression of your disease and, in some cases, may 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 condition. Your doctor may decide to permanently discontinue your treatment with this medicine.

• Gastrointestinal perforations have been observed (rare: may 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 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 discontinue your treatment.

• In rare instances, hepatitis (inflammation of the liver) 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 may be potentially fatal. If your blood tests indicate severe changes in your liver function, your doctor may need to discontinue 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 skin alteration or numbness in the extremities
• Difficulty breathing, cough
• Nausea
• Mouth irritation
• Abdominal pain, indigestion, and flatulence
• Abnormal results in blood tests performed to check liver function
• Itching
• Fatigue, fever, stiffness

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

• Skin dryness
• Hair loss
• Nasal bleeding
• Gastrointestinal bleeding
• Inflammatory reactions around the nail
• Folliculitis (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(may affect up to 1 in 100 people):

• Renal inflammation (nephritis)
• Excessive protein in 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(may affect up to 1 in 1,000 people):

• Pain or redness of the palms or soles (erythromelalgia)

Very rare side 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 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 leaflet. 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 and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and the

medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthepackaging and themedications you no longerneed. In this way, you will help protect the environment.

Composition ofErlotinib Tarbis

•The active ingredientof 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 components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, glycolated starch sodium type A, laurilsulfate sodium, magnesium stearate (see also section 2 for lactose monohydrate).

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

Appearance of the product and contents of the pack

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

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

Erlotinib Tarbis 150 mg is presented in the form of a film-coated, round, white tablet with the imprint “H” on one face 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

Responsible for manufacturing

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park

PLA 3000 Paola

Malta

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

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

Germany:Erlotinib Amarox 25, 100, 150 mg Filmtabletten

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

Netherlands:Erlotinib Amarox 25, 100, 150 mg filmomhulde tabletten

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

Last review date of this leaflet: January 2025

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)