ERLOTINIB TARBIS 150 MG FILM-COATED TABLETS EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Erlotinib Tarbis 25 mg film-coated tablets EFG

Erlotinib Tarbis 100 mg film-coated tablets EFG

Erlotinib Tarbis 150 mg film-coated tablets EFG

Please read all of this leaflet carefully before you start taking this medicine, as 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 or pharmacist.
• 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 adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

Erlotinib Tarbis 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 tumour 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 a treatment option if your disease has remained essentially unchanged 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. Before taking Erlotinib Tarbis

Do not take Erlotinib Tarbis

• 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 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 thrombosis or blood clots, e.g. warfarin), as Erlotinib Tarbis may make you more likely to experience bleeding. Consult your doctor, who will need to perform regular blood tests.
• if you are taking statins (medicines that lower blood cholesterol levels), since Erlotinib Tarbis may increase the risk of statin-related muscle problems, 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 “Taking Erlotinib Tarbis with other medicines”.

You should discuss with 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 Tarbis;
• if you have diarrhoea, as your doctor may need to prescribe an antidiarrhoeal (e.g. loperamide);

immediately if you experience persistent or severe diarrhoea, nausea, loss of appetite, or vomiting, as your doctor may need to interrupt the administration of Erlotinib Tarbis and treat you in 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 monitor whether your liver is functioning properly;
• if you experience sudden severe abdominal pain, blistering or severe peeling of the skin. Your doctor may need to interrupt or stop your treatment;
• if you notice 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 section 4 “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 whether this medicine 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 this medicine with caution.

Smoking

It is advisable to stop smoking if you are being treated with this medicine, 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 Tarbis

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

Taking Erlotinib Tarbis with food and drink

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

Pregnancy and breastfeeding

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 they will decide whether you should continue treatment.

You must not breastfeed while taking Erlotinib Tarbis.

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 Tarbis 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 Tarbis contains lactose.

If your doctor has informed you of an intolerance to certain sugars, consult with them 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 administration instructions for 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 food.

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

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

Your doctor may adjust your dose in 50 mg increments. For this reason, Erlotinib Tarbis is available in strengths of 25 mg, 100 mg, and 150 mg to allow adjustment to different dosage 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 interrupt your treatment.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 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 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, contact your doctor as soon as possible. In some cases, your doctor may need to reduce your dose or stop your treatment with Erlotinib Tarbis:

• Diarrhoea and vomiting (very common: may affect more than 1 in 10 people). Severe and persistent diarrhoea 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 diarrhoea worsens or becomes persistent, contact your doctor immediately, as you may require treatment in 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 inflammation 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 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 perforation.

• In rare cases, liver failure has been observed (rare: may affect up to 1 in 1,000 people). If your blood tests indicate serious changes in liver function, your doctor may need to stop 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 being unwell, 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 your blood tests indicate serious changes in liver function, your doctor may need to stop 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 sun protection (e.g. containing minerals)
• 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 blood test results used to monitor liver function
• Itching
• Tiredness, fever, stiffness

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

• Dry skin
• Hair loss
• Nosebleeds
• Bleeding in the stomach or intestines
• 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 growth of 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 coloured 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 Tarbis 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 carton following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE collection point. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Erlotinib Tarbis

• The active substance in 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, sodium starch glycolate type A, sodium lauryl sulfate, magnesium stearate (see also section 2 regarding 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 as a film-coated tablet, round, white in colour, with the imprint “H” on one side and “28” on the other, and is available in packs of 30 tablets.

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

Erlotinib Tarbis 150 mg is presented as a film-coated tablet, round, white in colour, with the imprint “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

The Netherlands

This medicinal product 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 Filmtabletten

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

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

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

Date of the most recent revision of this leaflet: January 2025

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