ERLOTINIB TEVA GROUP 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Erlotinib Teva Group 25 mg film-coated tablets EFG

Erlotinib Teva Group 100 mg film-coated tablets EFG

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

1. What is Erlotinib Teva Group and what is it used for

Erlotinib 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). This protein is known to be involved in the growth and spread of cancer 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. What you need to know before you take Erlotinib Teva Group

Do not take Erlotinib

• 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 side 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 take anticoagulants (medicines that help prevent the formation of blood clots, e.g. warfarin) you may be more prone to bleeding. Consult your doctor, he will need to have you undergo regular blood tests.
• if you are taking statins (medicines that lower blood cholesterol levels), since erlotinib 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 Teva Group 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;
• 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 have you treated in the 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 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 problems. Treatment with this medicine is not recommended if you have severe liver or 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 caution.

Smokers

It is recommended that you stop smoking if you are being treated with this medicine, 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.

Taking Erlotinibwithother medicines

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

Taking Erlotinibwithfood and drinks

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

Pregnancy andbreast-feeding

Avoid becoming pregnant while taking Erlotinib. 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 this medicine, inform your doctor immediately, as he will decide whether you should continue treatment.

Do not breast-feed your baby if you are taking this medicine, at least until 2 weeks after taking the last tablet of Erlotinib Teva Group.

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 this medicine 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 Teva Group contains lactose

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

Erlotinib Teva Group contains sodium

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

3. How to take Erlotinib Teva Group

Follow exactly the instructions for administration of this medicine 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 food intake.

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

The recommended dose is one 100 mg Erlotinib tablet per day if you have metastatic pancreatic cancer.

Erlotinib is used in combination with gemcitabine.

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

If you take more Erlotinib than you should

Contact your doctor or pharmacist immediately.

You may experience an increase in 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, Telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Erlotinib

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

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

If you have any further questions on 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 your treatment with Erlotinib:

• 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 have you treated 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 Japanese patients: 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, 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 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 (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
• Breathing difficulties, cough
• Nausea
• Mouth irritation
• Stomach pain, indigestion, and flatulence
• Abnormal blood test results 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
• Infected hair follicles
• Acne
• Cracks in the skin (skin fissures)
• Reduced kidney function (when given off-label in combination with chemotherapy)

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

• Kidney inflammation (nephritis)
• Excess protein in the 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 and redness or tingling of the hands and/or feet (Palmar-plantar erythrodysesthesia syndrome)

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

• Cases of corneal ulcers or perforation
• Blisters or severe skin peeling (indicative of Stevens-Johnson syndrome)
• Inflammation of the colored part of the eye (iris)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Erlotinib Teva Group

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

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal products in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofErlotinib Teva Group

• The active ingredientof Erlotinib Teva Group is erlotinib. Each film-coated tablet contains 25 mg, 100 mg, or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the dose.
• The other ingredients are:

Tablet core: lactose, microcrystalline cellulose, sodium carboxymethyl starch type A, sodium lauryl sulfate, stearic acid, and silicon dioxide (see also section 2 for lactose).

Coating: hypromellose (E464), titanium dioxide (E171), macrogol 8000 (E1521).

Appearance of the Product and Package Contents

Erlotinib Teva Group 25 mg are white, round, biconvex film-coated tablets, 6 mm in size, marked with A105 on one side, and available in packages of 30 tablets. The tablets are packaged in Al/PVC blisters.

Erlotinib Teva Group 100 mg are white, round, biconvex film-coated tablets, 10 mm in size, marked with A116 on one side, and available in packages of 30 tablets. The tablets are packaged in Al/PVC blisters.

Erlotinib Teva Group 150 mg are white, round, biconvex film-coated tablets, 11 mm in size, marked with A127 on one side, and available in packages of 30 tablets. The tablets are packaged in Al/PVC blisters.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

S.C. SINDAN-PHARMA S.R.L.

11, Ion Mihalache Blvd., 01117 Bucharest

Romania

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

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

Germany Erlotinib-ratiopharm 25 mg Filmtabletten

Erlotinib-ratiopharm 100 mg Filmtabletten

Erlotinib-ratiopharm 150 mg Filmtabletten

Bulgaria Erlotinib Actavis 25 mg film-coated tablets ????????? ??????? 25 mg ?????????

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Erlotinib Actavis 100 mg film-coated tablets ????????? ??????? 100 mg ????????? ????????

Erlotinib Actavis 150 mg film-coated tablets ????????? ??????? 150 mg ????????? ????????

Czech Republic Erlotinib Teva B. V.

Croatia Erlotinib Teva 25 mg film-coated tablets

Erlotinib Teva 100 mg film-coated tablets

Erlotinib Teva 150 mg film-coated tablets

Denmark Erlotinib Teva B.V.

Spain Erlotinib Teva Group 25 mg film-coated tablets EFG

Erlotinib Teva Group 100 mg film-coated tablets EFG

Erlotinib Teva Group 150 mg film-coated tablets EFG

Estonia Erlotinib Actavis

Finland Erlotinib Teva B.V. 25 mg tablet, film-coated

Erlotinib Teva B.V. 100 mg tablet, film-coated

Erlotinib Teva B.V. 150 mg tablet, film-coated

France Erlotinib Teva France 25 mg film-coated tablet

Erlotinib Teva France 100 mg film-coated tablet

Erlotinib Teva France 150 mg film-coated tablet

Greece Erlotinib/Teva B.V. 25 mg ????????? ??? ????????? ?????????

Erlotinib/Teva B.V. 100 mg ????????? ??? ????????? ?????????

Erlotinib/Teva B.V. 150 mg ????????? ??? ????????? ?????????

Hungary Erlotinib Actavis 25 mg film tablet

Erlotinib Actavis 100 mg film tablet

Erlotinib Actavis 150 mg film tablet

Iceland Erlotinib Teva B.V.

Netherlands Erlotinib xx mg Teva, film-coated tablets

Portugal Erlotinib Qritou

Poland Erlotinib Teva B.V.

Latvia Erlotinib Actavis 150 mg film-coated tablets

Sweden Erlotinib Teva B.V.

Slovenia Erlotinib Teva B.V. 25 mg film-coated tablets

Erlotinib Teva B.V. 100 mg film-coated tablets

Erlotinib Teva B.V. 150 mg film-coated tablets

Slovakia Erlotinib Teva B.V. 100 mg

Erlotinib Teva B.V. 150 mg

United Kingdom Erlotinib 25 mg, 100 mg, and 150 mg Film-coated Tablets

Romania Erlotinib Actavis 25 mg film-coated tablets

Erlotinib Actavis 100 mg film-coated tablets

Erlotinib Actavis 150 mg film-coated tablets

Date of the last revision of thisleaflet: December 2023

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