Prospect: information for the user

Erlotinib Teva Group 25 mg film-coated tablets

Erlotinib Teva Group 100 mg film-coated tablets

Erlotinib Teva Group 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 to you alone, 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 Teva Group and what is it used for

2. What you need to know before starting to take Erlotinib Teva Group

3. How to take Erlotinib Teva Group

4. Possible adverse effects

5. Storage of Erlotinib Teva Group

6. Contents of the pack and additional information

Erlotinib contains the active ingredient erlotinib. This medication is used to treat cancer and acts 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

• 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 adverse effects of erlotinib, and your doctor may need to adjust your treatment. Your doctor should avoid treating you with these medications while you are taking erlotinib.
• if you are taking anticoagulants (medications that help prevent the formation of blood clots or thrombi, for example, warfarin), you may be more prone to bleeding. Consult your doctor, who will need to perform regular blood tests.
• if you are taking statins (medications that lower cholesterol levels in the blood), since erlotinib 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 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 Teva Group with other medications”.

You should 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;
• 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 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 medication to monitor your liver function;
• 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 adverse 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 adverse 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.

Taking Erlotinib with other medications

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

Taking Erlotinib with food and drinks

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

Pregnancy and breastfeeding

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

If you become pregnant while taking this medication, inform your doctor immediately, as they will decide whether to continue treatment.

You should not breastfeed your baby while taking this medication for at least 2 weeks after taking the last Erlotinib Teva Group 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 medication.

Driving and operating machinery

We have not studied the possible effects of this medication on the ability to drive and operate machinery, but it is highly 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 certain sugars, consult with them before taking this medication.

Erlotinib Teva Group contains sodium

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

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 consuming 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, this medication is available in doses of 25 mg, 100 mg, and 150 mg to adjust different dosing regimens.

If you take more Erlotinib 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

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 compensate for the missed doses.

If you interrupt Erlotinib treatment

It is essential to take this medication 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 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 intense 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 insufficiency 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 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(can affect up to 1 in 10 people)

• Dry skin
• Hair loss
• Nasal bleeding
• Gastrointestinal bleeding
• Inflammatory reactions around the nail
• Folliculitis
• 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 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)

• Pain and redness or tingling of the hands and/or feet (erythromelalgia)

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 (iris)

Reporting 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 and on the box after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medicines should not be thrown into the drains or trash.Dispose of the packaging and the

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

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 components are:

Core tablet: lactose, microcrystalline cellulose,carboxymethylstarch sodium type A, sodium lauryl sulfate, stearic acid and sodium, colloidal silicon dioxide (see also section 2 for lactose).

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

Appearance of the product and contents of the pack

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

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

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

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

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

11, Ion Mihalache Blvd., 01117 Bucharest

Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

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

GermanyErlotinib-ratiopharm 25 mg Filmtabletten

Erlotinib-ratiopharm 100 mg Filmtabletten

Erlotinib-ratiopharm 150 mg Filmtabletten

BulgariaErlotinib 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 ????????? ????????

RepublicErlotinib Teva B. V.

Czech Republic

CroatiaErlotinib Teva 25 mg filmom obložene tablete

Erlotinib Teva 100 mg filmom obložene tablete

Erlotinib Teva 150 mg filmom obložene tablete

DenmarkErlotinib Teva B.V.

SpainErlotinib Teva Group 25 mg comprimidos recubiertos con película EFG

Erlotinib Teva Group 100 mg comprimidos recubiertos con película EFG

Erlotinib Teva Group 150 mg comprimidos recubiertos con película EFG

EstoniaErlotinib Actavis

FinlandErlotinib Teva B.V. 25 mg tabletti, kalvopäällysteinen

Erlotinib Teva B.V. 100 mg tabletti, kalvopäällysteinen

Erlotinib Teva B.V. 150 mg tabletti, kalvopäällysteinen

FranceErlotinib Teva France 25 mg comprimé pelliculé

Erlotinib Teva France 100 mg comprimé pelliculé

Erlotinib Teva France 150 mg comprimé pelliculé

GreeceErlotinib/Teva B.V. 25 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Erlotinib/Teva B.V. 100 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Erlotinib/Teva B.V. 150 mg επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

HungaryErlotinib Actavis 25 mg filmtabletta

Erlotinib Actavis 100 mg filmtabletta

Erlotinib Actavis 150 mg filmtabletta

IcelandErlotinib Teva B.V.

NetherlandsErlotinib xx mg Teva, filmomhulde tabletten

PortugalErlotinib Qritou

PolandErlotinibTeva B.V.

LithuaniaErlotinib Actavis 150 mg apvalkotas tabletes

SwedenErlotinib Teva B.V.

SloveniaErlotinib Teva B.V. 25 mg filmsko obložene tablete

Erlotinib Teva B.V. 100 mg filmsko obložene tablete

Erlotinib Teva B.V. 150 mg filmsko obložene tablete

SlovakiaErlotinib Teva B.V. 100 mg

Erlotinib Teva B.V. 150 mg

United KingdomErlotinib 25 mg, 100 mg and 150 mg Filmcoated Tablets

RomaniaErlotinib Actavis 25 mg comprimate filmate

Erlotinib Actavis 100 mg comprimate filmate

Erlotinib Actavis 150 mg comprimate filmate

Last revision date of thisleaflet: December 2023

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