Erlotinib Teva Group 100 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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, 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

Erlotinib 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 subsequent treatment if your disease has remained essentially stable after initial chemotherapy, provided that your cancer cells have specific mutations in the EGFR. It may also be prescribed if prior 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. What you need to know before starting to take Erlotinib Teva Group

Do not take Erlotinib

• 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 (Hypericum perforatum), or proteasome inhibitors), consult your doctor. In some cases, these medicines may reduce the effectiveness or increase the adverse effects of erlotinib, and therefore your doctor may need to adjust your treatment. Your doctor should avoid treating you with these medicines while you are taking erlotinib.
• if you are taking anticoagulants (medicines that help prevent thrombosis or blood clots, e.g. warfarin), you may be more prone to 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 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 corneal ulcers, inform your doctor.

See also below “Taking Erlotinib Teva Group 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;
• 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 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 liver function;
• if you have sudden abdominal pain, or severe blistering or peeling of the skin. Your doctor may need to interrupt or stop your treatment;
• if you experience 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 section 4 “Possible side effects” below);
• 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 recommended that you stop smoking while 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.

Taking Erlotinib with other medicines

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

Taking Erlotinib with food and drink

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

Pregnancy and breastfeeding

Avoid becoming pregnant while taking Erlotinib. If you are able to 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 they will decide whether to continue treatment.

You must not breastfeed while taking this medicine, and for at least 2 weeks after taking the last tablet of Erlotinib Teva Group.

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 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 informed you of an intolerance to certain sugars, consult with them 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 use provided 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 eating.

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

The recommended dose is one 100 mg erlotinib tablet daily if you have metastatic pancreatic cancer.

Erlotinib is used in combination with gemcitabine.

Your doctor may adjust your dose in 50 mg increments. For this reason, this medicine is available in 25 mg, 100 mg, and 150 mg strengths to allow for 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 interrupt your treatment.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take erlotinib

If you miss 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 missed doses.

If you stop taking erlotinib

It is important to take this medicine 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 below, contact your doctor as soon as possible. In some cases, your doctor may need to reduce your dose or stop your treatment with Erlotinib:

• 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 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 condition may also be related to the natural progression of your disease and, in some cases, can be fatal. If you suddenly develop symptoms such as difficulty breathing associated with cough or fever, contact your doctor immediately, as you may have 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 your risk of gastrointestinal perforation.

• 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 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 significant 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 areas exposed to sunlight. If you are exposed to sunlight, it is advisable to wear protective clothing and/or use sunscreen (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 check liver function
• Itching
• Fatigue, fever, stiffness

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

• Dry skin
• Hair loss
• Nosebleeds
• Stomach or intestinal bleeding
• Inflammatory reactions around the nails
• Hair follicle infection
• Acne
• Skin cracks (skin fissures)
• Reduced kidney function (when used outside the 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 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, redness or tingling in the hands and/or feet (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 (iris)

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

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Pack contents and other information

Composition of Erlotinib Teva Group

• The active substance in 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:

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

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

Description of the product and contents of the pack

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

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

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

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

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

11, Ion Mihalache Blvd., 01117 Bucharest

Romania

Further information about this medicine is available from 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) 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 ????????? ????????
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 filmom obložene tablete
Erlotinib Teva 100 mg filmom obložene tablete
Erlotinib Teva 150 mg filmom obložene tablete

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 tabletti, kalvopäällysteinen
Erlotinib Teva B.V. 100 mg tabletti, kalvopäällysteinen
Erlotinib Teva B.V. 150 mg tabletti, kalvopäällysteinen

France Erlotinib Teva France 25 mg comprimé pelliculé
Erlotinib Teva France 100 mg comprimé pelliculé
Erlotinib Teva France 150 mg comprimé pelliculé

Greece Erlotinib/Teva B.V. 25 mg επικαλυμμένα με λεπτό υμένιο δισκία
Erlotinib/Teva B.V. 100 mg επικαλυμμένα με λεπτό υμένιο δισκία
Erlotinib/Teva B.V. 150 mg επικαλυμμένα με λεπτό υμένιο δισκία

Hungary Erlotinib Actavis 25 mg filmtabletta
Erlotinib Actavis 100 mg filmtabletta
Erlotinib Actavis 150 mg filmtabletta

Iceland Erlotinib Teva B.V.

Netherlands Erlotinib xx mg Teva, filmomhulde tabletten

Portugal Erlotinib Qritou

Poland Erlotinib Teva B.V.

Latvia Erlotinib Actavis 150 mg apvalkotas tabletes

Sweden Erlotinib Teva B.V.

Slovenia Erlotinib 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

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 comprimate filmate
Erlotinib Actavis 100 mg comprimate filmate
Erlotinib Actavis 150 mg comprimate filmate

Date of the most recent review of this summary: December 2023

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