ERLOTINIB 100 mg Tablets

Contents of the leaflet

1. What Erlotinib SUN is and what it is used for
2. Important information before taking Erlotinib SUN
   1. When not to take Erlotinib SUN
   2. Warnings and precautions
   3. Erlotinib SUN and other medicines
   4. Erlotinib SUN with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Erlotinib SUN contains a sugar called lactose monohydrate.
3. How to take Erlotinib SUN
   1. If you take more Erlotinib SUN than you should
   2. If you forget to take Erlotinib SUN
   3. If you stop taking Erlotinib SUN
4. Possible side effects
   1. Reporting of side effects
5. How to store Erlotinib SUN
6. Contents of the pack and other information
   1. What Erlotinib SUN contains:
   2. What Erlotinib SUN looks like and contents of the pack:
   3. Marketing authorization holder:
   4. Manufacturer / Importer
   5. To obtain information on the names of the medicine in other European Economic Area countries, please contact the representative of the marketing authorization holder.

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

Erlotinib SUN contains the active substance erlotinib. Erlotinib SUN is a medicine used to treat cancer by blocking the activity of a protein called epidermal growth factor receptor (EGFR). This protein is involved in the growth and spread of cancer cells.

Erlotinib SUN is indicated for use in adult patients. This medicine may be prescribed to patients with advanced non-small cell lung cancer. It may be used as a first-line treatment or when the disease has not progressed after first-line chemotherapy and the tumor has specific EGFR mutations.

Erlotinib SUN may also be used when previous chemotherapy has not stopped the progression of the disease.

This medicine may also be prescribed in combination with another medicine called gemcitabine to patients with pancreatic cancer that has spread.

2. Important information before taking Erlotinib SUN

When not to take Erlotinib SUN

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

Warnings and precautions

Before taking Erlotinib SUN, talk to your doctor:

• if you are taking other medicines that may increase or decrease the levels of erlotinib in your blood, or affect its action (e.g., antifungal medicines such as ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine, St. John's Wort, or proteasome inhibitors).

In some cases, these medicines may reduce the effectiveness or increase the severity of side effects of Erlotinib SUN, and your doctor may modify your treatment. Your doctor may advise you to stop taking these medicines while taking Erlotinib SUN.

• if you are taking anticoagulant medicines (medicines that help prevent blood clots, e.g., warfarin). Erlotinib SUN may increase the risk of bleeding. In such cases, you should consult your doctor, who will need to regularly perform blood tests to monitor your condition.
• if you are taking statins (medicines used to lower cholesterol levels in the blood), Erlotinib SUN may increase the risk of muscle disease caused by statins, which can rarely lead to muscle breakdown (rhabdomyolysis) and cause kidney damage.
• if you wear contact lenses and (or) have previously had eye problems, such as severe dry eye, inflammation of the cornea, or ulcers in the cornea.

See also "Erlotinib SUN and other medicines" below.

You should inform your doctor:

• if you experience sudden difficulty breathing with cough or fever, as you may need to take other medicines and stop taking Erlotinib SUN;
• if you experience diarrhea, as you may need to take anti-diarrheal medicine (e.g., loperamide);
• immediately if you experience severe or persistent diarrhea, nausea, loss of appetite, or vomiting, as you may need to stop taking Erlotinib SUN and may need hospital treatment;
• if you have ever had liver problems. Erlotinib may cause serious liver problems, and some cases may be fatal. Your doctor may perform blood tests while you are taking this medicine to monitor liver function;
• if you experience severe abdominal pain, increased blistering of the skin, or skin peeling. You may need to temporarily stop treatment or discontinue it altogether;
• if you experience sudden or worsening redness and eye pain, increased tearing, blurred vision, and (or) sensitivity to light, you should immediately tell your doctor or nurse, as you may need urgent treatment (see "Possible side effects" below);
• if you are also taking statins and experience muscle pain of unknown cause, tenderness, weakness, or muscle cramps. In such cases, your doctor may temporarily stop treatment or discontinue it altogether.

See also section 4 "Possible side effects".

Liver or kidney disease

It is not known whether the action of Erlotinib SUN may be affected in cases of impaired liver or kidney function. The use of this medicine is not recommended in patients with severe liver or kidney disease.

Glucuronidation reaction disorders, such as Gilbert's syndrome

The doctor should exercise caution in patients with glucuronidation reaction disorders, such as those with Gilbert's syndrome.

Smokers

Patients taking Erlotinib SUN are advised to stop smoking, as smoking may reduce the levels of this medicine in the blood.

Children and adolescents

Erlotinib SUN has not been studied in patients under 18 years of age. This medicine is not recommended for use in children and adolescents.

Erlotinib SUN and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Erlotinib SUN with food and drink

Do not take this medicine with food. See also section 3 "How to take Erlotinib SUN".

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should avoid becoming pregnant while taking Erlotinib SUN. Women who may become pregnant should use effective contraception during treatment and for at least 2 weeks after taking the last tablet.

If you become pregnant while taking Erlotinib SUN, you should immediately inform your doctor, who will decide whether treatment can be continued.

Breastfeeding

Do not breastfeed while taking Erlotinib SUN and for at least 2 weeks after taking the last tablet.

Driving and using machines

Erlotinib SUN has not been studied for its ability to affect your ability to drive or use machines. It is unlikely that this treatment will affect your ability to drive or use machines.

Erlotinib SUN contains a sugar called lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Erlotinib SUN.

3. How to take Erlotinib SUN

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Erlotinib SUN should be taken orally.

The tablet should be taken at least one hour before a meal or at least two hours after a meal.

The usual dose of Erlotinib SUN is one 150 mg tablet per day for patients with non-small cell lung cancer.

In pancreatic cancer with metastases, the usual dose is one 100 mg tablet of Erlotinib SUN per day. Erlotinib SUN is given in combination with another medicine, gemcitabine.

Your doctor may advise you to reduce the dose by 50 mg. To allow for different dosing schedules, Erlotinib SUN is available in 25 mg, 100 mg, and 150 mg tablets.

If you take more Erlotinib SUN than you should

Contact your doctor or pharmacist immediately.

You may experience increased side effects, and your doctor may stop treatment.

If you forget to take Erlotinib SUN

Contact your doctor or pharmacist as soon as possible.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Erlotinib SUN

It is important to take Erlotinib SUN every day for as long as your doctor prescribes it.

If you have any doubts about your treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Erlotinib SUN can cause side effects, although not everybody gets them.

If you experience any of the following side effects, contact your doctor as soon as possible. In some cases, your doctor may reduce the dose of Erlotinib SUN or stop treatment:

• diarrhea and vomiting (very common: affects more than 1 in 10 people). Persistent and severe diarrhea may lead to low potassium levels in the blood and kidney problems, especially if you are also receiving other types of chemotherapy. If you experience more severe or persistent diarrhea, you should immediately contact your doctor, as you may need hospital treatment.
• eye irritation due to conjunctivitis or keratoconjunctivitis (very common: affects more than 1 in 10 people) and keratitis (common: affects less than 1 in 10 people).
• inflammation of the lung tissue, called interstitial lung disease (uncommon in the European population; common in the Japanese population: affects less than 1 in 100 in the European population and 1 in 10 in the Japanese population). This disease may also be related to the natural progression of the underlying disease and may be fatal in some cases. If you experience symptoms such as sudden difficulty breathing with cough or fever, you should immediately contact your doctor, as these may be signs of this disease. Your doctor may decide to permanently stop treatment with Erlotinib SUN.
• perforation of the digestive tract (uncommon: affects less than 1 in 100 people). You should inform your doctor if you experience severe abdominal pain. You should also inform your doctor if you have ever had stomach ulcers or diverticulitis, as these conditions may increase the risk of perforation of the digestive tract.
• in rare cases, liver inflammation (may affect up to 1 in 1,000 people) has been observed. Symptoms may include general malaise, 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, which may be fatal. If blood tests indicate severe changes in liver function, your doctor may advise you to stop treatment.

Very common side effects(affects more than 1 in 10 people):

• rash, which may appear or worsen on skin exposed to sunlight. Patients who are exposed to sunlight may be advised to use protective clothing and (or) sunscreens (e.g., containing minerals).
• infections;
• loss of appetite, weight loss;
• depression;
• headache, numbness or tingling of the skin, or numbness of the limbs;
• difficulty breathing, cough;
• nausea;
• mouth irritation;
• abdominal pain, indigestion, bloating;
• abnormal liver function test results;
• itching, dry skin, and hair loss;
• fatigue, fever, chills.

Common side effects(affects less than 1 in 10 people):

• nosebleeds;
• bleeding from the stomach or intestines;
• inflammatory reactions around the nails;
• inflammation of the hair follicles;
• acne;
• skin cracking;
• kidney failure (if this medicine is taken off-label in combination with chemotherapy).

Uncommon side effects(affects less than 1 in 100 people):

• changes in eyelashes;
• excessive hair growth on the body and face of male type;
• changes in eyebrows;
• brittle and fragile nails.

Rare side effects(affects less than 1 in 1,000 people):

• redness or pain in the palms of the hands or soles of the feet (palmar-plantar erythrodysesthesia syndrome).

Very rare side effects(affects less than 1 in 10,000 people):

• cases of corneal ulcers or perforation;
• increased blistering of the skin or skin peeling (resembling Stevens-Johnson syndrome);
• inflammation of the colored part of the eye.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, e-mail: [email protected].

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Erlotinib SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) stated on the blister and carton. The expiry date refers to the last day of that month.

The batch number is defined as Lot.

This medicine does not require any special storage precautions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Erlotinib SUN contains:

• - the active substanceis erlotinib. One film-coated tablet contains 25 mg, 100 mg, or 150 mg of erlotinib (as erlotinib hydrochloride), depending on the strength.
• - the other ingredientsare: tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), sodium lauryl sulfate, magnesium stearate. Tablet coating: Opadry White (YS-1-7040) hypromellose, titanium dioxide (E171), macrogol 8000, talc.

What Erlotinib SUN looks like and contents of the pack:

Erlotinib SUN 25 mg is a white or almost white round film-coated tablet, 6.18 mm in diameter, with "RL" engraved on one side and "11" on the other.

Erlotinib SUN 100 mg is a white or almost white round film-coated tablet, 9.63 mm in diameter, with "RL" engraved on one side and "12" on the other.

Erlotinib SUN 150 mg is a white or almost white round film-coated tablet, 11.2 mm in diameter, with "RL" engraved on one side and "13" on the other.

Packaging:

blister packs

30 (3 x 10) tablets in blister packs OPA/Aluminum/HDPE/PE + desiccant/HDPE/PE/Aluminum.

bottles

30 tablets in HDPE bottles with a child-resistant closure and a desiccant (silica gel).

Marketing authorization holder:

SUN Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer / Importer

SUN Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132 JH Hoofddorp, Netherlands

S.C. Terapia S.A.

Str. Fabricii nr.124, 400632, Cluj-Napoca, Jud. Cluj, Romania

To obtain information on the names of the medicine in other European Economic Area countries, please contact the representative of the marketing authorization holder.

Date of last revision of the leaflet:17.11.2022