ERLOTINIB 25 mg Tablets

Contents of the leaflet

1. What is Erlotinib SUN and what is it 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. Taking a higher dose of Erlotinib SUN than recommended
   2. Missing a dose of Erlotinib SUN
   3. Stopping treatment with Erlotinib SUN
4. Possible side effects
   1. Reporting side effects
5. How to store Erlotinib SUN
6. Contents of the packaging 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 is Erlotinib SUN and what is it used for

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

Erlotinib SUN is indicated for 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 remains largely unchanged after first-line chemotherapy and provided that the tumor cells have 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 with metastases.

2. Important information before taking Erlotinib SUN

When not to take Erlotinib SUN

Warnings and precautions

Before taking Erlotinib SUN, talk to your doctor:

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 the treatment. Your doctor may advise you to stop taking these medicines while taking Erlotinib SUN.

See also "Erlotinib SUN and other medicines" below.

Tell your doctor:

• immediately if you experience severe or persistent diarrhea, nausea, loss of appetite, or vomiting, as this may require discontinuation of Erlotinib SUN and hospital treatment;

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 abnormal liver or kidney function. The use of this medicine is not recommended in patients with severe liver or kidney disease.

Glucuronyl transferase conjugation disorders, such as Gilbert's syndrome

The doctor should exercise caution in patients with glucuronyl transferase conjugation disorders, such as those with Gilbert's syndrome.

Smokers

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

Children and adolescents

Erlotinib SUN has not been studied in patients under 18 years of age. The use of this medicine is not recommended 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 plan to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Avoid becoming pregnant while taking Erlotinib SUN. Women who may become pregnant should use appropriate contraceptive methods during treatment and for at least 2 weeks after taking the last tablet.

If you become pregnant while taking Erlotinib SUN, tell your doctor immediately, who will decide whether the 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 driving or using machines. It is very 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 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, consult your doctor or pharmacist.

Erlotinib SUN should be taken orally.

Take the tablet 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 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.

Taking a higher dose of Erlotinib SUN than recommended

Consult your doctor or pharmacist immediately.

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

Missing a dose of Erlotinib SUN

If you miss one or more doses of Erlotinib SUN, consult your doctor or pharmacist as soon as possible.

Do not take a double dose to make up for the missed tablets.

Stopping treatment with Erlotinib SUN

It is important to take Erlotinib SUN every day, as long as your doctor recommends.

If you have any doubts about taking the medicine, 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, tell your doctor as soon as possible. In some cases, your doctor may reduce the dose of Erlotinib SUN or interrupt the 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 consult your doctor, as hospital treatment may be necessary.
• 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 a cough or fever, tell your doctor immediately, as these may be signs of this disease. Your doctor may decide to permanently stop Erlotinib SUN treatment.
• perforation of the digestive tract (uncommon: affects less than 1 in 100 people). Tell your doctor if you experience severe abdominal pain. You should also tell 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 recommend interrupting the treatment.

Very common side effects(affect 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, decreased body weight;
• depression;
• headache, abnormal skin sensation, or numbness of the limbs;
• difficulty breathing, cough;
• nausea;
• mouth irritation;
• abdominal pain, indigestion, bloating;
• abnormal liver blood test results;
• itching, dry skin, and hair loss;
• fatigue, fever, chills.

Common side effects(affect 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(affect 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(affect less than 1 in 1,000 people):

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

Very rare side effects(affect 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 side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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].

Side effects can also be reported 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 the 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 packaging and other information

What Erlotinib SUN contains:

• - the active substanceis erlotinib. One 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 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 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 coated tablet, 11.2 mm in diameter, with "RL" engraved on one side and "13" on the other.

Packaging:

Blisters

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

Bottle

30 tablets in an HDPE bottle 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