GIOTRIF 20 mg FILM-COATED TABLETS

2. What you need to know before taking GIOTRIF

Do not take GIOTRIF

• if you are allergic to afatinib or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you are a woman, weigh less than 50 kg, or have kidney problems. If any of these criteria apply to you, your doctor may subject you to closer monitoring, as side effects may be more intense.
• if you have a history of lung inflammation (interstitial lung disease).
• if you have liver problems. Your doctor may perform liver tests. Treatment with this medication is not recommended if you have severe liver disease.
• if you have a history of eye problems such as severe dry eye, inflammation of the transparent layer of the front of the eye (cornea), or ulcers on the outer eye, or if you use contact lenses.
• if you have a history of heart problems. Your doctor may subject you to closer monitoring.

Inform your doctor immediately while taking this medication:

• if you have diarrhea. It is essential to start treatment at the first symptoms of diarrhea.
• if you develop a skin rash. It is crucial to start treatment for the rash as soon as possible.
• if you notice the onset or sudden worsening of difficulty breathing, possibly with cough or fever. This could be symptoms of lung inflammation (interstitial lung disease) that can be life-threatening.
• if you experience severe stomach or intestinal pain, fever, chills, nausea, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a tear in the stomach or intestinal wall (gastrointestinal perforation). Additionally, inform your doctor if you have had a history of gastrointestinal ulcers or diverticular disease, or if you are receiving concomitant treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and swelling) or steroids (used for inflammation and allergies), as this may increase the risk.
• if you experience redness and acute pain in the eye or worsening of these symptoms, increased tearing, blurred vision, and/or sensitivity to light. You may need urgent treatment.

See also section 4 "Possible side effects".

Children and adolescents

GIOTRIF is not recommended for use in children or adolescents. Do not administer this medication to children or adolescents under 18 years of age.

Other medications and GIOTRIF

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including herbal remedies and medications purchased without a prescription.

In particular, the following medications, if taken before GIOTRIF, may increase GIOTRIF levels in the blood and, therefore, the risk of side effects. Therefore, these medications should be taken with as much time as possible between them and the intake of GIOTRIF. This means leaving a gap of at least 6 hours (for medications taken twice a day) or 12 hours (for medications taken once a day) between them and the intake of GIOTRIF:

• Ritonavir, ketoconazole (except in shampoo), itraconazole, erythromycin, nelfinavir, and saquinavir, used to treat various types of infections.
• Verapamil, quinidine, and amiodarone, used to treat heart diseases.
• Cyclosporine A and tacrolimus, medications that affect the immune system.

The following medications may decrease the effectiveness of GIOTRIF:

• Carbamazepine, phenytoin, and phenobarbital, used to treat seizures.
• St. John's Wort (Hypericum perforatum), a herbal remedy for treating depression.
• Rifampicin, an antibiotic used to treat tuberculosis.

Ask your doctor if you are unsure when to take these medications.

GIOTRIF may increase blood levels of other medications, including the following:

• Sulfasalazine, used to treat inflammation/infection.
• Rosuvastatin, used to lower cholesterol.

Inform your doctor before taking these medications with GIOTRIF.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should avoid becoming pregnant while taking this medication. If you could become pregnant, you should use adequate contraceptive methods during treatment and for at least 1 month after the last dose of this medication. This is because there may be a risk of harm to the fetus.

If you become pregnant while taking this medication, you should inform your doctor immediately. Your doctor will decide with you whether to continue treatment or not.

You should ask your doctor for advice if you plan to become pregnant after taking the last dose of this medication, as your body may not have completely eliminated this medication.

Breastfeeding

You should not breastfeed your baby while taking this medication, as there may be a risk to the breastfed child.

Driving and using machines

If you notice symptoms related to treatment that affect your vision (e.g., redness and/or irritation of the eye, dry eye, tearing, sensitivity to light) or your ability to concentrate and react, it is recommended that you do not drive or use machines until the side effects have disappeared (see section 4 Possible side effects).

GIOTRIF contains lactose

This medication contains a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take GIOTRIF

Follow the administration instructions of this medication indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is 40 mg once a day.

Your doctor may adjust (increase or decrease) your dose based on how well you tolerate this medication.

When to take GIOTRIF

• It is essential to take this medication without food.
• Take this medication at least 1 hour before eating or
• If you have already eaten, wait at least 3 hours before taking this medication.
• Take this medication once a day, approximately at the same time each day. This makes it easier to remember to take the medication.
• Do not break, chew, or crush the tablet.
• Swallow the tablet whole with a glass of still water.

GIOTRIF should be taken orally. If you have difficulty swallowing the tablet, dissolve it in a glass of still water. Do not use other liquids. Place the tablet in the water without crushing it and stir the water occasionally for about 15 minutes until the tablet has dissolved into very small particles. Drink the liquid immediately. To ensure that you take all of the medication, fill the glass with water again and drink it.

If you are unable to swallow and have a gastric tube, your doctor may suggest that the medication be administered through the tube.

If you take more GIOTRIF than you should

Contact your doctor or pharmacist immediately. You may experience more intense side effects, and your doctor may interrupt treatment and provide supportive treatment.

If you forget to take GIOTRIF

• If your next dose is more than 8 hours away, take the missed dose as soon as you remember.
• If your next dose is within the next 8 hours, skip the missed dose and take the next dose at the usual time. Then continue taking your tablets as usual.

Do not take a double dose (two tablets at once instead of one) to make up for missed doses.

If you interrupt treatment with GIOTRIF

Do not stop taking this medication without consulting your doctor first. It is essential to take this medication every day, as long as your doctor prescribes it. If you do not take this medication as prescribed by your doctor, your cancer may grow again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, GIOTRIF can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you notice any of the following serious side effects. In some cases, your doctor may need to interrupt treatment and reduce your dose or stop treatment:

• Diarrhea(very common, may affect more than 1 in 10 patients).

Diarrhea that lasts more than 2 days or severe diarrhea can lead to fluid loss (frequent, may affect up to 1 in 10 patients), low potassium levels in the blood (frequent), and worsening of kidney function (frequent). Diarrhea can be treated. As soon as the first symptoms of diarrhea appear, drink plenty of fluids. Inform your doctor immediately and start antidiarrheal treatment as soon as possible. You should have an antidiarrheal medication on hand before starting treatment with GIOTRIF.

• Skin rash(very common).

It is essential to start treatment for the rash as soon as possible. Inform your doctor as soon as a rash appears. If the treatment for the rash does not work and the rash worsens (e.g., if your skin peels or blisters appear), you should inform your doctor immediately, as your doctor may decide to interrupt your treatment with GIOTRIF. The rash may appear or worsen in areas of the body exposed to the sun. It is recommended to use appropriate clothing and sunscreen as protective measures against the sun.

• Lung inflammation(uncommon, may affect up to 1 in 100 patients), known as "interstitial lung disease". Inform your doctor immediately if you notice the onset or sudden worsening of difficulty breathing, possibly with cough or fever.

• Eye irritation or inflammation

Eye irritation or inflammation can occur (conjunctivitis/dry eye occurs frequently and keratitis occurs uncommonly). Inform your doctor if you experience sudden onset or worsening of eye symptoms such as pain or redness of the eyes or dry eyes.

If you experience any of these symptoms, inform your doctor as soon as possible.

The following side effects have also been reported:

Very common side effects(may affect more than 1 in 10 patients):

• Mouth inflammation and ulcers
• Nail infections
• Loss of appetite
• Nosebleeds
• Nausea
• Vomiting
• Itching
• Dry skin

Common side effects(may affect up to 1 in 10 patients):

• Pain, redness, swelling, or peeling of the skin on your hands and feet
• Increased levels of liver enzymes aspartate aminotransferase and alanine aminotransferase in blood tests
• Inflammation of the inner layer of the bladder with a burning sensation when urinating and frequent or urgent need to urinate (cystitis)
• Altered taste (dysgeusia)
• Stomach pain, indigestion, heartburn
• Lip inflammation
• Weight loss
• Nasal congestion
• Muscle spasms
• Fever
• Nail problems

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

• Pancreatitis (inflammation of the pancreas)
• Appearance of a tear in the stomach or intestinal wall (gastrointestinal perforation)
• Abnormal growth of eyelashes (including misdirected growth that can cause damage to the ocular surface)

Rare side effects(may affect up to 1 in 1,000 patients):

• Severe skin blistering or peeling (indicative of Stevens-Johnson syndrome and toxic epidermal necrolysis)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of GIOTRIF

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

Do not use this medication after the expiration date stated on the carton, pouch, and blister after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture and light.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of GIOTRIF

• The active ingredient is afatinib. Each film-coated tablet contains 30 mg of afatinib (as dimaleate).
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553b), polysorbate 80 (E433), aluminum lake of indigo carmine (E132).

Appearance and Package Contents of the Product

GIOTRIF 30 mg are dark blue, round film-coated tablets. They have the code “T30” engraved on one side and the Boehringer Ingelheim logo on the other.

GIOTRIF film-coated tablets are presented in packs containing 1, 2, or 4 single-dose precut blisters. Each blister contains 7 x 1 film-coated tablets and is packaged in an aluminum bag along with a desiccant that should not be swallowed.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

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

Date of the Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.