Patient Information Leaflet

GIOTRIF 30mg Film-Coated Tablets

afatinib

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section4.

1.What GIOTRIF is and what it is used for

2.What you need to know before you start taking GIOTRIF

3.How to take GIOTRIF

4.Possible side effects

5.Storage of GIOTRIF

6. Contents of the pack and additional information.

GIOTRIF is a medication that contains the active ingredient afatinib. It works by blocking the activity of a group of proteins called the ErbB family (including the EGFR [Epidermal Growth Factor Receptor or ErbB1], HER2 [ErbB2], ErbB3, and ErbB4). These proteins are involved in the growth and spread of cancer cells, and can be affected by changes (mutations) in the genes that produce them. By blocking the activity of these proteins, this medication can inhibit the growth and spread of cancer cells.

This medication is used alone to treat adult patients with a specific type of lung cancer (non-small cell lung cancer):

• characterized by a change (mutation) in the gene for EGFR. They may be prescribed GIOTRIF as their first treatment or if previous chemotherapy has been insufficient.
• of the squamous type if previous chemotherapy has been insufficient.

Do not take GIOTRIF

-if you are allergic to afatinib or any of the other ingredients of this medicine (listed in section6).

Warnings and precautions

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

• if you are a woman, weigh less than50kg or have kidney problems. If you meet any of these criteria, your doctor may require closer monitoring, as the 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 medicine is not recommended if you have severe liver disease.
• if you have a history of eye problems such as a severe dry eye, inflammation of the transparent layer at the front of the eye (cornea) or ulcers on the outer part of the eye, or if you wear contact lenses.
• if you have a history of heart problems. Your doctor may require closer monitoring.

Inform your doctor immediately while taking this medicine:

• if you have diarrhea.It is essential to start treatment at the first symptoms of diarrhea.
• if you develop a skin rash. It is essential to start treatment as soon as possible.
• if you notice the onset or worsening of sudden difficulty breathing, possibly accompanied by cough or fever. This could be a sign of lung inflammation (interstitial lung disease) that may put your life at risk.
• if you experience severe stomach or intestinal pain, fever, chills, nausea, vomiting, or abdominal rigidity or swelling, as these may be symptoms of a perforation of the stomach or intestines (“gastrointestinal perforation”). Also, inform your doctor if you have had gastrointestinal ulcers or diverticulitis in the past, or if you are receiving concomitant treatment with anti-inflammatory drugs (NSAIDs) (used to treat pain and swelling) or steroids (used to treat inflammation and allergies), as this may increase the risk.
• if you experience acute redness and 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 section4 “Possible side effects”.

Children and adolescents

GIOTRIF is not recommended for children or adolescents. Do not administer this medicine to children or adolescents under18years.

Other medicines and GIOTRIF

Inform your doctor or pharmacist if you are taking, have taken recently, orpudierahave to take any other medicine, including herbal medicines and over-the-counter medicines.

Particularly, the following medicines, if taken before GIOTRIF, may increase the levels of GIOTRIF in the blood and, therefore, the risk of side effects. Therefore, these medicines should be taken with the maximum possible time interval from GIOTRIF. This means leaving a gap of6hours (for medicines taken twice a day) or12hours (for medicines taken once a day) from the time of taking GIOTRIF:

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

The following medicines may reduce the effectiveness of GIOTRIF:

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

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

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

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

Inform your doctor before taking these medicines with GIOTRIF.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

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

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

Breastfeeding

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

Driving and operating machines

If you experience symptoms related to treatment that affect your vision (e.g., redness and/or irritation of the eye, dry eye, watery eyes, sensitivity to light) or your ability to concentrate and react, it is recommended that you do not drive or operate machines until the side effects have disappeared (see section4 Possible side effects).

GIOTRIF contains lactose

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

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

Dosage

The recommended dose is 40 mg per 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 a minimum of 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 water without gas.

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

Immediately contact your doctor or pharmacist. You may experience more intense side effects, and your doctor may interrupt treatment and administer supportive treatment.

If you forgot 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 compensate for the 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 your doctor has prescribed it. If you do not take this medication as your doctor has prescribed it, your cancer may grow back.

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

Like all medicines, 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 have to interrupt treatment, reduce your dose, or stop treatment:

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

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

• Skin rash(very common).

It is essential to start treating the rash as soon as possible. Inform your doctor as soon as you notice a rash. If the rash treatment does not work and the rash worsens (for example, if your skin blisters or forms ulcers), inform your doctor immediately, as your doctor may decide to interrupt your treatment with GIOTRIF. The rash may appear or worsen in sun-exposed areas of the body. It is recommended to use suitable clothing and sunscreen as measures to protect against the sun.

• Pneumonitis(rare, may affect up to 1 in 100 patients), also 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 (conjunctivitis/dry eye occurs frequently, and keratitis occurs infrequently) may occur. Inform your doctor if you experience a sudden onset or worsening of eye symptoms such as eye pain or redness, 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):

• Oral inflammation and ulcers
• Fingernail infection
• Loss of appetite
• Nosebleeds
• Nausea
• Vomiting
• Itching
• Dry skin

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

• Dermatitis of the hands and feet, with redness, swelling, or peeling of the skin
• Increased levels of liver enzymes aspartate aminotransferase and alanine aminotransferase in blood tests
• Urinary tract inflammation with burning sensation while urinating and frequent or urgent need to urinate (cystitis)
• Altered taste (dysgeusia)
• Abdominal pain, indigestion, heartburn
• Oral inflammation
• Weight loss
• Runny nose
• Muscle spasms
• Fever
• Nail problems

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

• Pancreatitis (inflammation of the pancreas)
• Formation of a tear in the wall of the stomach or intestines (gastrointestinal perforation)
• Abnormal growth of eyelashes (including misdirected growth that may cause eye damage)

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box, bag, and blister pack after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of GIOTRIF

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

Appearance of the product and contents of the pack

GIOTRIF 30mg are blue-brown film-coated, round 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 blisters of unit dose. Each blister contains 7x1film-coated tablet and is packaged in an aluminium bag together with a desiccant sachet that should not be swallowed.

Only some pack sizes may be marketed.

Marketing authorisation holder

Boehringer Ingelheim International GmbH

Binger Strasse173

55216Ingelheim am Rhein

Germany

Responsible for manufacturing

Boehringer Ingelheim Pharma GmbH & Co.KG

Binger Strasse173

55216Ingelheim am Rhein

Germany

Boehringer Ingelheim France

100-104 Avenue de France

75013 Paris

France

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

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