InfoCons Consumer Protection informs you – Giotrif – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects ,talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Seesection 4.

ℹ️ 1. What GIOTRIF is and what it is used for

GIOTRIF is a medicine which contains the active substance afatinib. It works by blocking the activity of a group of proteins called the ErbB family (including 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 medicine can inhibit growth and spread of cancer cells.

This medicine is used on its own to treat adult patients with a specific type of cancer of the lung (non-small cell lung cancer):  that is identified by a change (mutation) in the gene for EGFR. GIOTRIF can be prescribed to you as your first treatment or if prior chemotherapy treatment has been insufficient.  of squamous type if prior chemotherapy treatment has been insufficient.

⚠️ 2. What yo u need to know before you take GIOTRIF

Do not take GIOTRIF

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:  if you are female, have a low body weight of less than 50 kg or have kidney problems. If any of these apply to you, your doctor may monitor you more closely as the side effects may be more pronounced.  if you have a history of lung inflammation (interstitial l ung disease).  if you have liver problems. Your doctor may do some liver tests. Treatment with this medicine is not recommended if you have a severe liver disease.  if you have a history of eye problems such as severe dry eyes, inflammation of the transparen t layer at the front of the eye (cornea) or ulcers involving the outer part of the eye, or if you use contact lenses.  if you have a history of heart problems. Your doctor may want to monitor you more closely.

72Inform your doctor immediately while taking th is medicine:  if you develop diarrhoea. Treatment at the first signs of diarrhoea is important.  if you develop skin rash. Early treatment of skin rash is important.  if you develop new or sudden worsening of shortness of breath, possibly with a cough or fever.

These could be symptoms of an inflammation of the lungs (interstitial lung disease) and can be life-threatening.  if you have severe pain in your stomach or intestines, fever, chills, sickness, vomiting, or abdominal rigidity or bloating, as these co uld be symptoms of a tear in the wall of your stomach or intestines (‘gastrointestinal perforation’). Also, tell your doctor if you had gastrointestinal ulcers or diverticular disease in the past, or are concomitantly treated with anti -inflammatory drugs ( NSAIDs) (used to treat pain relief and swelling) or steroids (used for inflammation and allergies), as this may increase this risk.  if you develop acute or worsening redness and pain in the eye, increased eye watering, 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 give this medicine to children or adolescents under the age of 18 years.

Other medicines and GIOTRIF

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.

In particular, if taken before GIOTRIF, the followi ng medicines may increase the blood levels of GIOTRIF and therefore the risk of side effects. They should therefore be taken as far apart in time as possible from GIOTRIF. This means preferably 6 hours (for medicines taken twice daily) or 12 hours (for med icines taken once daily) apart from GIOTRIF :  Ritonavir, ketoconazole (except in shampoo), itraconazole, erythromycin, nelfinavir, saquinavir –used to treat different kinds of infections.  Verapamil, quinidine, amiodarone –used to treat heart conditions.  Cyclosporine A, tacrolimus –medicines that affect your immune system.

The following medicines may reduce the effectiveness of GIOTRIF:  Carbamazepine, phenytoin, phenobarbital –used to treat seizures.  St. John’s wort (Hypericum perforatum) , a herbal medi cine to treat depression.  Rifampicin, an antibiotic used to treat tuberculosis.

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

GIOTRIF may increase the blood levels of other medicines including but not limited to:  Sulfasalazine, used t o treat inflammation/infection.  Rosuvastatin, used for lowering cholesterol.

Tell your doctor before taking these medicines together with GIOTRIF.

Pregnancy and breast -feeding If you are pregnant or breast -feeding, 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 this medicine. If you could become pregnant, you should use adequate birth control methods during trea tment and for at least 1 month after taking the last dose of this medicine. This is because there may be a risk that an unborn baby is harmed.

73If you become pregnant while receiving this medicine, you should immediately inform your doctor.

Your doctor will decide with you whether treatment should be continued or not.

If you plan to become pregnant after taking the last dose of this medicine, you should ask your doctor for advice as your body may not have fully eliminated this medicine.

Breast -feeding Do not breast -feed while taking this medicine as a risk to the breast -fed child cannot be excluded.

Driving and using machines

If you experience treatment -related symptoms affecting your eye sight (e.g. redness and/or irritation of the eye, dry eye, teari ng, light -sensitivity) or your ability to concentrate and react, it is recommended that you do not drive or use machines until the side effect disappears (see section 4 Possible side effects).

GIOTRIF contains lactose

This medicine contains a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

💊 3. How to take GIOTRIF

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage The recommended dose is 40 mg each day.

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

When to take GIOTRIF  It is important to take this medicine without food  Take this medicine at least 1 hour before eating, or  If you have already eaten, wait at least 3 hours before taking this medicine.  Take this medicine once daily about the same time each day. This makes it easier to remember to take this medicine.  Do n ot break, chew or crush the tablet.  Swallow the tablet whole with a glass of still water.

GIOTRIF is to be taken by mouth. If you have difficulties swallowing the tablet, dissolve it in a glass of still water. No other liquids should be used. Drop the tab let into the water without crushing it, and occasionally stir for up to 15 min until the tablet is broken up into very small particles. Drink the liquid straight away. Then fill the glass again with water and drink it to make sure all medicine is taken.

If you are not able to swallow and have a gastric tube your doctor might suggest that the medicine is given to you via the tube.

If you take more GIOTRIF than you should

Contact your doctor or pharmacist immediately. You may experience increased side effec ts and your doctor may interrupt your treatment and provide supportive care.

If you forget to take GIOTRIF

 If your next scheduled dose is more than 8 hours away, take the missed dose as soon as you remember.

74 If your next scheduled dose is due within 8hours, skip the missed dose and take your next dose at the usual time. Then carry on taking your tablets at regular times as usual.

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

If you stop taking GIOTRIF

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

❗ 4. Possible side effects

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

Contact your doctor as soon as possible if you suffer from any of the serious side effects listed below.

In some cases your doctor may need to interrupt treatment and reduce your dose or stop treatment:  Diarrhoea (very common, may affect more than 1 in 10 people).

Diarrhoea lasting mor e than 2 days or more severe diarrhoea may lead to fluid loss (common, may affect up to 1 in 10 people), low blood potassium (common) and worsening kidney function (common). Diarrhoea can be treated. At the first signs of diarrhoea drink plenty of fluids. Contact your doctor immediately and start appropriate antidiarrhoeal treatment as soon as possible. You should have antidiarrhoeal medicine available prior to taking GIOTRIF.  Skin rash (very common).

It is important to treat the rash early. Tell your doctor if a rash starts. If treatment for rash is not working and the rash is getting more severe (for example, you have peeling or blistering of the skin) you should notify your doctor immediately, since your doctor may decide to stop your treatment with GIOTRIF. Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.  Inflammation of the lungs (uncommon, may affect up to 1 in 100 people) call ed “interstitial lung disease”.

Tell your doctor immediately if you develop new or sudden worsening of shortness of breath, possibly with a cough or fever.  Eye irritation or inflammation Eye irritation or inflammation may occur (conjunctivitis/dry eye occ urs commonly and keratitis uncommonly). Tell your doctor if you have sudden or worsening of eye symptoms such as pain or redness or dry eye.

If you experience any of the symptoms above, contact your doctor as soon as possible.

The following other side ef fects have also been reported:

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

 Mouth sores and inflammation  Nail infection  Decreased appetite  Bleeding from the nose  Nausea  Vomiting  Itching  Dry skin 75Common side effects (may affect up to 1 in 10 people):  Pain, redness, swelling or peeling of the skin of your hands and feet  Increased levels of the liver enzymes (aspartate aminotransferase and alanine aminotransferase) in blood tests.  Inflammation of the lining of the blad der with burning sensations during urination and frequent, urgent need to urinate (cystitis)  Abnormal taste sensations (dysgeusia)  Stomach pain, indigestion, heartburn  Lip inflammation  Decreased weight  Runny nose  Muscle spasms  Fever  Nail problems

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

 Inflammation of the pancreas (pancreatitis)  Occurrence of a tear in the wall of your stomach or intestines (gastrointestinal perforation)

Rare side effects (may affect up to 1 in 1 000people)

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in th is leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store GIOTRIF

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

Do not use this medicine after the expiry date which is stated on the carton, the pouc h and the blister after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture and light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What GIOTRIF contains

• The active substance is afatinib. Each film -coated tablet contains 50mg of afatinib (as dimaleate).
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553b), poly sorbate 80 (E433) , indigo carmine (E132) aluminium lake .

76What GIOTRIF looks like and contents of the pack GIOTRIF 50mg film -coated tablets are dark blue and oval shaped. They are debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.

GIOTRIF film -coated tablets are available in packs containing 1, 2or4perforated unit dose blisters.

Each blister contains 7 ×1film-coated tablets and is packed in an aluminium pouch together with a desiccant sachet that sho uld not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorisation 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 77For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Boehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595942 България Бьорингер Ингелхайм РЦВ ГмбХ и Ко.

КГ-клон България Тел: +359 2 958 79 98Luxembourg/Luxemburg Boehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11 Česká republika Boehringer Ingelheim spol. s r.o.

Tel: +420 234 655 111Magyarország Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Tel: +36 1 299 89 00 Danmark Boehringer Ingelheim Danmark A/S Tlf.: +45 39 15 88 88Malta Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620 Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900Nederland Boehringer Ingelheim B.V.

Tel: +31 (0) 800 22 55 889 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8000Norge Boehringer Ingelheim Danmark Norwegian branch Tlf: +47 66 76 13 00 Ελλάδα Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.

Tηλ: +30 2 10 89 06 300Österreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105 -7870 España Boehringer Ingelheim España, S.A.

Tel: +34 93 404 51 00Polska Boehringer Ingelheim Sp. z o.o.

Tel: +48 22 699 0 699 France Boehringer Ingelheim France S.A.S.

Tél: +33 3 26 50 45 33Portugal Boehringer Ingelheim Portugal, Lda.

Tel: +351 21 313 53 00 Hrvatska Boehringer Ingelheim Zagreb d.o.o.

Tel: +385 1 2444 600România Boehringer Ingelheim RCV GmbH & Co KG Viena -Sucursala Bucure şti Tel: +40 21 302 28 00 Ireland Boehringer Ingelheim Ireland Ltd.

Tel: +353 1 295 9620Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podružnica Ljubljana Tel: +386 1 586 40 00 Ísland Vistor ehf.

Sími: +354 535 7000Slovenská republika Boehringer Ingelheim RCV GmbH & Co KG organizačná zložka Tel: +421 2 5810 1211 78Italia Boehringer Ingelheim Italia S.p.A.

Tel: +39 02 5355 1Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102 800 Κύπρος Boehringer Ingelheim Ελλάς Μονοπρόσωπη A.E.

Tηλ: +30 2 10 89 06 300Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 00 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas filiāle Tel: +371 67 240 011 This leaflet was last revised in {MM/YYYY} .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Giotrif (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/13/879).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.