GIOTRIF 40 mg FILM-COATED TABLETS

2. What you 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 you start taking this medicine:

• if you are a woman, weigh less than 50 kg or have kidney problems. If any of these apply to you, your doctor may monitor you more closely, 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 medicine 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 clear layer on the front of the eye (cornea) or ulcers on the outer eye, or if you wear contact lenses.
• if you have a history of heart problems. Your doctor may monitor you more closely.

Tell your doctor immediately while taking this medicine:

• if you have diarrhea. It is important to start treatment at the first symptoms of diarrhea.
• if you get a skin rash. It is important to start treatment for the rash as soon as possible.
• if you notice the sudden onset or 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 have severe stomach or intestinal pain, fever, chills, nausea, vomiting or abdominal stiffness or swelling, as these could be symptoms of a tear in the wall of the stomach or intestines (gastrointestinal perforation). Also, tell your doctor if you have had stomach or intestinal ulcers or diverticular disease in the past, or if you are taking 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 severe eye pain 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 and adolescents. Do not give this medicine to children or adolescents under 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, the following medicines, if taken before GIOTRIF, may increase GIOTRIF levels in the blood and, therefore, the risk of side effects. Therefore, these medicines should be taken as far apart as possible from GIOTRIF. This means leaving a gap of at least 6 hours (for medicines taken twice a day) or 12 hours (for medicines taken once a day) between taking these medicines and 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 conditions.
• Cyclosporine A and tacrolimus, medicines that affect the immune system.

The following medicines may decrease the effectiveness of GIOTRIF:

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

Ask your doctor if you are not sure when to take these medicines.

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

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

Tell your doctor before taking these medicines 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 must use effective contraception during treatment and for at least 1 month after taking the last dose of this medicine. This is because there may be a risk of harm to the unborn baby.

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

You should 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 fully eliminated this medicine.

Breast-feeding

You must not breast-feed while taking this medicine, as it may harm your baby.

Driving and using 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 use machines until the side effects have resolved (see section 4 Possible side effects).

GIOTRIF contains lactose

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

3. How to take GIOTRIF

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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 medicine.

When to take GIOTRIF

• It is important to take this medicine on an empty stomach.
• 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 a day, approximately at the same time each day. This will help you remember to take your medicine.
• Do not break, chew or crush the tablet.
• Swallow the tablet whole with a glass of water.

GIOTRIF should be taken by mouth. If you have problems swallowing the tablet, dissolve it in a glass of water. Do not use other liquids. Put the tablet in the water without crushing it and stir the water from time to time for about 15 minutes until the tablet has broken up into very small particles. Drink the liquid immediately. To make sure you take all of the medicine, 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 medicine be given 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 the same time instead of one) to make up for a missed dose.

If you stop taking GIOTRIF

Do not stop taking this medicine without talking to your doctor first. It is important that you take this medicine every day, while your doctor prescribes it for you. If you do not take this medicine as prescribed by your doctor, your cancer may start to 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.

Tell 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 loss of fluids (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. Tell your doctor immediately and start antidiarrheal treatment as soon as possible. You should have an antidiarrheal medicine ready before starting treatment with GIOTRIF.

• Skin rash(very common).

It is important to start treatment for the rash as soon as possible. Tell 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 tell 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) called “interstitial lung disease”. Tell your doctor immediately if you notice the sudden onset or 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). Tell your doctor if you experience sudden onset or worsening of eye symptoms such as eye pain or redness or dry eyes.

If you experience any of these symptoms, tell 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 lining of the bladder with a burning sensation when urinating and a frequent and urgent need to urinate (cystitis)
• Abnormal 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 wall of your stomach or intestines (gastrointestinal perforation)
• Abnormal growth of eyelashes (including misdirected growth that can cause damage to the eye 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 of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this 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. Storage of 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, pouch and blister after EXP. The expiry date is the last day of the month shown.

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

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. 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), colloidal anhydrous 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 available in packages 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 package 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 medication 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 medication is available on the European Medicines Agency website: https://www.ema.europa.eu.