Giotrif 40 mg film-coated tablets

• 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 any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

1. What GIOTRIF is and what it is used for
2. What you need to know before you take GIOTRIF
3. How to take GIOTRIF
4. Possible side effects
5. How to store GIOTRIF
6. Contents of the pack and other information

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

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 lung 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 transparent 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.

Inform your doctor immediately while taking this 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 could 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”.

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.

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 following 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 medicines 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 medicine 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 to treat inflammation/infection.
• Rosuvastatin, used for lowering cholesterol.

Tell your doctor before taking these medicines together with GIOTRIF.

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 treatment 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.

If 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.

If you experience treatment-related symptoms affecting your eye sight (e.g. redness and/or irritation of the eye, dry eye, tearing, 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).

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.

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.

• 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 not 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 tablet 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.

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

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

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 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

or search for MHRA Yellow Card in the Google Play or Apple App Store

• The active substance is afatinib. Each film-coated tablet contains 40 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), indigo carmine (E132) aluminium lake.

GIOTRIF 40 mg film-coated tablets are light blue and round shaped. They are debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.

GIOTRIF film-coated tablets are available in packs containing 1, 2 or 4 perforated unit dose blisters. Each blister contains 7 x 1 film-coated tablets and is packed in an aluminium pouch together with a desiccant sachet that should not be swallowed.

Not all pack sizes may be marketed.