Prospect: information for the patient

Vizimpro 15 mg film-coated tablets

Vizimpro 30 mg film-coated tablets

Vizimpro 45 mg film-coated tablets

dacomitinib

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

- Keep this prospect, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1. What is Vizimpro and for what it is used

2. What you need to know before starting to take Vizimpro

3. How to take Vizimpro

4. Possible side effects

5. Storage of Vizimpro

6. Contents of the pack and additional information

Vizimpro contains the active ingredient dacomitinib, which belongs to a group of medicines called tyrosine kinase inhibitors, used to treat cancer.

Vizimpro is used to treat adults with a type of lung cancer called “non-microcytic lung cancer”. If a test has shown that your cancer has certain changes (mutations) in a gene called “EGFR” (epidermal growth factor receptor) and has spread to your other lung or to other organs, it is likely that your cancer will respond to treatment with Vizimpro.

Vizimpro can be used as a first treatment once your lung cancer has spread to your other lung or to other organs.

Do not take Vizimpro

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Vizimpro:

• if you have ever had any other lung problem. Some lung problems may worsen during treatment with Vizimpro, as Vizimpro may cause lung inflammation during treatment. Symptoms may be similar to lung cancer. Inform your doctor immediately if you have new or worsening symptoms such as, for example, difficulty breathing, shortness of breath, cough with or without mucus (sputum) or fever;
• if you are being treated with any of the medications listed in the sectionOther medications and Vizimpro.

Inform your doctor immediately if while taking this medication:

• you experience diarrhea. Immediate treatment of diarrhea is important;
• you experience skin rash. Early treatment of skin rash is important;
• you experience any symptoms of a liver problem that may include: yellowing of the skin or the white part of the eyes (jaundice), dark or tea-colored urine, light-colored stools.

Children and adolescents

Vizimpro has not been studied in children or adolescents and should not be administered to patients under 18 years.

Other medications and Vizimpro

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In particular, the effects of some medicationsmay increasewhen taken with Vizimpro. These include, among others:

• Procainamide, used to treat cardiac arrhythmias.
• Pimozide and thioridazine, used to treat schizophrenia and psychosis.

Do not take these medications during treatment with Vizimpro.

The following medicationsmay reducethe effectiveness of Vizimpro:

• Long-acting medications to reduce stomach acid, such as proton pump inhibitors (for the treatment of ulcers, indigestion, and stomach acid).

Do not take these medications during treatment with Vizimpro. As an alternative, you may take a short-acting medication, such as an antacid, or an H2 antihistamine. If you take an H2 antihistamine, take the Vizimpro dose at least 2 hours before or 10 hours after taking the H2 antihistamine.

Pregnancy and breastfeeding

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

Pregnancy

You should not become pregnant during treatment with Vizimpro because this medication may be harmful to the baby. If there is any possibility of becoming pregnant, you must use effective contraceptive methods during treatment and for at least 17 days after completing treatment. If you become pregnant while taking this medication, consult your doctor immediately.

Breastfeeding

Do not breastfeed while taking this medication as it is unknown whether it may be harmful to your baby.

Driving and operating machines

You may experience fatigue and eye irritation while taking Vizimpro. If you feel tired or your eyes are irritated, be careful when driving or operating machines.

Vizimpro contains lactose and sodium

This medication contains lactose (found in milk or dairy products). If your doctor has told you that you have intolerance to certain sugars, contact him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is 45 mg per day administered orally.
• Take the tablet approximately at the same time every day.
• Swallow the tablet whole with a glass of water.
• You can take the tablet with or without food.

Your doctor may reduce the dose of your medication as tolerated.

If you take more Vizimpro than you should

If you take too much Vizimpro, consult a doctor or go immediately to a hospital.

If you forget to take Vizimpro

If you forget a dose or vomit, take the next dose as scheduled. Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Vizimpro

Do not stop treatment with Vizimpro unless your doctor tells you to. If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Contact your doctor immediately if you observe any of the following side effects; you may need emergency medical treatment:

• Pneumonia (frequent, may affect up to 1 in 10 people)

Difficulty breathing, shortness of breath, possibly with cough or fever. This may indicate that you have a lung inflammation called interstitial lung disease, which can be fatal.

• Diarrhea (very frequent, may affect more than 1 in 10 people)

Diarrhea can cause fluid loss (frequent), low potassium levels in the blood (very frequent), and worsening kidney function, and can be fatal. If you experience an increase in bowel movements, contact your doctor immediately, drink plenty of fluids, and start antidiarrheal treatment as soon as possible. Have an antidiarrheal medication available before starting to take Vizimpro.

• Skin rash (very frequent)

It is essential to treat the rash promptly. Inform your doctor if a rash appears. If the rash treatment does not work or the rash worsens (for example, you experience peeling or cracking of the skin), inform your doctor immediately, as your doctor may decide to discontinue Vizimpro treatment. The rash can occur or worsen in sun-exposed areas. We recommend sun protection with protective clothing and sunscreen.

Inform your doctor as soon as possible if you observe any of the following side effects:

Very frequent (may affect more than 1 in 10 people):

• Inflammation of the mouth and lips
• Nail problems
• Dry skin
• Loss of appetite
• Dry, red, or itchy eyes
• Weight loss
• Hair loss
• Itching
• Abnormal liver enzyme test results in the blood
• Nausea or vomiting
• Red or painful palms of the hands or soles of the feet
• Fatigue
• Weakness
• Skin cracking

Frequent (may affect up to 1 in 10 people):

• Taste disorder
• Skin peeling
• Eye inflammation
• Abnormal hair growth

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,

even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.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 and the blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

This medication may pose a risk to the environment. Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vizimpro

• The active ingredient is dacomitinib (as dacomitinib monohydrate). Vizimpro film-coated tablets are available in different concentrations.

Vizimpro 15 mg tablets: Each film-coated tablet contains 15 mg of dacomitinib.

Vizimpro 30 mg tablets: Each film-coated tablet contains 30 mg of dacomitinib.

Vizimpro 45 mg tablets: Each film-coated tablet contains 45 mg of dacomitinib.

• The other components are:

Core tablet: lactose monohydrate, microcrystalline cellulose, sodium glycolate starch, magnesium stearate (see section 2Vizimpro contains lactose and sodium).

Film coating: Opadry II blue 85F30716 containing partially hydrolyzed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol (E1521), and aluminium lake carmine (E132).

Appearance of the product and contents of the pack

-Vizimpro 15 mg film-coated tablets are presented as blue, biconvex, round tablets with “Pfizer” on one face and “DCB15” on the other.

-Vizimpro 30 mg film-coated tablets are presented as blue, biconvex, round tablets with “Pfizer” on one face and “DCB30” on the other.

-Vizimpro 45 mg film-coated tablets are presented as blue, biconvex, round tablets with “Pfizer” on one face and “DCB45” on the other.

They are available in packs of 30 film-coated tablets (tablets).

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Last revision date of this leaflet:MM/AAAA.

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