VIZIMPRO 15 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Vizimpro 15 mg Film-Coated Tablets

Vizimpro 30 mg Film-Coated Tablets

Vizimpro 45 mg Film-Coated Tablets

dacomitinib

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Vizimpro and what is it used for

Vizimpro contains the active substance 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-small cell 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.

2. What you need to know before you take Vizimpro

Do not take Vizimpro

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

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before you start taking Vizimpro:

• if you have ever had any other lung problems. Some lung problems may get worse during treatment with Vizimpro, as Vizimpro can cause inflammation of the lungs during treatment. The symptoms may be similar to those of lung cancer. Tell your doctor immediately if you have new or worsening symptoms such as difficulty breathing, shortness of breath, cough with or without mucus, or fever;
• if you are being treated with any of the medicines listed in the section Other medicines and Vizimpro.

Tell your doctor immediately if while taking this medicine:

• you have diarrhea. Immediate treatment of diarrhea is important;
• you have a skin rash. Early treatment of skin rash is important;
• you have any symptoms of a liver problem which may include: yellowing of the skin or the white part of the eyes (jaundice), dark or brown urine, pale or brown stools.

Children and Adolescents

Vizimpro has not been studied in children or adolescents and must not be given to patients under 18 years of age.

Other medicines and Vizimpro

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, the effects of some medicines may increase when taken with Vizimpro. These include, among others:

• Procainamide, used to treat heart rhythm disorders.
• Pimozide and thioridazine, used to treat schizophrenia and psychosis.

Do not take these medicines during treatment with Vizimpro.

The following medicines may reduce the effectiveness of Vizimpro:

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not become pregnant while taking Vizimpro because this medicine may harm your baby. If there is any possibility that you may become pregnant, you must use effective contraceptive methods during treatment and for at least 17 days after stopping treatment. If you become pregnant while taking this medicine, tell your doctor immediately.

Breastfeeding

Do not breastfeed while taking this medicine as it is not known whether it may harm your baby.

Driving and Using Machines

Fatigue and eye irritation can occur in patients taking Vizimpro. If you feel tired or your eyes are irritated, be careful when driving or using machines.

Vizimpro contains Lactose and Sodium

This medicine contains lactose (found in milk or milk products). If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

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

3. How to take Vizimpro

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist again.

• The recommended dose is 45 mg once a day taken orally.
• Take the tablet at approximately the same time each 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 medicine depending on how you tolerate it.

If you take more Vizimpro than you should

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

If you forget to take Vizimpro

If you forget a dose or vomit, take the next dose as planned. Do not take a double dose to make up for forgotten doses.

If you stop taking Vizimpro

Do not stop taking Vizimpro unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

• Lung inflammation (common, 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 life-threatening.

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

Diarrhea can cause loss of fluids (common), low potassium levels in the blood (very common), and worsening of kidney function, and can be life-threatening. If you notice the first signs of increased frequency of bowel movements, contact your doctor immediately, drink plenty of fluids, and start antidiarrheal treatment as soon as possible. Have an antidiarrheal medicine available before starting to take Vizimpro.

• Skin rash (very common)

It is important to treat the rash early. Tell your doctor if a rash appears. If the treatment for the rash does not work or if the rash gets worse (for example, you suffer from peeling or cracking of the skin), tell your doctor immediately, as your doctor may decide to stop treatment with Vizimpro. The rash can occur or get worse in areas exposed to the sun. Sun protection with protective clothing and sunscreen is recommended.

Tell your doctor as soon as possible if you notice any of the following side effects:

Very common (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 tests in the blood
• Nausea or vomiting
• Red or painful palms of the hands or soles of the feet
• Fatigue
• Weakness
• Cracking of the skin

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

• Taste disorder
• Peeling of the skin
• Eye inflammation
• Abnormal amount of body hair growth

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, including any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vizimpro

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 and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

This medicine may be harmful to the environment. 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. Contents of the pack and other information

Composition of Vizimpro

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

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 ingredients are:

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

Film coating: Opadry II blue 85F30716 which contains partially hydrolyzed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol (E1521), aluminum lake of indigo carmine (E132).

Appearance and packaging

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

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

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

Available in packs with blisters of 30 film-coated tablets.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

You can request more information about this medicine from the local representative of the Marketing Authorization Holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of last revision of this leaflet:MM/AAAA.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.