VIZIMPRO 30 mg FILM-COATED TABLETS

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 can get worse during treatment with Vizimpro, as Vizimpro can cause inflammation of the lungs during treatment. The symptoms can 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 that may include: yellowing of the skin or the white part of the eyes (jaundice), dark or brown urine, light-colored stools.

Children and adolescents

Vizimpro has not been studied in children or adolescents and should 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not become pregnant while taking Vizimpro because this medicine may harm your baby. If there is any possibility that you may become pregnant, you should use effective contraceptive methods during treatment and for at least 17 days after finishing treatment. If you become pregnant while taking this medicine, consult 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 dairy 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, consult 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, consult a doctor or go to the 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 the 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 that can be fatal.

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

Diarrhea can cause fluid loss (common), low potassium levels in the blood (very common), and worsening of kidney function, and can be fatal. 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 skin rash early. Tell your doctor if a rash appears. If the treatment for the rash does not work or if the rash worsens (for example, you suffer from skin peeling or cracking), tell your doctor immediately, as your doctor may decide to stop treatment with Vizimpro. The rash can occur or worsen 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
• Redness or pain on the palms of the hands or soles of the feet
• Fatigue
• Weakness
• Skin cracking

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

• Taste disorder
• Skin peeling
• 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, even if it is 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 stated.

This medicine does not require any special storage conditions.

This medicine may be a risk 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

What Vizimpro contains

• 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 as blue, biconvex, round tablets engraved with “Pfizer” on one side and “DCB15” on the other.

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

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

Available in packs with blister strips of 30 film-coated tablets (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 by contacting 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.