Vizimpro

Package leaflet: Information for the patient

Vizimpro 15 mg film-coated tablets, 30 mg film-coated tablets, 45 mg film-coated tablets

dacomitinib
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Vizimpro is and what it is 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 specific changes (mutations) in a gene called "EGFR" (epidermal growth factor receptor), and has spread to the other lung or to other organs, your cancer is likely to respond to treatment with Vizimpro.
Vizimpro can be used as first-line treatment when the lung cancer has spread to the other lung or to other organs.

2. What you should know before taking Vizimpro

Do not take Vizimpro

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vizimpro:

• if you have ever had other lung problems. Some lung conditions may worsen during treatment with Vizimpro, as this medicine can cause inflammation of the lungs. Symptoms may resemble those of lung cancer. Inform your doctor immediately if you develop new or worsening symptoms such as difficulty breathing, shortness of breath, or cough with or without sputum (mucus), or fever.
• if you are being treated with any of the medicines listed in the section Other medicines and Vizimpro.

Inform your doctor immediately during treatment with this medicine:

• if you develop diarrhoea. Prompt treatment of diarrhoea is important.
• if you develop a skin rash. Early treatment of skin rash is important.
• if you experience symptoms of liver problems, which may include: yellowing of the skin or whites of the eyes (jaundice), dark or brown-coloured urine (tea-coloured), or pale-coloured bowel movements (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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, the effects of certain medicines may be increased when taken with Vizimpro. These include, among others:

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

You must not take these medicines during treatment with Vizimpro.
The following medicines may reduce the effectiveness of Vizimpro:

• Long-acting drugs to reduce stomach acid, such as proton pump inhibitors (used for ulcers, indigestion, and heartburn)

You must not take these medicines during treatment with Vizimpro. As an alternative, you may take a short-acting medicine such as an antacid or an H2 blocker. If you take an H2 blocker, take your dose of Vizimpro at least 2 hours before or 10 hours after taking the H2 blocker.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must not become pregnant during treatment with Vizimpro, as this medicine could harm the unborn baby. If there is any possibility that you could become pregnant, you must use an effective method of contraception during treatment and for at least 17 days afterwards. If you become pregnant while taking this medicine, you must immediately speak to your doctor.
Breastfeeding
Do not breastfeed while taking this medicine, as it is not known whether it could harm the baby.
Driving and using machines
Fatigue and eye irritation may occur in patients taking Vizimpro. If you experience fatigue or eye irritation, you should exercise caution when driving or operating machinery.
Vizimpro contains lactose and sodium
This medicine contains lactose (found in milk and dairy products). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Vizimpro

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

• The recommended dose is 45 mg taken orally every day.
• Take the tablet at approximately the same time each day.
• Swallow the tablet whole with a glass of water.
• You may take the tablet on an empty stomach or with food.

Your doctor may reduce the dose of this medicine depending on your level of tolerance.
If you take more Vizimpro than you should
If you have taken too much Vizimpro, consult a doctor or go to hospital immediately.
If you forget to take Vizimpro
If you miss a dose or vomit, take your next dose as scheduled. Do not take a double
dose to make up for the missed tablet.
If you stop taking Vizimpro
Do not stop treatment with Vizimpro unless instructed by your doctor. If you have any doubts
about using this medicine, consult 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 (urgent medical treatment may be needed):

• Inflammation of the lungs (common, may affect up to 1 in 10 people)
  Difficulty breathing, shortness of breath, possibly with cough or fever. This may be a symptom of lung inflammation, better known as interstitial lung disease, which can be fatal.
• Diarrhoea (very common, may affect more than 1 in 10 people)
  Diarrhoea may lead to fluid loss (common), low levels of potassium in the blood (very common), worsening of kidney function, and may be fatal. At the first signs of increased frequency of bowel movements, contact your doctor immediately, drink plenty of fluids, and start anti-diarrhoeal treatment as soon as possible. Before starting Vizimpro, make sure you have an anti-diarrhoeal medicine available.
• Rash (very common)
  It is important to treat the rash promptly. Inform your doctor if you develop a rash. If treatment for the skin rash is not effective or if the rash is getting worse (for example, if you have skin peeling or cracking), inform your doctor immediately, as the doctor may decide to stop treatment with Vizimpro. The rash may occur or worsen in areas exposed to sunlight. It is recommended to protect yourself from sunlight by wearing protective clothing and using sunscreen.

Inform your doctor as soon as possible if you notice any of the following other 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 sensation
• Abnormal blood tests for liver enzymes
• Nausea or vomiting
• Redness or pain in the palms of the hands or soles of the feet
• Tiredness
• Weakness
• Skin fissures

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

• Altered taste
• Skin peeling
• Eye inflammation
• Abnormal body hair growth

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vizimpro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
This medicine may pose a risk to the environment. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Package contents 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 tablet: each film-coated tablet contains 15 mg of dacomitinib.
  Vizimpro 30 mg tablet: each film-coated tablet contains 30 mg of dacomitinib.
  Vizimpro 45 mg tablet: each film-coated tablet contains 45 mg of dacomitinib.
• The other components 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 containing partially hydrolysed polyvinyl alcohol (E1203), talc (E553b), titanium dioxide (E171), macrogol (E1521), aluminium lake containing indigo carmine (E132).

Description of the appearance of Vizimpro and contents of the pack

• Vizimpro 15 mg film-coated tablets are supplied as round, biconvex, blue film-coated tablets, with “Pfizer” printed on one side and “DCB15” on the other.
• Vizimpro 30 mg film-coated tablets are supplied as round, biconvex, blue film-coated tablets, with “Pfizer” printed on one side and “DCB30” on the other.
• Vizimpro 45 mg film-coated tablets are supplied as round, biconvex, blue film-coated tablets, with “Pfizer” printed on one side and “DCB45” on the other.

Available in blisters of 30 film-coated tablets.
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel. +370 52 51 4000
Tél/Tel: +32 (0)2 554 62 11
България Magyarország
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел.: +359 2 970 4333 Tel.: +36-1-488-37-00
Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel.: +420 283 004 111 Tel: +35621 344610
Danmark Nederland
Pfizer ApS Pfizer BV
Tlf.: +45 44 20 11 00 Tel: +31 (0)10 406 43 01
Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00
Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel.: +372 666 7500 Tel: +43 (0)1 521 15-0
Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z.o.o
Τηλ.: +30 210 6785 800 Tel.: +48 22 335 61 00
España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500
France România
Pfizer Pfizer Romania S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0) 21 207 28 00
Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: +385 1 3908 777 Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0)1 52 11 400
Ireland Slovenská republika
Pfizer Healthcare Ireland Unlimited Company Pfizer Luxembourg SARL, organizačná zložka
Tel: 1800 633 363 (toll free) Tel.: +421 2 3355 5500
+44 (0)1304 616161
Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh./Tel: +358 (0)9 43 00 40
Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00
Kýpros
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22 817690
Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: +371 670 35 775

More detailed information on this medicinal product is available on the European Medicines Agency website, https://www.ema.europa.eu.