Vizimpro 45 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
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 the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Vizimpro is and what it is used for
- What you need to know before taking Vizimpro
- How to take Vizimpro
- Possible side effects
- How to store Vizimpro
- 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 certain changes (mutations) in a gene called "EGFR" (epidermal growth factor receptor) and has spread to your other lung or to other organs, your cancer is likely to respond to treatment with Vizimpro.
Vizimpro can be used as first-line treatment once your lung cancer has spread to your other lung or to other organs.
2. What you need to know before starting 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 starting Vizimpro:
- if you have ever had any other lung problems. Some lung conditions may worsen during treatment with Vizimpro, as Vizimpro can cause inflammation of the lungs during treatment. Symptoms may be similar to those of lung cancer. Inform your doctor immediately if you experience new or worsening symptoms such as difficulty breathing, shortness of breath, cough with or without phlegm (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 if, while taking this medicine:
- you develop diarrhoea. Prompt treatment of diarrhoea is important;
- you develop a skin rash. Early treatment of skin rash is important;
- you experience any symptoms of liver problems, which may include yellowing of the skin or the whites of the eyes (jaundice), dark or brown-coloured urine (tea-coloured), or pale 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 need to 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 cardiac arrhythmias.
- 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 (used to treat ulcers, indigestion, and heartburn).
Do 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 antihistamine. If you take an H2 antihistamine, take your 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 become pregnant, consult your doctor or pharmacist before using 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 effective contraception during treatment and for at least 17 days after stopping treatment. If you become pregnant while taking this medicine, contact your doctor immediately.
Breastfeeding
Do not breastfeed while taking this medicine, as it is unknown whether it could be harmful to your baby.
Driving and using machines
Fatigue and eye irritation may occur in patients taking Vizimpro. If you feel tired or have eye irritation, take care when driving or using machines.
Vizimpro contains lactose and sodium
This medicine contains lactose (a sugar found in milk and dairy products). If your doctor has told you that you have 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; this is essentially “sodium-free”.
3. How to take Vizimpro
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.
- The recommended dose is 45 mg taken orally once daily.
- Take the tablet at approximately the same time each day.
- Swallow the tablet whole with a glass of water.
- You may take the tablet with or without food.
Your doctor may reduce your dose depending on how well you tolerate the medicine.
If you take more Vizimpro than you should
If you take too much Vizimpro, contact a doctor or go immediately to a hospital.
If you forget to take Vizimpro
If you miss a dose or vomit after taking the tablet, take your next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Vizimpro
Do not stop treatment with Vizimpro unless your doctor tells you to. If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following adverse effects; you may require urgent medical treatment:
- Inflammation of the lungs (common, may affect up to 1 in 10 people)
Breathing difficulties, shortness of breath, possibly with cough or fever. This may indicate that you have lung inflammation called interstitial lung disease, which can be life-threatening.
- Diarrhea (very common)
Diarrhea may lead to fluid loss (common), low blood potassium levels (very common), worsening of kidney function, and may be fatal. At the first sign of increased 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 treatment with Vizimpro.
- Skin rash (very common)
It is important to treat the rash promptly. Inform your doctor if a rash appears. If treatment for the rash is ineffective or if the rash worsens (for example, if you experience skin peeling or cracking), inform your doctor immediately, as your doctor may decide to discontinue treatment with Vizimpro. The rash may occur or worsen in sun-exposed areas. Sun protection using protective clothing and sunscreen is recommended.
Inform your doctor as soon as possible if you notice any of the following adverse 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 disturbance
- Skin peeling
- Eye inflammation
- Abnormal body hair growth
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
This medicine may pose a risk to the environment. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. 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 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 polyvinyl alcohol – partially hydrolysed (E1203), talc (E553b), titanium dioxide (E171), macrogol (E1521), indigo carmine aluminium lake (E132).
Appearance of the product and contents of the pack
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Vizimpro 15 mg film-coated tablets are presented as blue, round, biconvex film-coated tablets, engraved with “Pfizer” on one side and “DCB15” on the other.
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Vizimpro 30 mg film-coated tablets are presented as blue, round, biconvex film-coated tablets, engraved with “Pfizer” on one side and “DCB30” on the other.
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Vizimpro 45 mg film-coated tablets are presented as blue, round, biconvex film-coated tablets, engraved with “Pfizer” on one side and “DCB45” on the other.
Available in packs with 30 film-coated tablets in blister packs (tablets).
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany
For more information about this medicine, contact the local representative of the Marketing Authorisation Holder:
Spain
Pfizer, S.L.
Tel: +34 91 490 99 00
Date of the most recent revision of this leaflet: MM/YYYY.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.