IBRANCE – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine IBRANCE, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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, pharm acist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What IBRANCE is and what it is used for
IBRANCE is an anticancer medicine containing the active substance palbociclib.
Palbociclib works by blocking proteins called cyclin -dependent kinase 4 and 6, which regulate cell growth and division. Blocking these proteins can slow down growth of cancer cells and delay the progression of your cancer.
IBRANCE is used to treat patients with certain types of breast cancer (hormone receptor -positive, human epidermal growth factor receptor 2-negative ) which have spread beyond the original tumour and/or to other organs. It is given together with aromatase inhibitors or fulvestrant, which are used as hormonal anticancer therapies.
⚠️ 2. What you need to know before you take IBRANCE
Do not take IBRANCE
-if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6). -use of preparations containing St. John’s Wort , an herbal product used to treat mild depression and anxiety, should be avoided while you are taking IBRANCE.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking IBRANCE.
IBRANCE may reduce the number of your white blood cells and weaken your immune system.
Therefore, you may be at greater risk of getting an infection while you are taking IBRANCE.
104Tell your doctor, pharmacist or nurse if you experience signs or symptoms of an infection, such as chills or fever.
You will have regular blood tests during treatment to check whether IBRANCE affects your blood cells (white blood cells, red blood cells, and platelets).
IBRANCE may cause blood clots in the veins. Tell your doctor, pharmacist or nurse if you experience signs or symptoms of blood clots in the veins such as pain or stiffness, swelling and redness in the affected leg (or arm), chest pain, shortness of breath or lightheadedness.
IBRANCE may cause severe or life -threatening inflammation of the lungs during t reatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms including: difficulty breathing or shortness of breath dry cough chest pain
Children and adolescents
IBRANCE is not to be used in childre n or adolescents (under 18 years of age ).
Other medicines and IBRANCE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. IBRANCE may affect the way some other medicines work.
In particular , the following may increase the risk of side effects with IBRANCE: Lopinavir, indinavir, nelfinavir, ritonavir, telaprevir, and saquinavir used to treat HIV infection/AIDS. Clarithromycin and telithromycin antibiotics used to treat bacterial infections. Voriconazole, itraconazole, ketoconazole, and posaconazole used to treat fungal infections. Nefazodone used to treat depression.
The following medicines may have increased risk of side effects when given with IBRANCE: Quinidine generally used to treat he art rhythm problems. Colchicine used to treat gout. Pravastatin , simvastatin, atorvastatin ,fluvastatin and rosuvastatin used to treat high cholesterol levels. Sulfasalazine used to treat rheumatoid arthritis. Alfentanil used for anaesthesia in surgery; fe ntanyl used in pre -procedures as a pain reliever as well as an anaesthetic. Cyclosporine , everolimus, tacrolimus, and sirolimus used in organ transplantation to prevent rejection. Dihydroergotamine and ergotamine used to treat migraine . Pimozide used to tr eat schizophrenia and chronic psychosis.
The following medicines may reduce the effectiveness of IBRANCE : Carbamazepine and phenytoin, used to stop seizures or fits. Enzalutamide to treat prostate cancer. Rifampin used to treat tuberculosis (TB). St. John’s Wort, a nherbal product used to treat mild depression and anxiety.
IBRANCE with food and drink IBRANCE tablets may be taken with or without food.
105Avoid grapefruit and grapefruit juice while you are taking IBRANCE as it may increase the side effects of IBRANCE.
Pregnancy and breast -feeding and fertility You should not use IBRANCE if you are pregnant .
You should avoid becoming pregnant while taking IBRANCE .
Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant.
If you are pregnant or breast -feeding , think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women of childbearing potential who are receivin g this medicinal product, or their male partners should use adequate contraceptive methods (e.g., double -barrier contraception such as condom and diaphragm). These methods should be used during therapy and for at least 3 weeks after completing therapy for females and for at least 14 weeks for males.
Breast -feeding You should not breast -feed while taking IBRANCE. It is not known if IBRANCE is excreted in breast milk.
Fertility
Palbociclib may decrease fertility in men .
Therefore, men may consider sperm pr eservation before taking IBRANCE.
Driving and using machines
Tiredness is a very common side effect of IBRANCE . If you feel unusually tired ,take special care when driving or using machines .
💊 3. How to take IBRANCE
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 125 mg of IBRANCE taken once a day for 3 weeks followed by 1 week without taking IBRANCE. Your doctor will tell you how many tablet s of IBRANCE to take.
If you experience certain side effects while you are taking IBRANCE (see section 4 “Possible side effects” ), your doctor may lower your dose or stop treatment, either temporarily or permanently. The dose may be lowered to one of the other available strengths 100 mg or 75 mg.
Take IBRANCE once a day at about the same time every day with or without food.
Swallow the tablet whole with a glass of water. Do not chew or crush the tablet s.Do not split the tablets prior to swall owing. No tablet should be ingested if it is broken, cracked, or otherwise not intact.
If you take more IBRANCE than you should
If you have taken too much IBRANCE , see a doctor or go to a hospital immediately. Urgent treatment may be necessary.
106Take the carton and this leaflet, so that the doctor knows what you have been taking.
If you forget to take IBRANCE
If you miss a dose or vomit, take your next dose as scheduled. Do not take a double dose to make up for the forgotten tablet s.
If you stop taking IBRANCE
Do not stop taking IBRANCE unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them:
Contact your doctor immediately if you have any of these symptoms: fever, chills, weakness, shortness of breath, bleeding, or easy bruising which could be a sign of a serious blood disorder. difficulty breathing, dry cough or chest pain which could be a sign of inflammation of the lungs. painful swollen leg, chest pain, shortness of breath, rapid breathing or rapid heart rate as these can be signs of blood clots in the vein (which may affect up to 1 in 1 0 people).
Other side effects with IBRANCE may include
Very common side effects (may affect more than 1 in 10 people)
Infections Reduction in white blood cells, red blood cells, and blood platelets Feeling of tiredness Decreased appetite Inflamma tion of the mouth and lips (stomatitis) , nausea, vomiting, diarrhoea Rash Hair loss Weakness Fever Abnormalities in liver blood tests Dry skin
Common side effects (may affect up to 1 in 10 people)
Fever with a drop in the white blood cell count (f ebrile neutropenia) Blurred vision, increased tearing, dry eye Alteration in taste (dysgeusia) Nosebleed Redness, pain, peeling, swelling and blistering of palms of hands and/or soles of feet (Palmar -Plantar E rythrodys aesthesia Syndrome [PPES]) Abnormal kidney blood test result (high level of creatinine in the blood )
Uncommon side effects (may affect up to 1 in 100 people)
Inflammation of the skin causing red scaly patches and possibly occurring together with pain in the joints and fever (Cuta neous Lupus Erythematosus [CLE]).
A skin reaction that causes red spots or patches on the skin that may look like a target or “bulls -eye” with a dark red centre surrounded by paler red rings (erythema multiforme).
107Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store IBRANCE
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 blister and carton after “EXP”.
The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage con ditions. Store in the original blister package in order to protect from moisture.
Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pha rmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What IBRANCE contains
-The active substance is palbociclib. IBRANCE film-coated tablet s come in different strengths : -IBRANCE 75 mg film-coated tablet : each tablet contains 75 mg palbociclib. -IBRANCE 100 mg film-coated tablet : each tablet contains 100 mg palbociclib. -IBRANCE 125 mg film-coated tablet : each tablet contains 125 mg palbociclib. -The other ingredients are:
Tablet core: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, ma gnesium stearate, succinic acid.
Film-coating: hypromellose (E464), titanium dioxide (E171), triacetin , Indigo carmine aluminum lake (E132), iron oxide red (E172) (75 mg and 125 mg tablets only), iron oxide yellow (E172) (100 mg tablets only).
What IBRANCE looks like and contents of the pack
-IBRANCE 75 mg tablets are supplied as round, light purple, film -coated tablets with “Pfizer” on one side and “PBC 75” on the other side . -IBRANCE 100 mg tablets aresupplied as oval, green, film -coated tablets with “Pfizer” on one side and “PBC 100” on the other sid e. -IBRANCE 125 mg tablets aresupplied as oval, light purple, film -coated tablets with “Pfizer” on one side and “PBC 125” on the other side .
IBRANCE 75 mg, 100 mg, and 125 mg are available in blister packs of 21 tablets or 63 tablets in a carton.
IBRANCE 75 mg, 100 mg, and 125 mg are available in blister card with 7 tablets (1 tablet per cell) in a wallet card. Each carton contains 21 tablets (3 wallet cards per carton).
Not all pack sizes may be marketed.
108Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH Mooswaldallee 1 79108 Freiburg Im Breisgau Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: +32 (0)2 554 62 11Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel:+370 5 251 4000 България Пфайзер Люксембург САРЛ , Клон България Тел.: +359 2 970 4333Magyarország Pfizer Kft.
Tel.: +36 14883700 Česká republika Pfizer , spol. s r.o.
Tel: +420 283004111Malta Vivian Corporation Ltd.
Tel: +356 21344610 Danmark Pfizer ApS Tlf.: +45 44 20 11 00Nederland Pfizer bv Tel: +31 (0) 800 63 34 636 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055 -51000Norge Pfizer AS Tlf: +47 67 52 61 00 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500Österreich Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15 -0 Ελλάδα Pfizer Ελλάς A.E.
Τλ: +30 210 6785800Polska Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00 España Pfizer, S.L.
Tel: +34 91 490 99 00Portugal Laborat óriosPfizer ,Lda.
Tel: +351 21 423 5500 France Pfizer Tél: +33 (0)1 58 07 34 40România Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00 109Hrvatska Pfizer Croatia d.o.o.
Tel: +385 1 3908 777Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400 Ireland Pfizer Healthcare Ireland Unlimited Company Tel: 1800 633 363 (toll free) +44 (0)1304 616161Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: +421 2 3355 5500 Ísland Icepharma hf.
Sími: +354 540 8000Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040 Italia Pfizer S.r.l.
Tel: +39 06 33 18 21Sverige Pfizer AB Tel: +46 (0)8 550 520 00 Kύπρος Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22817690 Latvija Pfizer Luxembourg SARL filiāle Latvijā Tel: +371 670 35 775
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information IBRANCE (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1147).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.