75 mg, 100 mg, 125 mg film-coated tablets
palbociclib (palbociclib.)
1. What IBRANCE is and what it is used for
IBRANCE is a cancer medicine that contains the active substance palbociclib.
Palbociclib works by blocking proteins called cyclin-dependent kinases 4 and 6 which regulate cell growth and division. When these proteins are blocked, the growth of cancer cells can be slowed down so that the disease develops more slowly.
IBRANCE is used to treat patients with a certain type of breast cancer
(hormone receptor-positive, human epidermal growth factor receptor 2 ‑ negative) which has spread outside the original tumor one and/or to other organs. It is given together with aromatase inhibitors or fulvestrant, which are hormone treatments for cancer.
2. What you need to know before using IBRANCE
Do not take IBRANCE
- if you are allergic to palbociclib or any of the other ingredients of this medicine (listed in section 6).
- The use of St. John’s wort products , an herbal medicine used for mild depression and anxiety, should be avoided while taking IBRANCE.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking IBRANCE.
IBRANCE can reduce the number of white blood cells and weaken your immune system. Therefore, the risk of getting an infection while taking IBRANCE may increase.
Tell your doctor, pharmacist, or nurse if you get any signs or symptoms of an infection, such as chills or fever.
Blood samples are taken regularly during treatment to see if IBRANCE affects your blood cells (white and red blood cells and platelets ).
IBRANCE can cause severe or life-threatening inflammation of the lungs during treatment, which can lead to death. Tell your healthcare provider immediately if you experience new or worsening symptoms that include:
- difficulty breathing or shortness of breath
- dry cough
- chest pain
Children and young people
IBRANCE should not be used in children or adolescents (under 18 years of age).
Other medicines and IBRANCE
Tell your doctor or pharmacist if you have recently taken or might take any other medicines. IBRANCE may affect the way other medicines work.
In particular, the following medicines may increase the risk of side effects of IBRANCE:
- Lopinavir, indinavir, nelfinavir, ritonavir, telaprevir and saquvinavir, used to treat HIV infection / AIDS.
- Clarithromycin and telithromycin, which are antibiotics for bacterial infections.
- Voriconazole, itraconazole, ketoconazole and posaconazole, used to treat fungal infections.
- Nefazodone used to treat depression.
The following medicines may increase the risk of side effects if taken with IBRANCE:
- Quinidine which is often used to treat heart rhythm problems.
- Colchicine used to treat gout .
- Pravastatin and rosuvastatin, which are used to treat high cholesterol levels.
- Sulfasalazine used to treat rheumatoid arthritis .
- Alfentanil used in anesthesia. Fentanyl which is used as pain relief before surgery and also as an anesthetic.
- Ciclosporin, everolimus, tacrolimus and sirolimus, used in organ transplants to prevent rejection.
- Dihydroergotamine and ergotamine , which are used to treat migraines .
- Pimozide used to treat schizophrenia and chronic psychosis .
The following medicines may reduce the effect of IBRANCE:
- Carbamazepine and phenytoin , which are used to relieve seizures.
- Enzalutamide used to treat prostate cancer.
- Rifampin used to treat tuberculosis .
- St. John’s wort , herbal medicine or herbal product, used for mild depression and mild anxiety.
IBRANCE with food, drink and alcohol
IBRANCE tablets can be taken with or without food.
Avoid grapefruit and grapefruit juice while taking IBRANCE as it may increase the side effects of IBRANCE.
Pregnancy, breastfeeding and fertility
You should not use IBRANCE if you are pregnant.
You should avoid getting pregnant while taking IBRANCE.
Discuss contraception with your doctor if there is a risk that you or your partner may become pregnant.
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.
Women of childbearing potential receiving this medicine, or their male partner, should use appropriate contraception (eg two barrier methods such as condoms and diaphragms ). These contraceptives should be used during treatment and for at least 3 weeks after the end of treatment for women and 14 weeks for men.
Breast-feeding
You should not breastfeed while taking IBRANCE. It is not known whether IBRANCE is excreted in human milk.
Fertility
Palbociclib may reduce male fertility.
Men should therefore consider sperm storage before taking IBRANCE.
Driving and using machines
Fatigue 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. Ask your doctor or pharmacist if you are unsure.
The recommended dose of IBRANCE is 125 mg once daily for 3 weeks, followed by 1 week when you are not taking IBRANCE. Your doctor will tell you how many IBRANCE tablets to take.
If you get some side effect is when you take IBRANCE (see section 4 “Possible side effects”) may be the physician lower the dose of one or stop treatment, either temporarily or completely. Dose one can be reduced to one of the other available strengths, 100 mg or 75 mg.
Take IBRANCE once a day, at about the same time each day, with or without food.
Swallow the tablet whole with a glass of water. The tablets should not be chewed or crushed. Do not divide the tablets before swallowing them. Do not take a tablet that is broken, cracked, or otherwise intact.
If you take more IBRANCE than you should
If you have taken too much IBRANCE, see a doctor or go to the hospital immediately. You may need emergency treatment.
Take the carton and this leaflet with you so that your doctor knows what you have taken.
If you forget to take IBRANCE
If you miss a dose or vomit it up, take the next dose as planned. Do not take a double dose to make up for a forgotten tablet.
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 product, 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 get any of the following symptoms:
- fever, chills, weakness, shortness of breath, bleeding or tendency to bruise easily, which may be a sign of a serious blood disease
- difficulty breathing, dry cough or chest pain, which may be signs of inflammation in the lungs.
Other side effects of IBRANCE can be:
Very common side effects (may affect more than 1 user in 10):
Infection is.
Decreased number of white blood cells, red blood cells, and platelets.
Fatigue.
Decreased appetite.
Inflammation of the mouth and lips ( stomatitis ), nausea, vomiting, diarrhea.
Rash.
Hair loss.
Weakness.
Fever.
Abnormal liver function values in blood samples.
Dry skin.
Common side effects (may affect up to 1 in 10 people):
Fever with decreased white blood cell count (febrile neutropenia )
Blurred vision, watery eyes, dry eyes.
Taste change ( dysgeusia ).
Nasal blood
Uncommon side effects (may affect up to 1 in 100 people):
Inflammation of the skin causes red, scaly patches and which may occur together with pain in joints and fever ( cutaneous lupus erythematosus [CLE]).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 expiration date is the last day of the specified month.
No special temperature instructions. Store in the original blister. Moisture sensitive.
Do not use this medicine if you notice that the packaging is damaged or appears to have been tampered with.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is palbociclib. IBRANCE film-coated tablets are available in different strengths:
- IBRANCE 75 mg film-coated tablets: each tablet contains 75 mg palbociclib.
- IBRANCE 100 mg film-coated tablets: each tablet contains 100 mg palbociclib.
- IBRANCE 125 mg film-coated tablets: each tablet contains 125 mg palbociclib.
- The other ingredients are:
Tablet core: microcrystalline cellulose, colloidal silica, crospovidone, magnesium stearate, succinic acid.
Film coating: hypromellose (E464), titanium dioxide (E171), triacetin, indigo carmine aluminum lacquer (E132), red iron oxide (E172) (only 75 mg and 125 mg tablets), yellow iron oxide (E172) (only 100 mg tablets).
What the medicine looks like and contents of the pack
- IBRANCE 75 mg tablets are round, light purple film-coated tablets marked with “Pfizer” on one side and “PBC 75” on the other.
- IBRANCE 100 mg tablets are oval, green, film-coated tablets marked “Pfizer” on one side and “PBC 100” on the other.
- IBRANCE 125 mg tablets are oval, light purple film-coated tablets marked with “Pfizer” on one side and “PBC 125” on the other.
IBRANCE 75 mg, 100 mg, and 125 mg are available in blister packs containing 21 or 63 tablets in a carton.
IBRANCE 75 mg, 100 mg, and 125 mg are supplied in blister cards of 7 tablets (1 tablet per cell) in a wallet pack. Each carton contains 21 tablets (3 wallet packs per carton).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Establishment Freiburg
Mooswaldallee 1
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgique / België / BelgienPfizer SA / NVTel: +32 (0) 2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
| BulgariaPfizer Luxembourg SAR, Clone of BulgariaTel: +359 2 970 4333 | Luxembourg / LuxemburgPfizer SATel: +32 (0) 2 554 62 11 |
| Czech RepublicPfizer, spol. s roTel .: + 420-283-004-111 | HungaryPfizer Kft.Tel .: + 36-1-488-37-00 |
| DenmarkPfizer ApSTel: +45 44 20 11 00 | MaltaVivian Corporation Ltd.Tel: +356 21344610 |
| GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055 51000 | The NetherlandsPfizer BVTel: +31 (0) 10 406 43 01 |
| EestiPfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500 | NorwayPfizer ASTel: +47 67 52 61 00 |
| GreecePfizer Aλλάς AE:Ηλ: +30 210 6785 800 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| SpainPfizer, SLTel: +34 91 490 99 00 | PolandPfizer Polska Sp. z ooTel .: +48 22 335 61 00 |
| FrancePfizerTel: +33 (0) 1 58 07 34 40 | PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500 |
| CroatiaPfizer Croatia dooTel: + 385 1 3908 777 | RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | SloveniaPfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel .: + 386 (0) 1 52 11 400 |
| IcelandIcepharma hf.Phone: +354 540 8000 | Slovak RepublicPfizer Luxembourg SARL, organizerTel .: + 421 2 3355 5500 |
| ItalyPfizer SrlTel: +39 06 33 18 21 | Finland / FinlandPfizer OyPuh./Tel: +358 (0) 9 43 00 40 |
| ΎπροςPfizer Αλλάς Α.Ε. (Cyprus Branch)Tηλ + 357 22 817690 | SwedenPfizer ABTel: +46 (0) 8 550 520 00 |
| LatviaPfizer Luxembourg SARL subsidiary LatvijāTel .: + 371 670 35 775 | United Kingdom (Northern Ireland)Pfizer LimitedTel: +44 (0) 1304 616161 |