IBRANCE 125 MG ( PALBOCICLIB ) 21 CAPSULES

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IBRANCE 125 MG ( PALBOCICLIB ) 21 CAPSULES

Package leaflet:

Information for the patient
IBRANCE 75 mg film-coated tablets
IBRANCE 100 mg film-coated tablets
IBRANCE 125 mg film-coated tablets

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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

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

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.
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Tell 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 treatment 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 children 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 heart 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; fentanyl 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 treat 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, an herbal product used to treat mild depression and anxiety.
IBRANCE with food and drink
IBRANCE tablets may be taken with or without food

Avoid 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 receiving 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 preservation 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 tablets 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 tablets. Do not split the
tablets prior to swallowing. 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.
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Take 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 tablets.

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 10 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
Inflammation 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 (febrile 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 Erythrodysaesthesia 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 (Cutaneous Lupus Erythematosus [CLE]).
A skin reaction that causes red spots or patches on the skin that may look like a target or
“bullseye” with a dark red centre surrounded by paler red rings (erythema multiforme).
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Reporting 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 Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App
Store. 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 conditions. 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 pharmacist 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 tablets 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, magnesium
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 are supplied as oval, green, film-coated tablets with “Pfizer” on one
side and “PBC 100” on the other side.
- IBRANCE 125 mg tablets are supplied 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.

Marketing Authorisation Holder

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
For any information about this medicine, please contact:
Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone 01304 616161.
This leaflet was last revised in 11/2024.
Ref: IB TABS 9_0