IBRANCE 125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

IBRANCE 75 mg film-coated tablets

IBRANCE 100 mg film-coated tablets

IBRANCE 125 mg film-coated tablets

palbociclib

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 experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is IBRANCE and what is it used for

IBRANCE is a medicine for the treatment of cancer that contains the active substance palbociclib.

Palbociclib works by blocking certain proteins called cyclin-dependent kinases 4 and 6, which regulate cell growth and division. Blocking these proteins can slow down the growth of cancer cells and delay the progression of cancer.

IBRANCE is used to treat patients with certain types of breast cancer (positive for the hormonal receptor and negative for the human epidermal growth factor receptor 2) that have spread beyond the original tumor and/or to other organs. It is given together with aromatase inhibitors or fulvestrant, which are used as hormonal treatments for cancer.

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).
• You should avoid taking preparations that contain St. John's Wort, a herbal medicine used to treat mild depression and anxiety, during treatment with IBRANCE.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start taking IBRANCE.

IBRANCE can reduce the number of white blood cells and weaken your immune system. Therefore, you may be at a higher risk of getting an infection while taking IBRANCE.

Tell your doctor, pharmacist, or nurse if you have signs or symptoms of an infection, such as chills or fever.

You will have regular blood tests during treatment to check if IBRANCE is affecting your blood cells (white blood cells, red blood cells, and platelets).

IBRANCE can cause severe or potentially life-threatening lung inflammation during treatment, which can lead to death. Tell your healthcare professional immediately 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 indicated for the treatment of 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 can affect how other medicines work.

In particular, the following medicines may increase the risk of side effects with IBRANCE:

• • Lopinavir, indinavir, nelfinavir, ritonavir, telaprevir, and saquinavir used to treat HIV/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.

IBRANCE may increase the side effects associated with the following medicines:

• Quinidine, used to treat heart rhythm problems.
• Colchicine, used to treat gout.
• Pravastatin and rosuvastatin, used to lower cholesterol levels.
• Sulfasalazine, used to treat rheumatoid arthritis.
• Alfentanil, used for anesthesia in surgery; fentanyl, used preoperatively as an analgesic, as well as an anesthetic.
• Cyclosporine, everolimus, tacrolimus, and sirolimus, used in organ transplantation to prevent rejection.
• Dihydroergotamine and ergotamine, used to treat migraines.
• Pimozide, used to treat schizophrenia and chronic psychosis.

The following medicines may decrease the effectiveness of IBRANCE:

• Carbamazepine and phenytoin, used to stop convulsions or epileptic seizures.
• Enzalutamide for the treatment of prostate cancer.
• Rifampicin, used to treat tuberculosis (TB).

• St. John's Wort, a herbal medicine used to treat mild depression and anxiety.

Taking IBRANCE with food and drinks

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, breast-feeding, and fertility

Do not take IBRANCE if you are pregnant.

Avoid becoming pregnant while taking IBRANCE.

Talk to your doctor about the use of contraceptive methods if there is a 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 age who are taking this medicine or their partner must use adequate contraceptive measures (e.g., double-barrier contraception such as condoms and diaphragm). These measures should be used during treatment and for at least 3 weeks after finishing treatment in women and up to 14 weeks in men.

Breast-feeding

Do not breast-feed while taking IBRANCE. It is not known whether IBRANCE passes into breast milk.

Fertility

Palbociclib may decrease fertility in men.

Therefore, men should consider sperm preservation before starting treatment with IBRANCE.

Driving and using machines

Fatigue is a very common side effect of IBRANCE. If you feel unusually tired, be careful while driving or using machines.

3. How to take IBRANCE

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is 125 mg of IBRANCE once daily for 3 weeks, followed by 1 week without taking IBRANCE. Your doctor will tell you how many IBRANCE tablets to take.

If you experience certain side effects while taking IBRANCE (see section 4 "Possible side effects"), your doctor may reduce your dose or interrupt treatment, temporarily or permanently. The dose may be reduced to one of the available doses of 100 mg or 75 mg.

Take IBRANCE once daily, approximately at 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 break the tablets before swallowing. Do not take any tablet that is broken, cracked, or not intact.

If you take more IBRANCE than you should

If you take too much IBRANCE, talk to a doctor or go to a hospital straight away. You may need emergency treatment.

Take the pack and this leaflet with you to show the doctor what you have taken.

If you forget to take IBRANCE

If you miss a dose or vomit, take the next dose as planned. Do not take a double dose to make up for 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 experience any of the following symptoms:

• Fever, chills, weakness, difficulty breathing, bleeding, or bruising, which could be a sign of a serious blood disorder.
• Difficulty breathing, dry cough, or chest pain, which could be a sign of lung inflammation.

Other side effects of IBRANCE may include:

Very common side effects (may affect more than 1 in 10 people):

Infections.

Reduced number of white blood cells, red blood cells, and platelets.

Feeling tired.

Decreased appetite.

Inflammation of the mouth and lips (stomatitis), nausea, vomiting, diarrhea.

Rash.

Hair loss.

Weakness.

Fever.

Liver changes in blood tests.

Dry skin.

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

Fever with reduced white blood cell count (neutropenic fever).

Blurred vision, increased tear production, dry eye.

Taste disorder (dysgeusia).

Nosebleeds.

Uncommon side effects (may affect up to 1 in 100 people):

Skin inflammation that causes red scaly patches and may be accompanied by joint pain and fever (cutaneous lupus erythematosus [CLE]).

Reporting of side effects

If you experience 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 Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions. Store in the original blister to protect from moisture.

Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of IBRANCE

• 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 of palbociclib.
• IBRANCE 100 mg film-coated tablets: each tablet contains 100 mg of palbociclib.
• IBRANCE 125 mg film-coated tablets: each tablet contains 125 mg of palbociclib.
• The other ingredients are:

Tablet core: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and succinic acid.

Coating: hypromellose (E464), titanium dioxide (E171), triacetin, aluminum lake of indigo carmine (E132), red iron oxide (E172) (only for 75 mg and 125 mg tablets), yellow iron oxide (E172) (only for 100 mg tablets).

Appearance of the product and pack contents

• IBRANCE 75 mg tablets are presented as round, film-coated tablets, light purple in color, with "Pfizer" on one side and "PBC 75" on the other.
• IBRANCE 100 mg tablets are presented as oval, film-coated tablets, green in color, with "Pfizer" on one side and "PBC 100" on the other.
• IBRANCE 125 mg tablets are presented as oval, film-coated tablets, light purple in color, with "Pfizer" on one side and "PBC 125" on the other.

IBRANCE 75 mg, 100 mg, and 125 mg are available in blisters in packs of 21 or 63 tablets.

IBRANCE 75 mg, 100 mg, and 125 mg are available in blister cards of 7 tablets (1 tablet per blister) in a card box. Each pack contains 21 tablets (3 card boxes per pack).

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

You can request more information about this medicine from the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.