Patient Information Leaflet

IBRANCE 75mg Hard Capsules

IBRANCE 100mg Hard Capsules

IBRANCE 125mg Hard Capsules

palbociclib

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What IBRANCE is and what it is used for

2.What you need to know before you start taking IBRANCE

3.How to take IBRANCE

4.Possible side effects

5.Storage of IBRANCE

6.Contents of the pack and additional information

IBRANCE is a medication for the treatment of cancer that contains the active ingredient palbociclib.

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

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

Do not take IBRANCE

• if you are allergic to palbociclib or any of the other ingredients in this medication (listed in section6).
• Avoid taking preparations that contain St. John's Wort, a medicinal plant used to treat mild depression and anxiety, during treatment with IBRANCE.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take IBRANCE.

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

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

Regular blood tests will be performed during treatment to check if IBRANCE affects your blood cells (white blood cells, red blood cells, and platelets).

IBRANCE may cause severe or potentially fatal lung inflammation during treatment, which can lead to death. Inform 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 18years of age).

Other medications and IBRANCE

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. IBRANCE may affect how other medications work.

In particular, the following medications may increase the risk of adverse effects with IBRANCE:

• Lopinavir, indinavir, nelfinavir, ritonavir, telaprevir, and saquinavir used to treat HIV/AIDS.
• Claritromycin and telitromycin, 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 adverse effects associated with the following medications:

• Quinidine, used to treat heart rhythm problems.
• Colchicine, used to treat gout.
• Pravastatin and rosuvastatin, used to reduce cholesterol levels.
• Sulfasalazine, used to treat rheumatoid arthritis.
• Alfentanil, used for anesthesia in surgery; fentanyl, used as a preoperative analgesic and anesthetic.
• Ciclosporin, 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 medications may reduce the effectiveness of IBRANCE:

• Carbamazepine and phenytoin, used to stop seizures or epilepsy attacks.
• Enzalutamide for treating prostate cancer.
• Rifampicin, used to treat tuberculosis (TB).
• St. John's Wort, a medicinal plant used to treat mild depression and anxiety.

IBRANCE with food and beverages

Avoid grapefruit and grapefruit juice while taking IBRANCE, as it may increase the adverse effects of IBRANCE.

Pregnancy, breastfeeding, and fertility

You should not take IBRANCE if you are pregnant.

Avoid becoming pregnant while taking IBRANCE.

Consult your doctor about the use of contraceptive methods if there is any possibility that you or your partner may become pregnant.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Women of childbearing age taking this medication or their partner should use adequate contraceptive methods (e.g., double barrier methods such as condoms and diaphragm). These methods should be used during treatment and for at least 3 weeks after completing treatment in women and for 14 weeks in men.

Breastfeeding

You should not breastfeed while taking IBRANCE. It is unknown if 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 operating machinery

Drowsiness is a very common side effect of IBRANCE. If you feel unusually tired, be especially careful when driving or operating machinery.

IBRANCE contains lactose and sodium

This medication contains lactose (present in milk and dairy products). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1mmol of sodium (23mg) per capsule; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Take IBRANCE once a day, approximately at the same time every day and with food, preferably at a meal.

Swallow the entire capsule with a glass of water. Do not chew or crush the capsules. Do not open the capsules.

If you take more IBRANCE than you should

If you take too much IBRANCE, consult a doctor or go immediately to a hospital. Emergency treatment may be necessary.

Bring the packaging and this leaflet so that the doctor knows what you have been taking.

If you forget to take IBRANCE

If you forget a dose or vomit, take the next dose as scheduled. Do not take a double dose to make up for the missed capsules.

If you interrupt treatment with IBRANCE

Do not discontinue treatment with IBRANCE unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following symptoms:

• Fever, chills, weakness, difficulty breathing, bleeding, or a tendency to bruise, which could be a sign of a serious blood disorder.
• Difficulty breathing, dry cough, or chest pain that 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.

Reduction in white blood cell, red blood cell, and platelet count.

Feeling tired.

Decreased appetite.

Oral and lip inflammation (stomatitis), nausea, vomiting, diarrhea.

Rash.

Hair loss.

Weakness.

Fever.

Liver function abnormalities in blood tests.

Dry skin.

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

Fever with reduced white blood cell count (febrile neutropenia).

Blurred vision, increased tear production, dry eye.

Taste disorder (dysgeusia).

Nasal bleeding.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle or in the blister pack and on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of IBRANCE

• The active ingredient is palbociclib. IBRANCE hard capsules are available in different concentrations:
• IBRANCE 75 mg hard capsules: each capsule contains 75 mg of palbociclib.
• IBRANCE 100 mg hard capsules: each capsule contains 100 mg of palbociclib.
• IBRANCE 125 mg hard capsules: each capsule contains 125 mg of palbociclib.
• The other components are:

Capule content: microcrystalline cellulose, lactose monohydrate, sodium glycolate type A starch, anhydrous colloidal silica, magnesium stearate.

Capsule coating: gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171). Printing ink: shellac, titanium dioxide (E171), ammonium hydroxide (28% solution), propylene glycol, simethicone (see section 2 “IBRANCE contains lactose and sodium”).

Appearance of the product and contents of the package

• IBRANCE 75 mg is presented in the form of hard, opaque capsules with a light orange body (with “PBC 75” printed in white) and a light orange cap (with “Pfizer” printed in white).
• IBRANCE 100 mg is presented in the form of hard, opaque capsules with a light orange body (with “PBC 100” printed in white) and a caramel-colored cap (with “Pfizer” printed in white).
• IBRANCE 125 mg is presented in the form of hard, opaque capsules with a caramel-colored body (with “PBC 125” printed in white) and a caramel-colored cap (with “Pfizer” printed in white).

IBRANCE 75 mg, 100 mg, and 125 mg are available in blister packs of 21 or 63 hard capsules and in plastic bottles of 21 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

Pfizer Manufacturing Deutschland GmbH
Freiburg site
Mooswaldallee 1
79090 Freiburg
Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Phone: +34 91 490 99 00

Last revision date of this leaflet:

For detailed information about this medicine, please visit the European Medicines Agency website:http://www.ema.europa.eu.