IBRANCE 125 mg HARD CAPSULES

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 may reduce the number of white blood cells and weaken your immune system. Therefore, you may be at a greater 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 may cause severe or 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 may affect the way 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 infection.
• 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 before surgery as a pain reliever, 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 seizures or epileptic fits.
• 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

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

Pregnancy, breastfeeding, 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 any possibility 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 age who are taking this medicine or their partner must use adequate contraceptive measures (such as double-barrier contraception like 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.

Breastfeeding

Do not breastfeed while taking IBRANCE. It is not known 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 using machines

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

IBRANCE contains lactose and sodium

This medicine contains lactose (present in milk and dairy products). If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take IBRANCE

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, talk to 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 capsules 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, and with food, preferably in a meal.

Swallow the capsule whole 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, talk to a doctor or go to a hospital straight away. You may need emergency treatment.

Take the pack and this leaflet with you.

If you forget to take IBRANCE

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

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.

Tell 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.

Reduction in the 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 a reduced white blood cell count (febrile neutropenia).

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 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 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 carton or blister and on the container after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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 other information

Composition of IBRANCE

• The active substance is palbociclib. IBRANCE hard capsules are available in different strengths:
• 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 ingredients are:

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

Capsule shell: 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 pack size

• IBRANCE 75 mg is presented as hard capsules, opaque, 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 as hard capsules, opaque, with a light orange body (with "PBC 100" printed in white) and a caramel cap (with "Pfizer" printed in white).
• IBRANCE 125 mg is presented as hard capsules, opaque, with a caramel body (with "PBC 125" printed in white) and a caramel cap (with "Pfizer" printed in white).

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

Not all pack sizes may be marketed.

Marketing authorisation 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 authorisation 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.