Ibrance 100 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

IBRANCE 75 mg hard capsules

IBRANCE 100 mg hard capsules

IBRANCE 125 mg hard capsules

palbociclib

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What IBRANCE is and what it is used for
2. What you need to know before taking 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 a cancer treatment 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. By inhibiting these proteins, palbociclib can 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 has spread beyond the original tumor and/or to other organs. It is given in combination with aromatase inhibitors or fulvestrant, which are used as hormonal therapies for cancer.

2. What you need to know before taking 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 products containing St. John’s wort, a herbal remedy used to treat mild depression and anxiety, during treatment with IBRANCE.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting IBRANCE.

IBRANCE may reduce the number of white blood cells and weaken your immune system. Therefore, you may have an increased risk of developing an infection while taking IBRANCE.

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

You will have periodic blood tests during treatment to monitor whether 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 may lead to death. Immediately inform your healthcare provider if you develop 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 need to take any other medicines. IBRANCE may affect how other medicines work.

In particular, the following medicines may increase the risk of adverse 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 adverse effects associated with the following medicines:

• Quinidine, generally 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 preoperatively as an analgesic and 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 reduce 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 remedy used to treat mild depression and anxiety.

Taking IBRANCE with food and drink

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

Pregnancy, breastfeeding, and fertility

Do not take IBRANCE if you are pregnant.

Avoid becoming pregnant while taking IBRANCE.

Consult your doctor about using contraceptive methods if there is any chance that you or your partner could become pregnant.

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

Women of childbearing potential who are taking this medicine or whose partners are taking it should use adequate contraceptive measures (e.g., dual barrier methods such as condoms and diaphragm). These methods should be used during treatment and for at least 3 weeks after stopping treatment in women and for 14 weeks in men.

Breastfeeding

You should not breastfeed while taking IBRANCE. It is unknown whether IBRANCE passes into breast milk.

Fertility

Palbociclib may reduce fertility in men.

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

Driving and using machines

Fatigue is a very common adverse effect of IBRANCE. If you feel unusually tired, take special care when driving or operating machinery.

IBRANCE contains lactose and sodium

This medicine contains lactose (a sugar found in milk and dairy products). If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take IBRANCE

Follow exactly the instructions for administration of this medicine given to you by your doctor or pharmacist. If in doubt, consult 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 adverse reactions while taking IBRANCE (see section 4 "Possible side effects"), your doctor may reduce your dose or interrupt treatment, either temporarily or permanently. The dose may be reduced to one of the two available lower doses of 100 mg or 75 mg.

Take IBRANCE once daily, approximately at the same time each day, and with food, preferably with 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, consult a doctor or go immediately to a hospital. Emergency treatment may be necessary.

Take the packaging and this leaflet with you so the doctor knows what you have taken.

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 missed capsules.

If you stop taking IBRANCE

Do not stop treatment with IBRANCE unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse 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 tendency to bruise, which could be signs of a serious blood disorder.
• Difficulty breathing, dry cough or chest pain, which could be signs of lung inflammation.

Other adverse effects of IBRANCE may include:

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

Infections.

Reduction in the number of white blood cells, red blood cells, and platelets.

Feeling of tiredness.

Decreased appetite.

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

Rash.

Hair loss.

Weakness.

Fever.

Liver abnormalities in blood tests.

Dry skin.

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

Fever with reduction in white blood cell count (febrile neutropenia).

Blurred vision, increased tearing, dry eye.

Taste disturbance (dysgeusia).

Nosebleeds.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the bottle or blister pack and outer carton after EXP. The expiry date is the last day of the month indicated.

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 and packaging that you no longer need. 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 components are:

Capsule contents: 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”).

Nature of the product and pack contents

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 17
79090 Freiburg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Spain

Pfizer, S.L.
Tel: +34 91 490 99 00

Date of the most recent revision of this leaflet:

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