Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ibrance

Document Subject

Generated Narrative: MedicinalProductDefinition mpc81102ba15ecf1ae72d97505f0c21e9d

identifier: http://ema.europa.eu/identifier/EU/1/16/1147/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: IBRANCE 75 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-c81102ba15ecf1ae72d97505f0c21e9d

identifier: http://ema.europa.eu/identifier/EU/1/16/1147/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ibrance

Attesters

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

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.

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.

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 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

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.

IBRANCE contains lactose and sodium This medicine contains lactose (found in milk or dairy products). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say it is essentially sodium-free .

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 capsules 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 food, preferably 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 have taken too much IBRANCE, see a doctor or go to a hospital immediately. Urgent treatment may be necessary.

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 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.

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])

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]). 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 bottle or blister and carton after EXP . The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

What IBRANCE contains

• The active substance is palbociclib. IBRANCE hard capsules come in different strengths:

• IBRANCE 75 mg hard capsule: each capsule contains 75 mg palbociclib.

• IBRANCE 100 mg hard capsule: each capsule contains 100 mg palbociclib.

• IBRANCE 125 mg hard capsule: each capsule contains 125 mg 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, simeticone (see section 2 IBRANCE contains lactose and sodium ).

What IBRANCE looks like and contents of the pack

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH Betriebsst tte Freiburg Mooswaldallee 1 79090 Freiburg Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4
,
.: +359 2 970 4Magyarorsz g Pfizer Kft. Tel.: +36 1 488 37 esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer A.E. : +30 210 6785Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer
T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka
Tel: +421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige
Pfizer AB Tel: +46 (0)8 550 520 K
Pfizer . . (Cyprus Branch) T : +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij
Tel: +371 670 35 This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: