IBRANCE 75 mg Hard Capsules

Зміст інструкції

1. IBRANCE 75 mg hard capsules, 100 mg hard capsules, 125 mg hard capsules
   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. How to store IBRANCE
   6. Package contents and other information
2. IBRANCE 75 mg film-coated tablets, 100 mg film-coated tablets, 125 mg film-coated tablets
   1. What is IBRANCE and what is it 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. Package contents and other information

IBRANCE 75 mg hard capsules, 100 mg hard capsules, 125 mg hard capsules

palbociclib

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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

1. What is IBRANCE and what is it used for

IBRANCE is an antineoplastic 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. Blocking these proteins may slow the growth of cancer cells and delay tumor progression.
IBRANCE is used to treat patients with certain types of breast cancer (hormone receptor positive, human epidermal growth factor receptor 2 negative) that have spread
beyond the original tumor and/or to other organs. It is administered together with aromatase inhibitors or
fulvestrant, which are used as hormonal anticancer therapies.

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);
• the use of St John's wort (hypericum), a 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 can reduce the number of white blood cells and weaken the immune system. Therefore, you may
be at an increased risk of contracting an infection while taking IBRANCE.
Tell your doctor, pharmacist or nurse if you develop signs or symptoms of an infection, such as
chills or fever.
You will have regular blood tests during treatment to check for any effects
of IBRANCE on blood cells (white blood cells, red blood cells and platelets).
IBRANCE can cause blood clots to form in the veins. Tell your doctor, pharmacist
or nurse if you develop signs or symptoms of blood clots in the veins such as pain or stiffness,
swelling and redness of the affected leg (or arm), chest pain, shortness of breath or
feeling lightheaded.
IBRANCE can cause severe or potentially life-threatening inflammation of the lungs during
treatment, leading to a risk of death. Immediately inform your healthcare provider if
you experience or worsening of symptoms, including:

• difficulty breathing or shortness of breath
• dry cough
• chest pain

Children and adolescents
IBRANCE should not be used in children and 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 some other
medicines work.
In particular, the following medicines may increase the risk of side effects when taken
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.

The following medicines may have an increased risk of side effects when
given with IBRANCE:

• Quinidine generally used to treat heart rhythm problems.
• Colchicine used to treat gout.
• Pravastatin, simvastatin, atorvastatin, fluvastatin and rosuvastatin used to treat high cholesterol levels.
• Sulfasalazine used to treat rheumatoid arthritis.
• Alfentanil used for anesthesia during surgery; fentanyl used before surgery as both an analgesic and an anesthetic.
• Cyclosporine, everolimus, tacrolimus and sirolimus used in organ transplantation to prevent rejection.
• Dihydroergotamine and ergotamine used to treat migraine.
• Pimozide used for the treatment of schizophrenia and chronic psychosis.

The following medicines may reduce the effectiveness of IBRANCE:

• Carbamazepine and phenytoin used to stop seizures.
• Enzalutamide used for the treatment of prostate cancer.
• Rifampicin used in the treatment of tuberculosis (TB).
• St John's wort, a herbal product used to treat mild depression and anxiety.

IBRANCE with food and drink
Grapefruit and grapefruit juice should be avoided during treatment with
IBRANCE as it may increase the side effects of IBRANCE.

Pregnancy, breastfeeding and fertility
Do not use IBRANCE if you are pregnant.
You should avoid becoming pregnant during treatment with IBRANCE.
Ask your doctor for advice on contraception if you or your partner has the
potential to become pregnant.
If you are pregnant, suspect you may be pregnant or are planning a pregnancy or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Women of childbearing potential, or their male partners, should
use appropriate contraceptive methods (e.g., dual barrier contraception such as a condom
together with a diaphragm). Such methods should be used during therapy and for at least 3 weeks
after completion of therapy for women, and for at least 14 weeks for men.
Breastfeeding
Do not breast-feed during treatment with IBRANCE. It is not known whether IBRANCE is excreted
in breast milk.
Fertility
Palbociclib may reduce fertility in men.
Therefore, men may consider sperm preservation before
taking IBRANCE.

Driving and using machines
Fatigue is a very common side effect of IBRANCE. If you feel unusually tired,
be particularly careful when driving or using machines .
IBRANCE contains lactose and sodium
This medicine contains lactose (which is a type of sugar found in milk and 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 (23 mg) of sodium per capsule, that is to say it’s essentially “sodium-free”.

3. How to take IBRANCE

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
The recommended dose of IBRANCE is 125 mg once a day for 3 weeks followed by 1 week off treatment with IBRANCE. Your doctor will tell you how many IBRANCE capsules you need to take.
If some side effects occur during the intake of IBRANCE (see section 4 “Possible side effects”), your doctor may reduce the dose or stop the treatment, temporarily or permanently. The dose may be reduced to one of the other available strengths of 100 mg or 75 mg.
Take IBRANCE once a day at about the same time each 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, consult a doctor or go to hospital immediately. Urgent treatment may be necessary.
what you have taken.

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 forgotten capsules.

If you stop taking IBRANCE
Do not stop treatment with 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 everyone gets them.

Contact your doctor immediatelyif you have any of these symptoms:

• fever, chills, weakness, shortness of breath, bleeding, or easy bruising, which may be a sign of a serious blood problem.
• difficulty breathing, dry cough, or chest pain, which could be a sign of lung inflammation.
• swollen and painful leg, chest pain, shortness of breath, rapid breathing, or fast heartbeat, as these may be signs of blood clots in the veins (which can 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
Low white blood cells, red blood cells and platelets
Feeling tired
Loss of appetite
Inflammation of the mouth and lips (stomatitis), nausea, vomiting, diarrhea
Rash
Hair loss
Weakness
Fever
Abnormal liver function tests
Dry skin

Common side effects (may affect up to 1 in 10 people):
Fever with a decrease in the number of white blood cells (febrile neutropenia)
Blurred vision, increased tearing, dry eye
Altered taste (dysgeusia)
Nosebleeds
Redness, pain, scaling, swelling and rash with blisters on the palm of the hands and/or soles of the feet (palmar-plantar erythrodysesthesia [ Palmar Plantar

Erythrodysaesthesia Syndrome,PPES])
Abnormal kidney values in blood tests (high creatinine level in the blood)

Uncommon side effects (may affect up to 1 in 100 people):
Inflammation of the skin causing scaly red patches and which may occur together with joint pain and fever (cutaneous lupus erythematosus [CLE]).
Skin reaction causing the appearance of spots or red patches on the skin, which may look like a “target” or be “iris-like”, with a dark red core surrounded by light red rings (erythema multiforme).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 bottle or blister and on the
pack 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 packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What IBRANCE contains

• The active ingredient is palbociclib. IBRANCE hard capsules are available in several dosages:
• 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 contents: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate type A, anhydrous colloidal silicon dioxide, magnesium stearate. Capsule shell: gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

Printing ink: shellac, titanium dioxide (E171), ammonium hydroxide (solution at
28%), propylene glycol, simethicone (see paragraph 2 “IBRANCE contains lactose and sodium”).

Description of the appearance of IBRANCE and package contents

• IBRANCE 75 mg is supplied in the form of opaque hard capsules, with a light orange body (marked with the inscription “PBC 75” in white) and a light orange cap (with the inscription “Pfizer” in white).
• IBRANCE 100 mg is supplied in the form of opaque hard capsules, with a light orange body (marked with the inscription “PBC 100” in white) and a caramel-colored cap (with the inscription “Pfizer” in white).
• IBRANCE 125 mg is supplied in the form of opaque hard capsules, with a caramel-colored body (marked with the inscription “PBC 125” in white) and a caramel-colored cap (with the inscription “Pfizer” 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
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: +36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τ  λ: +30 210 6785800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

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

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Kύπρος
Pfizer Ελλάς A.E. (Cyprus Branch)
Tηλ: +357 22817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775
More detailed information on this medicine is available on the European Medicines Agency website, https://www.ema.europa.eu.

IBRANCE 75 mg film-coated tablets, 100 mg film-coated tablets, 125 mg film-coated tablets

palbociclib

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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

1. What is IBRANCE and what is it used for

IBRANCE is an anti-cancer 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. Blocking these proteins may slow the growth of cancer cells and delay tumor progression.
IBRANCE is used to treat patients with certain types of breast cancer (hormone receptor positive, human epidermal growth factor receptor 2 negative) that have spread
beyond the original tumor and/or to other organs. It is administered together with aromatase inhibitors or
fulvestrant, which are used as hormonal anti-cancer therapies.

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);
• the use of St John's wort (hypericum), a herbal remedy 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 can reduce the number of white blood cells and weaken the immune system. Therefore, you may
be at an increased risk of contracting an infection while taking IBRANCE.
Tell your doctor, pharmacist or nurse if you develop signs or symptoms of an infection, such as
chills or fever.
You will have regular blood tests during treatment to check for any effects
of IBRANCE on your blood cells (white blood cells, red blood cells and platelets).
IBRANCE can cause blood clots to form in the veins. Tell your doctor, pharmacist
or nurse if you develop 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
feeling lightheaded.
IBRANCE can cause severe or potentially life-threatening inflammation of the lungs during
treatment, leading to a risk of death. Immediately inform your healthcare provider if
you experience the onset or worsening of symptoms, including:

• difficulty breathing or shortness of breath
• dry cough
• chest pain

Children and adolescents
IBRANCE must not be used in children and 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 the way some other
medicines work.
In particular, the following medicines may increase the risk of side effects when taken
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.

The following medicines may have an increased risk of side effects when
given with IBRANCE:

• Quinidine generally used to treat heart rhythm problems.
• Colchicine used to treat gout.
• Pravastatin, simvastatin, atorvastatin, fluvastatin and rosuvastatin used to treat high cholesterol levels.
• Sulfasalazine used to treat rheumatoid arthritis.
• Alfentanil used for anesthesia during surgery; fentanyl used before surgery as both an analgesic and an anesthetic.
• Cyclosporine, everolimus, tacrolimus and sirolimus used in organ transplantation to prevent rejection.
• Dihydroergotamine and ergotamine used to treat migraine.
• Pimozide used for the treatment of schizophrenia and chronic psychosis.

The following medicines may reduce the effectiveness of IBRANCE:

• Carbamazepine and phenytoin used to block epileptic seizures.
• Enzalutamide used for the treatment of prostate cancer.
• Rifampicin used in the treatment of tuberculosis (TB).
• St John's wort, a herbal remedy used to treat mild depression and anxiety.

IBRANCE with food and drink
IBRANCE tablets can be taken with or without food.
Grapefruit and grapefruit juice should be avoided during treatment with
IBRANCE as it may increase the side effects of IBRANCE.

Pregnancy, breastfeeding and fertility
Do not take IBRANCE if you are pregnant.
You should avoid becoming pregnant during treatment with IBRANCE.
Ask your doctor for advice on contraception if you or your partner has the
potential to become pregnant.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Women of childbearing potential, or their male partners, should
use appropriate contraceptive methods (e.g., double barrier contraception such as a condom
together with a diaphragm). These methods should be used during therapy and for at least 3 weeks
after completion of therapy for women, and for at least 14 weeks for men.
Breastfeeding
Do not breastfeed during treatment with IBRANCE. It is not known whether IBRANCE is excreted
in breast milk.
Fertility
Palbociclib may reduce fertility in men.
Therefore, men may consider sperm banking before
taking IBRANCE.

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

3. How to take IBRANCE

Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose of IBRANCE is 125 mg once a day for 3 weeks followed by
1 week off treatment with IBRANCE. Your doctor will tell you how many IBRANCE tablets you
should take.
If some side effects occur while taking IBRANCE (see section 4 “Possible side effects”), your
doctor may reduce the dose or stop treatment, temporarily or permanently. The dose may be reduced
to one of the other available strengths of 100 mg or 75 mg.
Take IBRANCE once a day at approximately the same time each day with or without food.
Swallow the tablet whole with a glass of water. Do not chew or crush the tablets. Do not
split the tablets before swallowing them. Do not take any tablet that is broken,
damaged or otherwise not intact.

If you take more IBRANCE than you should
If you have taken too much IBRANCE, consult a doctor or go to hospital immediately. Urgent
treatment may be necessary.
what you have taken.

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 missed tablets.

If you stop taking IBRANCE
Do not stop treatment with IBRANCE unless your doctor tells you to.
If you have any questions about using 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 immediatelyif you have any of these symptoms:

• fever, chills, weakness, shortness of breath, bleeding, or easy bruising, which may be a sign of a serious blood problem.
• difficulty breathing, dry cough, or chest pain, which could be a sign of lung inflammation.
• swollen and painful leg, chest pain, shortness of breath, rapid breathing or fast heartbeat, as these may be signs of blood clots in the veins (which can 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
Low white blood cells, red blood cells and platelets
Feeling tired
Loss of appetite
Mouth and lip inflammation (stomatitis), nausea, vomiting, diarrhoea
Rash
Hair loss
Weakness
Fever
Abnormal liver function tests
Dry skin

Common side effects (may affect up to 1 in 10 people):
Fever with low white blood cell count (febrile neutropenia)
Blurred vision, increased tearing, dry eye
Altered taste (dysgeusia)
Nosebleeds
Redness, pain, peeling, swelling and blistering rash on the palm of the hands and/or soles of the feet (palmar plantar erythrodysesthesia [ Palmar Plantar

Erythrodysaesthesia Syndrome,PPES])
Abnormal kidney values in blood tests (elevated creatinine level in the blood)

Uncommon side effects (may affect up to 1 in 100 people):
Skin inflammation that causes scaly red patches and may occur with joint pain and fever (cutaneous lupus erythematosus [CLE]).
Skin reaction causing red spots or patches on the skin, which may look like a “target” or be “iris-like”, with a dark red central area surrounded by lighter red rings (erythema multiforme).

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 through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 the carton after
“EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original blister to protect the medicine from moisture.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What IBRANCE contains

• The active ingredient is palbociclib. IBRANCE film-coated tablets are available in different dosages:
• 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, succinic acid. Film coating: hypromellose (E464), titanium dioxide (E171), triacetin, indigo carmine aluminium lake (E132), iron oxide red (E172) (only 75 mg and 125 mg tablets), iron oxide yellow (E172) (only 100 mg tablets).

Description of the appearance of IBRANCE and package contents

• IBRANCE 75 mg tablets are supplied as round, film-coated tablets, light purple in colour, with the inscription “Pfizer” on one side and “PBC 75” on the other side.
• IBRANCE 100 mg tablets are supplied as oval, film-coated tablets, green in colour, with the inscription “Pfizer” on one side and “PBC 100” on the other side.
• IBRANCE 125 mg tablets are supplied as oval, film-coated tablets, light purple in colour, with the inscription “Pfizer” on one side and “PBC 125” on the other side.

IBRANCE 75 mg, 100 mg and 125 mg is available in blisters of 21 tablets or 63 tablets in a
box.
IBRANCE 75 mg, 100 mg and 125 mg is available in blisters of 7 tablets (1 tablet per cavity)
in a booklet pack. Each box contains 21 tablets (3 booklet packs per box).
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
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
For further information on this medicinal product, please contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: +36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

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

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Kύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Tηλ: +357 22817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu.