CRYPTARIO 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.
CRYPTARIO 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 CRYPTARIO
- 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, a herbal product used to treat mild
depression and anxiety, should be avoided while you are taking CRYPTARIO.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking CRYPTARIO .
CRYPTARIO 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
CRYPTARIO.
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 CRYPTARIO affects
your blood cells )white blood cells, red blood cells, and platelets(.
CRYPTARIO 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
CRYPTARIO is not to be used in children or adolescents )under 18 years of age(.
Other medicines and CRYPTARIO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines. CRYPTARIO may affect the way some other medicines work.
In particular, the following may increase the risk of side effects with CRYPTARIO:
• 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
CRYPTARIO :
• 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 CRYPTARIO :
• 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.
CRYPTARIO with food and drink
CRYPTARIO tablets may be taken with or without food.
Avoid grapefruit and grapefruit juice while you are taking CRYPTARIO as it may increase
the side effects of CRYPTARIO.
Pregnancy and breast-feeding and fertility
You should not use CRYPTARIO if you are pregnant.
You should avoid becoming pregnant while taking CRYPTARIO .
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 CRYPTARIO . It is not known if CRYPTARIO is
excreted in breast milk.
Fertility
Palbociclib may decrease fertility in men.
Therefore, men may consider sperm preservation before taking CRYPTARIO.
Driving and using machines
Tiredness is a very common side effect of CRYPTARIO. If you feel unusually tired, take
special care when driving or using machines.
 

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 CRYPTARIO taken once a day for 3 weeks followed
by 1 week without taking CRYPTARIO . Your doctor will tell you how many tablets of
CRYPTARIO to take.
If you experience certain side effects while you are taking CRYPTARIO )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 CRYPTARIO once a day at about the same time every 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 prior to swallowing. No tablet should be ingested if it is broken, cracked,
or otherwise not intact.
If you take more CRYPTARIO than you should
If you have taken too much CRYPTARIO , 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 CRYPTARIO
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 tablets.
If you stop taking CRYPTARIO
Do not stop taking CRYPTARIO 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.
Other side effects with CRYPTARIO 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
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[(.
 

• 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 carton
after “EXP”.
• The expiry date refers to the last day of that month.
• Store below 30 ºC.
• Store in the original blister package in order to protect from moisture.
• 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.