What you need to know before you take Ibract

Do not take Ibract:

• 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 Ibract.

 

 Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ibract.

Ibract 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 Ibract.

 

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 Ibract affects your blood cells (white blood cells, red blood cells, and platelets).

Ibract 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

Ibract is not to be used in children or adolescents (under 18 years of age).

 

Other medicines and Ibract

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ibract may affect the way some other medicines work.

 

In particular, the following may increase the risk of side effects with Ibract:

• 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 Ibract:

• 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 Ibract:

• Carbamazepine and phenytoin, used to stop seizures or fits.
• Enzalutamide to treat prostate cancer.
• Rifampin used to treat tuberculosis (TB).
• St. John’s Wort, a herbal product used to treat mild depression and anxiety.

 

Ibract with food and drink

Avoid grapefruit and grapefruit juice while you are taking Ibract as it may increase the side effects of Ibract.

 

Pregnancy, breast-feeding and fertility

You should not use Ibract if you are pregnant.

You should avoid becoming pregnant while taking Ibract.

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 males with reproductive potentials have to use contraception during the treatment and 3 months (12 weeks) after the last dose.

 

Breast-feeding

You should not breast-feed while taking Ibract. It is not known if Ibract is excreted in breast milk.

 

Fertility

Ibract may decrease fertility in men.

Therefore, men may consider sperm preservation before taking Ibract.

 

Driving and using machines

Tiredness is a very common side effect of Ibract. If you feel unusually tired, take special care when driving or using machines.

 

Ibract 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’.