Palbociclib Cipla 75 mg/100 mg/125 mg Capsules

PALBOCICLIB CIPLA 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 delays the progression of your cancer. PALBOCICLIB CIPLA is used to treat patients with certain types of breast cancer (hormone receptor [HR]-positive, human epidermal growth factor receptor [HERS] 2-negative) which have spread beyond the original tumour and/or to other organs. It is given together with letrozole as initial endocrine-based therapy in postmenopausal women or fulvestrant, which are used as hormonal anticancer therapies.

Do not take PALBOCICLIB CIPLA

• if you are hypersensitive (allergic) to palbociclib or any of the other ingredients of this medicine (listed in section 6).
• use of preparations containing St. John’s Wort should be avoided while you are taking PALBOCICLIB CIPLA.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking PALBOCICLIB CIPLA. PALBOCICLIB CIPLA 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 PALBOCICLIB CIPLA. Before you take PALBOCICLIB CIPLA Tell your healthcare provider if you:

• have fever, chills, or any other signs or symptoms of infection.
• have liver or kidney problems.
• have any other medical conditions.
• are pregnant, or plan to become pregnant. PALBOCICLIB CIPLA can harm your unborn baby.

You will have regular blood tests during treatment to check whether PALBOCICLIB CIPLA affects your blood cells (white blood cells, red blood cells, and platelets). PALBOCICLIB CIPLA 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

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

Other medicines and PALBOCICLIB CIPLA

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines) PALBOCICLIB CIPLA may affect the way some other medicines work. In particular, the following may increase the risk of side effects with PALBOCICLIB CIPLA:

• 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.

Do not share medicines prescribed for you with any other person. 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 usual dose is 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days. When co-administered with PALBOCICLIB CIPLA, the recommended dose of letrozole is 2,5 mg taken orally once daily continuously throughout the 28-day cycle. Please refer to the patient information leaflet of letrozole. When co-administered with PALBOCICLIB CIPLA, the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter. Please refer to the patient information leaflet of fulvestrant. Take PALBOCICLIB CIPLA once a day at about the same time every day with food, preferably a meal. Avoid grapefruit and grapefruit products during treatment with PALBOCICLIB CIPLA. Grapefruit may increase the amount of PALBOCICLIB CIPLA in your blood. Swallow the capsule whole with a glass of water. Do not chew or crush the capsules. Do not open the capsules.

PALBOCICLIB CIPLA can have side effects. Not all side effects reported for PALBOCICLIB CIPLA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PALBOCICLIB CIPLA, please consult your healthcare provider for advice. If any of the following happens, stop taking / using PALBOCICLIB CIPLA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to PALBOCICLIB CIPLA. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent side effects:

• Low red blood cell counts, and low platelet counts are common with PALBOCICLIB CIPLA
• weakness
• nosebleeds
• infections

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• Feeling of tiredness
• Decreased appetite
• Inflammation of the mouth and lips (stomatitis), nausea, vomiting, diarrhoea
• Rash
• Hair loss
• Fever
• Abnormalities in liver blood tests
• Dry skin
• Fever with a drop in the white blood cell count (febrile neutropenia)
• Blurred vision, increased tearing, dry eye
• Alteration in taste (dysgeusia)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your healthcare professional. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of PALBOCICLIB CIPLA.

Store all medicines out of reach of children. Store at or below 25 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).