Cyclocord 500 mg/1 g Solution

CYCLOCORD contains the active substance cyclophosphamide. Cyclophosphamide is a cytotoxic medicine or anti-cancer medicine. It works by killing cancer cells, this is sometimes called ‘chemotherapy’. Your doctor has prescribed CYCLOCORD alone or in combination with other medicines to treat the following:

• certain types of cancer of the white blood cells (acute lymphocytic leukaemia, chronic lymphocytic leukaemia)
• different forms of lymphomas that affect the immune system (Hodgkin’s disease, non-Hodgkin’s lymphoma and multiple myeloma)
• ovarian cancer and breast cancer
• small cell lung cancer
• in the treatment of advanced or metastatic tumour of the central nervous system (neuroblastoma)

CYCLOCORD may be used in preparation for bone marrow transplantation to treat certain types of cancer of the white blood cells (acute lymphoblastic leukaemia, chronic myeloid leukaemia and acute myeloid leukaemia). Occasionally, doctors may prescribe CYCLOCORD for other conditions not related to cancer:

• Life threatening autoimmune diseases: severe progressive forms of lupus nephritis (inflammation of the kidney caused by a disease of the immune system) and Wegener’s granulomatosis (a rare form of vasculitis).

CYCLOCORD should not be given to you:

• if you are allergic to cyclophosphamide or to any of the other ingredients listed in section 6.1
• if you currently have any infection
• if you have severe bone marrow disorder (in particular after chemotherapy or radiation therapy). You will have blood tests to check how well your bone marrow is working
• if you have urinary tract infection, which can be recognised as pain when passing urine (cystitis)
• if you have ever had kidney or bladder problems as a result of previous chemotherapy or radiotherapy
• if you have a condition which decreases your ability to urinate (urinary outflow obstruction)
• if you are pregnant (first trimester pregnancy)
• if you are breast-feeding
• if you have other conditions not related to cancer, except life limiting immune disorders

Warnings and precautions

Tell your doctor or health care provider before being given CYCLOCORD if you have:

• low blood cell counts
• severe infections
• liver or kidney problems. Your doctor will check how well your liver and kidneys are working by doing a blood test
• had your adrenal glands removed
• or already having, or have recently had, radiotherapy or chemotherapy
• heart problems or have had radiotherapy in the area of your heart
• diabetes
• poor general health or are frail
• are elderly
• had surgery less than 10 days ago

You will not be expected to give yourself CYCLOCORD. It will be given to you by a person who is qualified to do so. The medicine is usually administered in a vein. Duration of administration is typically from 30 minutes to 2 hours, which depends on the volume to be administered. CYCLOCORD is often given in combination with other anti-cancer medicines or radiotherapy. Your doctor will decide how much of the medicine you need and when you should be given it. Duration of treatment and/or treatment intervals depend on the indications for use, the regimen of a combination therapy, your general state of health, results of laboratory monitoring and blood cell recovery. It is advisable to get your treatment administered in the morning. Before, during and after the administration, it is important that you get adequate amounts of fluid, to avoid potential adverse effects on the urinary tract.

If you receive more CYCLOCORD than you should Since a health care provider will administer CYCLOCORD, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive CYCLOCORD Since a health care provider will administer CYCLOCORD, it is unlikely that the dose will be missed.

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

• Allergic reactions. Signs of these would be shortness of breath, wheezing, increased heart rate, decreased blood pressure (extreme tiredness), rash, itching or swelling of the face and lips. Severe allergic reactions could lead to difficulty in breathing or shock, with a possible fatal outcome (anaphylactic shock, anaphylactic/ anaphylactoid reaction).
• Getting bruises without knocking yourself, or bleeding from your gums. This may be a sign that the platelet levels in your blood are getting too low.
• Severe infection or fever, ulcers in the mouth, coughing, breathlessness, signs of sepsis like fever, rapid breathing, elevated heart rate, confusion and edema. This may be a sign of a lowering of your white blood cell count and antibiotics may be needed to fight infections, breakdown of red blood cells, decreased number of platelets and kidney failure (Haemolytic uremic syndrome).
• Severe hypersensitivity reactions with (high) fever, red spots on the skin, joint pain and/or eye infection (Stevens-Johnson syndrome), severe sudden (hypersensitive) reaction with fever and blisters on the skin/peeling of the skin (toxic epidermal necrolysis).
• Severe pain in the chest.

These are all very serious side effects. If you have them, you may have had a serious reaction to CYCLOCORD. 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:

• Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis).
• Different kind of blood disorders (Agranulocytosis).
• Being very pale, feeling fatigued and tired. This may be a sign of low red blood cells (anaemia). Usually, no treatment is required, your body will eventually replace the red blood cells. If you are very anaemic, you may need a blood transfusion.
• Having blood in your urine, pain while passing urine, or passing less urine.
• Symptoms like weakness, vision loss, impaired speech, loss of sense of touch.

• Store in a refrigerator (2 °C – 8 ºC).

• After opening the product should be used immediately.

• Chemical and physical in-use stability of the reconstituted solution (concentration 20 mg/ml) & diluted solution (concentration 2 mg/ml) has been demonstrated for 48 hours at 2 °C – 8 °C.

• For single use only. Discard any unused product.

• Store all medicines out of reach of children.

• Store in original package until use.

• Do not use after the expiry date stated on the label.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).