PATIENT INFORMATION LEAFLET Cyclophosphamide 50 mg Tablets Cyclophosphamide monohydrate Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Cyclophosphamide is and what it is used for 2. Before you are given Cyclophosphamide 3. How you will be given Cyclophosphamide 4. Possible side effects 5 How to store Cyclophosphamide 6. Further information 1. What Cyclophosphamide is and what it is used for Cyclophosphamide is used to treat a wide range of tumours. It belongs to a group of medicines called cytotoxics which are used to kill cells in tumours. Cyclophosphamide can be given alone or in combination with other medicines. Your doctor will be able to explain how Cyclophosphamide might help in your particular condition. 2. Before you are given Cyclophosphamide Do not take Cyclophosphamide if you: are allergic (hypersensitive) to Cyclophosphamide or any of the other ingredients of this medicine. have severe kidney disease, i.e inflammation of the bladder. Take special care with Cyclophosphamide: If you have: lowering of the levels of blood cells severe infections any kidney or liver disease received or are receiving radiotherapy received in the past any anti-tumour drugs or x-rays any other illnesses. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Cyclophosphamide, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Page 1 of 5
Additional signs to look for include ulcers in the mouth, throat, nose and genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Cyclophosphamide you must not be re-started on Cyclophosphamide at any time, ie. You must not take Cyclophosphamide in the future. If you develop a rash or these skin symptoms, stop taking Cyclophosphamide, seek immediate advice from a doctor and tell him that you are taking this medicine. Taking other medicines: Please tell your doctor or pharmacist if you are taking: any sulphonylurea-type hypoglycaemics (used to treat diabetes) doxorubicin (another cytotoxic drug used to kill tumours) allopurinol (used to treat painful joint swelling and reduce levels of uric acid) suxamethonium (a muscle relaxant used in surgery). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Cyclophosphamide with food & drink Cyclophosphamide should be taken on an empty stomach. If you suffer from severe stomach irritation, you may take Cyclophosphamide with a meal. Pregnancy and Breast-feeding If you are pregnant or planning to become pregnant it is important to tell your doctor this before you are given Cyclophosphamide. You should not breast-feed while taking Cyclophosphamide. Driving and using machinery There are no special precautions, and you can drive or operate machinery as long as you feel fully recovered following your treatment. Important information about some of the ingredients of Cyclophosphamide Cyclophosphamide contains lactose and sucrose, these are types of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How you will be given Cyclophosphamide Page 2 of 5
Always take Cyclophosphamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will advise you of how much and how often you will need to take your medicine. Your dosage is calculated from the ratio of your weight and total body surface area (in square metres); this is necessary because the dose is usually calculated as milligrams per square metre (mg/m 2 ) your medicine must be taken under the supervision of specialists Much higher doses may be used if the specialist thinks it is necessary. your medicine is to be swallowed whole; preferably on an empty stomach but if you suffer from severe stomach irritation, then you may take Cyclophosphamide with a meal you should be given Cyclophosphamide early in the day you should drink plenty of fluids Your doctor may also give you another drug called Mesna (Uromitexan) to try to prevent some of the side effects of treatment with Cyclophosphamide. 4. Possible side effects Like all medicines, Cyclophosphamide can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience: An allergic reaction such as sudden wheeziness, difficulty in breathing, increased heart rate, decreased blood pressure or swelling to the face. Cyclophosphamide can also cause the following side-effects: Effects on your blood cells: Platelets (these are cells that help the blood to clot) can be affected which could make you bruise or bleed more easily. It is important to seek medical advice if this happens. Thromoboembolism (blood clots usually in the leg, which causes pain, swelling or redness). Anaemia (a low red blood cell count) that can leave you feeling tired and drowsy. White blood cell counts (which fight infections) can also drop which might increase the chance of infections. Effects on your kidneys, bladder and liver: Burning sensations during urination and frequent need to urinate (cystitis). Appearance of blood in the urine (haematuria). Blood tests will be done by your doctor to monitor any abnormal effects. Effects on your heart and circulation: Alterations in blood sugar levels, heart damage. Effects on your respiratory system: Thickening of the lining of the lungs will lead to shortness of breath. Effects on your hair and skin: Hair loss, flushing and colouration of skin. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2) very rarely. Page 3 of 5
Effects on your mouth, stomach and intestines: Sore mouth, feeling sick (nausea), being sick (vomiting), ulcers and loss of appetite (anorexia). Effects on your nervous system: Headaches. Effects on your endocrine system: Inflammation of the pancreas. Effect on your reproductive system: Lack of menstruation (periods) in females and infertility in men. Both of which are reversible in most cases. It may leave children permanently sterile. Other effects: There is an increased risk of cancer of the white blood cells and some other cancers and tumours following Cyclophosphamide therapy. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Cyclophosphamide Keep out of the reach and sight of children. Cyclophosphamide should not be used after the expiry date stated on the carton and on the container. The expiry date refers to the last day of the month. Do not store above 25 C Store in the original container in order to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further Information What Cyclophosphamide contains The active ingredient is Cyclophosphamide monohydrate 50 mg The other ingredients are: maize starch, pregelatinised starch, lactose, gelatin, microcrystalline cellulose, sodium stearyl fumarate, magnesium stearate, Coating: polyethylene glycol, sucrose, maize starch, calcium carbonate, povidone, opalux AS-9486 (sucrose, titanium dioxide, purified water, red iron oxide, yellow iron oxide, polyvinylpyrrolidone, sodium benzoate (E211)) and carnauba wax. What Cyclophosphamide looks like and contents of the pack Cyclophosphamide 50 mg tablets are sugar coated and brown in colour. They are presented in a white plastic container. Cyclophosphamide is available in pack size of 100 tablets. Marketing Authorisation Holder: Pharmacia Ltd Ramsgate Road Sandwich, Kent Page 4 of 5
CT13 9NJ Manufacturer: Orion Corporation PO Box 425, FIN 20101, Turku, Finland This leaflet was revised in 03/2012 Ref: CP7_4 Page 5 of 5