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How does it work? This medicine contains the active ingredient temozolomide, which is an anticancer (chemotherapy or cytotoxic) medicine. Cancers form when some cells within the body multiply uncontrollably and abnormally. There are two types of cancer. Solid cancers where a lump forms, eg the bone, muscle, brain cells etc divide and multiply abnormally. The second type are leukaemias and lymphomas where the blood cells divide and multiply abnormally. Other characteristics of cancer besides uncontrolled growth include the ability of these abnormal cells to invade other tissues next to them or to break away from the original site, travel through the blood or lymph, and establish a new cancer at a different site of the body. These are called metastases. Like normal healthy cells, cancer cells go through a continuous process of change. Each cell divides into two daughter cells. These cells grow, rest and then divide again. The medicines used in chemotherapy are powerful chemicals designed to interupt this cycle and stop cells from growing. Several different types of anticancer medicines are used in chemotherapy. Each type kills cells at a different stage of the cell's life cycle. Each does its job in a different way. Temozolomide is a type of cytotoxic medicine known as an alkylating agent. This means it works by binding the genetic material (DNA) of the cancer cells together. This prevents the cells from growing and they therefore die. Unfortunately, anticancer medicines will also affect the growth and division of normal, healthy cells in the same way. The cells most often affecting are rapidly dividing cells such as blood, gut and hair cells. This can therefore cause several of the side effects seen with chemotherapy, eg hair loss. The body's immune system also becomes suppressed increasing the risk of infections. In most chemotherapy regimens, doses are administered in courses with intervals between to allow normal cells to recover from the adverse effects of the anticancer medicines between doses. However, during this period, cancer cells will also recover and start to replicate again. Successful treatment depends on the administration of the next course of therapy before the cancer has regrown to its previous size and the net effect is to decrease the amount of cancer with each successive course. Temozolomide is taken by mouth. What is it used for? Treatment of certain types of brain tumours (glioblastoma multiforme, anaplastic astrocytoma) which have recurred or have progressed after standard treatment.

Side effects Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. Headache Rash Itching (pruritus) Fatigue Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain Weight loss Indigestion (dyspepsia) Hair loss (alopecia) Fever (pyrexia) Pins and needles (paraesthesia) Dizziness Alteration in taste Loss of appetite Difficulty in breathing (dyspnoea) Sleepiness (somnolence) Decrease in the number of a type of white blood cell (neutrophil) in the blood (neutropenia) Weakness or loss of strength (asthenia) Decrease in the number of platelets in the blood (thrombocytopenia) A general feeling of being unwell (malaise) The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist. How can this medicine affect other medicines? Sodium valproate (valproic acid) may increase the blood level of this medicine. If this medicine is taken with other medicines that can decrease the production of blood cells by the bone marrow there may be an increased risk of this side effect. Warning! This medicine may be harmful to an unborn baby. Women of child-bearing age should use a reliable contraceptive method to prevent pregnancy while using this medicine. The manufacturer of this medicine states that they have no clinical experience with this medicine in children under three years of age, and experience in older children is very limited. Men should be aware that this medicine may cause damage to sperm that could result in infertility. You should talk to your doctor about this before starting treatment, and discuss the option of storing sperm samples before treatment for use at a later date. During treatment, and for six months following treatment, you should use effective contraception to avoid fathering a child. This medicine may cause fatigue and sleepiness, which may affect your ability to perform potentially hazardous tasks. If affected you should avoid driving or operating machinary. Do not open the capsules. If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose. Avoid inhaling the powder. If you accidentally get some in your eyes or nose, rinse the area with water. You should have regular blood tests during treatment with this medicine so that the composition of your blood can be monitored. Your doctor may need to change the dose of your medicine depending on the results of your blood tests. This medicine should be taken on an empty stomach, as the presence of food in the stomach makes the medicine less effective. If you vomit after taking a dose of this medicine you should not take a second dose the same day. If this medicine makes you vomit frequently you should talk to your doctor about taking medicines that can control this. Use with caution in Elderly people People with other severely debilitating diseases or infection Severely decreased kidney function Severely decreased liver function Not to be used in Allergy to the medicine dacarbazine (DTIC) Breastfeeding Pregnancy Severe myelosuppression (reduction in blood cell production in the bone marrow) This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Pregnancy and Breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. This medicine should not be used during pregnancy as it may be harmful to the unborn baby. Women of child bearing potential should use adequate contraception to prevent pregnancy while taking this medicine. Seek medical advice from your doctor. It is not known whether this medicine passes into breast milk. It should not be used by breastfeeding women because of the potential harm it may cause to nursing infants. Seek medical advice from your doctor. Label warnings Take this medication half to one hour before food. This medication is to be swallowed whole, not chewed.

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