Consumer Medicine Information
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DBL™ Docetaxel Concentrated Injection docetaxel Consumer Medicine Information What is in this leaflet It works by stopping cells from • wheezing or difficulty breathing growing and multiplying. or a tight feeling in your chest This leaflet answers some common Ask your doctor if you have any • swelling of the face, lips, tongue questions about DBL Docetaxel, questions about why this medicine or other parts of the body Concentrated Injection. has been prescribed for you. • rash, itching, hives or flushed, red It does not contain all the available Your doctor may have prescribed it skin information. It does not take the for another reason. • dizziness or light-headedness place of talking to your doctor or This medicine is not addictive. • back pain pharmacist. This medicine is available only with Do not use DBL Docetaxel, All medicines have risks and a doctor’s prescription. benefits. Your doctor has weighed Concentrated Injection if you have, You may have taken another the risks of you taking DBL or have had, any of the following Docetaxel, Concentrated Injection medicine to treat your breast, non medical conditions: small cell lung cancer, ovarian, against the benefits they expect it • severe liver problems prostate or head and neck cancer. will have for you. • blood disorder with a reduced However, your doctor has now number of white blood cells If you have any concerns about decided to treat you with docetaxel. taking this medicine, ask your There is not enough information to Do not use this medicine if you are doctor or pharmacist. recommend the use of this medicine pregnant or intend to become Keep this leaflet with the medicine. for children. pregnant either during treatment You may need to read it again. or in the three months following the last dose of docetaxel. Like most medicines used to treat Before you are given cancer, docetaxel is not What DBL Docetaxel, DBL Docetaxel, recommended for use during Concentrated Concentrated pregnancy, unless you and your Injection is used for Injection doctor have discussed the risks and benefits involved. Docetaxel is used to treat: When you must not be given Do not breast-feed if you are using this medicine. • breast cancer it • non small cell lung cancer It is not known if docetaxel passes Do not use DBL Docetaxel, into breast milk and there is a • ovarian cancer Concentrated Injection if you have possibility that your baby may be • prostate cancer an allergy to: affected. • any medicine containing • head and neck cancer If you are not sure whether you docetaxel or polysorbate 80 This medicine belongs to a group of should start using this medicine, medicines called antineoplastic or • any of the ingredients listed at the talk to your doctor. cytotoxic medicines. You may also end of this leaflet. hear of these being called Some of the symptoms of an allergic Before you are given it chemotherapy medicines. reaction may include: Tell your doctor if you have • shortness of breath allergies to any other medicines, foods, preservatives or dyes. DBL™ DOCETAXEL CONCENTRATED INJECTION 1 Docetaxel is not recommended for erythromycin, clarithromycin and • prescribe you an oral use in children. telithromycin. corticosteroid (eg Safety and effectiveness in children • Ketoconazole, itraconazole and dexamethasone) to help stop or have not been established. voriconazole, medicines used to reduce the severity of certain side treat fungal infections effects. For breast, lung, ovarian Tell your doctor if you have or and head and neck cancer, this • nifedipine, a medicine used to have had any of the following medicine is usually taken for treat high blood pressure and medical conditions: three days (one day before, the angina • blood disorder with a reduced day of and the day after your • some medicines called number of white blood cells infusion). These medicines are corticosteroids, such as very important. For prostate • hearing problems dexamethasone cancer, this is usually taken on • heart problems • medicines used to treat people the day of the infusion (12 hours, • high uric acid levels with epilepsy, such as 3 hours and 1 hour before your infusion). • kidney problems phenobarbitone • • test your blood to see how many • liver problems medicines used to treat or prevent HIV or Hepatitis C viral white blood cells you have. If infections, such as ritonavir, they are too low, your infusion Tell your doctor if you have an indinavir, nelfinavir and may be delayed. infection or high temperature. saquinavir. • test your blood for levels of liver Your doctor may decide to delay • medicines used to treat people enzymes. If these levels are high your treatment until the infection has with depression such as your doctor may reduce your dose gone. A mild illness, such as a cold, nefazodone or decide you should not have a docetaxel infusion at that time. is not usually a reason to delay These medicines may be affected by treatment. DBL Docetaxel, Concentrated Ask your doctor or pharmacist if Tell your doctor if you are Injection or may affect how well it you have any questions on these pregnant or plan to become works. You may need different medicines or tests. pregnant or are breast-feeding. amounts of your medicines, or you How much is given Your doctor can discuss with you the may need to take different medicines. risks and benefits involved. Your doctor and pharmacist have Your doctor will decide what dose more information on medicines to be you will receive. This depends on If you have not told your doctor your condition and other factors, careful with or avoid while taking about any of the above, tell such as your weight, kidney function this medicine. him/her before you start using and other chemotherapy medicines DBL Docetaxel, Concentrated you are being given. Injection. The usual dose of docetaxel is 75 to 100mg/m2 which is based on your Taking other medicines How DBL Docetaxel, 2 Concentrated body size (m ). Tell your doctor or pharmacist if you are taking any other Injection is given When docetaxel is given in medicines, including any that you combination with capecitabine Follow all directions given to you (another medicine used for the get without a prescription from by your doctor or pharmacist treatment of breast cancer) the usual your pharmacy, supermarket or carefully. dose of docetaxel is 75 mg/m2. health food shop. They may differ from the Some medicines and DBL Docetaxel, Docetaxel may be given alone or in information contained in this leaflet. Concentrated Injection may interfere combination with other drugs. with each other. These include: Docetaxel should only be administered by trained Several courses of docetaxel therapy • other medicines used to treat may be needed depending on your professionals, with appropriate cancer, radiation therapy or any response to treatment. handling, in a hospital or clinic other treatment which lowers environment. your immune system, including Additional treatment may not be repeated until your blood cell ciclosporin Before you are given your docetaxel infusion your doctor numbers return to acceptable levels • some medicines used to treat and any uncontrolled effects have should: bacterial infections, including been controlled. DBL™ DOCETAXEL CONCENTRATED INJECTION 2 check on your progress and detect be life threatening. In most cases, Ask your doctor if you want to know any unwanted side effects. fluid retention will go away within more about the dose of docetaxel you weeks or months after your receive. Tell any other doctors, dentists, treatments are completed. and pharmacists who treat you How it is given that you are taking this medicine. Things you must not do If you are about to be started on Do not use DBL Docetaxel, DBL Docetaxel, Concentrated any new medicine, tell your doctor, Concentrated Injection to treat any Injection is given as an infusion dentist or pharmacist that you are other complaints unless your (drip) into your veins, over 1 hour. having DBL Docetaxel, doctor tells you to. Concentrated Injection. How long it is given for If you plan to have surgery that Things to be careful of Docetaxel is given every 3 weeks. needs a general anaesthetic, tell Be careful driving or operating your doctor or dentist that you are machinery until you know how This is called one cycle of having docetaxel. DBL Docetaxel, Concentrated chemotherapy. Your doctor will Injection affects you. decide how many of these cycles you If you become pregnant while will need. having docetaxel, tell your doctor Docetaxel may cause dizziness, light- immediately. headedness, tiredness, drowsiness in If you are given too much some people. Make sure you know DBL Docetaxel, Concentrated how you react to docetaxel before (overdose) Injection can lower the number of you drive a car, operate machinery, white blood cells and platelets in As DBL Docetaxel, Concentrated or do anything else that could be Injection is given to you under the your blood. This means that you dangerous if you are dizzy or light- supervision of your doctor, it is have an increased chance of getting very unlikely that you will receive an infection or bleeding. headed. If this occurs do not drive. too much. However, if you If you drink alcohol, dizziness or experience any severe side effects The following precautions should light-headedness may be worse. after being given DBL Docetaxel, be taken to reduce your risk of Concentrated Injection, tell your infection or bleeding: doctor immediately or contact the • Avoid people who have National Poisons Centre (telephone infections. Check with your 0800 POISON or 0800 doctor immediately if you think Side effects 764 766) or go to Accident and you may be getting an infection, Emergency at the nearest hospital. or if you get a fever, chills, Tell your doctor or pharmacist as cough, hoarse throat, lower soon as possible if you do not feel back or side pain or find it You may need urgent medical well while you are taking DBL painful or difficult to urinate.