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Composition : EPIRUBICIN-10MG/5ML
Description : FARMORUBICIN 10MG/5ML R.T.U.
Route Of Administration : PARENTERAL
Pack : 1
Drug Ingredient Information


Information for patients
Drug Information Epirubicin is used in the treatment of various types of cancer. It may be used alone or with other medicines. Ask your doctor if you have any questions about why Epirubicin has been prescribed for you. Your doctor may have prescribed it for another purpose. Epirubicin is only available with a doctor’s prescription. It is not addictive
Drug Alert
Alert no data available
Before Consuming the Medicine
Avoid Drug Do not use Epirubicin if you have ever had an allergic reaction to epirubicin, other medicines tot reat cancer or any of the ingredients listed in the contents. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. Do not use the medicine for injection into a vein if you have: • a low number of red blood cells, white blood cells or platelets in your blood • sore, red mouth from previous treatment or radiation therapy • an infection • severe liver problems • heart problems or have ever had heart problems • already received the highest dose allowed for medicines such as mitozantrone, mitomycin C, doxorubicin or daunorubicin Do not use the medicine for injection into the bladder if you have: • cancer that has gone into the bladder wall • kidney or urinary tract infection • swollen or inflamed bladder • problems with a catheter (a tube in your bladder) • blood in the urine Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
Drug Special Care You must tell your doctor if you: • have heart problems or have ever had heart problems • have liver problems • have kidney problems • have had radiation therapy previously or are having radiation therapy • have been treated previously with medicines to treat cancer • you are going to be vaccinated (have an injection to prevent a certain disease) • are planning to have children Epirubicin may decrease the fertility of men and women. If you have not told your doctor about any of the above, tell your doctor before you start using Epirubicin. Things you must do ? Tell your doctor or nurse immediately if the injection stings or hurts while it is being given. The injection may need to be stopped and injected into a different vein. ? Make sure you follow your doctor’s instructions and keep all appointments. Your doctor will regularly check the function of your heart, liver and kidneys. You will also need to have blood tests. ? Use contraception to prevent pregnancy while you or your partner are being treated with Epirubicin. Epirubicin may cause birth defects if either the male or female is being treated with Epirubicin. Both men and women being treated with Epirubicin and their partners must use a reliable method of contraception (birth control) during treatment with Epirubicin. Tell your doctor immediately if you become pregnant while taking Epirubicin. ? Tell your doctor if you have an infection or fever. Epirubicin lowers your ability to fight infection. ? Tell your doctor if you would like to take medicine to prevent or treat nausea (feeling sick) or vomiting. Epirubicin may cause nausea and vomiting, ? Tell any doctor, dentist or pharmacist who treats you that you are being treated with Epirubicin. ? If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being treated with Epirubicin.
Drug Drug Interactions Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines and Epirubicin may interfere with each other. Some of these medicines include: •5-fluorouracil • cyclophosphamide • cisplatin • paclitaxel • docetaxel • trastuzumab • other medicines to treat cancer • nifedipine • verapamil • diltiazem • felodipine • amlodipine • lercanidipine • propranolol • cimetidine You may need to take different amounts of your medicines or you may need to use different medicines. Your doctor will advise you.
Drug Pregnancy Interaction Do not use Epirubicin if you are pregnant. Epirubicin may harm the unborn child.
Drug Breast feeding Interaction Do not use Epirubicin if you are breastfeeding. You should not breastfeed while taking Epirubicin.
Drug Machinery Interaction Be careful driving, operating machinery or doing jobs that require you to be alert, until you know how Epirubicin affects you. It may make some people feel tired or dizzy.
Drug More Information no data available
How to take the Medicine
Consumption Info no data available
Drug quanitty Epirubicin may be given alone or in combination with other medicines. Your doctor will decide the dose of Epirubicin to be given. Treatment is usually given every 3 to 4 weeks, in cycles of therapy. However, your doctor may give Epirubicin more or less frequently. Treatment will not be repeated until your blood counts have returned to acceptable levels and any unwanted effects have been controlled. Your doctor may change your dose during treatment. Your doctor will let you know how many cycles of treatment you will need.
Drug Dose Treatment will normally take place in a hospital. Epirubicin is usually given as a slow injection or a drip (infusion) into a vein. It might also be injected into the bladder. Do not drink fluids for 12 hours before treatment if Epirubicin is to be used in the bladder. Ask your doctor if you have any questions about the dose of Epirubicin and how it is given.
Excess Drug Consumption As Epirubicin is likely to be given to you in hospital under the supervision of a doctor, it is unlikely that you will receive too much. However, immediately tell your doctor or telephone the Poisons Information Centre for advice, or go to Accident and Emergency at your nearest hospital if you have side effects after being given Epirubicin. You may need urgent medical attention. Symptoms of overdose with Epirubicin include the side effects but of a more severe nature.
Forgot Drug Consumption Contact Your doctor
Stop Drug Consumption Do not stop the drug untill your doctor says you to do so.
Possible Side Effects
General Information Tell your doctor as soon as possible if you do not feel well while you are being treated with Epirubicin. All medicines can have unwanted side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Medicines can affect people in different ways. Ask your doctor or pharmacist to answer any questions you may have. After using Epirubicin Tell your doctor immediately if you notice any of the following side effects, even if they occur several months or years after stopping treatment with Epirubicin: • heart problems, fast or irregular heart beat, shortness of breath • swelling of ankles, feet, legs or hands, swelling in the stomach • fever or other signs of infection .Leukaemia may occur after treatment with Epirubicin and other medicines to treat cancer. It is rare.
Common Drug Side Effects Tell your doctor or pharmacist if you notice any of the following and they worry you: • nausea (feeling sick) or vomiting • diarrhoea • sore mouth or tongue, mouth ulcers, redness of mouth, sore vagina or rectum • redness of the skin or vein at the site of the injection • hair loss, beard stops growing • dehydration (thirsty, dry mouth, dry skin, loss of body fluid) • sore oesophagus (food pipe) • stomach pain or burning feeling in stomach • skin rash, itchy skin, hives, sensitive skin, blisters • change in colour of skin or nails • increased sensitivity to the sun • itchy eye, crusty eyelid, sore red eye, blurred vision, conjunctivitis • loss of appetite • absence of menstrual bleeding (temporary loss of periods) • hot flushes • weakness, tiredness, dizziness, confusion, depression • tingling or numbness of hands or feet; pins and needles • gout • red colored urine Epirubicin is red and may cause the urine to be a red colour for one or days after treatment. There is no cause for alarm.
Rare Drug Side Effects Tell your doctor immediately if you get any of the following sideeffects: • stinging, swelling or pain at the site of injection • flushing of face while the injection is being given • an infection or chills, fever, sore throat, swollen glands, shock • heart problems, fast or irregular heart beat, shortness of breath • swelling of ankles, feet, legs or hands, • bleeding or bruising under the skin The above side effects may be serious. You may need urgent medical attention. Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above, such as leukaemia, may also occur in some patients. Do not be alarmed by this list ofpossible side effects.You may not experience any of them.
Very Rare Drug Side Effects no data available
Drug Side Effects Symptoms no data available
How to Store the Medicine
How to Store the Medicine This medicine will be stored in the hospital pharmacy and will be looked after by your doctor or pharmacist. Vials of Epirubicin Injection should be kept in a refrigerator (2ºC to 8ºC). Do not freeze. EPIRUBICIN solution should not be used after 24 hours following the removal from the refrigerator. Shelf life of the product as package for sale: 2 years Shelf life after first opening the container: The vials are for single use only and any unused portion must be discarded after use. From a microbiological point of view, the product should be used immediately after the first penetration of the rubber stopper. If not used immediately, in use storage times and conditions are the responsibility of the user. Shelf life after dilution of the solution for injection: Epirubicin Hydrochloride 2 mg/ml Injection may be further diluted, under aseptic conditions, in Glucose 5% or Sodium Chloride 0.9% and administered as an intravenous infusion. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions. All material used for preparation, administration or otherwise coming into contact with Epirubicin should undergo disposal according to localguidelines for the handling of cytotoxic compounds.

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