PACKAGE LEAFLET: INFORMATION FOR THE USER. ETOPOSIDE-TEVA 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION etoposide

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER ETOPOSIDE-TEVA 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION etoposide Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Etoposide-Teva is and what it is used for 2. What you need to know before you receive Etoposide-Teva 3. How to receive Etoposide-Teva 4. Possible side effects 5. How to store Etoposide-Teva 6. Contents of the pack and other information 1. WHAT ETOPOSIDE-TEVA IS AND WHAT IT IS USED FOR Etoposide-Teva is an anti-cancer drug for intravenous use, which is used to treat certain types of cancer. Etoposide-Teva is used in chemotherapy either alone, or in combination with other drugs. Etoposide-Teva is used for: testicular cancer lung cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ETOPOSIDE-TEVA Do not receive Etoposide-Teva if you: are allergic to etoposide or any of the other ingredients of this medicine (listed in section 6) suffer from severe liver problems suffer from severe kidney problems have a weakened immune system and you have received a yellow fever vaccine or any other live vaccines (see section Other medicines and Etoposide-Teva). Etoposide-Teva must not be given by intra-cavitary injection (within a body cavity). Warnings and precautions Talk to your doctor or nurse before receiving Etoposide-Teva: if you have a low serum albumin level; the risk of toxicity caused by etoposide may be increased. if you have received other anticancer drugs or radiotherapy, your doctor should check the number of blood cells in your blood before treatment starts. if you have a bacterial infection, it should be treated before Etoposide Injection is given. in the case of the intravenous administration of Etoposide, paravenous injection must be carefully avoided. before the start of therapy, during the therapy, and before each course of treatment, a peripheral blood panel (white blood cells, platelets, haemoglobin), kidney and liver function should be checked, and neurological functions should be investigated.

2 if you are suffering from liver or kidney dysfunction, you should be treated with etoposide only if the dysfunction is attributable to the underlying condition. Furthermore, courses of therapy with etoposide should be carried out only if the peripheral nervous system is functioning normally. Tell your doctor immediately if you experience an allergic reaction with any of the following symptoms while receiving Etoposide-Teva: fever chills faster heart beat high blood pressure difficulty in breathing or wheezing shortness of breath. Your treatment will need to be stopped, and your doctor will need to treat these symptoms. Etoposide-Teva may cause your bone marrow to produce less blood cells. Therefore, your doctor will check on your blood cells regularly both during and after treatment. When your blood platelet count and white blood cell count become too low, your doctor will not start the next course until your blood cells have recovered sufficiently. Children There are no comprehensive studies of the use of etoposide in children. Other medicines and Etoposide-Teva Talk to your doctor if you are taking/receiving, have recently taken/received or might take/receive any of the following: immunosuppressant drugs (e.g. cyclosporine), which are usually used in organ transplantations to prevent rejection other drugs used for cancer treatment (e.g. cisplatin). The occurrence of acute leukaemia has been reported rarely in patients treated with Etoposide-Teva in combination with one of these drugs. antiepileptic drugs (e.g. phenytoin) blood thinning drugs (e.g. warfarin) vaccines (immunisations). Because your normal defence system may be suppressed by etoposide, your response to the vaccine may be decreased. Do NOT have any immunisations without your doctor s approval. anti-inflammatory drugs or painkillers (e.g. phenylbutazone, sodium salicylate and aspirin) anthracyclines (e.g. daunorubicin, doxorubicin, and epirubicin). Anthracyclines are a type of antibiotic used to treat many types of cancer. Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy, breast-feeding and fertility Etoposide-Teva is not recommended if you are pregnant, planning to become pregnant or breast-feeding. However, your doctor may decide that the benefit you will receive from treatment with this medicine outweighs the risks to your unborn child. Female patients of child bearing age should use an effective method of contraception, e.g. the barrier method or condoms, to avoid getting pregnant during treatment, as the drug may cause serious birth defects. Male patients receiving treatment with Etoposide-Teva should also take adequate contraception precautions to ensure that their partner does not become pregnant while they are being treated or for up to 6 months after treatment and might want consider having their sperm frozen, as this medicine may cause impaired fertility.

3 Both male and female patients who are considering having a child after the treatment should discuss this with their doctor or nurse. Driving and using machines Your ability to drive or use machines may be impaired after being administered Etoposide-Teva. If you feel dizzy or sleepy after receiving this medicine, do NOT drive or use machines. Etoposide-Teva contains alcohol This medicine contains 24% w/v of ethanol (5 ml vial contains up to 1.2 g of alcohol; 25 ml vial contains up to 6 g of alcohol). This can be harmful for those suffering from alcoholism. This must also be taken into account in pregnant and breast-feeding women, children and high-risk groups such as patients with liver disease, brain injury or epilepsy. The amount of alcohol in this medicine may alter the effects of other medicines. Etoposide-Teva contains polysorbate 80 Polysorbate 80 may cause serious conditions in premature children such as liver and kidney failure, lung deterioration, reduction in platelets which increases risk of bruising or bleeding and a build-up of fluid of around the stomach. 3. HOW TO RECEIVE ETOPOSIDE-TEVA Etoposide-Teva will be given to you by a suitably experienced doctor or nurse and you will have regular tests to monitor your condition. Your medicine will then be given to you by slow intravenous infusion (an injection into the vein) usually over a 30 to 60 minute period. The required dose of Etoposide-Teva Concentrate for Solution for Infusion will be diluted with either 5% dextrose solution for injection or 0.9% saline solution to give the correct concentration. The duration of your treatment will be decided by the doctor. Your doctor may consider it necessary to give you a repeat course of Etoposide-Teva. Treatment may be repeated at intervals, as decided by your doctor, after you have recovered adequately from any toxicity. The dosage for Etoposide-Teva is estimated on your body surface area in square metres (m 2 ) calculated from your height and weight. The usual dose is: Adults (including the elderly) mg/m 2 intravenously, daily for five days. The treatment with Etoposide-Teva can be repeated after days, depending on your blood test results. Patients with kidney problems If you suffer from kidney problems, talk to your doctor. Your dose might need to be reduced. Children Use in Children is not recommended. If you receive more Etoposide-Teva than you should As a doctor or nurse will be giving you your medicine, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive. If you have any further questions on the use of this product, ask your doctor or nurse.

4 4. POSSIBLE SIDE EFFECTS Like all medicines, Etoposide-Teva can cause side effects, although not everybody gets them. A few people may experience common serious side effects when taking this medicine. If you experience any of the following, tell your doctor immediately as your treatment will need to be stopped: a severe allergic reaction. The symptoms include chills, fever, faster heartbeat, high blood pressure, swelling of the face, mouth, and tongue, wheezing or difficulty breathing, shortness of breath, itchy skin, rash and/or hives. The following side effects have been reported: Very common (affecting more than 1 person in 10): blood test abnormalities caused by suppression of the bone marrow (myelosuppression), which can result in a low number of blood platelets, white or red blood cells, or anaemia abdominal pain, constipation, nausea and vomiting, lack or loss of appetite drug-induced liver damage reversible loss or thinning of hair (alopecia) abnormal pigmentation unusual tiredness or weakness (asthenia), feeling generally unwell. Common (affecting more than 1 person in 100 but less than 1 person in 10): disorders of the blood-forming bone marrow cells (acute leukaemia) heart attack, changes in heart rate (arrhythmia) dizziness, temporary low blood pressure when etoposide has been injected rapidly. To prevent this event, your doctor will administer Etoposide-Teva via a slow infusion over minutes. high blood pressure and flushing inflammation and ulceration of the mucous membranes of the digestive tract, diarrhoea rash, hives, or itching accidental leaking of the medicine into the surrounding tissue (extravasion) inflammation of veins (phlebitis), irritation and inflammation of soft tissue. Uncommon (affecting more than 1 person in 1,000 but less than 1 person in 100): constant numbness, tingling or pain in hands and feet (peripheral neuropathy). Rare (affecting more than 1 person in 10,000 but less than 1 person in 1,000): fits or spasms reversible loss of vision, inflammation of eye nerve unusual tiredness or fatigue (neurotoxicity) inflammation of the lungs or lung fibrosis difficulties swallowing, taste impairment, aftertaste rash, hives, itch, an acute skin condition with multiple red and purple blotches on the skin of the palms, soles, backs of the hands and feet and the upper surfaces of the arms and legs (Stevens- Johnson syndrome) an inflammatory skin reaction at bodily parts previously exposed to radiotherapy (radiation recall dermatitis). Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie.

5 By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE ETOPOSIDE TEVA You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. The following information is intended for the specialist only. Keep out of the sight and reach of children. Etoposide-Teva should be stored below 25 o C. It should be kept in the package or container supplied in order to protect from light. Do not transfer it to another container. Any solution showing signs of precipitation should not be used and should be discarded appropriately. Do not use Etoposide-Teva after the expiry date that is stated on the vial and outer packaging. The expiry date refers to the last day of that month. Storage instructions following dilution: On dilution with 0.9% sodium chloride injection or 5% dextrose, Etoposide-Teva 20 mg/ml is physically and chemically stable for 96 hours, however, from a microbiological point of view, the solution for infusion can only be used within 8 hours of preparation, when stored at room temperature (below 25C). Etoposide-Teva 20 mg/ml can be stored for 48 hours at room temperature (below 25C) following piercing of the rubber stopper. The vial should be pierced no more than three times during the 48 hour in-use storage period. Any remaining product after this time must be discarded appropriately. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Etoposide-Teva contains The active ingredient is etoposide. The other ingredients are citric acid, anhydrous, polysorbate 80, absolute ethanol, macrogol 300. What Etoposide-Teva looks like and contents of the pack Etoposide-Teva Concentrate for Solution for Infusion is a clear, yellowish, slightly viscous solution in clear, colourless glass vials. Etoposide-Teva contains etoposide 20 mg/ml and is available as a sterile concentrate for solution for infusion, in 5 ml and 10 ml sterile multiple dose vials. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder: Teva Pharma B.V. Swensweg GA Haarlem Netherlands Manufacturer: Pharmachemie B.V. Swensweg RN Haarlem The Netherlands

6 This leaflet was last revised in December 2016.