Package leaflet: Information for the user Vinorelbine Hikma, 10 mg/ml, Concentrate for solution for infusion Vinorelbine (as tartrate) Read all of this leaflet carefully before you start taking 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 or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. What Vinorelbine Hikma is and what it is used for 2. What you need to know before you take Vinorelbine Hikma 3. How to take Vinorelbine Hikma 4. Possible side effects 5. How to store Vinorelbine Hikma 6. Contents of the pack and other information 1. What Vinorelbine Hikma is and what it is used for The active substance of Vinorelbine Hikma, vinorelbine tartrate, is a semi-synthetic derivate of the vinca alkaloids which main action is to stop the multiplication of the cancer cells. It belongs to the Pharmaceutical Group: Antineoplastic and immunomodulating agents, with ATC code: L01C A04. Therapeutic indications This medicinal product is indicated to the treatment of the non small cell lung cancer and advanced breast cancer. 2. What you need to know before you take Vinorelbine Hikma Do not take Vinorelbine Hikma - Vinorelbine Hikma will not be given to you as an injection into your spine - if you are allergic (hypersensitivity) to Vinorelbine or other vinca alkaloids, or to any of the components of this medicine. - if your white blood cells count with affinity to neutral colours (neutrophils) is less than 1500/mm3 or if you have or recently had a severe infection (occured in the last 2 weeks) - if you have a severely reduced number of a type of blood cell called platelets in your blood (less than 100 000/mm3) - if you are pregnant or breast-feeding - in combination with yellow fever vaccine Warnings and precautions - if you have a background of inadequate blood flow (ischaemic heart disease). - if you have received radiotherapy where the treatment field includes the liver. - if you have signs or symptoms of infection /such as fever, chills, sore throat, etc), tell your doctor as soon as possible so that they may arrange any tests that may be necessary - if you have reduced liver function (severe or moderate) - if you are receiving a yellow-fever vaccine or other live attenuated vaccine - if you are taking inhibitors/inductors of CYP3A4, phenytoin and itraconazol - if you are taking any of the medicines listed in the section using other medicines of this leaflet - if you belong to Japanese population (related to lung disease) During treatment with Vinorelbine Hikma, blood samples should be taken and its components analysed (analysis of hematology). If the results of this analysis are not satisfactory, your treatment may be delayed and further checks made until these values return to normal. All eye contact should be strictly avoided: if any contact occurs immediate washing of the eye with normal saline solution should be undertaken. Other medicines and Vinorelbine Hikma Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Interactions common to all cytotoxics(medicines used to treat cancer): - anticoagulants (medicines that prevents blood clotting) - contra indicated use of yellow fever vaccine - not recommended use with other live attenuated vaccines - not recommended use with phenytoin (medicine to treat epilepsy) - take into consideration the use with ciclosporine and tacrolimus (medicines to stop immune response) Specific interactions to vinca-alkaloids: - not recommended use with itraconazole (antifungal medicine) - take into consideration use with mitomycin C (medicine used to treat cancer) - take into consideration in the use of strong modulators of the cell (P-glycoprotein membrane transporter) Specific interactions with vinorelbine: - combination with medicines with known bone marrow poisonousness - use with strong CYP3A4 inhibitors, such as, itraconazol and cetoconazol (antifungal medicines) and strong inducers, such us, rifampicin (medicine used against bacteria) and phenytoin (medicine to treat epilepsy) - simultaneous use with cisplatin (medicine used to treat cancer) - simultaneous use with lapatinib (medicine used to treat cancer) Vinorelbine Hikma with food and drink This medicinal product is not administered orally, thus there is no known interference between the food or drinks ingestion and this therapy. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Vinorelbine Hikma should not be given to pregnant women, because it can cause serious birth defects. If you will be pregnant during treatment you must to inform immediately your doctor. If you are pregnant or will be pregnant during treatment with vinorelbine, you should receive genetic counselling. If you are a woman of childbearing age you must use an effective method of contraception during treatment and up to 3 months after treatment. You must discontinue breast feeding before starting treatment with Vinorelbine Hikma as it is not known whether it might pass into breast milk thereby affect the baby. If you are a man, you should avoid fathering a child during treatment with Vinorelbine Hikma and for 3 months after treatment has stopped. There is also a risk that treatment with Vinorelbine Hikma will lead to male infertility and you may wish to seek advice about sperm storage before the treatment starts. Driving and using machines The effects on the ability to drive or operate machinery were not studied. However, caution is necessary considering some adverse effects of the medicine. 3. How to take Vinorelbine Hikma Vinorelbine Hikma will be given to you only under the supervision of a physician qualified in the use of these medicines. Your medicine will be strictly administered into a vein, after appropriate dilution. The administration system of the medicinal product varies according to patients and will depend on his/her body weight and general condition. The doctor will determine the administration dose based on calculation of the body surface area of the patient in square metres (m2). As single treatment (monochemotherapy), the usual dose is 25-30 mg/m2, once a week. In combined treatment (poly-chemotherapy) the dose and frequency of the administration depend on the doctor’s protocol. Mode and administration use Vinorelbine Hikma should be administered by slow injection (6-10 minutes) directly into a vein, after dilution in 20-50 ml of normal saline solution for injection (sodium chloride solution for injection 9 mg/ml (0.9%)) or 5% glucose solution for injection, or by short duration intravenous infusion (during 20-30 minutes), after dilution in 125 ml of normal saline solution for injection (0.9%) or 5% dextrose solution for injection. Administration should always be followed with at least 250 ml of an isotonic solution (with the same concentration of the blood) to ‘wash’ the vein used. Administration in the elderly Clinical experience did not identified relevant differences among elderly patients with regards to the response frequency, although greater sensitivity in some of these patients cannot be excluded. The age does not modify the action of vinorelbine. Administration in patients with reduced liver function The action of vinorelbine is not modified in patients with moderate or severe liver impairment. Nevertheless, as a precautionary measure a dose reduction and a close monitoring of the blood parameters is recommended in patients with severe reduced liver function. Administration in patients with reduced renal function The action of vinorelbine does not justify a dose reduction in patients with reduced renal function. Administration in children The administration in children is not recommended. If you take more Vinorelbine Hikma than you should Since Vinorelbine Hikma will be given to you only under the supervision of a physician it is unlikely that you get too much. If you have concerns please tell your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The following list of side effects is organized by body system and according to the frequency as follows: Very common (Side effects that occur in more than 1 out of 10 patients) Common (Side effects that occur in less than 1 out of 10 patients but in more than 1 out of 100 patients) Uncommon (Side effects that occur in less than 1 out of 100 patients but in more than 1 out of 1,000 patients) Rare (Side effects that occur in less than 1 out of 1,000 patients but in more than 1 out of 10,000 patients) Very rare (Side effects that occur in less than 1 out of 10,000 patients) Not known (can not be estimated from the available data) The most commonly reported adverse drug reactions are bone marrow depression with low white blood cell count (neutropenia), anaemia, nervous system-related disturbances (neurologic disorders), gastro-intestinal poisonousness (gastrointestinal toxicity) with nausea (feeling sick), vomiting, mouth inflammation (stomatitis) and intestinal blockage (constipation), abnormal liver function test results (transient elevations of liver function tests), baldness (alopecia) and local vein inflammation (phlebitis). The additional side effects noticed from post marketing experience were classified by Not known. Very common: - Bone marrow depression resulting mainly in low white blood cell count (neutropenia), - Decrease in the number of red blood cells (anemia). - Nervous system-related disturbances (neurological disorders) including loss of deep tendon reflexes. - Weakness of the lower extremities has been reported after a prolonged chemotherapy.