Package leaflet: Information for the user. LETROKS, 2,5 mg, film-coated tablets Letrozolum

Transcription

1 Package leaflet: Information for the user LETROKS, 2,5 mg, film-coated tablets Letrozolum 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 of illness 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 LETROKS is and what it is used for 2. What you need to know before you take LETROKS 3. How to take LETROKS 4. Possible side effects 5. How to store LETROKS 6. Contents of the pack and other information 1. What LETROKS is and what it is used for LETROKS are white, round, film-coated tablets containing 2.5 mg of letrozole. It is a drug used in postmenopausal women in the first-line treatment of advanced breast cancer having receptors for hormones LETROKS is also indicated for the treatment of advanced breast cancer in women with natural or artificially -induced menopause that have been treated with estrogen receptors blocking agents and who have relapsed or progressive disease. LETROKS is indicated for the adjuvant treatment of postmenopausal women with hormonedependent breast cancer at an early stage LETROKS is indicated for the adjuvant treatment extension postmenopausal patients with hormone-dependent breast cancer at an early stage, after surgery and standard adjuvant tamoxifen. Estrogens are sex hormones that can stimulate the growth of certain types of breast cancer. LETROKS inhibit the enzyme aromatase, and works by inhibiting the production of sex hormones - estrogen. There was no efficacy in patients with breast cancer do not have receptors for estrogen.. 2. What you need to know befor you take LETROKS Do not take LETROKS - - if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6), - if you are pregnant or if you are breast-feeding. - if you still have periods, i.e. if you have not yet gone through the menopause, If you have severe liver disease Warnings and precautions 1

2 Talk to your doctor or pharmacist before taking Letroks Particular caution should be: - if you have a severe kidney disease, - jeśli stosowana jest hormonalna terapia zastępcza; - jeśli stosowane są inne leki wskazane w chorobie nowotworowej. If any of these conditions apply to you, tell your doctor During treatment, your doctor may order a bone density test. Letrozole belongs to a lowering drugs, hormones responsible among other things for normal bone density in women. Reduction of bone density can lead to osteoporosis and fractures.. Children Children should not use this medicine Other medicines and LETROKS Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Pregnancy, breast-feeding and fertility -Do not use LETROKS in pregnant women. -Do not use LETROKS breast-feeding women. Driving and using machines Some people observed the occurrence of fatigue or dizziness. If you experience these symptoms, do not drive, operate machinery or engage in activities that require your full concentration. LETROKS contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take LETROKS Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.. The recommended dose is one tablet of 2.5 mg orally, once daily. The tablet should be swallowed with a small amount of water. The length of treatment is determined doctor. If you take more Letroks than you should If you have taken too much Letroks or if someone else accidentally takes your tablets, contact a doctor or hospital for advice immediately If you forget to take LETROKS - If it is almost time for your next dose skip the dose you missed and take your next dose when you are meant to. - Otherwise, take the dose as soon as your remember, and then take the next tablet as you would normally. - Do not take a double dose to make up for the one that you missed.. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. 2

3 Many of the observed adverse reactions are mild to moderate and rarely severe enough that it was necessary to discontinue the drug. Many side effects can be a symptom of underlying disease or a consequence of inhibiting the production of estrogen in the body (eg, hot flashes and hair loss). Not all of the side effects must occur, however, in the case of their appearance may be necessary medical intervention. You should contact your doctor if side effects persist during treatment or are bothersome. Side effects may occur: very common ( 1/10), common ( 1/100 to <1/10), uncommon ( 1/1 000 to <1/100), rare (rare 1/ to <1/1 000), very rare (<1/10 000). After application of letrozole following adverse reactions have been observed: Infections and infestations Uncommon: Urinary tract infection Neoplasms, benign, malignant and unspecified (including cysts and polyps) Uncommon: Tumour pain Blood and the lymphatic system disorders Uncommon: leukopenia Metabolism and nutrition disorders Common: Anorexia, appetite increase, Hypercholesterolaemia Uncommon: general edama Psychiatric disorders Common: Depression Uncommon: Anxiety (including nervousness), irritability Nervous system disorders Common: Headache, dizziness Uncommon: Somnolence, insomnia, memory impairment, dysaesthesia (including paraesthesia, hypoaesthesia), taste disturbance, cerebrovascular accident Eye disorders Uncommon: Cataract, eye irritation, blurred vision Cardiac disorders Uncommon: Palpitations, tachycardia Vascular disorders Uncommon:, Thrombophlebitis (including superficial and deep vein thrombophlebitis) hypertension, myocardial ischaemia Rare: Pulmonary embolism, arterial thrombosis, cerebrovascular infarction Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea Gastrointestinal disorders Common: Nausea, dyspepsia1, constipation, abdominal pain, diarrhoea, vomiting 3

4 Uncommon: Dry mouth, stomatitis, abdominal pain, Skin and subcutaneous tissue disorders Common: Alopecia, rash (including erythematous, maculopapular, psoriaform, and vesicular rash),increased sweating Uncommon: Pruritus, urticaria, dry skin Musculoskeletal and connective tissue disorders Common: bone pain, Myalgia Renal and urinary disorders Uncommon: Increased urinary frequency Reproductive system and breast disorders Uncommon: vaginal dryness, breast pain, vaginal bleeding General disorders and administration site conditions Very common: hot flushes Common: Fatigue (including asthenia, malaise), Peripheral oedema Uncommon: mucosal dryness, thirst, pyrexia Investigations Common: Weight increase Uncommon: Weight loss, increasing the activity of transaminases If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet Reporting of adverse reactions If you experience any side effects, including any side effects not listed in this leaflet, please tell your doctor or pharmacist. Adverse reactions can be reported directly to the {current address, telephone and fax numbers cited above. Department} 5. How to store Letroks Keep out of the reach and sight of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. Store in original container. Do not use if packaging has purchased signs of tampering or damage. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer uses. These measures will help to protect the environment 6. Contents of the pack and other information 4

5 What Letroks contains The active substance is letrozole. Each film-coated tablet contains 2.5 mg letrozole. The other ingredients are : microcrystalline cellulose, lactose monohydrate, maize starch sodium starch glycolate type C, magnesium stearate Film coat (Opadry AMB White): polyvinyl alkohol, titanium dioxide (E 171), talc, soya lecithin, xanthan gum celuloza What Letroks looks like and contents of the pack White, round, biconvex film-coated tablets In one container is 30 tablets. Marketing Authorisation Holder and Manufacturer Ogrodowa 2A, Kiełpin Łomianki tel. : (22) , info@celonpharma.com Manufacturer: ul. Mokra 41A, Kiełpin Łomianki ul. Marymoncka Kazuń Nowy For more detailed information, please contact marketing authorization holder. In order to protect the drug from access by unauthorized persons and children packing cap is provided with a ring warranty and child proof type protection In order to properly open the package must comply with the following drawings: 1 PUSH HARD THE CAP 2 PUSHED CAP TURN ABOUT HALF THE MARKET This leaflet was last revised in 5