Pregnancy<\/strong><\/p>\n\n\n\nAfinitor can have harmful effects on the fetus and is not recommended during pregnancy. Tell your doctor if you are pregnant or think you may be pregnant. Your doctor will discuss whether you should take this medicine during pregnancy.
Women who could become pregnant should use a very effective method of contraception during treatment and up to 8 weeks after the end of treatment. If, despite these measures, you think you may be pregnant, talk to your doctor before taki<\/b>ng any more Afinitor.<\/p>\n\n\n\n
Breast-feeding<\/strong><\/p>\n\n\n\nAfinitor can have harmful effects on breastfed babies. You should not breast-feed during treatment and up to 2 weeks after the last dose of Afinitor. Tell your doctor if you are breast-feeding.<\/p>\n\n\n\n
Female fertility<\/strong><\/p>\n\n\n\nMissed menstruation ( amenorrhea ) has occurred in some women who have used Afinitor.
Afinitor may affect female fertility. Talk to your doctor if you wish to become pregnant.<\/p>\n\n\n\n
Male fertility<\/strong><\/p>\n\n\n\nAfinitor may affect male fertility. Talk to your doctor if you want to become a father.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n If you feel unusually tired (fatigue is a very common side effect), be especially careful when driving or using machines.<\/p>\n\n\n\n
Afinitor contains lactose<\/h2>\n\n\n\n Afinitor contains lactose (milk sugar). 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 Afinitor<\/h2>\n\n\n\n Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 10 mg once daily. Your doctor will tell you how many tablets of Afinitor to take.
If you have liver problems, your doctor may give you a lower dose of Afinitor (2.5, 5, or 7.5 mg daily) at the beginning of treatment.<\/p>\n\n\n\n
If you experience any special side effects while taking Afinitor (see section 4), your doctor may reduce your dose or discontinue treatment, either for a short time or permanently.<\/p>\n\n\n\n
Take Afinitor once daily, at about the same time each day, consistently with or without food.<\/p>\n\n\n\n
Swallow the tablets whole with a glass of water. Do not chew or crush the tablets.<\/p>\n\n\n\n
If you take more Afinitor than you should<\/h2>\n\n\n\nIf you take more Afinitor than you should, or if someone else accidentally takes your tablets, contact a doctor or hospital immediately. Urgent medical treatment may be necessary.<\/li> Bring the tablet pack and this leaflet so that your doctor knows what you have taken.<\/li><\/ul>\n\n\n\nIf you forget to take Afinitor<\/h2>\n\n\n\n If you miss a dose, take the next dose as planned. Do not take a double dose to make up for a forgotten tablet.<\/p>\n\n\n\n
If you stop taking Afinitor<\/h2>\n\n\n\n Do not stop taking Afinitor unless your doctor tells you to.<\/p>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them.<\/p>\n\n\n\n
STOP taking Afinitor and seek medical help immediately if you experience any of the following signs of an allergic reaction:<\/p>\n\n\n\n
difficulty breathing or swallowing<\/li> swelling of the face, lips, tongue or throat (signs of angioedema )<\/li> severe skin itching with red or raised rash.<\/li><\/ul>\n\n\n\nSerious side effects of Afinitor can be:<\/strong>Very common <\/strong>(may affect more than 1 in 10 people)<\/em><\/p>\n\n\n\nfever, chills (signs of infection )<\/li> fever, cough, difficulty breathing, wheezing (signs of pneumonia, pneumonitis ).<\/li><\/ul>\n\n\n\nCommon <\/strong>(may affect up to 1 in 10 people)<\/em><\/p>\n\n\n\npronounced thirst, large urine production, increased appetite with weight loss, fatigue (signs of diabetes )<\/li> bleeding, eg in the intestinal wall<\/li> sharply reduced urine production (signs of renal failure ).<\/li><\/ul>\n\n\n\nUncommon <\/strong>(may affect up to 1 in 100 people)<\/em><\/p>\n\n\n\nfever, rash, joint pain, and inflammation as well as fatigue, loss of appetite, nausea, jaundice (yellowish skin), pain in the upper right part of the abdomen, pale stools, dark urine (may be signs of reactivation of hepatitis B)<\/li> shortness of breath, difficulty lying down, swollen feet or legs (signs of heart failure )<\/li> swelling and\/or pain in one of the legs, usually in the calf, redness or hot skin in the affected area (signs of a blood clot in a blood vessel (vein) in the legs)<\/li> sudden shortness of breath, chest pain, or bloody cough (possible signs of pulmonary embolism, a condition that occurs when one or more arteries in the lungs are blocked)<\/li> sharply reduced urine output, swelling of the legs, confusion, back pain (signs of sudden renal failure )<\/li> skin rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of a severe allergic reaction or so-called hypersensitivity reaction ).<\/li><\/ul>\n\n\n\nRare <\/strong>(may affect up to 1 in 1,000 people)<\/em><\/p>\n\n\n\nshortness of breath or rapid breathing (signs of acute respiratory distress syndrome).<\/li><\/ul>\n\n\n\nIf you get any of these side effects, talk to your doctor immediately as they can have life-threatening consequences.<\/strong><\/p>\n\n\n\nOther possible side effects of Afinitor may be:<\/strong>Very common <\/strong>(may affect more than 1 in 10 people)<\/em><\/p>\n\n\n\nhigh blood sugar levels (hyperglycemia)<\/li> decreased appetite<\/li> taste change<\/li> headache<\/li> nosebleeds<\/li> cough<\/li> cold sores<\/li> upset stomach including nausea or diarrhea<\/li> rash<\/li> itching<\/li> feeling weak or tired<\/li> fatigue, shortness of breath, dizziness, pale skin (signs of low red blood cell count, anemia )<\/li> swollen arms, hands, feet, ankles, or another body part (signs of edema )<\/li> weight loss<\/li> elevated blood fats ( hypercholesterolemia ).<\/li><\/ul>\n\n\n\nCommon <\/strong>(may affect up to 1 in 10 people)<\/em><\/p>\n\n\n\nspontaneous bleeding or bruising (signs of low platelet count ie thrombocytopenia )<\/li> shortness of breath ( dyspnoea )<\/li> thirst, low urine output, dark urine, dry skin, redness, irritability (signs of dehydration)<\/li> difficulty sleeping<\/li> headache, dizziness (signs of high blood pressure )<\/li> fever, sore throat, cold sores due to infection (signs of low white blood cell count, ie leukopenia, lymphopenia, and\/or neutropenia )<\/li> fever<\/li> inflammation inside the mouth, stomach, or intestines<\/li> dry mouth<\/li> heartburn ( dyspepsia )<\/li> vomiting<\/li> difficulty swallowing<\/li> abdominal pain<\/li> acne<\/li> rash and pain in palms or soles of the feet (hand-foot syndrome)<\/li> reddening of the skin<\/li> joint pain<\/li> pain in the mouth<\/li> menstrual disorders such as irregular menstruation<\/li> elevated blood lipids ( hyperlipidemia, hypertriglyceridemia )<\/li> low potassium levels in the blood<\/li> low phosphate level in the blood<\/li> low calcium levels in the blood<\/li> dry skin, skin peeling, skin damage<\/li> nail problems, broken nails<\/li> light hair loss<\/li> abnormal liver values \u200b\u200b(elevated AST or ALT )<\/li> abnormal kidney values \u200b\u200b(elevated creatinine )<\/li> swollen eyelids<\/li> protein in the urine.<\/li><\/ul>\n\n\n\nUncommon <\/strong>(may affect up to 1 in 100 people)<\/em><\/p>\n\n\n\nweakness, spontaneous bleeding or bruising and frequent infection with symptoms such as fever, chills, sore throat, or cold sores (signs of low levels of certain blood cells, pancytopenia)<\/li> loss of taste<\/li> bloody vomiting<\/li> menstrual disorders such as the absence of menstruation ( amenorrhea )<\/li> frequent urination during the day<\/li> chest pain<\/li> abnormal wound healing<\/li> hot flashes<\/li> watery eyes with itching and redness, red eyes ( conjunctivitis ).<\/li><\/ul>\n\n\n\nRare <\/strong>(may affect up to 1 in 1,000 people)<\/em><\/p>\n\n\n\nfatigue, shortness of breath, dizziness, pale skin (signs of the low level of red blood cells, possibly due to a type of anemia called erythroblastopenia)<\/li> swelling of the face, around the eyes, mouth, and inside the mouth and\/or throat and tongue as well as difficulty breathing or swallowing ( angioedema, which may be a sign of an allergic reaction ).<\/li><\/ul>\n\n\n\nIf these side effects become severe, consult a doctor and\/or pharmacist. Most side effects are mild to moderate and generally, go away if treatment is stopped for a few days.<\/strong><\/p>\n\n\n\nReporting of side effects<\/em><\/p>\n\n\n\nIf 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.<\/p>\n\n\n\n
5. How to store the medicine<\/h2>\n\n\n\nKeep this medicine out of the sight and reach of children.<\/li> Do not use this medicine after the expiry date which is stated on the carton and blister. The expiration date is the last day of the specified month.<\/li> Do not store above 25 \u00b0 C.<\/li> Store in the original package. Sensitive to light. Moisture sensitive.<\/li> Do not open the blister until the tablets are to be taken.<\/li> Do not use this medicine if you notice that the package is damaged or appears to have been opened earlier.<\/li><\/ul>\n\n\n\nMedicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n The active substance is everolimus.<\/p>\n\n\n\n
Each Afinitor 2.5 mg tablet contains 2.5 mg everolimus.<\/li> Each tablet of Afinitor 5 mg contains 5 mg of everolimus.<\/li> Each tablet of Afinitor 10 mg contains 10 mg of everolimus.<\/li><\/ul>\n\n\n\nThe other ingredients are butylhydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A, and anhydrous lactose.<\/p>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n Afinitor 2.5 mg tablets are white to yellowish, oblong tablets. They are marked with “LCL” on one side and “NVR” on the other.<\/p>\n\n\n\n
Afinitor 5 mg tablets are white to yellowish, oblong tablets. They are marked with “5” on one side and “NVR” on the other.<\/p>\n\n\n\n
Afinitor 10 mg tablets are white to yellowish, oblong tablets. They are marked with “UHE” on one side and “NVR” on the other.
Afinitor 2.5 mg is available in blister packs of 30 or 90 tablets. Afinitor 5 mg and Afinitor 10 mg are available in blister packs of 10, 30, or 90 tablets. Not all pack sizes may be marketed.<\/p>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n Novartis Europharm Limited<\/p>\n\n\n\n
Vista Building<\/p>\n\n\n\n
Elm Park, Merrion Road<\/p>\n\n\n\n
Dublin 4<\/p>\n\n\n\n
Ireland
Manufacturer<\/strong><\/p>\n\n\n\nNovartis Pharmac\u00e9utica SA<\/p>\n\n\n\n
Ronda de Santa Maria 158<\/p>\n\n\n\n
08210 Barber\u00e0 del Vall\u00e8s, Barcelona<\/p>\n\n\n\n
Spain
Novartis Pharma GmbH<\/p>\n\n\n\n
Roonstrasse 25<\/p>\n\n\n\n
D-90429 Nuremberg<\/p>\n\n\n\n
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\nBelgium \/ Belgique \/ Belgien<\/strong>Novartis Pharma NVTel: +32 2 246 16 11<\/td>Luxembourg \/ Luxemburg<\/strong>Novartis Pharma NV:Tel: +32 2 246 16 11<\/td><\/tr>Bulgaria<\/strong>Novartis Bulgaria EOODTel .: +359 2 489 98 28<\/td>Hungary<\/strong>Novartis Hungary Kft.Tel .: +36 1 457 65 00<\/td><\/tr>Czech Republic<\/strong>Novartis sroTel: +420 225 775 111<\/td>Malta<\/strong>Novartis Pharma Services Inc.Tel: +356 2122 2872<\/td><\/tr>Denmark<\/strong>Novartis Healthcare A \/ STel: +45 39 16 84 00<\/td>The Netherlands<\/strong>Novartis Pharma BVTel: +31 88 04 52 555<\/td><\/tr>Germany<\/strong>Novartis Pharma GmbHTel: +49 911 273 0<\/td>Norway<\/strong>Novartis Norge ASTel: +47 23 05 20 00<\/td><\/tr>Eesti<\/strong>SIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810<\/td>Austria<\/strong>Novartis Pharma GmbHTel: +43 1 86 6570<\/td><\/tr>Greece<\/strong>Novartis (Hellas) AEBE:\u0397\u03bb: +30 210 281 17 12<\/td>Poland<\/strong>Novartis Poland Sp. z ooTel .: +48 22 375 4888<\/td><\/tr>Spain<\/strong>Novartis Pharmac\u00e9utica, SATel: +34 93 306 42 00<\/td>Portugal<\/strong>Novartis Pharma-Pharmaceutical Products, Satel: +351 21 000 8600<\/td><\/tr>France<\/strong>Novartis Pharma SASTel: +33 1 55 47 66 00<\/td>Romania<\/strong>Novartis Pharma Services Romania SRLTel: +40 21 31299 01<\/td><\/tr>Croatia<\/strong>Novartis Hrvatska dooTel. +385 1 6274 220<\/td>Slovenia<\/strong>Novartis Pharma Services Inc.Tel: +386 1 300 75 50<\/td><\/tr>Ireland<\/strong>Novartis Ireland LimitedTel: +353 1 260 12 55<\/td>Slovak Republic<\/strong>Novartis Slovakia sroTel: +421 2 5542 5439<\/td><\/tr>Iceland<\/strong>Vistor hf.Phone: +354 535 7000<\/td>Finland \/ Finland<\/strong>Novartis Finland OyPuh \/ Tel: +358 (0) 10 6133 200<\/td><\/tr>Italy<\/strong>Novartis Farma SpATel: +39 02 96 54 1<\/td><\/td><\/tr> \u039a\u03cd\u03c0\u03c1\u03bf\u03c2<\/strong>Novartis Pharma Services Inc.:\u0397\u03bb: +357 22 690 690<\/td>United Kingdom<\/strong>Novartis Pharmaceuticals UK Ltd.Tel: +44 1276 698370<\/td><\/tr>Latvia<\/strong>SIA Novartis BalticsTel: +371 67 887 070<\/td> <\/td><\/tr> Lithuania<\/strong>SIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50<\/td> <\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"Afinitor is a cancer drug that contains the active substance everolimus. Everolimus reduces the blood supply to the tumor and delays the growth and spread of cancer cells.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2201,2200],"tags":[11430,11433,11434,11428,7420,7423,11435,11427,11431,7421,11432],"class_list":["post-4960","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-afinitor","tag-afinitor-tablet","tag-benefits-of-afinitor","tag-benefits-of-everolimus","tag-everolimus","tag-everolimus-tablet","tag-side-effects-of-afinitor","tag-what-everolimus-is-used-for","tag-what-is-afinitor","tag-what-is-everolimus","tag-wht-afinitor-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4960","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=4960"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4960\/revisions"}],"predecessor-version":[{"id":13030,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/4960\/revisions\/13030"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=4960"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=4960"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=4960"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}