Fertility in men<\/strong><\/p>\n\n\n\nAvailable data do not indicate an increased risk of malformations or miscarriages if the father takes less methotrexate than 30 mg\/week.\u00a0However, risk can not be completely ruled out and there is no information on higher\u00a0doses\u00a0of methotrexate.\u00a0Methotrexate may have genotoxic effects.\u00a0This means that the drug can cause gene mutations.\u00a0Methotrexate can affect sperm production, which is associated with the risk of congenital malformations.<\/p>\n\n\n\n
You should avoid getting a woman pregnant and donating sperm during treatment with methotrexate and for at least 6 months after stopping treatment.\u00a0Because treatment with methotrexate may cause\u00a0infertility\u00a0and gene mutations at higher\u00a0doses\u00a0that are common in cancer treatment, male patients treated with methotrexate at\u00a0doses\u00a0above 30 mg\/week should consider sperm preservation before starting treatment (see also section \u201cWarnings and precautions\u201d).<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Central nervous system\u00a0effects, such as fatigue and a tingling sensation, may occur during treatment with Methotrexate Ebewe and impair your ability to drive or use machines.\u00a0This can get worse if you have been drinking alcohol.<\/p>\n\n\n\n
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n
Methotrexate Ebewe contains sodium<\/h2>\n\n\n\n
This medicine contains 0.43 mmol (or 9.7 mg) sodium per ml.<\/p>\n\n\n\n
This medicine contains 48.5 mg\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per 5 ml\u00a0vial.\u00a0This corresponds to 2.4% of the highest recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n
This medicine contains 97 mg of\u00a0sodium\u00a0(the main ingredient in table salt\/table salt) per 10 ml\u00a0vial.\u00a0This corresponds to 4.85% of the highest recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n
This medicine contains 485 mg\u00a0of sodium\u00a0per 50 ml\u00a0vial.<\/p>\n\n\n\n
Talk to your doctor or pharmacist if you need 40 ml (4,000 mg) or more daily for a long period, especially if you have been prescribed a low-salt (sodium-poor) diet.<\/p>\n\n\n\n
How to use Methotrexate Ebewe<\/h2>\n\n\n\n
You will receive Methotrexate Ebewe from your healthcare provider. You should not take it yourself.<\/p>\n\n\n\n
The dose of medicine you receive depends on the disease you are being treated for, your medical condition, your age, your body weight or body surface area, and how well your kidneys are functioning.<\/p>\n\n\n\n
If you have kidney problems, your doctor may reduce the dose one, depending on how your kidneys work.<\/p>\n\n\n\n
If you have liver problems, mainly due to alcohol, your doctor will be very careful about prescribing one of Methotrexate Ebewe or you may not prescribe it at all.<\/p>\n\n\n\n
During treatment, your doctor will take blood samples to check your\u00a0blood cells\u00a0and to make sure your liver and kidneys are working properly.\u00a0You must attend all blood tests.<\/strong><\/p>\n\n\n\nIf you have the impression that the effect of Methotrexate Ebewe is too strong or too weak, talk to your doctor or pharmacist.<\/p>\n\n\n\n
If you take more Methotrexate Ebewe than you should<\/h2>\n\n\n\n
Because you are receiving this medicine from a healthcare professional, it is very unlikely that you would receive too much.<\/p>\n\n\n\n
Symptoms of overdose are e.g. bruising or bleeding, unusual weakness, sores in the mouth, nausea, vomiting, black or bloody stools, blood cough or vomiting that looks like coffee grounds, decreased amount of urine.<\/p>\n\n\n\n
If you have received the medicine intrathecally, symptoms such as headache, nausea, vomiting, and cramps as well as brain damage (\u00a0encephalopathy\u00a0) may occur.<\/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
Possible side effects<\/h2>\n\n\n\n
Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n
The side effects\u00a0are usually dependent on the\u00a0dose\u00a0and the duration of treatment, but serious\u00a0side effects\u00a0that can lead to the treatment having to be stopped temporarily or stopped completely can occur even at low\u00a0doses.\u00a0Side effects\u00a0can occur at any time during treatment.\u00a0Most go back if they were discovered early.<\/p>\n\n\n\n
The side effects do not always disappear completely if the treatment with methotrexate is stopped.<\/p>\n\n\n\n
Some of the serious side effects listed below can in very rare cases lead to sudden death. There is also a risk that some side effects will only appear after a while. Talk to your doctor about this.<\/p>\n\n\n\n
Tell your doctor immediately if you get any of the following symptoms as they may be signs of a serious and potentially life-threatening\u00a0side effect.\u00a0The doctor decides if the treatment needs to be stopped.<\/p>\n\n\n\n
- Allergic reactions such as sudden wheezing and wheezing, difficulty breathing, swelling of the eyelids, face or lips (which can lead to difficulty swallowing), rash or itching (especially if the whole body is affected) as this may be a sign of a severe allergic reaction .<\/li>
- Lung problems (symptoms such as general malaise, dry \/ cough, shortness of breath, shortness of breath at rest, chest pain or fever). This may be a sign of an infection in the lungs ( pneumonia , pneumonitis , alveolitis).<\/li>
- Symptoms of liver damage such as yellowing of the skin and whites of the eyes (jaundice), dark urine, nausea, vomiting, decreased appetite, pain on the right side of the stomach and itching<\/li>
- Symptoms of kidney damage such as swollen hands, ankles or feet or decreased urine output or no urine at all – this may be a sign of kidney failure .<\/li>
- Symptoms of infection such as fever, ache, sore throat. Methotrexate may reduce your body’s ability to fight infections . Serious infection is e.g. a specific type of pneumonia ( pneumocystis jirovecii<\/em> – pneumonia ) and sepsis may occur.<\/li>
- Fever, sore throat, sore mouth, general malaise and severe fatigue, nosebleeds or small red spots on the skin – can be signs that a bone marrow is not working properly.<\/li>
- Ulcers in the oral mucosa.<\/li>
- Abdominal pain (upper abdomen), nausea, vomiting or fever. This can be caused by an inflammation of the pancreas.<\/li>
- Severe abdominal pain, fever, nausea, vomiting, severe diarrhea, blood in the stool or altered bowel habits. This can be a sign of serious complications in the gastrointestinal tract, e.g. ulcers or perforation in the stomach or intestines.<\/li>
- Severe skin reactions ( Stevens-Johnson syndrome , toxic epidermal necrolysis , erythema multiforme). These begin with red spots or spots on the body, often with blisters in the middle, and are often accompanied by general malaise and fever. The rash can be aggravated by severe flaking or blistering which can be life threatening.<\/li>
- Symptoms that may indicate a blood clot (thromboembolism) such as pain or pressure over the chest, pain in the arms, back, neck or jaws, difficulty breathing, numbness or weakness in one side of the body, speech difficulties and dizziness.<\/li>
- Cough, chest pain, sudden shortness of breath or coughing up blood. This may be a symptom of pulmonary embolism (congestion in the lung).<\/li>
- Symptoms associated with tumor lysis syndrome, such as various gastrointestinal symptoms (nausea, vomiting, diarrhea), heart (irregular heartbeat), kidneys (decreased amount of urine, blood in the urine) and nerves and muscles (twitching, weakness, cramps).<\/li><\/ul>\n\n\n\n
The following side effects have also been reported:<\/p>\n\n\n\n
Very common<\/strong> (may affect more than 1 user in 10):<\/p>\n\n\n\n- altered white blood cell count (leukocytopenia) and platelets ( thrombocytopenia )<\/li>
- headache, tingling sensation<\/li>
- cough<\/li>
- decreased appetite, diarrhea (especially during the first 24-48 hours of treatment with Methotrexate Ebewe), stomach pain, nausea, vomiting, inflammation and sores in the mouth and throat (especially during the first 24-48 hours of treatment with Methotrexate Ebewe)<\/li>
- increase in liver enzymes<\/li>
- hair loss<\/li>
- decreased creatinine secretion (can be measured by a test performed by your doctor and is a sign of impaired kidney function)<\/li>
- fatigue, general malaise.<\/li><\/ul>\n\n\n\n
Common<\/strong> (may affect up to 1 in 10 people):<\/p>\n\n\n\n- shingles ( herpes zoster)<\/li>
- altered red blood cell count ( anemia ), bone marrow damage that can lead to a sharp decrease in the number of white blood cells ( agranulocytosis ) or of all blood cells (pancytopenia)<\/li>
- drowsiness, numbness and tingling<\/li>
- red eyes ( conjunctivitis )<\/li>
- skin rash, redness , itching , increased sensitivity to the sun, sores on the skin.<\/li><\/ul>\n\n\n\n
Uncommon<\/strong> (may affect up to 1 in 100 people):<\/p>\n\n\n\n- increased risk of infections \/ inflammations due to weakened immune system<\/li>
- certain types of cancer, so-called lymphoma , which can disappear when treatment with methotrexate is stopped<\/li>
- diabetes<\/li>
- Depression<\/li>
- paralysis of one side of the body, confusion, seizures<\/li>
- inflammation of the blood vessels ( vasculitis ), allergic vasculitis<\/li>
- increased amount of connective tissue in the lungs ( pulmonary fibrosis ), fluid between the different parts of the lungs (pleural effusion)<\/li>
- liver damage (hepatotoxicity), fatty liver , fibrosis (increased amount of connective tissue), cirrhosis (transformation of tissue through hardening and reduction of the normal structure of the liver), decreased serum albumin (a type of protein in the blood)<\/li>
- severe toxic reactions: accumulation of blisters similar to the skin lesions of herpes virus infection (herpetiform rash)<\/li>
- hives , dark skin, nodules in the skin (nodulos), impaired wound healing<\/li>
- joint or muscle pain , osteoporosis<\/li>
- inflammation and ulcers in the bladder (possibly with blood in the urine), problems with emptying the bladder, pain when urinating, little or no urine<\/li>
- fetal malformations<\/li>
- inflammation and ulcers in the vagina<\/li>
- fever.<\/li><\/ul>\n\n\n\n
Rare<\/strong> (may affect up to 1 in 100 people):<\/p>\n\n\n\n- anemia associated with enlarged red blood cells (megaloblastanemia)<\/li>
- mood swings, transient perception disorders<\/li>
- paralysis, speech problems, inflammation of the bone marrow (myelopathy)<\/li>
- visual disturbances (may be severe), clots in the retinal veins ( retinal thrombosis )<\/li>
- low blood pressure ( hypotension ), complications of blood clots in veins and arteries (thromboembolic events)<\/li>
- sore throat ( pharyngitis ), respiratory arrest<\/li>
- inflammation of the gastrointestinal tract, inflamed gums, black or tar-colored stools<\/li>
- inflammation of the liver ( hepatitis )<\/li>
- acne , red or purple dots, papular rash, bruising, dark nails, nail loss<\/li>
- stress fracture<\/li>
- increased amount of urea , creatinine and uric acid in the blood (signs of kidney problems), increased amount of blood urea (azotemia)<\/li>
- miscarriage<\/li>
- altered menstrual cycle and decreased sperm production that return to normal after stopping treatment.<\/li><\/ul>\n\n\n\n
Very rare<\/strong> (may affect up to 1 in 10,000 people):<\/p>\n\n\n\n- inflammation of the liver caused by herpes virus ( herpes simplex hepatitis )<\/li>
- fungal infections ( histoplasmosis , cryptococcosis ), viral infections ( cytomegalovirus – infection , including pneumonia ), spread herpes simplex, bacterial infection (nocardiosis)<\/li>
- anemia caused by insufficient production of red blood cells ( aplastic anemia ), decreased white blood cell count ( eosinophilia , neutropenia ), swollen lymph nodes in the head and neck area, in the armpits and groin (may partially return), uncontrolled increase in lymphocytes (may partly go back)<\/li>
- small number of antibodies in the blood ( hypogammaglobulinemia )<\/li>
- muscle weakness and pain in arms and legs, metallic taste, acute aseptic meningitis with symptoms such as severe headache, fever, nausea, vomiting and unconsciousness, damage to \/ problems with cranial nerves<\/li>
- swelling around the eyes, inflammation of the eyelids, increased tear production, increased photosensitivity, transient blindness, loss of vision<\/li>
- inflammation of the pericardium (pericarditis), impaired ability to fill the heart properly due to ejaculation in the pericardium (pericardial tamponade), fluid between different parts of the heart (pericardial effusion)<\/li>
- chronic damage to the lung structure, asthma-like reactions with cough, breathing problems abnormal lung function test<\/li>
- vomiting blood<\/li>
- degradation of liver cells ( acute liver necrosis), degradation of liver, liver failure<\/li>
- infection of the hair follicles ( furunculosis ), visible and prolonged enlargement of the small blood vessels under the skin (telangiectasia), inflammation of the nail bed a<\/li>
- blood in the urine, increased excretion of protein in the urine<\/li>
- fetal death<\/li>
- decreased production of ova and sperm, infertility , disruption of the menstrual cycle, lost sex drive, impotence , discharge from the vagina, enlarged breasts in men ( gynecomastia )<\/li>
- lymphoproliferative disorders (abnormal growth of white blood cells ).<\/li><\/ul>\n\n\n\n
Has been reported<\/strong>\u00a0\u00a0(occurs in an unknown number of users):<\/p>\n\n\n\n- pneumonia , reactivation of hepatitis B infection , exacerbated hepatitis C infection<\/li>
- damage to the nervous system (neurotoxicity), inflammation of the membranes around the brain (arachnoiditis), paralysis of the legs (paraplegia), stiffness of the whole body ( stupor ), poor muscle coordination, dementia, increased pressure in the cerebrospinal fluid (surrounding the brain and spinal cord) with symptoms such as headache, nausea, vomiting, high blood pressure and confusion<\/li>
- chest pain<\/li>
- hypoxia ( hypoxia )<\/li>
- inflammation of the peritoneum with symptoms such as abdominal pain and pressure soreness; inflammation of the tongue<\/li>
- drug reaction with rash all over the body and increased number of eosinophils (a type of blood cell ) in the blood (so-called DRESS syndrome); inflammation of the skin<\/li>
- bone tissue death ( osteonecrosis )<\/li>
- impaired function of the bladder and genitals ( urogenital dysfunction )<\/li>
- tremors<\/li>
- reddening of the skin and scaly skin<\/li>
- skeletal damage in the jaws (due to abnormal growth of white blood cells ).<\/li><\/ul>\n\n\n\n
Other complications that can occur when methotrexate is given directly in the\u00a0central nervous system\u00a0(intrathecal) are arachnoiditis (\u00a0inflammation\u00a0of the spinal cord membrane) in the brain, which causes symptoms such as headache, back pain, neck stiffness, and fever;\u00a0subacute\u00a0myelopathy (\u00a0inflammation\u00a0of the\u00a0bone marrow\u00a0) that can cause symptoms such as paresis (extreme muscle weakness in the arms or legs) or paraplegia (paralysis of the legs);\u00a0chronic\u00a0leukoencephalopathy leading to confusion, mood swings, drowsiness, coordination problems, dementia, seizures, and\u00a0coma.\u00a0The symptoms can worsen and lead to death.\u00a0There are indications that a combination of radiation to the skull and\u00a0intrathecal\u00a0treatment with methotrexate may increase the risk of leukoencephalopathy.<\/p>\n\n\n\n
When methotrexate is given into a muscle, it can lead to a burning sensation or the formation of a boil.<\/p>\n\n\n\n
How to store Methotrexate Ebewe<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n
Do not store above 25 \u00b0 C.<\/p>\n\n\n\n
Keep the vial in the outer carton. Sensitive to light.<\/p>\n\n\n\n
Waste materials must be disposed of by the hospital’s instructions for\u00a0chemotherapy\u00a0and current laws on the disposal of hazardous waste.<\/p>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n- The active substance is methotrexate.1 ml concentrate for solution for infusion contains 100 mg methotrexate.<\/li>
- The other ingredients are sodium hydroxide and water for injections.<\/li><\/ul>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Methotrexate Ebewe is a clear, dark yellow solution.<\/p>\n\n\n\n
Pack sizes:<\/p>\n\n\n\n
Individual pack containing 1 vial (500 mg \/ 5 ml, 1,000 mg \/ 10 ml, 5,000 mg \/ 50 ml).<\/p>\n\n\n\n
Multipack containing 5 vials (500 mg \/ 5 ml, 1,000 mg \/ 10 ml, 5,000 mg \/ 50 ml).<\/p>\n\n\n\n
Not all pack sizes may be marketed.<\/p>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/em><\/p>\n\n\n\nEBEWE Pharma Ges.mbH Nfg.KG, Mondseestrasse 11, 4866 Unterach, Austria<\/p>\n\n\n\n
Manufacturer<\/em><\/p>\n\n\n\nFareva Unterach GmbH, Mondseestrasse 11, 4866 Unterach, Austria<\/p>\n","protected":false},"excerpt":{"rendered":"
Methotrexate Ebewe contains the active substance methotrexate. Methotrexate is a so-called cytotoxic drug and is most often used to kill cells in tumors .<\/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":[2200,15580],"tags":[12794,17260,4858,17256,17259,4860,4859,17257,17258,12793],"class_list":["post-17744","post","type-post","status-publish","format-standard","hentry","category-medicines","category-m","tag-benefits-of-methotrexate","tag-benefits-of-methotrexate-ebewe","tag-methotrexate","tag-methotrexate-ebewe","tag-methotrexate-ebewe-side-effects","tag-methotrexate-side-effects","tag-what-is-methotrexate","tag-what-is-methotrexate-ebewe","tag-what-methotrexate-ebewe-is-used-for","tag-what-methotrexate-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17744","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=17744"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17744\/revisions"}],"predecessor-version":[{"id":17783,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/17744\/revisions\/17783"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=17744"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=17744"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=17744"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}