100 mg / ml concentrate for solution for infusion
methotrexate
What Methotrexate Teva is and what it is used for
Methotrexate Teva contains the active substance methotrexate. It is a cytostatic that inhibits cell growth. Methotrexate has the greatest effect on cells that multiply frequently, such as cancer cells, bone marrow cells, and skin cells.
Methotrexate Teva is used to treat the following types of cancer:
- acute leukemia (disease affecting the blood or bone marrow one with an increased number of white blood cells )
- cancer of the lymphatic system
- skeletal cancer (osteogenic sarcoma )
- breast cancer
- squamous cell carcinoma of the head and neck region
- gynecological cancer (trophoblastic tumor er – tumor development that is directly related to pregnancy)
- bladder cancer
- small cell lung cancer .
Methotrexate contained in Methotrexate Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you receive Methotrexate Teva
Do not use Methotrexate Teva
- if you are allergic to methotrexate or any of the other ingredients of this medicine (listed in section 6)
- if you have severe liver or kidney disease
- if you consume large amounts of alcohol
- if you have any defects in the blood formation
- if you have a severe or ongoing infection , e.g. tuberculosis or HIV
- if you have sores in your mouth and throat or sores in your stomach and intestines
- if you are breast-feeding (see section “Pregnancy, breast-feeding and fertility”)
- If you, your partner or your healthcare provider discover new or worsening neurological symptoms, such as general muscle weakness, visual disturbances, changes in thinking ability, memory and orientation that lead to confusion and personality changes, you should contact your doctor immediately as this may be a very rare symptom. , severe brain infection called progressive multifocal leukoencephalopathy (PML).
While you are being treated with Methotrexate Teva, you should not be vaccinated with a live vaccine.
Warnings and cautions
Before starting treatment with Methotrexate Teva Talk to your doctor, pharmacist, or nurse:
- if you are dehydrated or have problems leading to dehydration (vomiting, diarrhea, stomatitis )
- if you have an abnormal accumulation of fluid in the abdomen or in the cavity between the lungs and the chest wall ( ascites , pleural effusion)
- if you have or have had liver disease
- if you have impaired kidney function
- if you have an infection or if you have an inactive long-term infection (eg tuberculosis , hepatitis B or C, shingles ( herpes zoster))
- if you have diabetes treated with insulin , then methotrexate treatment should be closely monitored.
Talk to your doctor during treatment with Methotrexate Teva:
- if you are to undergo radiation therapy at the same time as methotrexate therapy. The risk of tissue and bone damage may increase with concomitant treatment.
- if you are to be vaccinated. Methotrexate may reduce the efficacy of the vaccines.
Methotrexate can cause severe and sometimes life-threatening side effects. Doctors will talk to you about the benefits and risks of treatment and what the early signs and symptoms of side effects are.
Methotrexate temporarily affects sperm and egg production. Methotrexate can cause miscarriage and severe congenital malformations. You and your partner should avoid having children while you are receiving methotrexate and for at least 6 months after stopping treatment with methotrexate. See also section “Pregnancy, breast-feeding and fertility”.
The skin may become extremely sensitive to sunlight and other light during treatment with Methotrexate Teva. Therefore, avoid sunlight and tanning beds.
Methotrexate may cause a decrease in the cells responsible for the immune system, oxygen transport, and the cells responsible for normal blood coagulation and may increase the risk of infection (ie pneumonia ) or increased bleeding.
Methotrexate may cause pneumonia. If you have problems with lung function with symptoms such as difficulty breathing, cough (dry cough), and fever, contact a doctor immediately.
Acute hemorrhage from the lungs of patients with the underlying rheumatic disease has been reported with methotrexate.
Brain disease ( encephalopathy ) has been reported as a side effect in patients receiving methotrexate for the treatment of cancer.
Other medicines and Methotrexate Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is extra important that you tell your doctor if you use or receive:
- painkillers and anti- inflammatory drugs (so-called NSAIDs and salicylates)
- probenecid (for gout )
- antibiotics for infection such as penicillins , sulfonamides , tetracycline , ciprofloxacin and chloramphenicol
- other anti-cancer drugs such as cisplatin, cytarabine, mercaptopurine
- radiation therapy
- leflunomide (used in rheumatism)
- azathioprine (used to prevent rejection after an organ transplant)
- sulfasalazine (used in ulcerative colitis )
- retinoids (used for psoriasis or severe acne)
- theophylline (used to treat asthma )
- phenytoin (for epilepsy )
- furosemide (for high blood pressure )
- vitamin preparations containing folic acid or substances similar to folic acid
- proton pump inhibitor (used to treat heartburn or stomach ulcers ).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
Do not use Methotrexate Teva during pregnancy unless your doctor tells you to
cancer treatment. Methotrexate can cause congenital malformations, birth defects, and miscarriages. It is associated with malformations of the skull, face, heart and blood vessels, brain arms, and legs. It is therefore very important that methotrexate is not given to pregnant women or to women planning to become pregnant unless used for cancer treatment.
For indications other than cancer, a possible pregnancy in fertile women must be ruled out, e.g. through pregnancy tests, before starting treatment.
Do not use Methotrexate Teva if you are trying to conceive. You must avoid becoming pregnant during treatment with methotrexate and for at least 6 months after stopping treatment. Be sure to use effective contraception throughout this time (see also section “Warnings and Precautions”).
If you become pregnant during treatment or suspect you may be pregnant, talk to your doctor as soon as possible. If you become pregnant during treatment, you should be offered medical advice on the risk of harmful effects on the baby due to the treatment.
If you want to get pregnant, talk to your doctor, who can refer you to specialist advice before the planned start of treatment.
Breast-feeding
Methotrexate passes into breast milk in such quantities that there is a risk of the baby being affected. Breast-feeding should therefore be discontinued before treatment with methotrexate.
Fertility in men
Available data do not indicate an increased risk of malformations or miscarriages if the father takes less methotrexate than 30 mg/week. However, risk can not be completely ruled out and there is no information on higher doses of methotrexate. Methotrexate may have genotoxic effects. This means that the drug can cause gene mutations. Methotrexate can affect sperm production, which is associated with the risk of congenital malformations.
You should avoid getting a woman pregnant and donating sperm during treatment with methotrexate and for at least 6 months after stopping treatment. Because treatment with methotrexate may cause infertility and gene mutations at higher doses that are common in cancer treatment, male patients treated with methotrexate at doses above 30 mg/week should consider sperm preservation before starting treatment (see also section “Warnings and precautions”).
Driving and using machines
Methotrexate can cause side effects such as vomiting and dizziness. If you feel tired or dizzy, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Methotrexate Teva contains sodium
This medicine contains 101 mg sodium (the main ingredient in table salt/table salt) per 10 ml vial and 506 mg sodium per 50 ml vial. This corresponds to 5% and 25% respectively of the highest recommended daily intake of sodium for adults.
How to get Methotrexate Teva
Methotrexate Teva is given to you by healthcare professionals.
The dose you receive and how often you receive it depends on the disease you are being treated for, your state of health, and your age, weight, and body surface area. Methotrexate Teva can be given in a vein ( intravenously ) or an artery (intraarterially).
Before starting treatment, your doctor may take blood samples and also check how well your kidneys and liver are working. You may also have a lung x-ray. Additional tests can also be done during and after treatment. Do not miss appointments for blood tests.
If you take more Methotrexate Teva than you should
In case of overdose, you may experience increased side effects. See also section 4.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Methotrexate Teva can have side effects that can be dangerous or life-threatening. During treatment, you should be alert for signs of side effects and tell your doctor about them.
Contact a doctor immediately if you experience any of the following side effects. You may need urgent medical attention.
- Unexplained shortness of breath, dry cough and fever (symptoms of lung disease).
- Sudden itching , rash ( hives ), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may make it difficult to breathe and swallow). It may also feel like you will faint (symptoms of an allergic reaction ).
- Yellowing of the skin or eyes, dark-colored urine (symptoms of hepatic impairment).
- Unexpected bleeding (eg bleeding gums, dark urine, blood in urine or vomiting) or unexpected bruising, black, tarry stools. This may be due to decreased coagulation ability or bleeding from the stomach or intestines due to low levels of platelets .
- An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals.
- Severe skin damage (skin detachment of the epidermis and superficial mucous membranes).
- Half-sided muscle weakness, seizures, dizziness. This may be a symptom ofbrain disease ( encephalopathy ) which can be life threatening.
Other side effects may occur
Very common (may affect more than 1 user in 10):
- Blood effects (eg low white blood cell levels )
- Loss of appetite, nausea, vomiting and abdominal pain
- Inflammation and ulceration and pain in the mouth and throat
- Elevated liver enzymes
Common (may affect up to 1 in 10 people):
- Shingles ( infection with Herpes zoster virus )
- Pneumonia
- Impact on bone marrow
- Anemia
- Deficiency of all types of blood cells in the blood (pancytopenia)
- Headache
- Diarrhea
- Liver damage during high-dose treatment for a long time
- Skin rash in the form of redness, itching and hives ,
- Renal impairment especially after treatment with high doses
- Feeling sick, tired
Uncommon (may affect up to 1 in 100 people):
- Cystitis , vaginitis, increased susceptibility to infection
- Infection is seen in patients with weakened immune systems
- Immunocompromised
- Acceleration of diabetes
- Eye inflammation
- Lymphoma ( tumor of the lymph nodes)
- Inflammation of the blood vessels in the hands and feet
- Lung disease ( lung fibrosis ).
- Bleeding or ulcers in the abdomen and intestines, inflammation of the intestines.
- Cirrhosis of the liver, fatty liver .
- Hair loss
- Osteoporosis , joint pain ( arthralgia ) , muscle aches ( myalgia ).
- Renal impairment, kidney damage, pain and difficulty emptying the bladder
- Fertility disorders in the form of defects when eggs and sperm are formed, low sperm count, menstrual disorders, infertility .
- Inflammation and ulceration of the vagina.
- Congenital malformations
- Decreased serum albumin levels seen in blood tests
- Fever
Rare (may affect up to 1 in 1,000 people )
- Blood poisoning, pharyngitis
- Anemia due to abnormal development of the red blood cells
- Mood swings
- Temporarily impaired cognitive function such as memory, learning and problem solving,
- Paralysis
- Impact on speech including dysarthria (difficulty speaking due to reduced muscle mobility) and aphasia (inability or impaired ability to use and / or understand language)
- Brain disease with high-dose treatment
- Epileptic seizures
- Eye irritation, blurred vision, blurred vision.
- Blood clots
- Gingivitis
- Black, tarry, foul-smelling feces containing decomposed blood.
- Liver damage
- Nodules, bruises, acne , skin rashes, skin ulcers, psoriasis flare-ups ,
- Elevated levels of nitrogen in the blood (azotemia), blood in the urine
- Abortion
- Stress fracture
Very rare (may affect up to 1 in 10,000 people ):
- Bacterial infection, usually in the lungs, with Nokardia bacteria.
- Fungal infection, usually in the lungs
- Herpes virus infection in the liver or with widespread blisters on the skin
- Widespread skin infection with abscesses
- Inflammation of the pericardium, accumulation of fluid in the pericardium
- Severe decrease in blood cells which may cause weakness, bruising or increase the risk of infection ( aplastic anemia ), low levels of neutrophils (a type of white blood cell ), swollen lymph nodes ( lymphadenopathy )
- Low levels of antibodies
- Decreased sex drive
- Disorder of sensory impressions such as sight, hearing, smell and touch.
- Transient blindness, loss of vision
- Rapid decay of tumor cells (tumor lysis syndrome)
- Lymphoproliferative disorders (abnormal growth of white blood cells )
- Prolonged lung disease with dry cough, shortness of breath and fever ( chronic interstitial lung disease)
- Bloody vomiting
- Reduction of liver size (liver atrophy), decay and death of liver cells (liver necrosis)
- Enlargement of the superficial blood vessels of the skin (telangiectasias)
- Impotence
- Sudden death
Has been reported: occurs in an unknown number of users:
- Bone damage in the jaw (as a result of abnormal growth of white blood cells ).
- Reddening and flaky skin
How to store Methotrexate Teva
Keep this medicine out of the sight and reach of children.
Store in the outer carton. Sensitive to light.
Used before the expiration date specified after Expiration Date / EXP. The expiration date is the last day of the specified month.
Medicines 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.
Contents of the pack and other information
Content declaration
- The active substance is methotrexate. 1 ml of concentrate contains 100 mg of methotrexate.
- The other ingredients are sodium hydroxide, hydrochloric acid and water for injections.
What the medicine looks like and contents of the pack
Stained glass vial.
Pack sizes:
1 x 10 ml, 10 x 10 ml and 1 x 50 ml
Not all pack sizes may be marketed.