50 mg / ml solution for injection
fluorouracil

What Fluorouracil Teva is and what it is used for

Fluorouracil Teva contains the active substance fluorouracil. It is a cancer drug.

Fluorouracil Teva is used to treat many common cancers, such as colon cancer, esophageal cancer, stomach cancer, and breast cancer.

Fluorouracil contained in Fluorouracil Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Fluorouracil Teva

Do not use Fluorouracil Teva

  • if you are allergic to fluorouracil or any of the other ingredients of this medicine (listed in section 6).
  • if you have a serious infection (eg shingles, chickenpox).
  • if you are severely debilitated by long-term illness.
  • if your bone marrow has been damaged by other treatments (including radiation therapy).
  • if your tumor is not malignant.
  • if you have severe hepatic impairment.
  • if you are being treated with, or within the last 4 weeks have been treated with brivudine to treat herpes zoster (chickenpox or shingles ).
  • if you have identical pairs of genes for the enzyme DPD (dihydropyrimide dehydrogenase).
  • if you know you are completely devoid of the activity of the enzyme dihydropyrimide dehydrogenase (DPD).
  • if you are pregnant or breastfeeding.

Warnings and cautions

Talk to your doctor or nurse before using Fluorouracil Teva.

Take special care with Fluorouracil Teva:

  • if you have too low several white blood cells and platelets (you will have to take blood samples to check this).
  • if you have a sore mouth, fever, or any bleeding or if you are weakened (these symptoms may be due to your blood containing a very low number of blood cells ).
  • if you have kidney problems.
  • if you have liver problems.
  • if you have heart problems. Tell your doctor if you feel chest pain during treatment.
  • if you know that the enzyme dihydropyrimide dehydrogenase (DPD) is partially inactive in you. 
  • if the enzyme a dihydropyrimide dehydrogenase (DPD) is partially or completely inactive in someone in your family
  • if you have received high doses of radiation in the pelvic area.
  • if you have gastrointestinal side effects (diarrhea, gastrointestinal bleeding), inflammation of the oral mucosa, or bleeding elsewhere.
  • if you experience nerve damage such as lack of coordination of muscle movements or tremors.
  • if you are of childbearing age. Women and men of childbearing potential must use effective contraception during treatment and 6 months afterward. See also section “Pregnancy, breast-feeding and fertility”.

DPD Deficiency: DPD deficiency is a congenital condition that is not usually associated with health problems unless you use certain medications. If you have DPD deficiency and are taking Fluorouracil Teva, you have an increased risk of serious side effects (listed in section 4 Possible side effects ). It is recommended that you be tested for DPD deficiency before starting treatment. If you have no enzyme activity, do not take Fluorouracil Teva. If you have reduced enzyme activity ( partial deficiency), your doctor may prescribe a lower dose. Serious and life-threatening side effects can still occur even if your test result for DPD deficiency is negative. 

Contact healthcare professionals immediately if you experience the following signs or symptoms: new onset of confusion, disorientation or otherwise altered mental status, problems with balance or coordination, visual disturbances. These can be signs of brain disease that can lead to coma and death if left untreated.

Avoid prolonged exposure to sunlight when treated with this medicine as fluorouracil may increase sensitivity to sunlight. Radiation just before or after treatment with fluorouracil can cause increased pigmentation on skin areas exposed to sunlight.

Other medicines and Fluorouracil Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is very important, as taking more than one medicine at the same time may intensify or weaken the effect of the medicines. Show larger

You must not take brivudine (antiviral medicine used to treat shingles or chickenpox) while you are being treated with fluorouracil (including during the rest period when you are not using fluorouracil). If you have taken brivudine, you must wait at least 4 weeks after stopping brivudine before starting fluorouracil treatment. See also section “Do not use Fluorouracil Teva”.

The effect of Fluorouracil Teva may be affected by certain medicines containing the following active substances:

  • cyclophosphamide (an anticancer medicine)
  • vincristine (a medicine used to treat cancer)
  • methotrexate, (an anticancer medicine)
  • cisplatin (an anticancer medicine)
  • doxorubicin (an anticancer medicine)
  • metronidazole (an antibiotic )
  • calcium leucovorin (also called calcium folinate – used to reduce the harmful effects of anti-cancer drugs)
  • interferon alfaallopurinol (used to treat gout )
  • folic acid
  • cimetidine (used to treat stomach ulcers )

Fluorouracil Teva may affect the effectiveness of certain medicines containing the following active substances:

  • phenytoin (used to treat epilepsy/seizures) as combined treatment with fluorouracil may increase the levels of phenytoin in the blood.
  • warfarin (used to counteract blood clots). Combination with fluorouracil may affect the breakdown of warfarin so that the warfarin dose needs to be lowered.

Other medicines in combination with Fluorouracil Teva

  • levamisole (used to treat machine infection), in combination with Fluorouracil Teva, may cause liver damage.
  • clozapine (an antipsychotic drug) in combination with Fluorouracil Teva should be avoided due to the increased risk of the severe reduction in granulocytes, a type of white blood cell vinorelbine (a medicine used to treat cancer) in combination with Fluorouracil Teva and folic acid can cause painful damage and inflammation of the oral mucosa.
  • tamoxifen (a medicine used to treat cancer) in combination with cyclophosphamide, methotrexate, and Fluorouracil Teva may increase the risk of blood clots.
  • Thiazide diuretics (diuretics, antihypertensive drugs) in addition to a combination of cyclophosphamide, methotrexate, and Fluorouracil Teva may result in a decrease in the number of granulocytes (a type of white blood cell ).
  • Mitomycin (cytotoxic antibiotic ) in combination with Fluorouracil Teva may reduce red blood cell counts and acute renal failure.

People treated with Fluorouracil Teva are at risk of developing a weakened immune system. Vaccination with live vaccines should therefore be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

You must not use this medicine if you are pregnant or planning to become pregnant.

If you are a woman of childbearing potential, you must use an effective method of contraception while you are taking this medicine and for at least 6 months afterward. If you become pregnant during treatment, tell your doctor.

Breast-feeding

Do not breast-feed while you are being treated with Fluorouracil Teva. The medicine can be passed on to the baby via breast milk.

Fertility

If you are a man, you should avoid becoming the father of a child during treatment and for 6 months afterward. You are advised to apply for sperm preservation before treatment as there is a risk that treatment with Fluorouracil Teva will cause persistent infertility.

Driving and using machines

Fluorouracil Teva can cause side effects such as nausea and vomiting. It can also have unwanted effects on the nervous system and vision changes. You should not drive or use machines if you have these symptoms.

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.

Fluorouracil Teva contains sodium

This medicine contains 41 mg sodium (the main ingredient in common table salt) per 5 ml vial, 82 mg sodium per 10 ml vial, 164 mg sodium per 20 ml vial, and 821 mg sodium per 100 ml vial. This corresponds to 2%, 4%, 8%, and 41% respectively of the daily recommended maximum intake of sodium for an adult.

3. How to use Fluorouracil Teva

The dose of medicine you receive depends on your medical condition, your body weight, whether you have recently had surgery, and how well your liver and kidneys are functioning. It also depends on your blood test results. Your first course of treatment may consist of one dose a week or daily for 3-5 consecutive days.

The medicine can be diluted with a glucose solution, sodium chloride solution, or water for injections before you get it. You usually receive the medicine in a vein, either as a regular injection or as a slow drip ( infusion ).

Additional treatment regimens may be given depending on how you respond to the treatment.

If you take more Fluorouracil Teva then you should

This medicine is given to you under medical supervision, so it is unlikely that you will get too little or too much. If you still have questions, or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Blood samples will be taken during and after treatment with Fluorouracil Teva to check the number of white blood cells. Treatment may need to be stopped if the number of white blood cells becomes too low.

The following symptoms may occur in patients who have received too much fluorouracil: Nausea, vomiting, diarrhea, severe mucositis (ulcers in the oral mucosa), and ulcers or bleeding in the gastrointestinal tract. If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following occur, tell your doctor or healthcare provider immediately:

  • severe allergic reaction – you may suddenly have an itchy rash ( hives ), swelling of your hands, feet, ankles, face, lips, mouth, or throat (which may make it difficult to swallow or breathe) and you may feel dizzy
  • chest pain
  • respiratory distress
  • your stool is bloodstained or black
  • you get a sore mouth or a sore mouth
  • numbness, tingling, or trembling in the hands or feet
  • heart rate increases and you feel short of breath
  • you feel confused or unsteady on your feet, have problems with coordination in arms and legs, difficulty thinking / speaking, problems with vision/memory
  • If severe stomatitis (sores in your mouth and/or throat), mucositis, diarrhea, neutropenia (increased risk of infections ), or neurotoxicity occurs during the first treatment cycle, this may be due to DPD deficiency (see section 2 Warnings and precautions).

These are serious side effects. You may need urgent medical attention.

Very common (may affect more than 1 user in 10):

  • neutropenia (abnormally low neutrophil leukocyte s, a type of white blood cells in the blood)
  • leukopenia (abnormally low white blood cell count, leukocytes, in the blood)
  • thrombocytopenia (abnormally low number of platelets, platelets, blood)
  • agranulocytosis (abnormally low number of granulocytes, a type of white blood cell )
  • anemia (decreased number of red blood cells which can lead to fatigue and lack of energy)
  • pancytopenia (drastic reduction or cessation of bone marrow blood cell production)
  • bronchospasm (spasm of the trachea)
  • weakened immune system with increased risk of infection
  • hyperuricemia (increased level of uric acid in the blood)
  • heart problems ( ECG changes)
  • mucositis (oral inflammation, esophagitis, pharyngitis, inflammation of the rectum or rectum)
  • loss of appetite
  • vomiting
  • diarrhea
  • nausea
  • hair loss
  • hand-foot syndrome (a harmful skin reaction that can cause redness, tenderness, and possible scaling of the palms and soles of the feet)
  • delayed wound healing
  • nosebleeds
  • fatigue
  • general weakness
  • infection is
  • fatigue
  • lack of energy

Common (may affect up to 1 in 10 people):

  • angina pectoris
  • skin changes, eg dry skin, cracks, flaky skin (scaling), redness, itchy maculopapular rash (a rash that begins on the legs and continues to the arms and then to the chest) skin rash, hives, photosensitivity, dark spots on the skin ( hyperpigmentation ), dark streaks on the skin (streaked hyperpigmentation ) or light skin areas ( depigmentation ) near veins
  • cerebral ataxia (lack of movement coordination due to damage or disease of the cerebellum)
  • redness and hyperpigmentation (dark spots on the skin) along the vein used for injection a
  • low white blood cell count with fever

Uncommon (may affect up to 1 in 100 people):

  • abnormal heart rhythm
  • heart attack
  • cardiac ischemia (decreased oxygen supply to the heart muscle)
  • myocarditis ( inflammation of the heart muscle)
  • heart failure
  • dilated cardiomyopathy (a heart disease in which the heart muscle is abnormally enlarged, thickened, and/or frozen)
  • the shock caused by severe heart failure
  • low blood pressure
  • dehydration
  • bacterial infection in blood circulation or body tissue
  • ulcers or bleeding in the gastrointestinal tract, flaking of the skin
  • damage to liver cells
  • disturbed sperm or egg production
  • nail changes (eg blue pigmentation near the surface, hyperpigmentation, deformed nails) pain and thickening of the nail bed a
  • involuntary twitching eye movements
  • headache
  • the feeling of imbalance and instability
  • symptoms similar to those of Parkinson’s disease (a movement disorder characterized by tremors, stiffness, and slow movements)
  • pyramidal symptoms (such as loss of fine motor skills and reflex disorders)
  • feeling of well-being
  • somnolence
  • increased tear flow
  • dimsyn
  • disturbance in the eye movements
  • optic neuritis (visual disturbance caused by inflammation of the optic nerve )
  • double vision
  • decreased visual acuity
  • extreme light sensitivity and avoidance of sunlight and brightly lit places
  • conjunctivitis ( inflammation or redness of the membrane (conjunctiva) that covers the white of the eye and the back of the eyelid)
  • eye disease with chronic inflammation of the eyelid rim
  • the lower eyelid is facing outwards
  • blocked tear ducts

Rare (may affect up to 1 in 1,000 people):

  • general allergic reaction
  • severe allergic reaction involving the whole body ( anaphylaxis )
  • dilation of blood vessels throughout the body resulting in a drop in blood pressure
  • increase in thyroid hormones T4 ( thyroxine ) and T3 (triiodothyronine)
  • insufficient blood supply to the brain, intestines, and peripheral organs
  • discoloration of fingers and toes and in some cases also other parts of the body, due to decreased blood flow
  • the occurrence of a blood clot in artery or vein
  • swelling ( inflammation ) in a vein
  • disorientation, mental confusion, or impaired consciousness, in particular about time, space, and identity

Very rare (may affect up to 1 in 10,000 people):

  • sudden cardiac death (unexpected death due to heart problem)
  • damage to liver cells (in rare cases with fatal outcome)
  • slow increasing degradation of the small bile ducts
  • inflammation of the gallbladder
  • symptoms such as leukoencephalopathy (a disease affecting the white matter of the brain) with loss of muscle coordination ability
  • acute cerebellar syndrome (difficulty coordinating muscle movements)
  • difficulty articulating words
  • abnormal muscle weakness or muscle fatigue
  • partial or total loss of the ability to communicate verbally or use written language
  • seizures or coma in patients receiving high- dose fluorouracil and in patients with a deficiency of the enzyme dihydropyrimide dehydrogenase (DPD)
  • kidney failure
  • cardiac arrest

Has been reported (occurs in an unknown number of users):

  • fever
  • numbness or weakness in the arms and legs may occur
  • hyperammonemia encephalopathy (impaired function in the brain due to increased levels of ammonia)

Numbness or weakness in the arms and legs may occur

5. How to store Fluorouracil Teva

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C. Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

Completed solutions should be used within 12 hours.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is fluorouracil. 1 ml solution for injection contains 5 ‑ fluorouracil 50 mg.
  • The other ingredients are sodium hydroxide and water for injections.

What the medicine looks like and the contents of the pack

Vials: 5 ml, 10 ml, 20 ml, and 100 ml.

Ampoules: 5 ml and 10 ml

Infusion bottles: 100 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Teva AB

Box 1070

251 10 Helsingborg

Muhammad Nadeem

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