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Product

Therapeutic Category

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5-fluorouracil

Fluorouracil is an anti-cancer medication.


Oncology Name

5-fluorouracil


Strength

50mgmg/Ml, 25MG/ml(10Ml)


Therapeutic Category

Multiple keratoses & Chronic lymphocytic leukemia


Storage

Store below 25°C. Do not refrigerate or freeze.


adobe-pdf-logoProduct Insert(PIL)

adobe-pdf-logoPrescribing Information(SPC)


Product Description

Product Overview


WHAT FLUOROURACIL INJECTION IS AND WHAT IT IS USED FOR

The name of medicine is ‘Fluorouracil 50 mg/ml, Solution for Injection or Infusion’ but in the rest of the leaflet it will be called ‘Fluorouracil Injection’.

What Fluorouracil Injection is
Fluorouracil Injection contains the active ingredient Fluorouracil. It is an anti-cancer medication.

What Fluorouracil Injection is used for

Fluorouracil Injection is used to treat many common cancers, particularly cancers of the large bowel, oesophagus, pancreas, stomach, head and neck and breast. It may be used in combination with other anti-cancer medicines and radiotherapy.

WHAT YOU NEED TO KNOW BEFORE YOU USE FLUOROURACIL INJECTION

Do not use Fluorouracil Injection
•if you are allergic (hypersensitive) to Fluorouracil or any of the other ingredients of Fluorouracil Injection
•if you have serious infections (e.g. Herpes zoster, chickenpox)
•if your tumour is non-malignant,if you have been very much weakened by long illness.
•if your bone marrow has been damaged by other treatments(including radiotherapy).
•if you are taking brivudin, sorivudin and analogues (an antiviral drug)
•if you are pregnant or breast feeding women
•if you have serious impaired liver function
•if you are homozygotic for dihydropyrimidine dehydrogenase (DPD) enzyme

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Fluorouracil Injection.
Take special care with Fluorouracil Injection:
•if the number of cells in your blood become too low (you will have blood tests to check this)
•if you have oral ulceration, fever or hemorrhage at any site or weakness (these symptoms may be the consequence of the very low number of cells in your blood),
•if you have any problems with your kidneys
•if you have any problems with your liver including jaundice (yellowing of the skin)
•if you problem with your heart. Tell your doctor if you experience any chest pain during treatment.
•if you have reduced activity/deficiency of the enzyme DPD (dihydropyrimidine dehydrogenase).
•if you have had high-dose pelvic radiation.
•if you have gastrointestinal side effects (stomatitis, diarrhoea, bleeding from the G.I. tract) or hemorrhage at any site.

Other medicines and Fluorouracil Injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
•Methotrexate (an anti-cancer medicine)
•Metronidazole (an antibiotic)
•Calcium leucovorin (also called calcium folinate – used to reduce the harmful effects of anti-cancer medicines)
•Allopurinol (used to treat gout)
•Cimetidine (used to treat stomach ulcers)
•Warfarin (used to treat blood clots)
•Interferon alpha 2a; brivudin, sorivudin and analogues (an antiviral)
•Cisplatin (an anticancer medicine)
•Phenytoin (used to control epilepsy/fits and irregular heart rhythm)
•Vaccines,Vinorelbine (an anti-cancer medicine),Cyclophosphamide (an anti-cancer medicine)
•Levamisol (medicine used to treat worm infection)
•Tamoxifen (an anti-cancer medicine)

The above medicines affect the effect of Fluorouracil.

Pregnancy, breast-feeding and fertility
You must not take this drug if you are pregnant or planning to become pregnant. If you are a women of childbearing potential you must use an effective method of contraception while taking this drug and atleast for 6 months afterwards. If pregnancy occurs during your treatment you must inform your doctor and should use genetic counsellation.

Since it is not known whether fluorouracil passes into breast milk, breast-feeding must be discontinued if the mother is treated with Fluorouracil Injection.

If you are a man you should avoid father a child during and for up to 6 months following cessation of treatment with Flurouracil Injection. You are advice to sought conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Flurouracil Injection.

Ask your doctor for advice before taking any medicine.

Driving and using machines
Do not drive or use machines because fluorouracil may produce side effects like nausea and vomiting. It can also produce adverse event on your nervous system and visual changes. If you experience any of this effect, do not drive or use any tools or machines, it may impair your ability to drive or use machines.

HOW TO USE FLUOROURACIL INJECTION

The dose of medicine given to you will depend on your medical condition, your body weight, if you have had recent surgery and how well your liver and kidneys are working. It will also depend on the results of your blood tests. Your first course of treatment may be given daily or at weekly intervals. Further courses may be given according to your response to treatment. You may also receive treatment in combination with radiotherapy.

The medicine may be diluted with glucose solution, sodium chloride solution or Water for injections before it is given to you. It will be given into a vein either as a normal injection or a slow injection via a drip (infusion).

If you are given more Fluorouracil Injection than you should
As this medicine will be given to you whilst you are in hospital is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.

You will need to have blood tests during and after treatment with Fluorouracil Injection to check the levels of cells in your blood. Treatment may have to be stopped if the level of white blood cells drops too low.

Nausea, vomiting, diarrhoea, severe mucositis and gastrointestinal ulceration and bleeding may occur if you have too much fluorouracil. If you have any further question on the use of this product ask your doctor.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, tell your doctor immediately:
•severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.
•chest pains,your bowel motions are bloodstained or black,your mouth becomes sore or develops ulcers
•numbness, tingling or tremor in the hands or feet,quickening of your heart rate and breathlessness
•feeling confused or feeling unsteady on your feet, coordination problems in arms and legs, thinking/speech difficulties, vision/memory problems

Very common side effects (more than 1 in 10 patients):
•Ischemic ECG abnormalities(an insufficient supply of blood to an organ, usually due to a blocked artery)
•Neutropenia (an abnormally low level of neutrophils in the blood)
•Leucopenia (an abnormally low number of white blood cells in the circulating blood)
•Anemia (condition in which the circulating red cell mass is insufficient)
•Decrease in the production of blood cells
•High fever and a sharp drop in circulating granular white blood
•Inflammation of the rectum or anus The inflammation of the lining of the mouth and
•Loss of appetite
•Pharyngitis (inflammation of the mucous membranes lining the
•Watery diarrhoea
•Nausea,Delayed wound healing,Bleeding from the nose
•Hair loss,Hand-foot syndrome is a toxic skin
•General weakness,Inflammation of the mucous
•lining of any of the structures in the mouth,Increase in uric acid in the blood
•Inflammation of the esophagus,Tiredness

Common side effects (less than 1 in 10 patients):
•Angina pectoris (Severe pain in the chest associated with an insufficient supply of blood to the heart)

Uncommon side effects (less than 1 in 100 patients):
•Abnormality in the heart’srhythm
•Myocarditis (inflammatory disease of the heart muscle)
•Symptoms of Parkinson’s disease (a progressive movement disorder marked by tremors, rigidity, slow movements)
•Rhythmic motions of the eyes,Dehydration,Cardiac shock,Heart attack,Heart insufficiency
•Bacterial infection in the bloodstream or body tissues
•Heart insufficiency,Pyramidal signs
•Myocardial ischemia (a loss of oxygen to the heart muscle)
•Dilative cardiomyopathy (a type of heart disease in which the heart muscle is abnormally enlarged, thickened and/or stiffened)
•Sleepiness,Gastrointestinal ulceration and bleeding, casting off the skin
•Feeling of being sick,Inflammation of the skin
•Skin alterations e.g. dry skin, fissure erosion, Redness of the skin, pruritic maculopapular rash (rash that had originated on the lower extremities and had progressed to the arms, and then to the chest)
•A skin eruption accompanying certain infectious diseases
•A layer or mass of dead tissue separated from surrounding living tissue, as in a wound, a sore, or an inflammation.

Rare side effects (more than 1 in 10,000 but less than 1 in 1,000 patients):
•Insufficient blood flow in brain, intestine and peripheral organs
•Discoloration of the fingers, toes, and occasionally other areas
•Generalized allergic reaction
•Swelling (inflammation) of a vein caused by a blood clot
•Severe, whole-body allergic reaction (anaphylaxis)
•Development of a clot within blood vessels, can occur in arteries or veins
•systemic vasodilation (widening of blood vessels) which results in low blood pressure
•Confusion
•Increase of T4 (total thyroxin), increase of T3 (total trijodthyronin

Very rare side effects (less than 1 in 10,000 patients):
Cardiac arrest (sudden cessation of heartbeat and cardiac function)
•Sudden cardiac death (unexpected death due to heart problems)
•Symptoms of leucoencephalopathy (diseases affecting the white substance of the brain) including
•Ataxia (loss of the ability to coordinate muscular movement)
•Acute cerebellar syndrome,Difficulty in articulating words
•Confusion,Mental confusion or impaired awareness especially regarding to time, place or identity
•Partial or total loss of the ability to communicate verbally or using written words.
•Abnormal muscular weakness or fatigue
•Convulsion or coma in patients receiving high doses of 5-fluorouracil and in patients with Dihydropyrimidine dehydrogenase deficiency
•Kidney failure,Damage of liver cells (cases with fatal outcome

Not Known (Frequency can not be estimated):
•Fever
•Numbness or weakness of the arms and legs

HOW TO STORE FLUOROURACIL INJECTION

•Keep this medicine out of the sight and reach of children.
•Do not use this medicine after the expiry date, which is stated on the Label and carton after EXP.
The expiry date refers to the last day of that month.
•Store below 25°C. Do not refrigerate or freeze.
•Keep container in the outer carton in order to protect from light.
•Single use only. Discard any unused portion.

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