PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluorouracil Injection 50 mg/ml,

solution for injection

Fluorouracil

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Fluorouracil Injection 50 mg/ml is and what it is used for

2. Before you use Fluorouracil Injection 50 mg/ml

3. How to use Fluorouracil Injection 50 mg/ml

4.    Possible side effects

5. How to store Fluorouracil Injection 50 mg/ml

6.    Further information

1.WHAT FLUOROURACIL INJECTION 50 MG/ML IS AND WHAT IT IS USED FOR

Fluorouracil is an anti-cancer drug.

Fluorouracil Injection 50 mg/ml, solution for injection, is used to treat the symptoms of many common cancers, particularly cancers of the large bowel and breast. It may be used in combination with other anti-cancer drugs.

2.BEFORE YOU USE FLUOROURACIL INJECTION 50 MG/ML

Do not use Fluorouracil Injection 50 mg/ml

•    if you are allergic (hypersensitive) to fluorouracil,

•    if you are pregnant or breast-feeding,

•    if you have been seriously weakened by long illness or other treatments (including radiotherapy) for your cancer,

•    if you are receiving treatment for chickenpox or shingles (Herpes zoster) with brivudine, sorivudine or similar substances, or have received such treatment in the last four weeks.

Take special care with Fluorouracil Injection 50 mg/ml

Before you receive fluorouracil tell your doctor if you

•    have suffered from angina (heart condition marked by sudden attacks of chest pain),

•    have a history of heart disease,

•    have ever experienced chest pain,

•    have had problems with your kidneys or liver,

•    take phenytoin for epileptic fits.

Your treatment will be first given to you in hospital. Before you are given fluorouracil you will have to have a blood test, and possibly other tests, so that your doctor can be sure that you can undergo fluorouracil treatment.

Tell your doctor if you experience any chest pain during treatment. Taking other medicines

Fluorouracil is known to interact with the following medicines:

•    allopurinol (used to treat high levels of uric acid),

•    leucovorin (also called folinic acid - used in cancer therapy and treatment of folic acid deficiency),

•    cimetidine (used to treat heartburn and gastrointestinal ulcers),

•    clozapine (used to treat schizophrenia),

•    methotrexate (used to treat cancer or autoimmune diseases),

•    metronidazole (used to treat infections),

•    phenytoin (used to treat epilepsy),

•    sorivudine (used to treat viral infections) or chemically related analogues (e.g. brivudine),

•    warfarin (used to prevent blood from clotting).

Tell your doctor if you are taking or have recently taken any of these medicines. Your doctor may decide that you can be given fluorouracil at the same time as these medicines.

Please also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use Fluorouracil Injection 50 mg/ml if you are pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

Fluorouracil may induce side effects such as nausea and vomiting. This may influence your ability to drive or use machines.

3.HOW TO USE FLUOROURACIL INJECTION 50 MG/ML

If you are using Fluorouracil Injection 50 mg/ml, solution for injection, at home, it is important to follow the instructions given to you by your doctor, nurse and pharmacist. If the container is damaged, and fluorouracil is spilt, you should contact your nurse or pharmacist. If fluorouracil comes into contact with your skin, wash the area with soap and water and contact your doctor, nurse or pharmacist. Do not clean up spilt fluorouracil without first contacting your nurse or pharmacist.

Fluorouracil is given by intravenous injection or infusion (drip or pump). If you are in hospital it may be given by intra-arterial infusion.

The dosage will depend on the condition being treated and whether or not other drugs are being administered. It will also depend on the results of your blood tests and the state of your health.

The usual fluorouracil dose is around 1 g (1000 mg) per day. Your treatment may be given daily or at weekly intervals initially. Further courses may be prescribed by your doctor according to your response to treatment.

If you take more Fluorouracil Injection 50 mg/ml

If you are given more fluorouracil than intended, consult your doctor immediately.

If you forget to take Fluorouracil Injection 50 mg/ml

If you miss a dose or if you are at home and have any trouble with your pump, contact your nurse or pharmacist as soon as possible.

If you stop using Fluorouracil Injection 50 mg/ml

When your course of fluorouracil is finished you may feel tired and experience some of the undesirable effects (see below) associated with fluorouracil treatment.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Fluorouracil Injection 50 mg/ml can cause side effects, although not everybody gets them.

Prior to commencement of treatment, your doctor will inform you of the expected benefits and potential risks of the use of Fluorouracil Injection 50 mg/ml, solution for injection.

If your bowel motions are bloodstained or if your mouth becomes very sore, tell your doctor immediately.

Common side effects are:

•    an increased risk of infections,

•    changes in the components of the blood,

•    inflammation of the eyes,

•    unsteady on feet,

•    increase in heart rate,

•    chest pain,

•    breathlessness,

•    diarrhoea,

•    nausea,

•    vomiting,

•    sore mouth,

•    hair loss,

•    reddening of palms of hands and soles of feet,

•    tiredness,

•    fever.

Diarrhoea and sickness are quite common, but your doctor may be able to give you medicine(s) to reduce this.

Hair loss is particularly common in women. The hair usually grows again when fluorouracil is stopped. Talk to your nurse if you are unhappy about this.

You may become unsteady on your feet or experience a quickening of your heart rate and breathlessness. Tell your doctor or nurse if this occurs.

If you experience chest pain tell your doctor or nurse.

Fluorouracil affects the components of blood and you will need to have blood tests during and after treatment with fluorouracil.

Less common side effects are:

•    severe infection,

•    increase in the level of uric acid in the blood,

•    allergic reaction,

•    headache,

•    seizure,

•    painful and/or watering eyes,

•    vision changes,

•    nose-bleeds,

•    wheezing,

5.HOW TO STORE FLUOROURACIL INJECTION 50 MG/ML

Do not store above 25 °C.

Do not refrigerate or freeze.

Keep the container in the outer carton.

Do not use Fluorouracil Injection 50 mg/ml after the expiry date which is stated on the carton.

Keep out of the reach and sight of children!

#

6. FURTHER INFORMATION

What Fluorouracil Injection 50 mg/ml contains

The active substance is fluorouracil. Each septum vial contains 10 ml (20 ml, 50 ml, 100 ml) of solution containing 500 mg (1000 mg, 2500 mg, 5000 mg) fluorouracil.

The other ingredients are: sodium hydroxide and water for injections.

What Fluorouracil Injection 50 mg/ml looks like and contents of the pack

Fluorouracil Injection 50 mg/ml, solution for injection, is a clear, colourless or almost colourless solution.

Fluorouracil Injection 50 mg/ml, solution for injection, is an aqueous solution for injection which is supplied in colourless glass vials. Fluorouracil Injection 50 mg/ml, solution for injection vials are supplied in packs containing one vial or ten vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

medac

Gesellschaft fur klinische Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany

Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany

This leaflet was last revised in 03/2014.

The following information is intended for medical or healthcare professionals only:

Instructions on how to store, handle, and dispose Fluorouracil Injection 50 mg/ml

Shelf life after preparing the solution for infusion ready for use Chemical and physical in-use stability of the solution diluted with glucose 5 % or sodium chloride 0.9 % injection has been demonstrated for 24 hours at a temperature not exceeding 25 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

If a precipitate has formed as a result of exposure to low temperatures, redissolve by heating to 40 °C accompanied by vigorous shaking.

Allow to cool to body temperature prior to use.

Handling and disposal

Preparation of solution for administration should be carried out in a designated handling area and working over a washable tray or disposable plastic-backed absorbent paper.

Suitable eye protection, disposable gloves, face mask and disposable apron should be worn. Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended).

All materials that have been utilised for dilution and administration should be disposed of according to standard procedures (incineration). Any solution remaining after first use should be discarded. Waste disposal procedures should take into account the cytotoxic nature of this substance.

81260-VP1GB

CA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluorouracil Injection 50 mg/ml,

solution for injection

Fluorouracil

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Fluorouracil Injection 50 mg/ml is and what it is used for

2.    Before you use Fluorouracil Injection 50 mg/ml

3.    Flow to use Fluorouracil Injection 50 mg/ml

4.    Possible side effects

5.    Flow to store Fluorouracil Injection 50 mg/ml

6.    Further information

1. WHAT FLUOROURACIL INJECTION 50 MG/ML IS AND WHAT IT IS USED FOR

Fluorouracil is an anti-cancer drug.

Fluorouracil Injection 50 mg/ml, solution for injection, is used to treat the symptoms of many common cancers, particularly cancers of the large bowel and breast. It may be used in combination with other anti-cancer drugs.

2. BEFORE YOU USE FLUOROURACIL INJECTION 50 MG/ML

Do not use Fluorouracil Injection 50 mg/ml

•    if you are allergic (hypersensitive) to fluorouracil,

•    if you are pregnant or breast-feeding,

•    if you have been seriously weakened by long illness or other treatments (including radiotherapy) for your cancer,

•    if you are receiving treatment for chickenpox or shingles (Plerpes zoster) with brivudine, sorivudine or similar substances, or have received such treatment in the last four weeks.

Take special care with Fluorouracil Injection 50 mg/ml

Before you receive fluorouracil tell your doctor if you

•    have suffered from angina (heart condition marked by sudden attacks of chest pain),

•    have a history of heart disease,

•    have ever experienced chest pain,

•    have had problems with your kidneys or liver,

•    take phenytoin for epileptic fits.

Your treatment will be first given to you in hospital. Before you are given fluorouracil you will have to have a blood test, and possibly other tests, so your doctor can be sure that you can undergo fluorouracil treatment.

Tell your doctor if you experience any chest pain during treatment.

Taking other medicines

Fluorouracil is known to interact with the following medicines:

•    allopurinol (used to treat high levels of uric acid),

•    leucovorin (also called folinic acid - used in cancer therapy and treatment of folic acid deficiency),

•    cimetidine (used to treat heartburn and gastrointestinal ulcers),

•    clozapine (used to treat schizophrenia),

•    methotrexate (used to treat cancer or autoimmune diseases),

•    metronidazole (used to treat infections),

•    phenytoin (used to treat epilepsy),

•    sorivudine (used to treat viral infections) or chemically related analogues (e.g. brivudine),

•    warfarin (used to prevent blood from clotting).

Tell your doctor if you are taking or have recently taken any of these medicines. Your doctor may decide that you can be given fluorouracil at the same time as these medicines.

Please also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use Fluorouracil Injection 50 mg/ml if you are pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

Fluorouracil may induce side effects such as nausea and vomiting. This may influence your ability to drive or use machines.

3. HOW TO USE FLUOROURACIL INJECTION 50 MG/ML

If you are using Fluorouracil Injection 50 mg/ml, solution for injection, at home, it is important to follow the instructions given to you by your doctor, nurse and pharmacist. If the container is damaged, and fluorouracil is spilt, you should contact your nurse or pharmacist. If fluorouracil comes into contact with your skin, wash the area with soap and water and contact your doctor, nurse or pharmacist. Do not clean up spilt fluorouracil without first contacting your nurse or pharmacist.

Fluorouracil is given by intravenous injection or infusion (drip or pump). If you are in hospital it may be given by intra-arterial infusion.

The dosage will depend on the condition being treated and whether or not other drugs are being administered. It will also depend on the results of your blood tests and the state of your health.

The usual fluorouracil dose is around 1 g (1000 mg) per day. Your treatment may be given daily or at weekly intervals initially. Further courses may be prescribed by your doctor according to your response to treatment.

If you take more Fluorouracil Injection 50 mg/ml

If you are given more fluorouracil than intended, consult your doctor immediately.

If you forget to take Fluorouracil Injection 50 mg/ml

If you miss a dose or if you are at home and have any trouble with your pump, contact your nurse or pharmacist as soon as possible.

If you stop using Fluorouracil Injection 50 mg/ml

When your course of fluorouracil is finished you may feel tired and experience some of the undesirable effects (see below) associated with fluorouracil treatment.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Fluorouracil Injection 50 mg/ml can cause side effects, although not everybody gets them.

Prior to commencement of treatment, your doctor will inform you of the expected benefits and potential risks of the use of Fluorouracil Injection 50 mg/ml, solution for injection.

If your bowel motions are bloodstained or if your mouth becomes very sore, tell your doctor immediately.

Common side effects are:

•    an increased risk of infections,

•    changes in the components of the blood,

•    inflammation of the eyes,

•    unsteady on feet,

•    increase in heart rate,

•    chest pain,

•    breathlessness,

•    diarrhoea,

•    nausea,

•    vomiting,

•    sore mouth,

•    hair loss,

•    reddening of palms of hands and soles of feet,

•    tiredness,

•    fever.

Diarrhoea and sickness are quite common, but your doctor may be able to give you medicine(s) to reduce this.

Hair loss is particularly common in women. The hair usually grows again when fluorouracil is stopped. Talk to your nurse if you are unhappy about this.

You may become unsteady on your feet or experience a quickening of your heart rate and breathlessness. Tell your doctor or nurse if this occurs.

If you experience chest pain tell your doctor or nurse.

Fluorouracil affects the components of blood and you will need to have blood tests during and after treatment with fluorouracil.

Less common side effects are:

•    severe infection,

•    increase in the level of uric acid in the blood,

•    allergic reaction,

•    headache,

•    seizure,

•    painful and/or watering eyes,

•    vision changes,

•    nose-bleeds,

•    wheezing,

•    stomach ulceration and bleeding,

•    liver problems,

•    skin and nail changes,

•    pain or discoloration of the vein where Fluorouracil Injection 50 mg/ml is administered,

•    confusion,

•    abnormal movements,

•    blood circulation disorders.

Fluorouracil treatment may cause you to become confused; however this is reversible when treatment is stopped. Tell your doctor immediately if this occurs.

Blood circulation disorders can lead to e.g. numbness or paleness (extremities), pain (digestive tract), paralysis or speech difficulties (brain).

You may experience one or several of these symptoms during therapy or after your fluorouracil treatment: be sure to inform your doctor if you do.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE FLUOROURACIL INJECTION 50 MG/ML

Do not store above 25 °C.

Do not refrigerate or freeze.

Keep the container in the outer carton.

Do not use Fluorouracil Injection 50 mg/ml after the expiry date which is stated on the carton.

Keep out of the reach and sight of children!

6. FURTHER INFORMATION

What Fluorouracil Injection 50 mg/ml contains

The active substance is fluorouracil. Each septum vial contains 10 ml (20 ml, 50 ml, 100 ml) of solution containing 500 mg (1000 mg, 2500 mg, 5000 mg) fluorouracil.

The other ingredients are: sodium hydroxide and water for injections.

What Fluorouracil Injection 50 mg/ml looks like and contents of the pack

Fluorouracil Injection 50 mg/ml, solution for injection, is a clear, colourless or almost colourless solution.

Fluorouracil Injection 50 mg/ml, solution for injection, is an aqueous solution for injection which is supplied in colourless glass vials.

Fluorouracil Injection 50 mg/ml, solution for injection vials are supplied in packs containing one vial or ten vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

medac

Gesellschaft fur klinische Spezialpraparate mbFI Theaterstr. 6 22880 Wedel Germany

Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate mbFI Theaterstr. 6 22880 Wedel Germany

This leaflet was last revised in 03/2014.

The following information is intended for medical or healthcare professionals only:

Instructions on how to store, handle, and dispose Fluorouracil Injection 50 mg/ml

Shelf life after preparing the solution for infusion ready for use Chemical and physical in-use stability of the solution diluted with glucose 5 % or sodium chloride 0.9 % injection has been demonstrated for 24 hours at a temperature not exceeding 25 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

If a precipitate has formed as a result of exposure to low temperatures, redissolve by heating to 40 °C accompanied by vigorous shaking. Allow to cool to body temperature prior to use.

Handling and disposal

Preparation of solution for administration should be carried out in a designated handling area and working over a washable tray or disposable plastic-backed absorbent paper.

Suitable eye protection, disposable gloves, face mask and disposable apron should be worn. Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended).

All materials that have been utilised for dilution and administration should be disposed of according to standard procedures (incineration).

Any solution remaining after first use should be discarded. Waste disposal procedures should take into account the cytotoxic nature of this substance.

81250-VP1GB