What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL11184/0138.

Fungizone 50mg Powder for Sterile Concentrate

Package leaflet: Information for the patient

Fungizone 50mg Powder for Sterile Concentrate

Amphotericin B

Please read all of this leaflet carefully before you start taking your medicine because it contains important information for you.

  • Please keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet;

1. What Fungizone 50mg Powder for Sterile Concentrate is and what it is used for
2. What you need to know before being given your medicine
3. How you will be given your medicine
4. Possible Side Effects
5. How to store your medicine
6. Contents of the pack and other information

1. What Fungizone 50mg Powder for Sterile Concentrate is and what it is used for

The name of your medicine is Fungizone 50mg Powder for Sterile Concentrate. It contains the active ingredient amphotericin B, which belongs to a group of medicines called anti-fungal antibiotics.

Fungizone 50mg Powder for Sterile Concentrate is used to treat serious infections caused by yeasts and certain fungi.

2. What you need to know before being given your medicine

You should not be given this medicine if you:

  • are allergic (hypersensitive) to amphotericin or any of the other ingredients in this medicine.

Take special care with Fungizone 50mg Powder for Sterile Concentrate if you:

  • have any kidney or liver problems

If this applies to you, talk to your doctor before being given Fungizone 50mg Powder for Sterile Concentrate.

Taking other medicines

Always tell your doctor or pharmacist about other medicines you may be taking or have recently taken including those obtained without a prescription.

This is especially important if you are taking:

  • any anti-cancer medicines (e.g. methotrexate, cyclophosphamide, cisplatin)
  • any medicines which affect your kidney function (e.g. gentamicin, vancomycin)
  • any muscle relaxants (e.g. baclofen, dantrolene, diazepam)
  • any corticosteroids (e.g. beclamethasone) or corticotrophins
  • any medicines to treat heart failure (e.g. digoxin)
  • a medicine called flucytosine used to treat fungal infections

If you have recently had a specific type of transfusion called a leukocyte transfusion, please tell your doctor.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, or if you are breast-feeding, speak to your doctor before being given Fungizone 50mg Powder for Sterile Concentrate.

Driving and using machinery

Fungizone 50mg Powder for Sterile Concentrate should not affect your ability to drive.

Fungizone contains amphotericin B:

This medicinal product also contains less than 1mmol sodium (23mg) per dose, i.e. essentially ‘sodium-free’.

3. How you will be given your medicine

Fungizone 50mg Powder for Sterile Concentrate will be given to you in hospital by a doctor or nurse.

The daily dose is 0.25-1.0 mg per kg of your body weight. In some cases your doctor may consider it necessary to increase this dose to 1.5 mg/kg. If you are given too much of this medicine, you may experience life-threatening heart or lung problems. If you have any concerns about the amount of medicine you have been given, please speak to the person who has given you the infusion for further advice.

It will be given to you slowly through a drip into a vein (an infusion). This will usually take between 2-6 hours.

A test dose may be given before you start treatment with this medicine. Several months of treatment is usually necessary to get rid of the infection completely.

In some patients, the doctor may give other medicines to help reduce other unwanted effects.

These include:

  • medicines to help stop you feeling sick or being sick,
  • aspirin,
  • an anti-allergy medicine (antihistamine),
  • a corticosteroid,
  • a medicine to stop your blood from clotting (anticoagulant).

4. Possible side effects

Like all medicines, Fungizone 50mg Powder for Sterile Concentrate can cause side effects, although not everybody gets them.

Treatment with Fungizone 50mg Powder for Sterile Concentrate may affect your blood cells, kidneys, liver or heart. For this reason, your doctor will want to monitor all these things before, during and after giving you this medicine.

If you notice any of the following, contact your doctor immediately:

  • swelling of the face, lips, or tongue
  • skin reactions including severe rash and itching
  • difficulty breathing

As these may be signs of an allergic reaction.

There have been reports of blood disorders which may be characterised by fever or chills, sore throat, ulcers in the mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises.

Tell your doctor immediately if you notice any of these symptoms.

Fungizone 50mg Powder for Sterile Concentrate can cause kidney problems. If you notice that you are more thirsty, need to go to the toilet more frequently, or the volume of urine increases, tell your doctor immediately.

Patients treated with Fungizone have reported the following side effects:

Very common: may affect more than 1 in 10 people

  • Feeling sick and being sick
  • High temperature (sometimes with shaking chills)
  • Decrease in potassium in the blood
  • Increase in creatinine in the blood
  • Kidney problems which may lead to abnormal urine production, kidney stones and imbalances of substances in the blood (e.g. potassium)
  • Difficulty in breathing
  • Low blood pressure

Common: may affect up to 1 in 10 people

  • Anaemia-low level of red blood cells
  • Abnormal liver function shown by abnormal liver function tests
  • Decreased magnesium in the blood
  • Headache
  • Diarrhoea
  • Rash
  • Decreased appetite
  • Sudden loss of kidney function
  • Pain at the injection site with or without swollen veins or a blood clot

Uncommon: may affect up to 1 in 100 people

  • A rare form of anaemia where there is a low level of white blood cells
  • Low counts of white blood cells in the blood
  • Low counts of platelets in the blood
  • Irregular heartbeat, sometime severe
  • Impaired sensation or movement
  • Spasm of the lungs
  • Pain in the stomach
  • Yellowing of the skin and eyes
  • Pain in muscles
  • Impaired or abnormal kidney function
  • Flushing

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

  • Abnormal blood clotting
  • High counts of white blood cells in the blood
  • Allergic reaction
  • Increased potassium in the blood
  • Altered mental state
  • Convulsion
  • Vision blurred or double vision
  • Hearing loss, ringing in the ears
  • Short-lived spinning sensation (vertigo)
  • Heart attack or heart not working properly
  • High blood pressure
  • Shock
  • Inflammation of the lungs and fluid in the lungs
  • Stomach cramps, indigestion
  • Bleeding in intestines, resulting in black faeces
  • Loss of liver function
  • Rash- characterized by a flat red area on the skin that is covered with small bumps
  • Itching
  • Flu like symptoms followed by a painful red or purple spreading rash
  • Skin conditions including skin coming off in layers
  • Pain in joints
  • Abnormal kidney function including increased or decreased amounts of urine produced
  • Pain and tiredness
  • Decreased weight

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 your medicine

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

Unopened product will be stored in a refrigerator (2-8°C) in the pharmacy and should not be used after the expiry date shown on the carton/label.

This medicine will be prepared in a special area before the doctor or nurse gives it to you. After being mixed together the medicine will be kept for no more than 8 hours at room temperature (25°C) or 24 hours in a refrigerator (2-8°C). It should be stored protected from light.

6. Contents of the pack and other information

What Fungizone 50mg Powder for Sterile Concentrate contains

The active substance is amphotericin B. Each vial contains 50mg (50,000 units) Amphotericin B. The other ingredients are desoxycholic acid, concentrated phosphoric acid, sodium hydroxide, disodium phosphate dodecahydrate, monosodium phosphate dehydrate, water.

What Fungizone 50mg Powder for Sterile Concentrate looks like and contents of the pack

Fungizone 50mg Powder for Sterile Concentrate is a fine yellow to orange, fluffy powder and is supplied in glass vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bristol-Myers Squibb Pharmaceuticals Limited
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex
UB8 1DH
England
Tel: 0800 7311736

Manufacturer

Famar L’Aigle
Usine de Saint-Remy
Rue de I’Isle
28380 Saint-Remy-Sur-Avre
France

This leaflet was last revised in: October 2017