WHAT YOU SHOULD KNOW ABOUT AMPHOCIL

The information in this leaflet applies only to your medicine, AMPHOCIL, please read it carefully.  It gives you important information but it can’t tell you everything.  If you have any questions or are not sure about anything ask your doctor or pharmacist.

WHAT IS YOUR MEDICINE?

AMPHOCIL is available as powder which is made up in sterile water for intravenous infusion (an injection into one of your veins, which is given over a period of time).  AMPHOCIL vials contain either 50 mg or 100 mg of amphotericin B lipid complex.

Each infusion contains a number of inactive ingredients which allow it to be made.  These are disodium edetate, lactose, sodium cholesteryl sulphate, tromethamine and hydrochloric acid.

AMPHOCIL comes in containers of 50 mg and 100 mg vials.

AMPHOCIL belongs to a group of medicines called antifungal antibiotics.  This means that within the body it can kill a wide range of fungi which may be the cause of serious infections.

WHO HAS MADE YOUR MEDICINE?.

The product licence holder of AMPHOCIL is:
Beacon Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells, TN1 1YG, UK

AMPHOCIL is manufactured by:
Penn Pharmaceuticals Ltd., Gwent, NP2 3AA, UK

WHAT IS YOUR MEDICINE FOR?

AMPHOCIL is used to treat serious fungal infections, which can occur throughout the body.  It is used when other similar treatments have not been successful or have caused unacceptable adverse experiences.

WHEN SHOULD AMPHOCIL NOT BE USED?

Before receiving your medicine, you should tell your doctor if you have ever had any reaction to amphotericin B or any of the inactive ingredients (as listed above).

These infusions should not be given to anyone other than the patient for whom they are prescribed.

Before receiving your medicine, tell your doctor if:

• You have any other medical problems, especially any problems with your kidneys;
• You are pregnant or suspect you are pregnant;
• You are breast feeding;
• You are diabetic, since AMPHOCIL contains a sugar additive, lactose, which may alter the control of your diabetes;
• You are taking any other medicines including those which you have bought.  In particular, if you are taking steroid tablets or receiving steroid injections (for such conditions as asthma or rheumatism), tablets for heart failure (such as digoxin), or treatment for cancer (e.g. cisplatin), pentamidine, digitalis glycosides, muscle relaxants or other anti fungal drugs (such as flucytosine)

Your infusion is unlikely to adversely affect your ability to drive a car or to operate machinery.

This product is unsuitable for people with lactase insufficiency, galactosaemia or glucose/galactose malabsorption syndrome.

Your infusion should not be mixed with or added to solutions containing other drugs.

• AMPHOCIL will normally be given to you by your doctor or by a nurse
• AMPHOCIL is administered by intravenous infusion (directly into your blood) usually over a period of 2 to 4 hours.  The exact dose you are given will be decided by your doctor.
• The dose range for AMPHOCIL is usually decided by using your body weight as a guide.  Usually the starting daily dose is 1.0 mg/kg body weight increasing to the recommended dose of 3.0 to 4.0 mg/kg.
• If an infusion is missed, it should be given as soon as possible.  Two infusions should not normally be given at the same time.
• If you are accidentally given more than your prescribed dose, your doctor will know to treat you accordingly.

As with all medicines, undesirable events are sometimes experienced.  The following effects have been noted with AMPHOCIL:-

• Fever (high temperature) and chills (feeling cold)
• Feeling faint                                     
• Abdominal pain   
• Nausea or vomiting                         
• Back pain
• Shortness of breath                         
• Diarrhoea  
• Rapid heart beat                    
• Headache

Occasionally, AMPHOCIL may be associated with changes in your blood which may require your doctor to do certain blood tests.  Do not be alarmed by the possibility of such events.  You may not have any.

Tell you doctor or pharmacist if you experience any problems with your treatment.

Store below 30°C.  The vials will normally be stored for you by the hospital.  The staff are responsible for the correct storage, use and disposal of AMPHOCIL.

AMPHOCIL is a trademark, the property of Three Rivers Pharmaceuticals LLC