Caspolyn 50 mg/70 mg Solution

CASPOLYN contains the active substance Caspofungin. This belongs to a group of medicines called anti-fungals. CASPOLYN is used to treat a variety of fungal infections in children, adolescents and adults. CASPOLYN makes fungal cells fragile and stops the fungus from growing properly. This stops the infection from spreading and gives the body’s natural defences a chance to completely get rid of the infection.

CASPOLYN should not be administered to you:

• if you are hypersensitive (allergic) to caspofungin or any of the other ingredients of CASPOLYN (listed in section 6).

If you have any liver problems, talk to your doctor before you are given CASPOLYN. If you are not sure, talk to your doctor, nurse or pharmacist before you are given your medicine.

Warnings and precautions

Tell your doctor immediately if you experience a rash or inflamed skin, swelling around the eyes, lips, hands or feet or difficulty breathing. You may be experiencing an allergic reaction to CASPOLYN. Tell your doctor or health care provider before being given CASPOLYN if:

• you are allergic to any other medicines
• you have ever had liver problems - you might need a different dose of this medicine
• you are already taking cyclosporin (used to help prevent organ transplant rejection or to suppress your immune system) - as your doctor may need to run extra blood tests during your treatment.
• if you have ever had any other medical problem.

CASPOLYN may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). CASPOLYN can have an effect on your liver. Your doctor will conduct tests to monitor your liver function.

Do not share medicines prescribed for you with any other person. You will not be expected to give CASPOLYN to yourself. It will be given to you by a person who is qualified to do so. You will be given CASPOLYN:

• once each day
• by slow injection into a vein (intravenous infusion)
• over about 1 hour

Your doctor will determine the duration of your treatment and how much CASPOLYN you will be given each day. Your doctor will monitor how well the medicine works for you.

Children and adolescents

The dose for children and adolescents may differ from the adult dose. If you have the impression that the effect of CASPOLYN is too strong or too weak, tell your doctor or pharmacist.

If you receive more CASPOLYN than you should:

Since a healthcare professional will administer CASPOLYN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to take CASPOLYN

Since a healthcare professional will administer CASPOLYN, it is unlikely that the dose will be missed. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

CASPOLYN can have side effects. Not all side effects for CASPOLYN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CASPOLYN, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to CASPOLYN. You may need urgent medical attention.

Other side effects include:

Frequent side effects

• Decreased haemoglobin (decreased oxygen carrying substance in the blood), decreased white blood cells
• Decreased blood albumin (a type of protein) in your blood, decreased potassium or low potassium levels in the blood
• Headache
• Inflammation of the vein
• Shortness of breath
• Diarrhoea, nausea or vomiting
• Changes in some laboratory blood tests (including increased values of some liver tests)
• Itching, rash, skin redness or sweating more than usual
• Joint pain
• Chills, fever
• Itching at the injection site.

Less Frequent side effects

• Changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood cells and white blood cells)
• Loss of appetite, increase in amount of body fluid, imbalance of salt in the body, high sugar level in the blood, low calcium level in the blood, increase calcium level in the blood, low magnesium level in the blood, increase in acid level in the blood
• Disorientation, feeling nervous, being unable to sleep
• Feeling dizzy, decreased feeling or sensitivity (especially in the skin), shaking, feeling sleepy, change in the way things taste, tingling or numbness
• Blurred vision, increase in tears, swollen eyelid, yellowing of the whites of the eyes
• Sensation of fast or irregular heartbeats, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
• Flushing, hot flush, high blood pressure, low blood pressure, redness along a vein which is extremely tender when touched
• Tightening of the bands of muscle around the airways resulting in wheezing or coughing, fast breathing rate, shortness of breath that wakes you up, shortage of oxygen in the blood, abnormal breath sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, throat pain
• Belly pain, upper belly pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to build-up of fluid around the belly
• Decreased flow of bile, enlarged liver, yellowing of the skin and/or whites of the eyes, liver injury caused by a drug or chemical, liver disorder
• Abnormal skin tissue, generalized itching, hives, rash of varying appearance, abnormal skin, red often itchy spots on your arms and legs and sometimes on the face and the rest of the body
• Back pain, pain in an arm or leg, bone pain, muscle pain, muscle weakness
• Loss of kidney function, sudden loss of kidney function
• Catheter site pain, injection site complaints (redness, hard lump, pain, swelling, irritation, rash, hives, leaking of fluid from the catheter into the tissue), inflammation of vein at injection site
• Increased blood pressure and alterations in some laboratory blood tests (including kidney electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the immune system
• Chest discomfort, chest pain, feeling of body temperature change, generally feeling unwell, general pain, swelling of the face, swelling of the ankles, hands or feet, swelling, tenderness, feeling tired.

Side effects in children and adolescents

Frequent

• Fever
• Headache
• Fast heart beat
• Flushing, low blood pressure
• Changes in some laboratory blood tests (increased values of some liver tests)
• Itching, rash
• Catheter site pain
• Chills
• Changes in some laboratory blood tests.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• Store all medicines out of reach of children
• Store in a refrigerator (2 °C to 8 °C).
• Do not use this medicine after the expiry date which is stated on the carton and the vial (the first two numbers are the month; the next four numbers are the year). The expiry date refers to the last day of that month.
• Once CASPOLYN has been prepared, it should be used straight away. This is because it does not contain any ingredients to stop the growth of bacteria. Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see “Instructions of how to reconstitute and dilute CASPOLYN”).
• Store in original package until use.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).