Friday, 14 September 2012

Ancotil 2.5g / 250ml Solution for infusion






Ancotil 2.5 g/250ml



(1g in 100 ml)



Solution for Infusion


Flucytosine




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


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

  • This leaflet tells you about Ancotil.

  • It does not contain all the information about Ancotil.

  • If you have any questions or are unsure of anything ask the doctor or nurse.

  • If you experience any side effect and this becomes serious, tell your doctor or pharmacist.



In this leaflet:


1. What Ancotil is and what it is used for

2. Before you are given Ancotil

3. How Ancotil is given

4. Possible side effects

5. How Ancotil is stored

6. Further information





What Ancotil Is And What It Is Used For


Ancotil Solution for Infusion contains an anti-fungal agent. It is used to treat certain yeast and fungal infections.




Before You Are Given Ancotil Solution For Infusion



You should not be given Ancotil


  • If you are allergic (hypersensitive) to flucytosine or any of the other ingredients of Ancotil (these are listed in section 6, “Further Information”).

  • If you are breast-feeding.



Take special care with Ancotil


Tell your doctor before you start treatment


  • If you have a liver, kidney or blood problem. Your doctor may need to carry out blood tests during your treatment.



Using other medicines


Tell your doctor before you start treatment if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking the medicine cytarabine, which is used to treat certain leukaemias.




Pregnancy and breast-feeding


You must tell your doctor before you start treatment if you are pregnant, if you think you may get pregnant or if you are breast-feeding.


  • Your doctor will decide whether you should be given Ancotil if you are pregnant.

  • You should not be given Ancotil if you are breast-feeding.




How Ancotil Is Given


Ancotil is administered only in a hospital and is administered by a doctor or nurse. It is usually given into a vein or by a procedure called “intraperitoneal infusion” while you are in hospital.


The usual total daily dose is 100 to 150 mg/kg bodyweight in divided doses.


In some instances, you may be given up to a total daily dose of 200 mg/kg bodyweight in divided doses.


Smaller doses may be given to patients with kidney problems.


The treatment period with Ancotil will vary on a patient by patient basis, but treatment will not usually be longer than a week.


Ancotil can be given with a glucose and/or saline infusion. It should not be mixed in the same solution with other medicines.




Possible Side Effects


Like all medicines, Ancotil can cause side effects, although not everybody gets them.


Your doctor will monitor your reaction to Ancotil. Possible side effects include:


  • Nausea, vomiting, diarrhoea and skin rashes may occur but these usually do not last long.

Less frequent side effects include:


  • Allergic reaction. If you have an allergic reaction you may experience palpitations, swelling of eyelids, face, lips, mouth or tongue, sudden wheeziness, chest tightness, lumpy skin rash.

  • Skin inflammation that may lead to severe blistering.

  • Effects on the heart muscle and its pumping.

  • Confusion, effects on your senses (e.g. seeing or hearing things), fits, headache, sleepiness and dizziness.

  • Tests on your blood may show changes to your liver or certain factors in your blood.

If you are concerned about any of these side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How Ancotil Solution For Infusion Is Stored


  • All medicines should be kept out of the reach and sight of children.

  • Hospital staff should store Ancotil between 18°C and 25°C.

  • This product should not be used after the expiry date shown on the bottle label after “EXP”. The expiry date refers to the last day of that month.

  • The product should only be handled by experienced healthcare professionals.

  • Medicines should not be disposed of via wastewater or household waste. The pharmacist should provide instructions as to how to dispose of medicines no longer required. These measures will help to protect the environment.



Further Information



What Ancotil Solution for Infusion contains


Active substance: Flucytosine. Each 250 ml contains 2.5 g of flucytosine.


Other ingredients: Sodium chloride, tromethamine, hydrochloric acid, and water for injections.




What Ancotil Solution for Infusion looks like and contents of the pack


  • Ancotil Solution for Infusion is a clear, colourless to slightly yellow solution.

  • Ancotil Solution for Infusion is available in packs of 5 bottles of 250 ml.



Marketing Authorisation Holder



Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop’s Stortford

CM22 6PU

UK



Manufacturer



Meda Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany


For any information about this medicine, please contact the Marketing Authorisation Holder.




This leaflet was last revised in October 2009.





562103V9105UK00





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