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: PL 15142/0002.

Ancotil 2.5g/250ml Solution for Infusion

Patient Information Leaflet

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

1. 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.

2. 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.
  • If you are using any medicine known as an antiviral nucleoside (e.g. ganciclovir, valganciclovir, brivudine, sorivudine). These medicines are usually used to treat chickenpox and shingles.

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

Females of childbearing potential under treatment must use effective contraceptive during treatment and for one month after treatment. Male patients (or their female partners of childbearing potential) must use effective contraception during treatment and for three months after treatment (See Pregnancy and breastfeeding section).

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), medicines to treat chickenpox or shingles (brivudine, sorivudine) or have used them in the last 4 weeks.

These medicines may increase the possibility of unwanted effects with Ancotil. If you are taking medicines for epilepsy containing phenytoin, your doctor may do some blood tests.

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. If Ancotil is administered in pregnancy, there is a risk of causing malformations (abnormally formed parts of the body) to the unborn baby and careful before and after birth monitoring should be performed.
  • You should not be given Ancotil if you are breast-feeding.

Contraception in males and females

Females of childbearing potential under treatment must use effective contraceptive during treatment and for one month after treatment. Male patients (or their female partners of childbearing potential) must use effective contraception during treatment and for three months after treatment.

3. 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.

4. 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.
  • Ancotil contains 34.5 mmol (or 0.8 g) sodium/250 ml solution for infusion. To be be taken into consideration by patients on a controlled sodium diet.

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.

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

For the United Kingdom:

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

For the Republic of Ireland:

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie

5. 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.
  • Before administration, Ancotil should be visually inspected for any particulate matter and discolouration.
  • Do not use Ancotil if you notice that there are any visible particles, precipitation or discolouration.
  • For single use only. Discard any remaining contents after use.
  • 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.

6. FURTHER INFORMATION

What Ancotil Solution for Infusion contains

Active substance: Flucytosine. Each infusion bottle contains 2.5 g in 250 ml (1 g in 100 ml) 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
Bishops Stortford
CM22 6PU
UK

Meda Health Sales Ireland Limited
Unit 34/35
Block A
Dunboyne Business Park
Dunboyne
Co. MeathIreland

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 April 2017.

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