10 mg / mL infusion solution 
flucytosine

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read about it.

– If you have any further questions, ask your doctor, nurse, or pharmacist.

– If you get any side effects, talk to your doctor, nurse, or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Ancotil is and what it is used for 
2. What you need to know before using Ancotil 
3. How to use Ancotil 
4. Possible side effects 
5. How to store Ancotil 
6. Contents of the packaging and other information 

1. What Ancotil is and what it is used for

Ancotil contains flucytosine. Ancotil is used to treat fungal infections in children, adolescents, and adults.

2. What you need to know before you use Ancotil

Do not use Ancotil

  • if you are allergic to flucytosine or any of the other ingredients of this medicine (listed in section 6).
  • if you know that the enzyme a dihydropyridine dehydrogenase (DPD) is completely inactive in you (total DPD deficiency).
  • if you are already being treated with certain medicines for viral infections.
  • if you are breastfeeding.

Warnings and cautions

Talk to your doctor or nurse before receiving Ancotil:

  • if you have impaired liver or kidney function
  • if you have a blood problem
  • if you are being treated with a medicine that weakens your immune system
  • if you are deficient in the enzyme a DPD (dihydropyridine dehydrogenase). This is determined by your doctor based on blood test results.

You may need to submit blood samples before and during treatment.

Other medicines and Ancotil

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Ancotil may affect or be affected by treatment with other medicines:

  • Ganciclovir, valganciclovir, brivudine, sorivudine or similar medicines (against certain viruses )
  • Phenytoin (for epilepsy )
  • Cytarabine (cytotoxic drug )

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, you must tell your doctor before using this medicine.

  • Your doctor will decide if you should be treated with Ancotil when you are pregnant. If Ancotil is given during pregnancy, there is a risk of birth defects. Close monitoring before and after delivery must therefore be ensured.
  • Ancotil should not be used if you are breast-feeding.

Contraceptive methods for men and women

Women of childbearing potential treated with Ancotil should use effective contraception during treatment and one month thereafter. Men treated with Ancotil and their female partners of childbearing potential should use effective contraception during treatment and for three months thereafter.

Driving and using machines

During treatment with Ancotil you may experience confusion, hallucinations, and fatigue. This should be taken into account when sharper attention is required, e.g. while driving.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ancotil contains sodium

This medicine contains 792 mg sodium (the main ingredient in table salt/table salt) per bottle (250 ml). This corresponds to 40% of the maximum recommended daily intake of sodium for adults.

The sodium content per dose depends on the estimated amount of Ancotil infusion solution you are receiving. Talk to your doctor or pharmacist if you need Ancotil daily for a long period of time, especially if you have been prescribed a low-salt (sodium-poor) diet.

3. How to use Ancotil

Ancotil is given in hospitals by healthcare professionals. Your doctor will decide how long the treatment should last and how much Ancotil you should receive per day.

Ancotil is given as an infusion into a friend. The infusion is usually given four times a day at 6-hour intervals. Each infusion lasts 20-40 minutes. The length of treatment varies from a few weeks to several months.

Use for children

Although some data are available for use in children, they are not sufficient to provide accurate dose recommendations for this age group. If this medicine is prescribed for your child, your doctor will decide on the most appropriate dose.

Due to delayed secretion of flucytosine in children, especially in very young children, the use of flucytosine may cause the amount of drug in the blood to become too high. Therefore, the concentrations of flucytosine in your baby’s blood will be measured regularly throughout the treatment.

If you use more Ancotil than you should 

Your doctor will decide how much Ancotil to get and for how long. If you are concerned that you have received too much Ancotil, talk to your doctor or nurse.

If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.

4. Possible side effects

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

Common (may affect up to 1 in 10 people):

  • Altered blood count (eg decreased red or white blood cell count or decreased platelet count )
  • Nausea, vomiting, diarrhea
  • Hepatic impairment, altered liver values

Uncommon (may affect up to 1 in 100 people):

  • Confusion
  • Rash

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

  • Bone marrow changes
  • Severe skin damage (skin detachment of the epidermis and superficial mucous membranes).
  • Hallucinations
  • Cramps
  • Tingling and numbness
  • Fatigue
  • Damage to the heart
  • Intestinal injuries
  • Severe liver disease

Most side effects occur during the first two to three weeks of treatment.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Ancotil

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Ancotil should only be stored at 18ºC – 25ºC.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is flucytosine 10 mg/ml.
  • The other ingredients are sodium chloride, tromethamine, hydrochloric acid, water for injections.

What the medicine looks like and the contents of the pack

Ancotil is supplied in 250 ml glass infusion bottles in packs of 5 bottles.

Marketing Authorization Holder and Manufacturer

Meda AB

Box 906

170 09 Solna

08-630 19 00

Muhammad Nadeem

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