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NYSTATIN Holsten film-coated tablets

Holsten Pharma GmbH

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NYSTATIN Holsten film-coated tablets

Nystatin Holsten FT
Active ingredient: Nystatin

1 film-coated tablet contains: Medicinally active ingredient: 500,000 IU Nystatin. Other ingredients: lactose monohydrate, cellulose powder, colloidal silicon dioxide, povidone, magnesium stearate, poly(butyl methacrylate, (2-dimethylaminoethyl) methacrylate, methyl methacrylate) 1:2:1, 150,000, titanium dioxide (E 171), talc, dye, E 124 Carboxymethyl starch sodium (type A).

Areas of application:
For topical therapy in infections of the gastrointestinal tract caused by nystatin-sensitive yeasts (especially Candida albicans and other Candida species).

Nystatin Holsten FT must not be taken if you have a history of allergy to nystatin or one of the components of the formulation. Hypersensitivity can manifest itself, for example, through increased itching, burning and redness of the skin or mucous membranes.

Side effects:
The following side effects are to be expected during treatment:
After high oral doses, gastrointestinal disorders in the form of anorexia (loss of appetite), nausea, vomiting and diarrhea can occasionally occur, which are usually mild in nature and often occur during, otherwise after discontinuation of therapy decay quickly. In very rare cases, further hypersensitivity reactions to the active ingredient nystatin or one of the other ingredients may occur.

For fungal infections of the gastrointestinal area.

Active ingredients

  • 500000 IU nystatin


  • Stearic acid
  • Magnesium stearate
  • Ponceau 4R
  • Silicon dioxide, highly disperse
  • Cellulose powder
  • Butyl methacrylate copolymer, basic
  • Povidone K25
  • carboxymethyl starch, sodium
  • Azorubine, aluminum salt
  • Sodium dodecyl sulfate
  • Carmellose sodium
  • Lactose-1-water
  • Titanium dioxide
  • talc
Indication :
  • The preparation is an agent for the treatment of fungal infections (antifungal).
  • It is used for the topical intestinal treatment of proven nystatin-sensitive yeast infections of the gastrointestinal tract, especially as a result of therapy with antibiotics, cytostatics or corticosteroids.
Dosage :
  • Always use the medicine exactly as directed. Please ask your doctor or pharmacist if you are not sure.
  • Unless otherwise prescribed by the doctor, the usual dose for adults and children aged 6 and over is: Take 1 film-coated tablet 3 times a day.


  • Duration of application
    • The duration of use is 2 weeks, or as long as the treatment with medications that promote yeast growth lasts.
  • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.


  • If you have taken more than you should
    • Very little information is available regarding overdose when using oral nystatin. Since absorption from the gastrointestinal tract into the body after oral administration is negligible even at high doses, side effects of nystatin on the organism are not to be expected, even in the event of an overdose. If necessary, the usual measures to remove medication from the gastrointestinal tract should be taken.


  • If you forget to use it
    • Do not take a double dose if you forget to take the previous dose. Continue treatment as directed.


  • If you cancel the application
    • They could jeopardize the success of the treatment. Please talk to your doctor or pharmacist before stopping treatment with the medicine.


  • If you have any further questions about using the medicine, ask your doctor or pharmacist.
Way :
  • Take the medicine whole after meals with a little liquid.
Side effects :
  • Like all medicines, this can have side effects, although not everyone gets them.
  • When evaluating side effects, the following frequency information is used:
    • Very common: More than 1 in 10 people treated
    • Common: 1 to 10 treated in 100
    • Uncommon: 1 to 10 people treated in 1000
    • Rare: 1 to 10 people treated in 10,000
    • Very rare: less than 1 person treated in 10,000
    • Not known: Frequency cannot be estimated from the available data.
  • possible side effects
    • Nystatin, the active ingredient in this medicine, is generally well tolerated.
    • Gastrointestinal complaints, nausea, vomiting and diarrhea can often occur.
    • Skin rashes, including hives (urticaria), have been reported occasionally.
    • Stevens-Johnson syndrome (fever and painful blisters on the skin and mucous membranes) has rarely been observed.
    • Other possible ingredients can cause allergic reactions.
  • special instructions
    • If a hypersensitivity reaction occurs, the drug should be discontinued and, if necessary, appropriate treatment should be administered by a doctor.
  • Please inform your doctor or pharmacist if any of the side effects listed seriously affects you or if you notice side effects that are not listed.
Interactions :
  • When used with other medicines
    • Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines.
Contraindications :
  • The medicine must not be used
    • if you are hypersensitive (allergic) to nystatin or a related active ingredient (amphotericin B, natamycin), or any of the other ingredients of the medicine
    • for the treatment of systemic fungal infections (affecting the internal organs).
Pregnancy and breast feeding period :
  • Nystatin, the active ingredient in this medicine, is hardly absorbed in therapeutic doses after oral administration via the intact skin or mucous membranes.
  • Nystatin does not cross the placenta and is not expected to pass into breast milk.
  • The medicine can be used during pregnancy and breastfeeding.
Patient information :
  • Particular care is required when using it
    • Children
      • Due to the high osmolarity of nystatin, its use in infants and young children is not recommended.


  • Ability to drive and use machines
    • There is no experience with regard to impairment of the ability to drive or use machines.