Consumer medicine information

Nilstat Oral

Nystatin

BRAND INFORMATION

Brand name

Nilstat Oral

Active ingredient

Nystatin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nilstat Oral.

SUMMARY CMI

NILSTAT tablets and capsules

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using NILSTAT?

NILSTAT contains the active ingredient nystatin. It is used to treat a condition called intestinal candidiasis or thrush.

For more information, see Section 1. Why am I using NILSTAT? in the full CMI.

2. What should I know before I use NILSTAT?

Do not use if you have ever had an allergic reaction to nystatin or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use NILSTAT? in the full CMI.

3. What if I am taking other medicines?

NILSTAT does not usually interact with other medicines, but always tell your doctor about other medicines you are taking.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use NILSTAT?

  • The usual dose of NILSTAT is 1-2 tablets or capsules three times a day.
  • Swallow the tablets or capsules whole with a glass of water.
  • Continue taking it until you have finished all the tablets or capsules in the bottle or until your doctor tells you to stop.

More instructions can be found in Section 4. How do I use NILSTAT? in the full CMI.

5. What should I know while using NILSTAT?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using NILSTAT.
  • Tell your doctor if you feel NILSTAT is not helping your condition.
  • See your doctor if symptoms persist or recur.
Things you should not do
  • Do not stop taking NILSTAT or change the dose, without first checking with your doctor or pharmacist.
  • Do not use this medicine to treat any other complaints unless your doctor or pharmacist says to.
Looking after your medicine
  • Keep the tablets or capsules in the bottle until it is time to take them.
  • Keep NILSTAT in a cool dry place, away from moisture or heat where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using NILSTAT? in the full CMI.

6. Are there any side effects?

Side effects for NILSTAT are uncommon. However, it has been found that large doses occasionally result in feeling sick/nausea, vomiting, stomach upset or diarrhoea. Potentially serious side effects include an allergic reaction. Signs of serious allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue, or any other parts of the body; and rash, itching or hives on the skin.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

NILSTAT tablets and capsules

Active ingredient: nystatin

Consumer Medicine Information (CMI)

This leaflet provides important information about using NILSTAT.

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using NILSTAT.

Where to find information in this leaflet:

1. Why am I using NILSTAT?
2. What should I know before I use NILSTAT?
3. What if I am taking other medicines?
4. How do I use NILSTAT?
5. What should I know while using NILSTAT?
6. Are there any side effects?
7. Product details

1. Why am I using NILSTAT?

NILSTAT contains the active ingredient nystatin. It belongs to a group of medicines called antifungal agents.

NILSTAT is used to treat a condition called intestinal candidiasis or thrush. It works by damaging the cell wall of the Candida fungus, causing it to die. NILSTAT only works inside your gut. The amount of NILSTAT absorbed into the bloodstream is minute and therefore is not effective for treating any other infections in the body.

Ask your doctor if you have any questions about why NILSTAT has been prescribed for you.

Your doctor may have prescribed NILSTAT for another purpose.

2. What should I know before I use NILSTAT?

Warnings

Do not use NILSTAT if:

  • you are allergic to nystatin or any of the ingredients listed at the end of this leaflet.
    Some symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue, or any other parts of the body; rash, itching or hives on the skin.
  • the expiry date printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • have any other medical conditions, especially the following:
    - Diabetes – people with diabetes are more likely to get thrush.
  • take any medicines for any other condition.
  • have had any allergy to any other medicines, or any other substances, such as foods, preservatives, or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

It is unlikely that NILSTAT will harm your developing baby. However, it is recommended that you talk to your doctor about the risks and benefits of taking this medicine during pregnancy.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

It is unlikely that NILSTAT will pass into breast milk in sufficient amounts to affect your baby. However, it is recommended that you talk to your doctor about the risks and benefits of taking NILSTAT when breastfeeding.

Use in children

Do not give NILSTAT to children or infants unless your doctor tells you to.

Your doctor will check to make sure that NILSTAT is the right treatment for your child's symptoms.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

NILSTAT is not known to interact with other medicines, but always tell your doctor about other medicines that you are taking.

4. How do I use NILSTAT?

How much to take

  • The usual dose of NILSTAT is 1-2 tablets or capsules three times a day.
  • If your doctor or pharmacist tells you to take a different dose, follow their instructions.

How long to take it for

Continue taking NILSTAT until you have finished all the tablets or capsules in the bottle or until your doctor tells you to stop.

How to take it

Swallow the tablets or capsules whole with a glass of water.

NILSTAT can be taken with or without food.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you take too much

If you think that you have used too much NILSTAT, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much NILSTAT you may get diarrhoea, stomach upset, nausea and vomiting.

5. What should I know while using NILSTAT?

Things you should do

Use NILSTAT exactly as your doctor has recommended.

Tell all doctors, dentists and pharmacists who are treating you that you are taking NILSTAT.

If you become pregnant while you are taking NILSTAT, tell your doctor.

Tell your doctor or pharmacist if you feel NILSTAT is not helping your condition.

Always discuss with your doctor or pharmacist any problems or difficulties during or after taking NILSTAT.

Tell your doctor or pharmacist if, for any reason, you have not taken your medicine exactly as recommended.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Keep enough NILSTAT to last weekends and holidays.

Things you should not do

Do not stop taking NILSTAT or change the dose, without first checking with your doctor or pharmacist.

If you stop taking NILSTAT or change the dose, NILSTAT may not work as well.

Do not use this medicine to treat any other complaints unless your doctor or pharmacist says to.

Do not give NILSTAT to anyone else, even if their symptoms seem similar to yours.

Looking after your medicine

Keep the medicine in the bottle until it is time to take them. Keep it in a cool dry place, away from moisture or heat where the temperature stays below 25°C.

For example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills

Heat and dampness can destroy some medicines.

Follow the instructions in the carton on how to take care of your medicine properly.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

This medicine helps most people with Candida infections in the gut but it may have unwanted side effects in some people. As only minute amounts of NILSTAT are absorbed into the bloodstream, side effects are very rare.

See the information below and, if you need to, ask your doctor if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
  • feeling sick or nausea
  • vomiting
  • stomach upset
  • diarrhoea.
Speak to your doctor if you have any of these less serious side effects and they worry you.

These side effects are rare and usually occur if too much NILSTAT is taken.

Serious side effects

Serious side effectsWhat to do
Signs of serious allergic reaction.
  • shortness of breath, wheezing or difficulty in breathing
  • swelling of the face, lips, tongue, or any other parts of the body
  • rash, itching or hives on the skin
Call your doctor straight away or go to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What NILSTAT capsules contains

Active ingredient
(main ingredient)
  • nystatin 500,000 I.U./capsule
Other ingredients
(inactive ingredients)
  • lactose monohydrate
  • magnesium stearate
  • gelatin
  • iron oxide yellow
  • titanium dioxide
  • shellac
  • isopropyl alcohol.
Capsule ink printing
  • carbon black
  • ethanol.
Potential allergens
  • lactose monohydrate

What NILSTAT tablets contains

Active ingredient
(main ingredient)
  • nystatin 500,000 I.U./tablet
Other ingredients
(inactive ingredients)
  • lactose monohydrate
  • ethylcellulose
  • magnesium stearate
  • sodium starch glycollate
  • carnauba wax
  • purified water
  • opadry yellow OY-2144A.
The colouring agent in NILSTAT tablets is opadry yellow OY-2144A, which contains hypromellose, titanium dioxide, macrogol 400, iron oxide & yellow CI 77492.
Potential allergens
  • lactose monohydrate

NILSTAT tablets and capsules do not contain gluten, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What NILSTAT looks like

NILSTAT capsules are size 2, opaque, buff-coloured hard capsules, printed "Nilstat" on cap and body in black ink, filled with a uniform, yellow, granular powder. Supplied in a glass bottle containing 50 capsules.

Australian Registration number: AUST R 15228

NILSTAT tablets are round, biconvex, buff-coloured, film-coated tablets. Supplied in an amber glass bottle containing 50 tablets.

Australian Registration number: AUST R 15227

Who distributes NILSTAT?

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

This leaflet was revised in April 2025.

Published by MIMS July 2025

BRAND INFORMATION

Brand name

Nilstat Oral

Active ingredient

Nystatin

Schedule

S4

 

1 Name of Medicine

Nystatin.

2 Qualitative and Quantitative Composition

Nilstat Oral tablets and capsules contains nystatin 500,000 I.U.

Excipients with known effect.

Contains sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nilstat capsules.

Size 2, opaque, buff-coloured capsules, printed "Nilstat" on cap and body in back ink, and filled with a uniform, yellow granular powder.

Nilstat tablets.

Round, biconvex, buff-coloured, film-coated tablets approximately 3/8" (9.5 mm) in diameter.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of intestinal infections caused by Candida albicans and other candida species.

4.2 Dose and Method of Administration

Usual adult and adolescent dosage.

500,000 to 1 million units (1 to 2 tablets or capsules) 3 times daily.
Note that use is not recommended in infants and children up to 5 years of age, as this group may not be capable of using the tablet safely.
Treatment should generally be continued for at least 48 hours after clinical cure to prevent a relapse.

4.3 Contraindications

Hypersensitivity to the drug.

Nystatin is contraindicated in individuals who are hypersensitive to the drug or any ingredient in the respective formulation. If irritation or sensitization occurs, nystatin should be discontinued.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Nystatin oral tablets or capsules should not be used in the treatment of systemic fungal infections since it is not absorbed from the gastrointestinal tract.

Use in the elderly.

No information is available on the relationship of age to the effects of oral nystatin in geriatric patients.

Paediatric use.

Nystatin oral tablets or capsules should not be used in infants and children up to 5 years of age. (See Section 4.2 Dose and Method of Administration).

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies have not been conducted to date, to determine whether nystatin affects fertility in males or females.
(Category A)

Teratogenic effects.

Animal reproduction studies have not been performed with nystatin and it is also not known whether the drug can cause foetal harm when administered to pregnant women. Nystatin should be used during pregnancy only when clearly needed.
 Since it is not known whether nystatin is distributed into human milk, the drug should be used with caution in nursing women.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Nystatin is nontoxic and nonsensitising and well tolerated by all age groups, even with prolonged administration. Nausea, vomiting and diarrhoea have occasionally been reported after oral use of nystatin. Oral irritation or sensitisation may occur. Rashes, including urticaria, have occurred and Stevens-Johnson syndrome has been reported rarely.

Effects on the skin.

Generalised pustular eruptions were reported in 3 patients following oral nystatin. Subsequent sensitivity testing revealed delayed (type IV) hypersensitivity to nystatin.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Since the absorption of nystatin from the gastrointestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Nystatin is an antifungal antibiotic active against yeasts and sensitive yeast like fungi, including Candida albicans. Its main action is against Candida spp. The antifungal activity is probably due to the binding of sterols, chiefly ergosterol, in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. As a result of this binding, the membrane is no longer able to function as a selective barrier and potassium and other cellular constituents are lost. The drug is absorbed very sparingly following oral administration, with no detectable blood levels when given in the recommended doses.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Nystatin is poorly absorbed from the gastrointestinal tract. Following oral administration, nystatin is excreted almost entirely in feces, as unchanged drug. The drug is not absorbed from intact skin or mucous membranes.
The drug is not active against organisms (e.g. bacteria) that do not contain sterols in their cell membrane.

5.3 Preclinical Safety Data

Genotoxicity.

Studies have not been conducted to date to assess the genotoxicity potential of nystatin in humans.

Carcinogenicity.

Studies have not been conducted to date to assess the carcinogenic potential of nystatin in humans.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each Nilstat tablet contains purified water, magnesium stearate, sodium starch glycollate, ethylcellulose, carnauba wax, lactose monohydrate, titanium dioxide, iron oxide yellow, macrogol 400, and hypromellose.
Each Nilstat capsule contains magnesium stearate, lactose monohydrate, titanium dioxide, iron oxide yellow, shellac, ethanol, gelatin, isopropyl alcohol and carbon black.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Nilstat tablets are available in glass bottles containing 50 tablets and in PVC/PVDC/Al blister packs of 4*.
Nilstat capsules are available in glass bottles containing 50 capsules and in PVC/PVDC/Al blister packs of 4*.
* Blister are not currently marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

An antifungal substance obtained by fermentation using certain strains of Streptomyces noursei. It contains mainly tetraenes, the principal component being nystatin A1. It is a yellow or slightly brownish hygroscopic powder, with an odour suggestive of cereals; it is affected by long exposure to light, heat, and air.

Physical and chemical properties.

Practically insoluble in water and in alcohol; insoluble in chloroform and in ether; freely soluble in dimethylformamide and in dimethyl sulfoxide; slightly to sparingly soluble in methyl alcohol, in n-butyl alcohol, and in n-propyl alcohol. A 3% suspension in water has a pH of 6.0 to 8.0. Store in air tight containers.

Chemical structure.

The structural formula of nystatin:
Molecular formula is C47H75NO17 with a molecular weight of 926.09.

CAS number.

1400-61-9.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes