Consumer medicine information

Chemists' Own Nystatin Oral Drops

Nystatin

BRAND INFORMATION

Brand name

Chemists' Own Nystatin Oral Drops

Active ingredient

Nystatin

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chemists' Own Nystatin Oral Drops.

SUMMARY CMI

Chemists' Own Nystatin Oral Drops

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 Chemists' Own Nystatin Oral Drops

CHEMISTS' OWN NYSTATIN ORAL DROPS contains the active ingredient Nystatin. CHEMISTS' OWN NYSTATIN ORAL DROPS is used to treat a condition called intestinal candidiasis or thrush.

For more information, see Section 1. Why am I using CHEMISTS' OWN NYSTATIN ORAL DROPS? in the full CMI.

2. What should I know before I use Chemists' Own Nystatin Oral Drops?

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 CHEMISTS' OWN NYSTATIN ORAL DROPS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CHEMISTS' OWN NYSTATIN ORAL DROPS and affect how it works.

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 Chemists' Own Nystatin Oral Drops?

  • Use the syringe provided to measure the dose. The dose for infants, children & adults is 1.0 mL to be taken 4 times daily
  • Fill the syringe to 1.0 mL mark and squirt into your mouth. Hold or swish around as long as possible before swallowing.

More instructions can be found in Section 4. How do I use CHEMISTS' OWN NYSTATIN ORAL DROPS? in the full CMI.

5. What should I know while using Chemists' Own Nystatin Oral Drops?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using CHEMISTS' OWN NYSTATIN ORAL DROPS
  • If you become pregnant while you are taking Chemists' Own Nystatin, tell your doctor. Tell your doctor or pharmacist, if you feel Chemists' Own Nystatin is not relieving your symptoms.
  • See your doctor if symptoms persist or recur.
Things you should not do
  • Do not stop using this medicine or alter the dose without checking with your doctor or pharmacist.
Drinking alcohol
  • Tell your doctor or pharmacist if you drink alcohol
Looking after your medicine
  • After use wash the syringe with hot water
  • Keep drops in their bottle until time to take them
  • Store in a cool dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using Chemists' Own Nystatin Oral Drops? in the full CMI.

6. Are there any side effects?

The most common side effects are feeling sick or nausea, vomiting, stomach upset, diarrhoea

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

Chemists' Own Nystatin Oral Drops

Active ingredient(s): Nystatin

Consumer Medicine Information (CMI)

This leaflet provides important information about using CHEMISTS' OWN NYSTATIN ORAL DROPS. 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 CHEMISTS' OWN NYSTATIN ORAL DROPS.

Where to find information in this leaflet:

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

1. Why am I using CHEMISTS' OWN NYSTATIN ORAL DROPS?

CHEMISTS' OWN NYSTATIN ORAL DROPS contains the active ingredient Nystatin. CHEMISTS' OWN NYSTATIN ORAL DROPS is an antifungal agent.

It works by damaging the cell wall of the Candida fungus, causing it to die. CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops work inside the mouth. The amount of CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops absorbed into the bloodstream is minute and therefore is not effective for treating any other infections in the body.

CHEMISTS' OWN NYSTATIN ORAL DROPS is used to treat oral candidiasis or thrush. This is an infection in the mouth caused by the fungus Candida and is marked by sore, creamy-yellow, raised patches in the mouth.

Your doctor, however, may have prescribed CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops for another purpose.

Ask your doctor if you have any questions about why CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops has been prescribed for you.

2. What should I know before I use CHEMISTS' OWN NYSTATIN ORAL DROPS?

Warnings

Do not use CHEMISTS' OWN NYSTATIN ORAL DROPS if:

  • you are allergic to Nystatin, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • Drops if the packaging is torn or shows signs of tampering.
  • Do not use it after the expiry date (EXP) printed on the pack.
  • Do not give CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops to children or infants unless your doctor tells you to.
    Your doctor will check if this is the right treatment for your child's symptoms

Check with your doctor if you:

  • Have diabetes or any other medical conditions. People with diabetes are more likely to get thrush.
  • take any medicines for any other condition

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 if you are pregnant or intend to become pregnant.

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

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.

CHEMISTS' OWN NYSTATIN ORAL DROPS does not usually react with other medicines, but always tell your doctor about other medicines you are taking.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CHEMISTS' OWN NYSTATIN ORAL DROPS.

4. How do I use CHEMISTS' OWN NYSTATIN ORAL DROPS?

How much to take / use

  • Use the syringe provided to measure the dose. The dose for infants, children & adults is 1.0 mL to be taken 4 times daily. Do not take more than the recommended dose.
  • Follow the instructions provided and use CHEMISTS' OWN NYSTATIN ORAL DROPS until your doctor tells you to stop. It is important that you always follow your doctor or pharmacist instructions as they may differ from the information in this leaflet.

How take CHEMISTS' OWN NYSTATIN ORAL DROPS

  • Shake the bottle well before inserting the measuring syringe
  • Fill the syringe to the 1.0 mL mark
  • Squirt the medicine into your mouth and hold or swish around as long as possible before swallowing.

How Long to take CHEMISTS' OWN NYSTATIN ORAL DROPS

Continue taking CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops for at least 48 hours after symptoms have subsided or until your doctor or pharmacist tells you to stop.

If you forget to use CHEMISTS' OWN NYSTATIN ORAL DROPS

If it is less than 1 hour before your next dose, skip the dose you missed and take your next dose when you are meant to.

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

This may increase the chance of you getting an unwanted side effect.

If you use too much CHEMISTS' OWN NYSTATIN ORAL DROPS

If you think that you have used too much CHEMISTS' OWN NYSTATIN ORAL DROPS, 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 CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops you may get diarrhoea, stomach upset, nausea and vomiting.

5. What should I know while using CHEMISTS' OWN NYSTATIN ORAL DROPS?

Things you should do

Use CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops exactly as your doctor or pharmacist has recommended.

If you become pregnant while you are taking CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops, tell your doctor

Tell your doctor or pharmacist if you feel CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops is not helping your condition.

Keep enough CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops to last weekends and holidays.

Call your doctor straight away if you:

  • Have persistent symptoms or recurrence. Your doctor will check your progress and see whether you need to keep taking CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops.
  • Always discuss with your doctor or pharmacist any problems or difficulties during or after taking CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops.
  • 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

Remind any doctor, dentist or pharmacist you visit that you are using CHEMISTS' OWN NYSTATIN ORAL DROPS.

Things you should not do

  • Do not stop taking CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops or change the dose, without first checking with your doctor or pharmacist.
  • If you stop taking CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops or change the dose, CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops 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 CHEMISTS' OWN NYSTATIN ORAL DROPS Oral Drops to anyone else, even if their symptoms seem similar to yours.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CHEMISTS' OWN NYSTATIN ORAL DROPS affect you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

  • After you finish using the syringe, wash it with hot water. Keep the dropper away from other house utensils and crockery. This will help stop re-infection or the spread of infection to other household members.
  • Keep the drops in their bottle until it is time to take them. If you take the drops out of the bottle they may not keep well.

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

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

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

Keep it where young children cannot reach it.

When to discard your medicine

The expiry date is printed on the pack. Do not use after this date.

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.

Do not use this medicine after the expiry date.

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.

See the information below and, if you need to, ask your doctor or pharmacist 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.

Serious side effects

Serious side effectsWhat to do
  • Swelling of the face, mouth lips or tongue
  • Feeling unwell after use
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist 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 or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What CHEMISTS' OWN NYSTATIN ORAL DROPS contains

Active ingredient
(main ingredient)		Nystatin 100,000 IU/mL
Other ingredients
(inactive ingredients)
  • sucrose
  • saccharin sodium
  • carmellose sodium
  • sodium citrate dihydrate
  • sodium hydroxide
  • methyl hydroxybenzoate
  • propyl hydroxybenzoate
  • purified water
  • vanilla flavour cream 9/HO7915
Potential allergens-

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

What CHEMISTS' OWN NYSTATIN ORAL DROPS looks like

CHEMISTS' OWN NYSTATIN ORAL DROPS is a vanilla flavoured yellowish suspension.

Chemists' Own Nystatin Oral Drops is supplied in a 24mL bottle with a separate measuring syringe. (Aust R 301569).

Who distributes CHEMISTS' OWN NYSTATIN ORAL DROPS

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne, VIC 3121
Australia
www.arrotex.com.au

This leaflet was prepared in December 2024

Published by MIMS March 2025

BRAND INFORMATION

Brand name

Chemists' Own Nystatin Oral Drops

Active ingredient

Nystatin

Schedule

S3

 

1 Name of Medicine

Nystatin.

2 Qualitative and Quantitative Composition

Nystatin 100,000 units per mL.

Excipients with known effect.

Methyl hydroxybenzoate and propyl hydroxybenzoate as preservatives, sucrose and saccharin sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Chemists' Own Nystatin Oral Drops (Nystatin) is a sweet vanilla-flavoured yellowish suspension.
Dosage form: oral drops.

4 Clinical Particulars

4.1 Therapeutic Indications

Infection of the oral cavity caused by Candida albicans.

4.2 Dose and Method of Administration

Infants, children and adults.

1 mL (100,000 I.U.) four times daily.
After shaking the bottle well, the dose should be measured using the calibrated syringe supplied and administered in the mouth and held with swishing for as long as possible before swallowing.

4.3 Contraindications

Nystatin is contraindicated for use in patients with hypersensitivity to nystatin or any of the other listed ingredients in the formulation.

4.4 Special Warnings and Precautions for Use

This medication is not to be used for the treatment of systemic mycoses. If irritation or sensitization occurs with nystatin therapy, treatment should be discontinued and appropriate therapy instituted. If there is lack of therapeutic response, appropriate microbiological studies (e.g. KOH smears and/or cultures) should be repeated to confirm diagnosis of candidiasis and rule out other pathogens before instituting another course of therapy.

Use in the elderly.

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

4.5 Interactions with Other Medicines and Other Forms of Interactions

Nystatin is not known to interact with other medicines.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies have not been conducted to date, to determine whether nystatin effects fertility in males or females.
(Category A)
Animal reproduction studies have not been performed with nystatin and it is also not known whether the drug can cause fetal 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 breastfeeding 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)

Use in immunocompromised patients.

Higher doses, for example 500,000 units 4 times daily, may be needed. However, the use of alternate antifungal antibiotics is preferred for the treatment of oral thrush in patients with immunosuppression.
Nystatin is non-toxic, non-sensitizing and is well tolerated by all age groups even with prolonged administration. Large doses have occasionally produced diarrhoea, gastrointestinal distress, nausea and vomiting.
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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Nystatin is a fungistatic and fungicidal antibiotic, which interferes with the permeability of the cell membrane of sensitive fungi by binding to sterols, chiefly ergosterol. Its main action is against Candida spp.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Nystatin is a polyene antifungal antibiotic obtained by fermentation of certain strains of Streptomyces noursei. Nystatin is poorly absorbed from the gastrointestinal tract. Nystatin, applied as oral suspension, is not detectable in the saliva after 2 hours of application.

5.3 Preclinical Safety Data

Genotoxicity.

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

Carcinogenicity.

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

6 Pharmaceutical Particulars

6.1 List of Excipients

Methyl hydroxybenzoate and propyl hydroxybenzoate as preservatives with sucrose, saccharin sodium, sodium hydroxide, sodium citrate dihydrate, carmellose sodium, purified water and vanilla cream flavour as excipients.

6.2 Incompatibilities

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

6.3 Shelf Life

24 months.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Chemists' Own Nystatin Oral Drops is supplied in a 24 mL amber glass bottle with a separate measuring syringe.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Molecular formula is C47H75NO17.

CAS number.

1400-61-9.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Summary Table of Changes