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.

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Nystatin Oral Drops.

It does not contain all the available information. Seek advice from your pharmacist or doctor.

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking Chemists’ Own Nystatin oral drops against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine. You may need to read it again.

What Chemists’ Own Nystatin Oral Drops is used for

Chemists’ Own Nystatin Oral Drops is used to treat candidal infections of the mouth and throat (e.g. thrush)
Ask your pharmacist or doctor if you have any questions about this medicine.

Your doctor may have given it for another reason.

This medicine is only available from a pharmacist.

Before you take Chemists’ Own Nystatin Oral Drops

When you must not take it

Do not take Chemists’ Own Nystatin Drops if you have an allergy to:

  • Nystatin
  • Any of the ingredients in the medicine (See Product description below).

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering. If you take it after the expiry date has passed, it may not work as well.

Do not give Chemists’ Own Nystatin to children or infants unless your doctor tells you to. Your doctor will check to make sure that Chemists’ Own Nystatin is the right treatment for your child’s symptoms.

Before you start to take it

Tell your doctor or pharmacist if:

  • You are pregnant or plan to become pregnant
  • You are breastfeeding or plan to breastfeed
  • You have any allergies to other medicines, foods, preservatives or dyes.
  • You have diabetes or any other medical condition.

People with diabetes are more likely to get thrush.

Taking other medicines

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

Chemists’ Own Nystatin is not known to interact with other medicines but your doctor still needs to know what other medicines you are taking.

How to take Chemists’ Own Nystatin Drops

How much to take

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. If your doctor or pharmacist tells you to take a different dose, follow their instructions.

How to take it

  • Shake the bottle well before inserting the measuring syringe
  • Fill the syringe to 1.0 mL mark.
  • Squirt the medicine into your mouth and hold or swish around as long as possible before swallowing.
  • Avoid taking food or drink for one hour after the dose.

How long to take it

Take the medicine for at least for 48 hours after obtaining symptomatic relief.

If you forget it

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.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take double dose to make up for the dose you have missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your pharmacist or doctor.

If you have trouble remembering to take your medicine, ask your doctor or pharmacist for some hints.

If you take too much (overdose)

Taking an overdose of Chemists’ Own Nystatin may upset your stomach with nausea, vomiting and diarrhoea.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Chemists’ Own Nystatin Oral drops. Do this even if there are no signs of discomfort or poisoning. Report if you have taken any other medicine or alcohol. You may need urgent medical attention.

While you are using Chemists’ Own Nystatin

Things you must do

Use Chemists’ Own Nystatin exactly as your doctor or pharmacist has recommended.

Tell all doctors, dentists and pharmacists who are treating you that you are taking Chemists’ Own Nystatin.

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.

Always discuss with your doctor or pharmacist any problems or difficulties during or after taking Chemists’ Own Nystatin.

Tell your doctor or pharmacist if, for any reason, you have not taken your medicine exactly as recommended.

Keep enough Chemists’ Own Nystatin to last weekends and holidays. Discard the medicine after 4 weeks of opening.

Things you must not do

Do not stop taking Chemists’ Own Nystatin or alter the dose without checking with your doctor or pharmacist. If you stop taking Chemists’ Own Nystatin or change the dose, Chemists’ Own Nystatin may not work as well.

Do not use Chemists’ Own Nystatin Oral Drops to treat other complaints unless your doctor says to.

Do not give Chemists’ Own Nystatin to anyone else, even if their symptoms seem similar to yours.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Chemists’ Own Nystatin.

Chemists’ Own Nystatin helps most people with thrush but may have side effects in some people. As only minute amounts of Chemists’ Own Nystatin are absorbed into blood, the side effects are rare.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following symptoms and they worry you:

  • feeling sick or nausea,
  • vomiting,
  • stomach upset,
  • diarrhoea.

These side effects are rare and usually occur if too much Chemists’ Own Nystatin is taken. Other side effects not listed above may occur in some patients.

Tell your doctor if you notice anything else that is making you feel unwell when you are taking or soon after you have finished taking, Chemists’ Own Nystatin.

After using Chemists’ Own Nystatin

Storage

Keep Chemists’ Own Nystatin Oral Drops in the bottle until it is time to use. If you take the medicine out of the bottle before it is time to use, it may not keep well.

Keep Chemists’ Own Nystatin in a cool dry place with temperature below 25°C. Do not freeze. Do not store it, or any other medicines, in bathroom or near a sink. Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one and a half meters above the ground is a good place to keep the medicines.

Disposal

If your doctor or pharmacist tells you to stop taking Chemists’ Own Nystatin Oral Drops or the drops have passed the expiry date, ask your pharmacist what to do with any drops left over.

Product description

What it 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.

Ingredients

The active ingredient in Chemists’ Own Nystatin Oral Drops is Nystatin.

Each 1mL contains 100,000 international units of Nystatin.

Chemists’ Own Nystatin Oral Drops also contain the following inactive ingredients:

  • sucrose
  • saccharin sodium
  • carmellose sodium
  • sodium citrate dihydrate
  • sodium hydroxide
  • methyl hydroxybenzoate
  • propyl hydroxybenzoate
  • purified water
  • vanilla flavour cream 9/HO7915

Chemists’ Own Nystatin does not contain gluten, lactose, tartrazine or any other azo dyes.

Distributed By:

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne, VIC 3121
Australia

AUST R 301569

This leaflet was prepared in April 2024

Published by MIMS May 2024

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