Consumer medicine information

Chemists' Own Nystatin 100,000 U/mL 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 100,000 U/mL Oral drops.

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.

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

4.9 Overdose

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

5 Pharmacological Properties

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

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSNYSTAT.gif Molecular formula is C47H75NO17.
CAS number. 1400-61-9.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CHENYSST.gif