Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Nystatin 100,000 unit/ml Oral suspension (Ready Mixed)
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Nystatin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of this medicine is Nystatin Oral Suspension. This medicine contains nystatin as the active ingredient. Nystatin belongs to a group of medicines called anti-fungal antibiotics. Nystatin Oral Suspension is used to prevent and treat fungal infections (thrush) of the mouth, throat or gut. It also provides effective prevention against oral thrush in those born of mothers with vaginal thrush. This medicine works by killing the yeast or fungus that has caused your symptoms.
What you need to know before you take it
e Nystatin Oral Suspension Do not take Nystatin Oral Suspension: If you are allergic to nystatin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Nystatin Oral Suspension. Talk to your doctor or pharmacist as nystatin should not be used if you have a fungal infection in the lungs or on the skin (systemic mycoses). Other medicines and Nystatin Oral Suspension Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not known whether Nystatin Oral Suspension can cause harm to your unborn baby when taken by a pregnant woman or if nystatin can affect your ability to conceive, however absorption of nystatin from the digestive system is small. It is not known whether nystatin is excreted in breast milk. Caution should be used when nystatin is given to women who are breast-feeding. Driving and using machines Nystatin Oral Suspension should not affect your ability to drive.
Nystatin Oral Suspension contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), alcohol, sucrose (sugar) and is essentially "sodium free" Nystatin Oral Suspension contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). This medicine contains 228 mg of alcohol (ethanol) in each 30 ml which is equivalent to 0.76 g in 100 ml. The amount in 1 ml of this medicine is equivalent to less than 0.2 ml beer or 0.1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine. Nystatin Oral Suspension contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially "sodium free".
How to take it
Nystatin Oral Suspension Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults and children is 1 ml of suspension dropped into the mouth four times a day. In the case of newborn babies, the recommended dose is 1 ml once a day dropped into the mouth. There are no specific dosage recommendations or precautions for older people. Taking this medicine:
- Shake the bottle well before use.
- Use the measuring syringe provided, which is graduated in 0.5 ml steps.
- Doses should be equally spaced throughout the day. A dosing syringe for oral administration graduated from 0.5 to 5 ml with an adapter to attach to the bottle is provided in the box. On first use: 1. Remove the adapter from the syringe (see picture 1) 2. Remove the cap from the bottle 3. Insert the adapter into the bottle (see picture 2) 4. Close the bottle. Each time you use it:
- Preparation of the delivery device 1. Shake the suspension before each use 2. Remove the cap from the bottle 3. Attach the syringe to the adapter (see picture 3) 4. Turn the vial/syringe assembly (see picture 4) 5. Fill the syringe with a small amount of medicine by pulling the plunger and then pushing the plunger upwards to avoid the formation of air bubbles.
Job No: 1314 Job Title: 1314_Nystatin_Leaflet_UKPiggyBack_30ml_NEWStyle_St15 Size: 160 x 220mm Colours: Black Trace Version No: 15 Date Created: 21.08.2024 Fonts:
Ridley Grotesk Frutiger LT Min font size: 8pt
Notes :
Launch
Article code: P10013-01-A CMO code: 85002368
Pharmacode number 1019
- Dose preparation 1. Make sure the plunger is at the bottom of the syringe (see picture 5) 2. Slowly pull the plunger to extract the required dose with the dosing syringe 3. Once the dose has been extracted, turn the vial/syringe assembly upside down and remove it by gently turning the syringe containing the dose to be administered. 4. Introduce the tip of the syringe directly into the mouth 5. Immediately administer the entire extracted volume by slowly pressing the plunger. After each use: 1. Close the bottle with the cap, leaving the adapter in the bottle. 2. Rinse the syringe with water repeating the action. 3. Store the dry syringe in the box. Never separate the dosing syringe from the other parts of the medicinal product package (box, package leaflet).
Picture 1
Picture 2
Picture 4
Picture 3
Picture 5
If you are taking this medicine for an infection in the mouth or throat, try not to swallow the suspension too quickly, as the longer the medicine is in contact with the site of infection the better. Your doctor will normally have given you sufficient medicine to enable you to continue treatment for 48 hours after all symptoms have disappeared. This will help to clear up your infection completely and prevent a relapse. If signs and symptoms worsen or persist (beyond 14 days of treatment), you should talk to your doctor. If you take more Nystatin Oral Suspension than you should Taking more Nystatin Oral Suspension than recommended should not cause any severe effects as the amount of nystatin absorbed by the body is very small. With very high doses, nausea and gastrointestinal upset were reported. However, in the case of a child, you may wish to check with your doctor or hospital emergency department. If you forget to take Nystatin Oral Suspension If you forget to take Nystatin Oral Suspension, take your medicine as soon as you remember, unless it is close to the time you would normally take your next dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If irritation or sensitisation develops, treatment should be discontinued. Nausea has also been reported occasionally during therapy. Large oral doses can occasionally cause:
- sickness and diarrhoea
- bloating
- stomach cramps, indigestion Rare side effects: may affect up to 1 in 1,000 people
- rash including urticaria (itching)
- hypersensitivy, and allergic reactions such as swelling of the lips or tongue and swelling of the face. Very rare side effects: may affect up to 1 in 10,000 people
- serious allergic reaction called Steven-Johnson Syndrome (a serious illness with blistering of the skin, mouth, eyes and genitals). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
Nystatin Oral Suspension Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle label and carton. This expiry date refers to the last day of that month. Do not store above 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Nystatin Oral Suspension contains
- The active substance is nystatin. Each ml of the suspension contains 100,000 units of nystatin.
- The other ingredients are ethanol, flavours*, glycerol, methyl parahydroxybenzoate (E218), pH adjusters (hydrochloric acid, sodium hydroxide), propyl parahydroxybenzoate (E216), carmellose sodium (E466), disodium phosphate, sucrose and water. *cherry flavour, cinnamic aldehyde, peppermint oil. What Nystatin Oral Suspension looks like and contents of the pack Nystatin Oral Suspension is supplied in a bottle filled with 30 ml. A graduated syringe (in 0.5 ml steps) and an adapter are also included in the pack. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Vygoris Limited 930 High Road London N12 9RT United Kingdom Tel: +44 (0) 1223 395301 Manufacturer Vetprom AD The Vpharma site, 26 Otets Paisiy Str., Radomir, 2400, Bulgaria For any information about this medicine, please contact the Marketing Authorisation Holder. This leaflet was last revised in April 2024. 85002368 P10013-01-A
Job No: 1314 Job Title: 1314_Nystatin_Leaflet_UKPiggyBack_30ml_NEWStyle_St15 Size: 160 x 220mm Colours: Black Trace Version No: 15 Date Created: 21.08.2024 Fonts:
Ridley Grotesk Frutiger LT Min font size: 8pt
Notes :
Launch
Article code: P10013-01-A CMO code: 85002368
Pharmacode number 1019
Frequently asked questions about Nystatin 100,000 unit/ml Oral suspension (Ready Mixed)
How do I take Nystatin 100,000 unit/ml Oral suspension (Ready Mixed)?
Nystatin 100,000 unit/ml Oral suspension (Ready Mixed) comes as oral solution containing 100iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Nystatin 100,000 unit/ml Oral suspension (Ready Mixed)?
The active substance in Nystatin 100,000 unit/ml Oral suspension (Ready Mixed) is nystatin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Nystatin 100,000 unit/ml Oral suspension (Ready Mixed), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Nystatin 100,000 unit/ml Oral suspension (Ready Mixed) without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: nystatin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
The prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract. The suspension provides effective prophylaxis against oral candidosis in those born of mothers with vaginal candidosis.
4.2. Posology and method of administration
Posology
Adults:
For the treatment of denture sores, and oral infections in adults caused by C.albicans, 1 ml of the suspension should be dropped into the mouth four times daily; it should be kept in contact with the affected areas as long as possible.
Children:
In intestinal and oral candidosis (thrush) in infants and children, 1 ml should be dropped into the mouth four times a day. The longer the suspension is kept in contact with the affected area in the mouth, before swallowing, the greater will be its effect.
For prophylaxis in the newborn the suggested dose is 1 ml once daily.
Older people:
No specific dosage recommendations or precautions.
In the prevention and treatment of candidiasis, the dosage regimen for nystatin should be continued for at least 48 hours after symptoms have disappeared. If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be reevaluated, and alternate therapy considered.
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Nystatin Oral Suspension contains sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains 228 mg of alcohol (ethanol) in each 30 ml which is equivalent to 0.76 g in 100 ml. The amount in 1 ml of this medicine is equivalent to less than 0.2 ml beer or 0.1 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effect.
This medicinal product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium free”.
Nystatin oral preparations should not be used for treatment of systemic mycoses.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Fertility, pregnancy and lactation
Pregnancy
Animal reproductive studies have not been conducted with nystatin.
It is not known whether nystatin can cause foetal harm when administered to a pregnant woman or can affect reproductive capacity, however absorption of nystatin from the gastro-intestinal tract is negligible. Nystatin should be prescribed during pregnancy only if the potential benefits to be derived outweigh the potential risk to the foetus.
Breast-feeding
It is not known whether nystatin is excreted in human milk. Although gastrointestinal absorption is insignificant, caution should be exercised when nystatin is prescribed for a nursing woman.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Nystatin is generally well tolerated by all age groups, even during prolonged use. If irritation or sensitisation develops, treatment should be discontinued. Nausea has been reported occasionally during therapy.
Large oral doses of Nystatin have occasionally produced diarrhoea, gastrointestinal distress, nausea and vomiting. Rash, including urticaria, has been reported rarely. Steven-Johnson Syndrome has been reported very rarely. Hypersensitivity and angioedema, including facial oedema have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.”
4.9. Overdose
Since the absorption of nystatin from the gastro-intestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity. Oral doses of nystatin in excess of 5 million units daily have caused nausea and gastrointestinal upset.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- NISTATINA ATB 500000 UI prescriptionNYSTATINUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Nystatyna TevaNystatinum · taken by mouth
- NystapolNystatinum · taken by mouth
- NyscandinNystatinum · taken by mouth
- Nystatin TZFNystatinum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Nystatin 100,000 unit/ml Oral suspension (Ready Mixed). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.