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.
Nystan 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 Nystan Oral Suspension. This medicine contains nystatin as the active ingredient. Nystatin belongs to a group of medicines called anti-fungal antibiotics. Nystan 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 Nystan Oral Suspension Do not take Nystan 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 Nystan Oral Suspension. Talk to your doctor or pharmacist as Nystan should not be used if you have a fungal infection in the lungs or on the skin (systemic mycoses). Other medicines and Nystan Oral Suspension Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and 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 Nystan can cause harm to your unborn baby when taken by a pregnant woman or if Nystan can affect your ability to conceive, however absorption of Nystan from the digestive system is small. It is not known whether Nystan is excreted in breast milk. Caution should be used when Nystan is given to women who are breast-feeding. Driving and using machines Nystan Oral Suspension should not affect your ability to drive. Nystan Oral Suspension contains Nystan 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 of beer or 0.1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. Nystan Oral Suspension contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially "sodium free". If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take it
Nystan 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. 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 case. 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. Coat 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.
- 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 case. Never separate the dosing syringe from the other parts of the medicinal product package (box, package leaflet).
Picture 1
Picture 2
Picture 4
Picture 5
Picture 3
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 Nystan Oral Suspension than you should Taking more Nystan Oral Suspension than recommended should not cause any severe effects as the amount of Nystan 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 Nystan Oral Suspension If you forget to take Nystan 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. 4. 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 Rash including urticaria (itching) have been reported rarely. Hypersensitivity, angioedema (swelling of the lips or tongue) and facial oedema (swelling of the face) have also been reported. There have been very rare cases of a more serious allergic reaction called StevenJohnson 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, pharmacist or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
How to store it
Nystan Oral Suspension Keep this medicine out of the sight and reach of children. Do not store above 25°C. 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 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 Nystan Oral Suspension contains –
The active substance is nystatin, containing 100,000 units nystatin per ml. The other ingredients are: ethanol, flavours*, glycerine, methyl parahydroxybenzoate (E218), pH adjusters (hydrochloric acid, sodium hydroxide), propyl parahydroxybenzoate (E216), sodium carboxymethylcellulose (E466), sodium phosphate, sucrose and water.
*Cherry flavour, cinnamic aldehyde, peppermint oil. What Nystan Oral Suspension looks like and contents of the pack Nystan 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. The leaflet was revised in July 2023.
Frequently asked questions about Nystan Oral Suspension (Ready -Mixed)
How do I take Nystan Oral Suspension (Ready -Mixed)?
Nystan Oral Suspension (Ready -Mixed) comes as oral solution. 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 Nystan Oral Suspension (Ready -Mixed)?
The active substance in Nystan Oral Suspension (Ready -Mixed) is nystatin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Nystan 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 Nystan 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 Nystan 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
Nystan 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 of beer or 0.1 ml of wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
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”.
Nystan 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
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 Nystan 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.