Nystatin 100 000 Units/Ml Oral Suspension
NYSTATIN 100,000 UNITS/ML ORAL SUSPENSION
POM
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available as Nystatin 100,000 units/ml Oral Suspension, but will be referred to as Nystatin throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Nystatin is and what it is used for
2. What you need to know before you take Nystatin
3. How to take Nystatin
4. Possible side effects
5. How to store Nystatin
6. Contents of the pack and other information
1. What Nystatin is and what it is used for
The name of this medicine is Nystatin. This medicine contains nystatin as the active ingredient.
Nystatin belongs to a group of medicines called anti-fungal antibiotics. Nystatin 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.
2. What you need to know before you take Nystatin
Do not take Nystatin:
■ 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.
■ 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
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 can cause foetal harm when administered to a pregnant woman, however absorption of nystatin from the gastro-intestinal tract is negligible. Nystatin should be prescribed during pregnancy only if the potential benefits outweigh the possible risks involved.
It is not known whether nystatin is excreted in breast milk. Caution should be used when nystatin is prescribed for nursing women.
Driving and using machines
Nystatin should not affect your ability to drive.
Nystatin contains methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216) which may cause allergic reactions
(possibly delayed).
Nystatin contains small amounts of ethanol (alcohol), less than 100mg per dose.
Nystatin contains less than 1mmol sodium (23mg) per dose, i.e. essentially "sodium free".
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Nystatin
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 1ml of suspension dropped into the mouth four times a day. In the case of newborn babies, the recommended dose is 1ml once a day dropped into the mouth.
Shake the bottle well before use.
Use the measuring dropper provided.
Doses should be equally spaced throughout the day.
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. There are no specific dosage recommendations or precautions for the elderly.
If you take more Nystatin than you should
Taking more Nystatin 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
If you forget to take Nystatin, 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 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nystatin
■ Do not use your medicine after the expiry date shown on the carton, and bottle labels. The expiry date refers to the last day of that month.
■ KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Do not store above 25°C.
■ If your doctor decides to stop your treatment, return any left over medicine to the pharmacist. Only keep it if your doctor tells you to.
■ If your medicine appears to be discoloured or shows other signs of deterioration, please return to your pharmacist who will advise you.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Nystatin contains
Nystatin contains nystatin as the active ingredient. Each ml contains 100,000 units of nystatin.
Also contains: sucrose, glycerine, carmellose, disodium phosphate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethanol, cherry flavour, peppermint essential oil, cinnamic aldehyde, hydrochloric acid, sodium hydroxide and purified water.
What Nystatin looks like and contents of the pack
Nystatin is a yellow suspension in an amber glass bottle with a graduated dropper.
Your medicine is available in bottles of 30ml.
Manufacturer
Your medicine is manufactured by:
Haupt Pharma Wolfratshausen GmbH, Pfaffenrieder Str. 5,
D-82515 Wolfratshausen, Germany. or
Bristol-Myers Squibb, Rue du Docteur Gilles, 28230 Epernon, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0415
Leaflet issue and revision date: 16.02.15
POM
PACKAGE LEAFLET: INFORMATION FOR THE USER
NYSTAN™ 100,000 UNITS/ML ORAL SUSPENSION
(nystatin)
Your medicine is available as Nystan 100,000 units/ml Oral Suspension, but will be referred to as Nystan throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Nystan is and what it is used for
2. What you need to know before you take Nystan
3. How to take Nystan
4. Possible side effects
5. How to store Nystan
6. Contents of the pack and other information
1. What Nystan is and what it is used for
The name of this medicine is Nystan. This medicine contains nystatin as the active ingredient.
Nystatin belongs to a group of medicines called anti-fungal antibiotics. Nystan 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.
2. What you need to know before you take Nystan
Do not take Nystan:
■ 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.
■ 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
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 can cause foetal harm when administered to a pregnant woman, however absorption of nystatin from the gastro-intestinal tract is negligible. Nystatin should be prescribed during pregnancy only if the potential benefits outweigh the possible risks involved.
It is not known whether nystatin is excreted in breast milk. Caution should be used when nystatin is prescribed for nursing women.
Driving and using machines
Nystan should not affect your ability to drive.
Nystan contains methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216) which may cause allergic reactions
(possibly delayed).
Nystan contains small amounts of ethanol (alcohol), less than 100mg per dose.
Nystan contains less than 1mmol sodium (23mg) per dose, i.e. essentially "sodium free".
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Nystan
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 1ml of suspension dropped into the mouth four times a day. In the case of newborn babies, the recommended dose is 1ml once a day dropped into the mouth.
Shake the bottle well before use.
Use the measuring dropper provided.
Doses should be equally spaced throughout the day.
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. There are no specific dosage recommendations or precautions for the elderly.
If you take more Nystan than you should
Taking more Nystan 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
If you forget to take Nystan, 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 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nystan
■ Do not use your medicine after the expiry date shown on the carton, and bottle labels. The expiry date refers to the last day of that month.
■ KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Do not store above 25°C.
■ If your doctor decides to stop your treatment, return any left over medicine to the pharmacist. Only keep it if your doctor tells you to.
■ If your medicine appears to be discoloured or shows other signs of deterioration, please return to your pharmacist who will advise you.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Nystan contains
Nystan contains nystatin as the active ingredient. Each ml contains 100,000 units of nystatin.
Also contains: sucrose, glycerine, carmellose, disodium phosphate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethanol, cherry flavour, peppermint essential oil, cinnamic aldehyde, hydrochloric acid, sodium hydroxide and purified water.
What Nystan looks like and contents of the pack
Nystan is a yellow suspension in an amber glass bottle with a graduated dropper.
Your medicine is available in bottles of 30ml.
Manufacturer
Your medicine is manufactured by:
Haupt Pharma Wolfratshausen GmbH, Pfaffenrieder Str. 5,
D-82515 Wolfratshausen, Germany. or
Bristol-Myers Squibb, Rue du Docteur Gilles, 28230 Epernon, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0415
Leaflet issue and revision date: 16.02.15
Nystan™ is a trademark of E.R. Squibb & Sons Limited.
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