®    Ref: LTT126/080413/1/F

Nystan 100,000 units/ml Oral Suspension

(nystatin)

Patient Information 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.

Your medicine is called Nystan 100,000 units/ml Oral Suspension, however throughout this leaflet it will be referred to as Nystan Oral Suspension.

In this leaflet:

3 What Nystan Oral Suspension is and what it is used for

3 What you need to know before you take Nystan Oral Suspension 3 How to take Nystan Oral Suspension 3 Possible side effects 3 How to store Nystan Oral Suspension 3 Contents of the pack and other information

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 Oral Suspension should not affect your ability to drive.

Nystan Oral Suspension contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Nystan Oral Suspension contains small amounts of ethanol (alcohol), less than 100mg per dose.

Nystan Oral Suspension 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 What Nystan Oral Suspension is and what it is used 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.

3 What you need to know before you take 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.

3 How to take 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 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 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.

^ 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).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet

What Nystan Oral Suspension looks like and contents of the pack

Nystan is an opaque, light creamy yellow suspension with a cherry/mint odor in a 30ml amber glass bottle with a graduated dropper and a black rubber bulb with a white screw cap.

Nystan Oral Suspension is supplied in a 30ml amber bottle. A graduated dropper is also included in the pack.

This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e. essentially "sodium free”.

Manufacturer and Licence Holder

Nystan Oral Suspension is manufactured by Haupt Pharma Wolfratshausen GmbH, Pfaffenrieder Strasse 5, Wolfratshausen, D-82515, Germany and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.

Nystan is a registered trademark of E.R. Squibb & Sons Limited.

How to store Nystan Oral Suspension

•    Do not store above 25°C.

•    Do not freeze

•    Do not use your medicine after the expiry date which you will find on the bottle label and carton.

•    Keep your medicine out of the reach and sight of children.

•    If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

•    Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer require or medicines that have expired. These measures will help to protect the environment.

| POM PL 33723/0126 Leaflet revision date: 08/04/13

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

(6) Further Information

What Nystan Oral Suspension contains

Each ml contains 100,000 units of nystatin.

Also contains cherry flavour, cinnamic aldehyde, ethanol 1%, glycerin, methyl parahydroxybenzoate (E218), peppermint oil, pH adjusters (hydrochloric acid, sodium hydroxide), propyl parahydroxybenzoate (E216), sodium carboxymethylcellulose, sodium phosphate, sucrose and water.

Please note that this medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose.

®    Ref: LTT126/080413/2/F

Nystatin 100,000 units/ml Oral Suspension

(nystatin)

Patient Information 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.

Your medicine is called Nystatin 100,000 units/ml Oral Suspension, however throughout this leaflet it will be referred to as Nystatin Oral Suspension.

In this leaflet:

^ What Nystatin Oral Suspension is and what it is used for

^ What you need to know before you take Nystatin Oral Suspension .3) How to take Nystatin Oral Suspension ^ Possible side effects ^ How to store Nystatin Oral Suspension ^ Contents of the pack and other information

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 Oral Suspension should not affect your ability to drive.

Nystatin Oral Suspension contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

Nystatin Oral Suspension contains small amounts of ethanol (alcohol), less than 100mg per dose.

Nystatin Oral Suspension 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.

™ What Nystatin Oral Suspension is and what it is used 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 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 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.

How to take 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 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 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

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).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet

What Nystatin Oral Suspension looks like and contents of the pack

Nystatin is an opaque, light creamy yellow suspension with a cherry/mint odor in a 30ml amber glass bottle with a graduated dropper and a black rubber bulb with a white screw cap.

Nystatin Oral Suspension is supplied in a 30ml amber bottle. A graduated dropper is also included in the pack.

This medicinal product contains less than 1mmol sodium (23mg) per dose, i.e. essentially "sodium free”.

Manufacturer and Licence Holder

Nystatin Oral Suspension is manufactured by Haupt Pharma Wolfratshausen GmbH, Pfaffenrieder Strasse 5, Wolfratshausen, D-82515, Germany and is procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.

Nystatin is a registered trademark of E.R. Squibb & Sons Limited.

How to store Nystatin Oral Suspension

•    Do not store above 25°C.

•    Do not freeze

•    Do not use your medicine after the expiry date which you will find on the bottle label and carton.

•    Keep your medicine out of the sight and reach of children.

•    If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

•    Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer require or medicines that have expired. These measures will help to protect the environment.

| POM PL 33723/0126 Leaflet revision date: 08/04/13

Blind or partially sighted?

Is this leaflet hard to see or read? Phone Lexon (UK) Limited,

Tel: 01527 505414 for help.

Further Information

What Nystatin Oral Suspension contains

Each ml contains 100,000 units of nystatin.

Also contains cherry flavour, cinnamic aldehyde, ethanol 1%, glycerin, methyl parahydroxybenzoate (E218), peppermint oil, pH adjusters (hydrochloric acid, sodium hydroxide), propyl parahydroxybenzoate (E216), sodium carboxymethylcellulose, sodium phosphate, sucrose and water.

Please note that this medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose.