PATIENT INFORMATION LEAFLET TEXT

Nystatin Oral Suspensions BP

100,000 units/ml

Please read this leaflet carefully before you start to taking this medicine because it contains important information for you.

This leaflet provides only a summary of the information known about the medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. 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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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.    Content of the pack and other information

1. WHAT NYSTATIN IS AND WHAT IT IS USED FOR

The name of your medicine is nystatin. This is the generic (common) name for your medicine which is an anti-fungal agent.

Nystatin is an antibiotic which is used to treat or prevent fungal (candidal) infections of the mouth, throat and bowels.

It also provides effective prevention against oral thrush in those born from mothers with vaginal thrush.

Remember, this medicine is for you. Only a doctor can prescribe it for you. Never give it to anyone else, it may harm them

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).

Warning 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 Nystan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

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.

Nystatin Oral Suspension contains sodium benzoate may cause irritation to the mucous membranes which line the mouth, stomach and intestines. If you are sensitive to sodium benzoate you may notice slight discomfort while taking your medicine.

Nystatin Oral Suspension contains glycerol, if taken in large amounts, may cause headaches, stomach upset and diarrhoea.

Nystatin Oral Suspension contains sodium methylhydroxybenzoate may cause allergic reactions (possibly delayed).

Nystatin Oral Suspension contains sorbitol, 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

The pharmacists label will tell you exactly how much medicine to take and how often it should be taken. The amount of medicine you take is called the ‘dose’. As a guide, the following information is provided for treatment and prevention of infection in adults and children:

100,000 units/ml (1ml of suspension)

Adults

Treatment:

For the treatment of mouth infections 100,000 units (1ml of suspension) four times a day. It should be kept in the mouth as long as possible. For the treatment of bowel infections 500,000 Units (5ml of suspension) four times daily. This dose may be doubled in severe infections. Prevention:

To prevent fungal infections a daily dosage of 1 million units (10ml of suspension) may be given.

New born babies, infants and children ( from birth to children of 2 years of age and above)

Treatment:

In mouth and bowel infections in new born babies, infants and children (from birth to children of 2 years of age and above) 100,000 units (1ml of suspension) should be dropped in the mouth four times a day.

New born babies ( birth -1 month)

Prevention:

In the new born babies ( birth -1 month) the suggested dose for mouth or bowel infections is

100,000 Units (1ml of suspension) once daily.

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.

The medicine should be used as follows:

•    Shake the bottle vigorously, then draw up the correct amount into the dropper device.

•    Squeeze the contents of the dropper into the mouth. If the medicine is being used for a mouth infection, use after eating and coat the affected areas of the mouth with the suspension, holding in the mouth for as long as possible before swallowing.

•    Empty the dropper as much as possible when giving each dose.

•    It is important to keep taking this medicine for the period specified by your doctor to ensure that the infection does not return.

If you take more Nystatin than you should

It is important not to take too much medicine.

Contact your nearest hospital casualty department or a doctor for advice if you have swallowed too much medicine or if you think a child has accidentally swallowed any.

Take this leaflet and any medicine you still have to show the doctor.

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

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).

Hypersensitivity angioedema (swelling of the lips or tongue) and facial oedema (swelling of the face) have also been reported. Rash including urticaria (itching) have been reported rarely.

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

Reporting of side effects:

If you get any side effects, talk to your doctor, or 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE THIS MEDICINE

Keep this medicine out of the sight and reach of children.

Keep your medicine in a safe place where children cannot get hold of it. Store at room temperature (below 25°C) in a dark place.

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.

6. FURTHER INFORMATION What this medicine contains:

Each millilitre (ml) of oral suspension contains:

•    Nystatin BP 100,000 units (active ingredient)

•    Sorbitol solution 70%, glycerol, sodium citrate, dispersible cellulose, sodium benzoate, saccharin sodium, glyceryl mono/di-oleate, citric acid, purified water. Nystatin Oral Suspensions also contain xantham gum, sodium methylhydroxybenzoate (500,000 and 100,000 units solutions only) and mixed sodium hydroxybenzoate esters, hydroxyethylcellulose, polysorbate 80

(1 million units solution only).

What this medicine looks like and contents of the pack:

Nystatin Oral Suspension comes in bottles of 30ml.

Marketing Authorisation Holder and Manufacturer

These suspensions are produced by Letap Laboratories Ltd., Ashford, Kent for H.N. Norton and Co. Ltd. The product licence holder is Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG, UK.

Nystatin Oral Suspension BP 100,000 units/ml: PL 00289/1869

This leaflet was last revised :May 2014.

Teva Pharmaceuticals Europe B.V 1.3.1 pil-uk-clean

Approvals

Signed by	Meaning of Signature	Server Date
Poonam Shelar	Regulatory Affairs Approval	25-Jul-2014 11:23:58 AM

REG0118357 Version 0.5 Approved Page 7 of 7