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NYSTAN 100 000 UNITS/ML ORAL SUSPENSION

Active substance(s): NYSTATIN

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Nystan® 100,000 units/ml Oral Suspension (Ready-Mixed)/
Nystatin 100,000 units/ml Oral Suspension (Ready-Mixed)
(nystatin)
Your medicine is known by either of the above names, but will be referred to
as Nystan Oral Suspension throughout this Leaflet.
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.
What is in this leaflet
1) What Nystan Oral Suspension is and what it is used for
2) What you need to know before you take Nystan Oral Suspension
3) How to take Nystan Oral Suspension
4) Possible side effects
5) How to store Nystan Oral Suspension
6) Contents of the pack and other information

1) 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.

2) 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.
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).
Nystan Oral Suspension contains small amounts of ethanol (alcohol), less
than 100mg per dose.
Nystan Oral Suspension contains less than 1 mmol sodium (23mg) 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.

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. For thrush of
the mouth or throat: The recommended dose for newborns (from birth to 1
month) is 1ml four times a day dropped into the mouth. The recommended
dose for infants (1 month to 2 years) is 2ml four times a day dropped into
the mouth (1 ml for each side of the mouth).
The recommended dose for children (over 2 years) and adults is 4 to 6ml
four times a day dropped into the mouth (half dose in each side of the
mouth).
For thrush of the gut:
The recommended dose for newborns (from birth to 1 month) and infants (1
month to 2 years) is 1 to 2ml four times a day to be given with milk or other
liquid.

The recommended dose for children (over 2 years) and adults is 4 to 6ml
four times a day. The suspension should be kept in the mouth for as long as
possible (e.g., a few minutes) before swallowing.
There are no specific dosage recommendations or precautions for older
people.
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. 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
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, 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 Nystan Oral Suspension
 Keep all medicines out of the sight and reach of children.
 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.
 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 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 Oral Suspension contains:
Each ml contains 100,000 units of nystatin.
Also contains cherry flavour, cinnamic aldehyde, ethanol, glycerin, methyl
parahydroxybenzoate (E218), peppermint oil, pH adjusters (hydrochloric
acid, sodium hydroxide), propyl parahydroxybenzoate (E216), sodium
carboxymethylcellulose, sodium phosphate, sucrose and water.
What Nystan Oral Suspension looks like and contents of the pack
Nystan is an opaque, light creamy yellow suspension with a cherry/mint
odour 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”.
PL 10383/2004 Nystan 100,000 Units/ml Oral Suspension (Ready-mixed)/
Nystatin 100,000 Units/ml Oral Suspension (Ready-mixed)
POM
Who makes and repackages your medicine?
Your medicine is manufactured by Haupt Pharma Wolfratshausen GmbH
Pfaffenrieder Str. 5, D-82515 Wolfratshausen, Germany. Procured from
within the EU and repackaged by Product Licence Holder Primecrown Ltd,
4/5 Northolt Trading Estate, Belvue Road, Northolt UB5 5QS
Leaflet date: 06.04.2016
Nystan® is a registered trademark of Bristol-Myers Squibb Pharmaceuticals
Limited.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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