Nystatin Oral Suspension Bp
PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000 If you, or the child you are giving this medicine to, have an intolerance to some sugars.
Nystatin Oral Suspension
Please read 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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Nystatin Oral Suspension is and what it is used for
2. What you need to know before you take Nystatin Oral Suspension
3. How to take Nystatin Oral Suspension
4. Possible side effects
5. How to store Nystatin Oral Suspension
6. Contents of the pack and other information
The name of this medicine is Nystatin Oral Suspension. This medicine contains nystatin as the active ingredient. Nystatin belongs to a group of medicines known as anti-fungal antibiotics.
Nystatin Oral Suspension is used for the prevention and treatment of infections of the mouth, throat and intestinal tract caused by a fungus called Candida. It also provides effective protection against Candida infection in children born to mothers with vaginal Candida infection.
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
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 with food and drink
If you have a gut infection you can take Nystatin Oral Suspension before or after food as you prefer.
If you have a mouth or throat infection, food and drink will reduce the amount of time the medicine is in contact with the site of infection.
You can drink alcohol while taking Nystatin Oral Suspension. If you are concerned about how much alcohol you can drink while taking Nystatin Oral Suspension, you should discuss this with your doctor.
Driving and using machines
Nystatin Oral Suspension should not affect your ability to drive or operate machinery.
Important information about some of the ingredients of Nystatin Oral Suspension
The product contains:
• Sucrose - contains 0.2 g of sucrose per 1 ml dose. If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.
This should also be taken into account in patients with diabetes mellitus.
• Propyl-p-hydroxybenzoate (E216) and methyl-p-hydroxybenzoate (E218) - may cause allergic reactions (possibly delayed) such as nettle rash, wheezing and skin type reactions.
• Sodium metabisulphite (E223) - may rarely cause severe hypersensitivity reactions and bronchospasm (difficulty in breathing).
• Sodium - this medicinal product contains 0.3 mmol (or 1.3 mg) sodium per 1 ml dose. To be taken into consideration by patients on a controlled sodium diet.
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).
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Warnings and precautions
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Talk to your doctor or pharmacist before taking 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.
Do not use the suspension if the seal is broken. Do not dilute the medicine. Shake well before use.
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Hold the medicine in the mouth and keep in contact with the affected area(s) for as long as possible before swallowing.
The usual doses are as follows:
|
Adults and older people | |
|
Denture sores and mouth infections caused by Candida albicans: |
1 ml, 4 times a day. |
|
Gut infections: |
5 ml, 4 times a day. |
|
Prevent candidal infection/overgrowth: |
If you are also taking other antibiotics, a total daily dosage of 10 ml will probably be sufficient. |
|
Infants (1 month to 2 years) and Children (> 2 years) | |
|
Intestinal and mouth infections caused by Candida albicans in infants and children: |
1 ml, 4 times a day. |
|
Newborn | |
|
Protection against infection in newborn babies |
1 ml, once a day. |
Side effects when taking nystatin are unusual, except if taking large doses of 40-50 ml daily. Large oral doses can occasionally cause:
• sickness and diarrhoea
• bloating
• stomach cramps, indigestion
Other reported symptoms:
• feeling sick (nausea).
• mouth irritation and sensitisation.
Reporting of side effects
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. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Doses should be equally spaced throughout the day.
You should continue to take Nystatin Oral Suspension for 48 hours after your infection has cleared. This is important to prevent the infection returning.
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.
Keep this medicine out of the sight and reach of children.
Store this product in a cool place, but do not freeze. Protect from light.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not use the suspension if the seal is broken or if you notice any visible signs of deterioration. 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and contact your doctor or the nearest hospital immediately if you experience any of the following:
• Allergic (hypersensitivity) reactions such as severe itchy skin rash, swelling of the hands, facial oedema (swelling of the face), angioedema (swelling of the lips or tongue), or difficulty breathing.
Stevens-Johnson Syndrome (symptoms include cough, aches, headache, fever, vomiting, diarrhoea, rash and blisters).
What Nystatin Oral Suspension contains
The active ingredient is nystatin. Each 1ml of suspension contains 100,000 International Units (IU) of nystatin.
The other ingredients are: sodium carboxymethylcellulose, methyl-p-hydroxybenzoate (E218), propyl-p-hydroxybenzoate (E216), sodium metabisulphite (E223), sucrose, saccharin sodium, sodium citrate, aniseed flavour and purified water.
What Nystatin Oral Suspension looks like and contents of the pack
Nystatin Oral Suspension is supplied in a 30 ml brown glass bottle with either a plastic cap or a child-resistant cap.
Marketing Authorisation Holder and Manufacturer
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
This leaflet was last revised in 06/2015.
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