Mycostatin

Package leaflet: Information for the patient

MYCOSTATIN 100,000 I.U./ml oral suspension

nystatin
Please read this entire leaflet carefully before you start taking/giving this medicine to your child, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and/or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you and/or your child experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Mycostatin is and what it is used for
2. What you need to know before taking/giving Mycostatin to your child
3. How to take/give Mycostatin to your child
4. Possible side effects
5. How to store Mycostatin
6. Contents of the pack and other information

1. What Mycostatin is and what it is used for

Mycostatin contains nystatin, an active substance belonging to the group of medicines known as intestinal antifungals, antibiotics.
Mycostatin is indicated in paediatric patients (from 1 month of age up to 18 years) and in adults (age greater than 18 years):

• for the prevention and treatment of mouth infections caused by fungi of the genus Candida (candidiasis or moniliasis). Mycostatin is indicated in newborns (up to 1 month of age):
• for the effective prevention of mouth infection caused by the fungus Candida Albicans (oral candidiasis or thrush).

As with all antibiotics, your doctor will instruct you to take/give Mycostatin to your child only after obtaining the results of a test assessing whether your child's fungal infection is sensitive to this antibiotic (sensitivity test).

2. What you need to know before taking/giving Mycostatin to your child

Do not take/give Mycostatin to your child

• If you and/or your child are allergic to nystatin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Mycostatin to your child.
Your doctor will not prescribe Mycostatin for you and/or your child to treat fungal infections affecting multiple organs and tissues (systemic mycoses), as Mycostatin acts locally.
In case of an allergic reaction, stop treatment immediately and inform your doctor right away (see section 4).
N D E S
Before taking Mycostatin, it is important that you ensure good oral hygiene, especially if you wear dentures or prostheses.
For people engaged in sports
Since Mycostatin contains ethyl alcohol, please note that the use of medicinal products containing ethyl alcohol may lead to a positive result in anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.
Children and adolescents
For children and adolescents, the doctor will determine the appropriate dose based on the patient's age and type of infection (see section 3).
Other medicines and Mycostatin
Inform your doctor or pharmacist if you and/or your child are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, your doctor will prescribe Mycostatin only if the benefit to you outweighs the potential risk to the fetus.
Breastfeeding
If you are breastfeeding, the decision to take Mycostatin will be made by your doctor.
Driving and using machines
There is no evidence to suggest that Mycostatin may affect the ability to drive or use machinery, including riding a bicycle.
Mycostatin contains Parahydroxybenzoates, Ethyl alcohol and Sucrose
Mycostatin contains parahydroxybenzoates (methylparahydroxybenzoate and propylparahydroxybenzoate) which may cause allergic reactions (including delayed reactions) and, in rare cases, bronchospasm.
This medicine contains small amounts of ethanol (ethyl alcohol), less than 100 mg per dose.
Mycostatin also contains sucrose in an amount of 500 mg per ml, which may be harmful if you and/or your child have diabetes mellitus.
If your doctor has informed you or your child that you have an intolerance to certain sugars (e.g. sucrose), contact your doctor before taking this medicine.

3. How to take/give Mycostatin to your child

Take/give this medicine to your child exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Prevention and treatment of oral Candida infections in adults (age over 18
years)
The recommended dose is 4-6 ml (400,000-600,000 International Units, IU), taken four times daily.
Your doctor may decide, if necessary, to increase the dosage.
Use in children and adolescents
Prevention and treatment of oral Candida infections in infants (from 1 month up to 2 years of age)
The recommended dose is 2 ml (equivalent to 200,000 IU), taken four times daily.
Your doctor may decide, if necessary, to increase the dosage.
Prevention and treatment of oral Candida infections in children and adolescents (aged between 2 and 18 years)
The recommended dose is 4-6 ml (400,000-600,000 IU), taken four times daily.
Your doctor may decide, if necessary, to increase the dosage.
Prevention of oral candidiasis (thrush) in newborns (up to 1 month of age)
The recommended average dose is 1 ml, administered once daily directly into the newborn's mouth using the dropper.
Route and method of administration
Mycostatin must be administered orally.
Method of administration

• Shake the bottle well before use.
• Draw up the prescribed amount using the dropper provided with the bottle.
• Administer the drops directly into the mouth using the dropper. The medicine should be administered by placing half the dose on each side of the mouth and holding it in the mouth as long as possible before swallowing.

Duration of treatment

• Your doctor will determine the duration of treatment.
• To prevent relapses, it is advisable to continue Mycostatin treatment for at least 48 hours after clinical recovery.
• If symptoms worsen or persist after 14 days of treatment, consult your doctor, who will prescribe an alternative therapy.

If you take/give your child more Mycostatin than you should
If you accidentally take/give your child more Mycostatin than recommended, contact your doctor or the nearest hospital immediately.
Possible symptoms associated with oral doses of nystatin exceeding 5 million units daily include:

• nausea
• stomach and intestinal disturbances.

If you forget to take/give your child Mycostatin
Do not take/give your child a double dose to make up for a forgotten dose.
If you stop treatment with Mycostatin
Even if symptoms improve during the first days of treatment, do not stop or interrupt the treatment until completion of the therapy as prescribed by your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking Mycostatin and contact your doctor immediately if you experience an allergic reaction (hypersensitivity), which may manifest as:

• skin rash
• urticaria (appearance on the skin of red or white wheals of various sizes)
• Stevens-Johnson Syndrome (destruction and detachment of the skin and mucous membranes due to an allergic reaction)
• angioedema (swelling of the face, tongue or throat)

The side effects that may occur during the use of Mycostatin, classified by frequency, are:

Uncommon (may affect up to 1 in 100 people):

• Diarrhoea
• Abdominal discomfort
• Nausea
• Vomiting
• Skin rash

Rare (may affect up to 1 in 1000 people):

• Allergic reaction (hypersensitivity)
• Angioedema (swelling of the face, tongue or throat)
• Stevens-Johnson Syndrome (destruction and detachment of the skin and mucous membranes due to an allergic reaction)
• Urticaria

Reporting of side effects
If you and/or your child experience any side effect, including those not listed in this leaflet, please contact your doctor. You may also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mycostatin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp." The expiry date refers to the last day of that month and applies to the medicine kept in its original packaging and stored correctly.
Store below 25°C.
After first opening the bottle, the medicine is valid for 14 days (record the date of first opening in the designated space on the packaging).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mycostatin contains

• The active substance is nystatin. 1 ml of oral suspension contains 100,000 IU of nystatin.
• The other components are: sucrose (see section 2 "Mycostatin contains Parahydroxybenzoates, Ethyl alcohol and Sucrose"), glycerol, sodium saccharin, sodium carmellose, dibasic sodium phosphate, methyl parahydroxybenzoate (see section 2 "Mycostatin contains Parahydroxybenzoates, Ethyl alcohol and Sucrose"), propyl parahydroxybenzoate (see section 2 "Mycostatin contains Parahydroxybenzoates, Ethyl alcohol and Sucrose"), ethyl alcohol (see section 2 "Mycostatin contains Parahydroxybenzoates, Ethyl alcohol and Sucrose"), cherry flavouring, peppermint oil, cinnamaldehyde, and purified water.

Description of the appearance of Mycostatin and contents of the pack
Ready-to-use oral suspension.
Each pack contains a 100 ml polyethylene bottle. Each bottle is equipped with a calibrated dropper delivering 1 ml.
Marketing Authorization Holder
Substipharm
24 rue Erlanger
Paris, France
Manufacturer
Haupt Pharma Wolfratshausen GmbH
Pfaffenrieder strasse 5,
Wolfratshausen, Germany