Mycostatin 100,000 units/ml Oral Suspension (Ready Mixed)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nystatin

Available from:

Substipharm

ATC code:

A07AA; A07AA02

INN (International Name):

Nystatin

Dosage:

100,000 international unit(s)/millilitre

Pharmaceutical form:

Oral suspension

Therapeutic area:

Antibiotics; nystatin

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYCOSTATIN 100,000 UNITS/ML ORAL SUSPENSION
(READY MIXED)
Nystatin
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 Mycostatin Oral Suspension is and what it is used for
2. What you need to know before you take Mycostatin Oral Suspension
3. How to take Mycostatin Oral Suspension
4. Possible side effects
5. How to store Mycostatin Oral Suspension
6. Contents of the pack and other information
1. WHAT MYCOSTATIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR
The name of this medicine is Mycostatin Oral Suspension. This medicine
contains
nystatin as the active ingredient.
Nystatin belongs to a group of medicines called anti-fungal
antibiotics.
Mycostatin Oral Suspension is used to prevent and treat fungal
infections (thrush) of the
mouth. This medicine works by killing the yeast or fungus that has
caused your
symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYCOSTATIN ORAL SUSPENSION
DO NOT TAKE MYCOSTATIN 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 Mycostatin Oral
Suspension if you have
a fungal infection in the lungs or on the skin (systemic mycoses), as
Mycostatin should
not be used for these types of infections.
OTHER MEDICINES AND MYCOSTATIN 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

Summary of Product characteristics

Health Products Regulatory Authority
03 August 2022
CRN00CZC7
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mycostatin 100,000 units/ml Oral Suspension (Ready Mixed)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ready mixed oral suspension containing 100,000 units nystatin per ml.
Excipient(s) with known effect:
Ethanol (8.06 mg/ml),
Sucrose (500 mg/ml),
Sodium (1 mg/ml),
Methyl parahydroxybenzoate (E218, 1.0 mg/ml),
Propyl parahyrdroxybenzoate (E216, 0.2 mg/ml).
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
Light creamy, yellow suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The prevention and treatment of mycotic infections due to _Candida
albicans_, affecting the oral cavity. Consideration should be
given to official guidance on the appropriate use of antifungal
agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Neonates (from birth to 1 month):
Clinical studies of limited size in neonates, including preterm and
babies of low weight at birth, indicate that 1 ml (100,000 U)
three times daily is an effective regimen.
Infants (1 month to 2 years):
The recommended dose is one to two mL (100,000 to 200,000 units
nystatin) four times daily.
Children (over 2 years) and adults:
Dosage ranges of one to six mL (100,000 to 600,000 units nystatin)
four times daily have been used. It is recommended to keep
the medication in contact with the affected areas as long as possible.
Older people:
No specific dosage recommendations or precautions.
In the prevention and treatment of candidiasis, the dosage regimen for
Mycostatin should be continued for at least 48 hours
after symptoms have disappeared.If signs and symptoms worsen or
persist (beyond 14 days of treatment), the patient should
be reevaluated, and alternate therapy considered.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Health Products Regulatory Authority
03 August 2022
CRN00CZC7
Page 2 of 4
4.4 SPECIAL WA