MYCOSTATIN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

NYSTATIN

Available from:

Bristol-Myers Squibb Pharmaceuticals uc

ATC code:

A07AA02

INN (International Name):

NYSTATIN

Dosage:

100,000 IU/ML

Pharmaceutical form:

Oral Suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

nystatin

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

Artwork Development & Prepress Department
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notes:
BMS ANAGNI (FR)
IE
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148 X 210 MM
4641 (LAETUS)
MYCOSTATIN R/MIX (1BTLX30ML)
723406 IE7
product name:
product code:
X
client:
country:
cutting die:
colors:
measures:
Pharma code:
27/10/2017
M. Bugarski
X
23/11/2017
M. Bugarski
MAH address change
MAH address change
BLACK - DIECUT
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BARCODE READING VERIFICATION
4641
BARCODE READING VERIFICATION
4641
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 PRECAUTIO

Summary of Product characteristics

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:
Excipients with known effect: ethanol, methyl parahydroxybenzoate
(E218, 1.0mg), propyl parahyrdroxybenzoate
(E216, 0.2mg), sodium and sucrose (500mg).
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.
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