Nystatin Orifarm 100 000 IE/ml Oral suspension

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

nystatin

Available from:

Orifarm Generics A/S

ATC code:

A07AA02

INN (International Name):

nystatin

Dosage:

100 000 IE/ml

Pharmaceutical form:

Oral suspension

Composition:

metylparahydroxibensoat Hjälpämne; xylitol Hjälpämne; nystatin 100000 IE Aktiv substans

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Flaska, 100 ml

Authorization status:

Godkänd

Authorization date:

2018-03-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NYSTATIN ORIFARM 100000 IU/ML ORAL SUSPENSION
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, 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 Orifarm is and what it is used for
2.
What you need to know before you take Nystatin Orifarm
3.
How to take Nystatin Orifarm
4.
Possible side effects
5.
How to store Nystatin Orifarm
6.
Contents of the pack and other information
1.
WHAT NYSTATIN ORIFARM IS AND WHAT IT IS USED FOR
Nystatin Orifarm belongs to the group of antifungal medicines. It
contains the active ingredient nystatin. It
has a local effect on the mucosa and is not absorbed into the body.
Nystatin Orifarm is used to treat fungal infections in the mouth and
intestines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NYSTATIN ORIFARM
DO NOT TAKE NYSTATIN ORIFARM
-
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, pharmacist or nurse before taking Nystatin
Orifarm
OTHER MEDICINES AND NYSTATIN ORIFARM
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
PREGNANCY, 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.
_Pregnancy_
You should only take this medicine if your doctor finds the benefits
for you overweighing the potentiel risk
for the foetus.
_Breast-feeding_
It is not known w

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Nystatin Orifarm, 100 000 IU/ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 000 IU nystatin.
Excipients with known effect:
-
Methyl parahydroxybenzoate 1 mg
-
Sodium 1.2 mg/ml, equivalent to 0.053 mmol/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension.
Light yellow, opalescent suspension with peppermint odour and flavour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral and intestinal candidiasis. As adjuvant treatment with other
local nystatin preparations to prevent
reinfection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Oral candidiasis_
Posology
_Adults, children (> 2 years), infants (1 month to 2 years) and
neonates (from birth to 1 month):_
1 ml
(100,000 IU) 4 times daily. The dose may be increased if necessary.
Duration of treatment
Usual treatment duration for oral candidiasis is 1-2 weeks.
Treatment may be prolonged to 4 to 6 weeks in special circumstances,
such as in immunocompromised
patients.
Method of administration
The suspension is preferably taken after meals and is retained in the
mouth for as long as possible before
swallowing. For infants, the suspension may be administered drop by
drop or diluted with water and brushed
on the lesions.
The bottle should be shaken well before use.
_Intestinal candidiasis_
Posology
_Adults:_
5 ml (500,000 IU) 3 times daily. The dose may be doubled if necessary.
2
_Children ( > 2 years) and infants (1 month to 2 years):_
1 ml (100,000 IU) 4 times daily.
Duration of treatment.
Treatment should continue for 2-3 days after symptoms have ceased, in
order to prevent relapse.
When used in combination with antibiotics, nystatin treatment should
be given at least as long as the
antibiotic in question.
Method of administration
The suspension is swallowed directly.
The bottle should be shaken well before use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS