Nitrofurantoin/IASIS 25mg/5ml Oral Suspension

国家: 马耳他

语言: 英文

来源: Medicines Authority

可用日期:

Iasis Pharmaceuticals Hellas S.A. 137 Filis Ave., 13451 Kamatero Attica, , Greece

ATC代码:

J01XE01

INN（国际名称）:

NITROFURANTOIN 25 mg/5ml

药物剂型:

ORAL SUSPENSION

组成:

NITROFURANTOIN 25 mg/5ml

处方类型:

POM

治疗领域:

ANTIBACTERIALS FOR SYSTEMIC USE

授权状态:

Authorised

授权日期:

2022-10-20

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
NITROFURANTOIN/IASIS 25MG/5ML ORAL SUSPENSION
nitrofurantoin
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nitrofurantoin/IASIS 25mg/5ml Oral Suspension is and what it is
used for
2.
What you need to know before you take Nitrofurantoin/IASIS 25mg/5ml
Oral Suspension
3.
How to take Nitrofurantoin/IASIS 25mg/5ml Oral Suspension
4.
Possible side effects
5.
How to store Nitrofurantoin/IASIS 25mg/5ml Oral Suspension
6.
Contents of the pack and other information
1.
WHAT NITROFURANTOIN/IASIS 25MG/5ML ORAL SUSPENSION IS AND WHAT IT IS
USED FOR
Nitrofurantoin (the active substance in Nitrofurantoin/IASIS 25mg/5ml
Oral Suspension) is an
antibiotic.
It is used to prevent and treat infections of the bladder, kidney and
other parts of the urinary tract.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITROFURANTOIN/IASIS 25MG/5ML
ORAL SUSPENSION
DO NOT TAKE NITROFURANTOIN/IASIS 25MG/5ML ORAL SUSPENSION
-
if you are allergic to Nitrofurantoin or any of the ingredients of
this medicine (listed in Section
6)
-
you have a disease of the kidneys which is severely affecting the way
they work (ask your
doctor if you are not sure)
-
you are in the final stages of pregnancy (labour or delivery) as there
is a risk that it might affect
the baby
-
you suffer from a blood disorder called porphyria
-
you are deficient in an enzyme called G6PD (glucose-6-phosphate
dehydrogenase)
-
in infants under three months of age
Tell your doctor if you are not sure about any of the above.
WARNINGS AND PRECAUTION

产品特点

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Nitrofurantoin/IASIS 25mg/5ml Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml oral suspension contains 25 mg Nitrofurantoin (as
monohydrate)
Excipients with known effect:
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate
Glycerol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral Suspension
A yellow suspension with characteristic apricot odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nitrofurantoin/IASIS 25mg/5ml Oral Suspension is indicated for the
treatment of and prophylaxis
against acute or recurrent, uncomplicated lower urinary tract
infections or pyelitis either spontaneous
or following surgical procedures when due to susceptible
micro-organisms (see section 4.4 and 5.1).
Nitrofurantoin/IASIS 25mg/5ml Oral Suspension is indicated in adults
and children over 3 months of
age.
Nitrofurantoin is specifically indicated for the treatment of
infections when due to susceptible strains
of
_Escherichia coli_
,
_Enterococci_
,
_Staphylococci_
,
_Citrobacter_
,
_Klebsiella _
and
_Enterobacter_
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
Acute Uncomplicated Urinary Tract Infections: 50mg four times daily
for seven days.
Severe Chronic Recurrence: 100mg four times day for seven days.
Long Term Suppression: 50mg - 100mg once a day.
Prophylaxis: 50mg four times daily for the duration of procedure and 3
days thereafter.
_Paediatric population _
CHILDREN AND INFANTS OVER THREE MONTHS OF AGE
Acute Urinary Tract Infections: 3mg/kg/day in four divided doses for
seven days.
Suppressive: 1mg/kg, once a day.
_ _
_ _
ELDERLY
2
Provided there is no significant renal impairment, in which
Nitrofurantoin is contraindicated, the
dosage should be that for any normal adult. See precaution and risks
to elderly patients associated with
long term therapy (Section 4.8).
_Renal impairment _
Nitrofurantoin is contraindicated in patients with renal dysfunction
and in patients with an eGFR of
less