Macrodantin Capsules 100mg

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

NITROFURANTOIN

Beschikbaar vanaf:

Amdipharm Limited Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

ATC-code:

J01XE01

INN (Algemene Internationale Benaming):

NITROFURANTOIN 100 mg

farmaceutische vorm:

HARD CAPSULE

Samenstelling:

NITROFURANTOIN 100 mg

Prescription-type:

POM

Therapeutisch gebied:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisatie-status:

Authorised

Autorisatie datum:

2006-03-29

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MACRODANTIN
® 50MG AND 100MG CAPSULES, HARD
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, 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 of the side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Macrodantin 50mg and 100mg Capsules,
hard.
It will be referred to as Macrodantin Capsules for ease hereafter.
WHAT IS IN THIS LEAFLET:
1.
What Macrodantin Capsules are and what they are used for
2.
What you need to know before you take Macrodantin Capsules
3.
How to take Macrodantin Capsules
4.
Possible side effects
5.
How to store Macrodantin Capsules
6.
Contents of the pack and other information
1. WHAT MACRODANTIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Nitrofurantoin (the active substance in Macrodantin Capsules) 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 MACRODANTIN CAPSULES
DO NOT TAKE MACRODANTIN CAPSULES:

If you are allergic to nitrofurantoin or any of the ingredients of
this medicine (listed in Section 6)

If you are allergic to other nitrofuran

If you have been advised by your doctor that you have a low kidney
function (eGFR less than 45ml per
minute)

If you are in the final stages of pregnancy (labour or delivery) or
breast-feeding or in babies under three
months of age, as there is a risk that it might affect the baby

If you lack an enzyme (body chemical) called glucose-6- phosphate
dehydrogenase, which causes your
red blood cells to be more easily damaged (this is more common in
black p

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Macrodantin 100mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg Nitrofurantoin.
Excipient with known effect
Each capsule contains 207.0mg lactose monohydrate
_For the full list of excipients, see section 6.1. _
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
Hard gelatin capsule with an opaque yellow cap and body, containing a
pale yellow odourless powder
in macrocrystalline form. The capsules are printed with the logo
‘Eaton 009’ in edible black ink on
both body and cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of and prophylaxis against acute or recurrent,
uncomplicated lower urinary tract
infections or pyelitis either spontaneous or following surgical
procedures. Nitrofurantoin is
specifically indicated for the treatment of infections when due to
susceptible strains of
_Escherichiacoli, _
Enterococci, Staphylococci, Citrobacter, Klebsiella and Enterobacter.
Most strains of
Proteus and Serratia are resistant. All Pseudomonas strains are
resistant. Macrodantin is not indicated
for the treatment of associated renal cortical or perinephric
abscesses (see section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Indication
Age group
Dose regimen
Duration
Acute Urinary Tract
Infections
Children over the age of
three months
3 mg/kg/day in four
divided doses
7 days
Acute uncomplicated urinary
tract Infections
Children over the age of
10 and Adults (18 – 64
years)
50mg four times
daily
7 days
Elderly (65years and
over)*
50mg four times
daily
Severe chronic recurrent
infections**
Children over the age of
10 and Adults (18 – 64
years)
100 mg four times
7 days
Elderly (65years and
over)*
daily**
Long Term suppressive
therapy***
Children over the age of
10 and Adults (18 – 64
years)
50 - 100mg once a
day
bedtime is suggested
Elderly (65years and
over)*
Suppressive therapy
Childr