Macrodantin 50mg, Capsules hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NITROFURANTOIN

Available from:

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

ATC code:

J01XE01

INN (International Name):

NITROFURANTOIN 50 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

NITROFURANTOIN 50 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-03-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MACRODANTIN
® 50MG 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 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 people and people of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Macrodantin 50mg, Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg Nitrofurantoin
Excipient with known effect: Each capsule contains 175.6mg lactose
monohydrate.
_For the full list of excipients, see section 6.1. _
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
Hard gelatin capsules with an opaque yellow cap and opaque white body
containing a pale yellow
odourless powder in macrocrystalline form. The capsules are printed
with the logo ‘Eaton 008’ 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)*
Severe
chronic
recurrent
infections**
Children over the age of
10 and Adults (18 – 64
years)
100
mg
four
times
daily**
7 days
Elderly
(65years
and
over)*
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
Children over t