Macrodantin 100mg Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nitrofurantoin

Available from:

Mercury Pharmaceuticals Ltd

ATC code:

J01XE; J01XE01

INN (International Name):

Nitrofurantoin

Dosage:

100 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Nitrofuran derivatives; nitrofurantoin

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

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 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
Mediterranean, Middle

Summary of Product characteristics

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
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
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