Macrodantin 100mg Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nitrofurantoin

Available from:

Amdipharm Limited

ATC code:

J01XE; J01XE01

INN (International Name):

Nitrofurantoin

Dosage:

100 milligram(s)

Pharmaceutical form:

Capsule, hard

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 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

Summary of Product characteristics

Health Products Regulatory Authority
12 May 2021
CRN00C7Y2
Page 1 of 8
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 (65 years 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 (65 years and over)*
Long Term
suppressive
therapy*** ​
Children over the age of 10 and Adults (18 – 64 years)
50