MacroBID 100mg Prolonged-Release Capsules

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Nitrofurantoin

Disponible desde:

Mercury Pharmaceuticals Ltd

Código ATC:

J01XE; J01XE01

Designación común internacional (DCI):

Nitrofurantoin

Dosis:

100 milligram(s)

formulario farmacéutico:

Prolonged-release capsule

tipo de receta:

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

Área terapéutica:

Nitrofuran derivatives; nitrofurantoin

Estado de Autorización:

Marketed

Fecha de autorización:

1994-10-14

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MACROBID
®
100MG PROLONGED-RELEASE CAPSULES
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 MacroBID 100mg Prolonged-Release
Capsules.
It will be referred to as MacroBID 100 mg Capsules for ease hereafter.
WHAT IS IN THIS LEAFLET:
1.
What MacroBID 100 mg Capsules are and what they are used for
2.
What you need to know before you take MacroBID 100 mg Capsules
3.
How to take MacroBID 100 mg Capsules
4.
Possible side effects
5.
How to store MacroBID 100 mg Capsules
6.
Contents of the pack and other information
1. WHAT MACROBID 100 MG CAPSULES ARE AND WHAT THEY ARE USED FOR
Nitrofurantoin is an antibacterial agent that 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 MACROBID 100 MG CAPSULES
DO NOT TAKE MACROBID 100MG CAPSULES:
• If you are allergic (causing itching, reddening of the skin or
difficulty in breathing) 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 labour or delivering your baby or breast-feeding
• If you have acute porphyria (group of blood disorders that affect
the nervous system or skin, or both)
• If you lack an enzyme called G6PD (Glucose 6 Phosphate
Dehydrogenase), which causes your blood
cells to be more easily damaged (this is more common in black

Ficha técnica

Health Products Regulatory Authority
17 April 2019
CRN008Z45
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MacroBID 100mg Prolonged-Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains the equivalent of 100mg of Nitrofurantoin as the
anhydrous form and monohydrate form.
Excipients: each capsule contains lactose monohydrate 194.6 mg and
sucrose 31 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsule, hard.
The 100mg capsule has an opaque blue cap and opaque yellow body and
bears the monogram “GS 100”.
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 prophylaxis. Nitrofurantoin is
specifically indicated for the treatment of infections due to
susceptible strains of Escherichia coli, enterococci, staphylococci,
citrobacter, klebsiella and enterobacter. Most strains of
proteus and serratia are resistant. All Pseudomonas strains are
resistant. Nitrofurantoin is not indicated for the treatment of
associated renal cortical or perinephric abscesses (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 or Recurrent Uncomplicated UTI and Pyelitis
Adults
(18 – 64
years) &
Children
over 12
years of
age
100mg twice daily
7 days
Elderly
(65years
and
over)*
Surgical Prophylaxis
Adults
(18 – 64
years) &
Children
over 12
years of
age
100mg twice daily
on the day
of the
procedure
and three
days
thereafter
Elderly
(65years
and
over)*
Health Products Regulatory Authority
17 April 2019
CRN008Z45
Page 2 of 8
Long term suppressive therapy**
Adults
(18 – 64
years) &
Children
over 12
years of
age
100mg once a day
bedtime is
suggested
Elderly
(65years
and
over)*
* Dosage adjustments may be necessary for