Nitrofurantoin 50 mg Capsules, hard.

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Nitrofurantoin

Beschikbaar vanaf:

Azure Pharmaceuticals Ltd

ATC-code:

J01XE01

INN (Algemene Internationale Benaming):

Nitrofurantoin

Dosering:

50 milligram(s)

farmaceutische vorm:

Capsule, hard

Therapeutisch gebied:

nitrofurantoin

Autorisatie-status:

Marketed

Autorisatie datum:

2021-09-03

Bijsluiter

SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
NITROFURANTOIN CAPSULES - 50/100 MG - PIL - CUTTERGUIDE
DIM: 130 X 320 MM
NITROFURANTOIN CAPSULES - 50/100 MG - PIL - CUTTERGUIDE
DIM: 130 X 320 MM
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
NITROFURANTOIN 50 MG AND 100 MG CAPSULES, HARD
Package leaflet: Information for the patient
nitrofurantoin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS
MPORTANT 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 side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Nitrofurantoin Capsules are and what
they are used for
2. What you need to know before you take
Nitrofurantoin Capsules
3. How to take Nitrofurantoin Capsules
4. Possible side effects
5. How to store Nitrofurantoin Capsules
6. Contents of the pack and other information
1. WHAT NITROFURANTOIN CAPSULES ARE AND WHAT
THEY ARE USED FOR
Nitrofurantoin (the active substance in
Nitrofurantoin Capsules) is an antibiotic.
It is used to prevent and treat infections of the
bladder, kidney and other parts of the urinary tract.
You must talk to a doctor if you do not feel better
or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NITROFURANTOIN CAPSULES
DO NOT TAKE NITROFURANTOIN CAPSULES:
•
if you are allergic (causing itching, reddening of
the skin or difficulty in breathing) to
nitrofurantoin or any of the ingredients of
Nitrofurantoin Capsules (listed in Section 6 at
the end of the leaflet) or other medicines
containing nitrofurantoin.
•
if you have a disease of the kidneys which is
severely affecting the way they work (ask your
doctor if you are not sure)
•
if you are in the final stages

Productkenmerken

Health Products Regulatory Authority
03 September 2021
CRN008TT4
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nitrofurantoin 50 mg Capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg nitrofurantoin Ph. Eur. macrocrystalline
form.
Excipient(s) with known effect:
Each capsule contains 99.40 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
Hard gelatin capsule of size '2' with white opaque cap marked 'NF 50'
with red colour and white opaque body marked 'NF 50'
with red colour and 360 degree red colour band on cap and body
containing pale yellow to yellow granular powder.
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. It is indicated in
adults, children and infants over 3 months old.
Nitrofurantoin is specifically indicated for the treatment of
infections when due to susceptible strains of
_Escherichia coli, _
enterococci, staphylococci, _Citrobacter, Klebsiella _and
_Enterobacter._
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS_
Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times
daily for seven days.
Severe chronic recurrence (UTIs): 100 mg four times daily for seven
days.
Long term suppression: 50-100 mg once a day.
Prophylaxis: 50 mg four times daily for the duration of procedure and
for three days thereafter.
_PAEDIATRIC POPULATION - CHILDREN AND INFANTS OVER THREE MONTHS OF
AGE_
Acute Urinary Tract Infections: 3mg/kg day in four divided doses for
seven days.
Suppressive - 1mg/kg, once a day.
For children under the age of 6 years or under 25 kg body weight
consideration should be given to the use of Nitrofurantoin
oral suspension.
_ _
_ELDERLY_
Provided there is no significant