Macrodantin Capsules 50mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NITROFURANTOIN

Available from:

Mercury Pharmaceuticals Limited

ATC code:

J01XE01

INN (International Name):

NITROFURANTOIN

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

ADULTS:
The normal dosage depends on the type of infection you have and
instructions should be written on the label provided by the
pharmacist. Consult
your pharmacist or doctor if these instructions are not clear. The
usual doses are:
•
For treatment of infections: Either one 50mg capsule or one 100mg
capsule four times a day for seven days
•
For prevention of further infections: Either one 50mg capsule or one
100mg capsule at bedtime
•
For prevention of infections during surgery: One 50mg capsule four
times a day on the day of the operation and three days thereafter.
CHILDREN AND INFANTS OVER THREE MONTHS OF AGE:
The dose depends on the weight of the child and will be provided by
your doctor. Follow your doctor’s instructions exactly.
CHILDREN BELOW 3 MONTHS OF AGE SHOULD NOT TAKE MACRODANTIN CAPSULES.
MACRODANTIN CAPSULES SHOULD BE TAKEN WITH FOOD OR MILK.
MEDICAL CHECKS:
Your doctor will watch carefully for any effects on the liver, lungs,
blood or nervous system.
Macrodantin Capsules may interfere with the results of some tests for
glucose in the urine.
IF YOU TAKE MORE MACRODANTIN CAPSULES THAN YOU SHOULD:
Consult your doctor or pharmacist immediately or go to the emergency
department of the nearest hospital. Always take any left over capsules
with you, as well as the container and label, so that the medical
staff knows what you have taken.
IF YOU FORGET TO TAKE MACRODANTIN CAPSULES:
Do not worry. If you remember later on that day, take that day’s
dose as usual. If you miss a whole day’s dose take the normal dose
on the next
day. Do not take a double dose to make up for a forgotten capsule. If
you are not sure ask your doctor or pharmacist.
IF YOU STOP TAKING MACRODANTIN CAPSULES:
Your doctor will tell you how long to take the treatment. Do not stop
earlier than you are told, even if you feel better.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Macrodantin Capsules can cause side effects,
although not ev

Summary of Product characteristics

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Macrodantin 50mg Capsules
Nitrofurantoin 50mg Capsules, Hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nitrofurantoin capsules, Hard containing 50 mg Nitrofurantoin Ph Eur
in
macrocrystalline form.
3
PHARMACEUTICAL FORM
The 50 mg hard gelatin capsule has an opaque yellow cap and opaque
white
body marked ‘Eaton 008’divided between the body and the 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 _ Escherichia coli,_ enterococci,
staphylococci,_ _
_Citrobacter, Klebsiella _and _Enterobacter._
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE:
_ADULTS _
Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times
daily
for seven days.
Page 2 of 10
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.
_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 25 kg body weight consideration should be given to
the use
of Furadantin® Suspension.
_ELDERLY _
Provided there is no significant renal impairment, in which
Nitrofurantoin is
contraindicated, the dosage should be that for any normal adult. See
precaution
and risks to elderly patients associated with long-term therapy
(Section 4.8).
4.3 CONTRAINDICATIONS
Patients with known hypersensitivity to nitrofurantoin or other
nitrofurans.
Patients suffering from renal dysfunction with an eGFR of less than 45
ml/minute.
Nitrofurantoin may be used with caution as short-course therapy only
for the
treatment of uncompl