Nitrofurantoin 25mg/5ml oral suspension sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nitrofurantoin

Available from:

Advanz Pharma

ATC code:

J01XE01

INN (International Name):

Nitrofurantoin

Dosage:

5mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011300; GTIN: 5021691163428

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
NITROFURANTOIN 25MG/5ML ORAL SUSPENSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
This product will be referred to as Nitrofurantoin Oral Suspension for
ease hereafter.
WHAT IS IN THIS LEAFLET:
1. What Nitrofurantoin Oral Suspension is and what it is used for
2. What you need to know before you take Nitrofurantoin Oral
Suspension
3. How to take Nitrofurantoin Oral Suspension
4. Possible side effects
5. How to store Nitrofurantoin Oral Suspension
6. Contents of the pack and other information
1. WHAT NITROFURANTOIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Nitrofurantoin (the active substance in Nitrofurantoin Oral
Suspension) 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 NITROFURANTOIN ORAL
SUSPENSION
DO NOT TAKE NITROFURANTOIN ORAL SUSPENSION:
• if you are allergic to Nitrofurantoin, other medicines containing
nitrofurantoin or to any of the other ingredients of this medicine
(listed in Section 6)
• 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 of pregnancy (labour or delivery)
as there is a risk that it might affect the baby
• if you suffer from a blood disorder called porphyria
• if you are deficient in an enzyme called G6PD (glucose-6-phosphate
dehydrogenase)
• if your child is under three months of age.
Tell your doctor i

Summary of Product characteristics

OBJECT 1
FURADANTIN 25MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 16-Apr-2018 | Concordia
International - formerly AMCo
1. Name of the medicinal product
Furadantin 25mg/5ml Oral Suspension OR Nitrofurantoin 25mg/5ml Oral
Suspension
2. Qualitative and quantitative composition
Contains 25mg Nitrofurantoin Ph. Eur. per 5ml
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
An opaque yellow liquid with a lemon/apricot charateristic odour.
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 and
children over 3 months of age.
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
POSOLOGY
ADULTS
Acute Uncomplicated Urinary Tract Infections: 50mg four times daily
for seven days
Severe Chronic Recurrence: 100mg four times a day for seven days
Long Term Suppression: 50mg - 100mg once a day.
Prophylaxis: 50mg four times daily for the duration of procedure and 3
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.
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 (see section 4.8).
RENAL IMPAIRMENT
Nitrofurantoin is contraindicated in patients with renal dysfunction
and in patients with an eGFR of less
than 45 ml/minute (see sections 4.3 & 4.4).
METHOD OF ADMINISTRATION
For oral use
4.3 Contraindications
• Hypersensitivity to nitrofurantoin