Nitrofurantoin 25mg/5ml oral suspension

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Nitrofurantoin

זמין מ:

Special Order

קוד ATC:

J01XE01

INN (שם בינלאומי):

Nitrofurantoin

כמות:

5mg/1ml

טופס פרצבטיות:

Oral suspension

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 05011300

עלון מידע

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

מאפייני מוצר

OBJECT 1
NITROFURANTOIN 25MG/5ML ORAL
SUSPENSION
Summary of Product Characteristics Updated 02-Apr-2019 | ADVANZ Pharma
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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_ an