Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Nitrofurantoin
Mercury Pharmaceuticals Ltd
J01XE; J01XE01
Nitrofurantoin
100 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Nitrofuran derivatives; nitrofurantoin
Not marketed
1997-04-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FURADANTIN ® 50MG TABLETS FURADANTIN ® 100MG TABLETS 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. WHAT IS IN THIS LEAFLET 1. What Furadantin is and what it is used for 2. What you need to know before you take Furadantin 3. How to take Furadantin 4. Possible side effects 5. How to store Furadantin 6. Contents of the pack and other information 1. WHAT FURADANTIN IS AND WHAT IT IS USED FOR Nitrofurantoin is an antibacterial agent which is used to prevent and treat infections of the bladder, kidneys and other parts of the urinary tract. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FURADANTIN DO NOT TAKE FURADANTIN: If you are allergic (causing itching, reddening of the skin or difficulty in breathing) to nitrofurantoin, other medicines containing nitrofurantoin or any of the other 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 breastfeeding If you are suffering from porphyria (group of blood disorders that affect the nervous system or skin, or both) If you have lack of an enzyme (body chemical) called “glucose-6-phosphate dehydrogenase”, which causes your red blood cells to be more easily damaged (this is more common in black people and people of Mediterranean, Near Eastern or Asian origin, speak with your doctor about this) Furadantin should not be given to infants less than Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Furadantin 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg nitrofurantoin. Excipient(s) with known effect Each tablet contains 113.05 mg lactose (as monohydrate). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. Yellow, pentagonal tablets imprinted with a monogram ‘100’ on one face and a single breakline on the opposite face. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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 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. Furadantin 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 Children over 3 months 3mg/kg/day in four divided doses 7 days Children (10years and over) & Adults (18 – 64 years) 50mg four times daily 7 days Elderly (65years and over) * Severe Chronic Recurrent Infections** Children (10years and over) & Adults (18 – 64 years) 100mg four times daily** 7 days Elderly (65years and over) * Surgical Prophylaxis Children (10years and over) & Adults (18 – 64 years) 50mg 4 times daily on the day of the procedure and three days thereafter H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Lees het volledige document