Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Nitrofurantoin
Mercury Pharmaceuticals Ltd
J01XE; J01XE01
Nitrofurantoin
100 milligram(s)
Prolonged-release capsule
Product subject to prescription which may not be renewed (A)
Nitrofuran derivatives; nitrofurantoin
Marketed
1994-10-14
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MACROBID ® 100MG PROLONGED-RELEASE CAPSULES 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. The name of your medicine is MacroBID 100mg Prolonged-Release Capsules. It will be referred to as MacroBID 100 mg Capsules for ease hereafter. WHAT IS IN THIS LEAFLET: 1. What MacroBID 100 mg Capsules are and what they are used for 2. What you need to know before you take MacroBID 100 mg Capsules 3. How to take MacroBID 100 mg Capsules 4. Possible side effects 5. How to store MacroBID 100 mg Capsules 6. Contents of the pack and other information 1. WHAT MACROBID 100 MG CAPSULES ARE AND WHAT THEY ARE USED FOR Nitrofurantoin is an antibacterial agent that 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 MACROBID 100 MG CAPSULES DO NOT TAKE MACROBID 100MG CAPSULES: • If you are allergic (causing itching, reddening of the skin or difficulty in breathing) to nitrofurantoin or any of the 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 breast-feeding • If you have acute porphyria (group of blood disorders that affect the nervous system or skin, or both) • If you lack an enzyme called G6PD (Glucose 6 Phosphate Dehydrogenase), which causes your blood cells to be more easily damaged (this is more common in black Perskaitykite visą dokumentą
Health Products Regulatory Authority 17 April 2019 CRN008Z45 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MacroBID 100mg Prolonged-Release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains the equivalent of 100mg of Nitrofurantoin as the anhydrous form and monohydrate form. Excipients: each capsule contains lactose monohydrate 194.6 mg and sucrose 31 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard. The 100mg capsule has an opaque blue cap and opaque yellow body and bears the monogram “GS 100”. 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 prophylaxis. 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. Nitrofurantoin 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 Adults (18 – 64 years) & Children over 12 years of age 100mg twice daily 7 days Elderly (65years and over)* Surgical Prophylaxis Adults (18 – 64 years) & Children over 12 years of age 100mg twice daily on the day of the procedure and three days thereafter Elderly (65years and over)* Health Products Regulatory Authority 17 April 2019 CRN008Z45 Page 2 of 8 Long term suppressive therapy** Adults (18 – 64 years) & Children over 12 years of age 100mg once a day bedtime is suggested Elderly (65years and over)* * Dosage adjustments may be necessary for Perskaitykite visą dokumentą