Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Nitrofurantoin
Azure Pharmaceuticals Ltd
J01XE01
Nitrofurantoin
100 milligram(s)
Capsule, hard
nitrofurantoin
Marketed
2021-09-03
SPACE FOR PHARMACODE SPACE FOR PHARMACODE NITROFURANTOIN CAPSULES - 50/100 MG - PIL - CUTTERGUIDE DIM: 130 X 320 MM NITROFURANTOIN CAPSULES - 50/100 MG - PIL - CUTTERGUIDE DIM: 130 X 320 MM SPACE FOR PHARMACODE SPACE FOR PHARMACODE NITROFURANTOIN 50 MG AND 100 MG CAPSULES, HARD Package leaflet: Information for the patient nitrofurantoin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS MPORTANT 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. WHAT IS IN THIS LEAFLET 1. What Nitrofurantoin Capsules are and what they are used for 2. What you need to know before you take Nitrofurantoin Capsules 3. How to take Nitrofurantoin Capsules 4. Possible side effects 5. How to store Nitrofurantoin Capsules 6. Contents of the pack and other information 1. WHAT NITROFURANTOIN CAPSULES ARE AND WHAT THEY ARE USED FOR Nitrofurantoin (the active substance in Nitrofurantoin Capsules) is an antibiotic. It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITROFURANTOIN CAPSULES DO NOT TAKE NITROFURANTOIN CAPSULES: • if you are allergic (causing itching, reddening of the skin or difficulty in breathing) to nitrofurantoin or any of the ingredients of Nitrofurantoin Capsules (listed in Section 6 at the end of the leaflet) or other medicines containing nitrofurantoin. • 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 Pročitajte cijeli dokument
Health Products Regulatory Authority 03 September 2021 CRN008TT4 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nitrofurantoin 100 mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg nitrofurantoin Ph. Eur. macrocrystalline form. Excipient(s) with known effect: Each capsule contains 198.80 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules, hard. Hard gelatin capsule of size '2' with white opaque cap marked 'NF 100' with black colour and white opaque body marked 'NF 100' with black colour and 360 degree black colour band on cap and body containing pale yellow to yellow granular powder. 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, children and infants over 3 months old. Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible strains of _Escherichia coli, _ enterococci, staphylococci, _Citrobacter, Klebsiella _and _Enterobacter._ Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _ADULTS_ Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for seven days. 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. _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. For children under the age of 6 years or under 25 kg body weight consideration should be given to the use of Nitrofurantoin oral suspension. _ _ _ELDERLY_ Provided there is no si Pročitajte cijeli dokument