Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
Iasis Pharmaceuticals Hellas S.A. 137 Filis Ave., 13451 Kamatero Attica, , Greece
J01XE01
NITROFURANTOIN 25 mg/5ml
ORAL SUSPENSION
NITROFURANTOIN 25 mg/5ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2022-10-20
PACKAGE LEAFLET: INFORMATION FOR THE USER NITROFURANTOIN/IASIS 25MG/5ML ORAL SUSPENSION 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 or pharmacist. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Nitrofurantoin/IASIS 25mg/5ml Oral Suspension is and what it is used for 2. What you need to know before you take Nitrofurantoin/IASIS 25mg/5ml Oral Suspension 3. How to take Nitrofurantoin/IASIS 25mg/5ml Oral Suspension 4. Possible side effects 5. How to store Nitrofurantoin/IASIS 25mg/5ml Oral Suspension 6. Contents of the pack and other information 1. WHAT NITROFURANTOIN/IASIS 25MG/5ML ORAL SUSPENSION IS AND WHAT IT IS USED FOR Nitrofurantoin (the active substance in Nitrofurantoin/IASIS 25mg/5ml 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/IASIS 25MG/5ML ORAL SUSPENSION DO NOT TAKE NITROFURANTOIN/IASIS 25MG/5ML ORAL SUSPENSION - if you are allergic to Nitrofurantoin or any of the ingredients of this medicine (listed in Section 6) - you have a disease of the kidneys which is severely affecting the way they work (ask your doctor if you are not sure) - you are in the final stages of pregnancy (labour or delivery) as there is a risk that it might affect the baby - you suffer from a blood disorder called porphyria - you are deficient in an enzyme called G6PD (glucose-6-phosphate dehydrogenase) - in infants under three months of age Tell your doctor if you are not sure about any of the above. WARNINGS AND PRECAUTION Διαβάστε το πλήρες έγγραφο
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Nitrofurantoin/IASIS 25mg/5ml Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml oral suspension contains 25 mg Nitrofurantoin (as monohydrate) Excipients with known effect: Methyl parahydroxybenzoate Propyl parahydroxybenzoate Glycerol For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Oral Suspension A yellow suspension with characteristic apricot odour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nitrofurantoin/IASIS 25mg/5ml Oral Suspension is indicated for the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures when due to susceptible micro-organisms (see section 4.4 and 5.1). Nitrofurantoin/IASIS 25mg/5ml Oral Suspension 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 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 2 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 (Section 4.8). _Renal impairment _ Nitrofurantoin is contraindicated in patients with renal dysfunction and in patients with an eGFR of less Διαβάστε το πλήρες έγγραφο