Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nitrofurantoin
Advanz Pharma
J01XE01
Nitrofurantoin
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011300; GTIN: 5021691400141
PACKAGE LEAFLET: INFORMATION FOR THE USER FURADANTIN ® 50MG AND 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 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 Furadantin Tablets for ease hereafter. WHAT IS IN THIS LEAFLET 1. What Furadantin Tablets are and what they are used for 2. What you need to know before you take Furadantin Tablets 3. How to take Furadantin Tablets 4. Possible side effects 5. How to store Furadantin Tablets 6. Contents of the pack and other information 1. WHAT FURADANTIN TABLETS ARE AND WHAT THEY ARE USED FOR Nitrofurantoin (the active substance in Furadantin Tablets) 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 FURADANTIN TABLETS DO NOT TAKE FURADANTIN TABLETS: • if you are allergic to Nitrofurantoin, other medicines containing nitrofurantoin or 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 have porphyria (blood disorder) • if you are a patient with G6PD (glucose-6-phosphate dehydrogenase) deficiency • if your child is under three months of age • if you are breast-feeding a baby with suspected or known defic Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Furadantin 50mg Tablets Nitrofurantoin 50mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50mg Nitrofurantoin. Excipients with known effect Lactose-157mg per tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellow, pentagonal tablets with a break line on one face and the tablet strength on the opposite face. The score line is not intended for breaking the tablet. 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_. 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 a day for seven days Long Term Suppression: 50mg - 100mg once a day. Prophylax i s: 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. For children under 25kg body weight consideration should be given to the use of Furadantin Suspension. ELDERLY 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 (see section 4.8). RENAL IMPAIRMENT Nitrofurantoin is contraindicated in patients with renal dysfunction and in patients with an eGFR of less than 45 ml/minute (see sections 4.3 & 4.4). Method of administration For oral use. This medicine should alwa Przeczytaj cały dokument