Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nitrofurantoin
Dr Reddy's Laboratories (UK) Ltd
J01XE01
Nitrofurantoin
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011300; GTIN: 05036072005464 05036072005426
PATIENT LEAFLET: INFORMATION FOR THE USER NITROFURANTOIN 50 MG & 100 MG 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 symptoms 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 NITROFURANTOIN TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITROFURANTOIN TABLETS 3. HOW TO TAKE NITROFURANTOIN TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NITROFURANTOIN TABLETS 6. CONTENT OF THE PACK AND OTHER INFORMATION _ _ 1. WHAT NITROFURANTOIN TABLETS ARE AND WHAT THEY ARE USED FOR Nitrofurantoin (the active substance in Nitrofurantoin) 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 TABLETS DO NOT TAKE NITROFURANTOIN 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 deficiency in an enzyme called G6PD (glucose- 6- phosphate dehydrogenase). Tell your doctor if you are not sure about any of th Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT URANTOIN/Nitrofurantoin 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nitrofurantoin tablets contain 100mg of Nitrofurantoin BP _Excipients with known effect_: Each tablet also contains 160.000 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Nitrofurantoin tablets are flat, yellow bevelled and scored tablets. 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, when due to susceptible strains of Escherichia coli, Enterococci, Staphylococci, Citrobacter, Klebsiella and Enterobacter. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Poso logy ADU LTS Acute uncomplicated urinary tract infections: 50 mg four times daily for 7 days Severe chronic recurrence: 100 mg four times day for 7 days Long term suppression: 50mg-100 mg once a day Prophylaxis: 50 mg 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 Nitrofurantoin 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 (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 always be taken with food or milk. Taking Urantoin Tablets/ Nitrofurantoin Tablets with a me Read the complete document