Страна: Мальта
Язык: английский
Источник: Medicines Authority
NITROFURANTOIN
Mercury Pharmaceuticals Limited
J01XE01
NITROFURANTOIN
HARD CAPSULE
NITROFURANTOIN 50 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2006-03-29
ADULTS: The normal dosage depends on the type of infection you have and instructions should be written on the label provided by the pharmacist. Consult your pharmacist or doctor if these instructions are not clear. The usual doses are: • For treatment of infections: Either one 50mg capsule or one 100mg capsule four times a day for seven days • For prevention of further infections: Either one 50mg capsule or one 100mg capsule at bedtime • For prevention of infections during surgery: One 50mg capsule four times a day on the day of the operation and three days thereafter. CHILDREN AND INFANTS OVER THREE MONTHS OF AGE: The dose depends on the weight of the child and will be provided by your doctor. Follow your doctor’s instructions exactly. CHILDREN BELOW 3 MONTHS OF AGE SHOULD NOT TAKE MACRODANTIN CAPSULES. MACRODANTIN CAPSULES SHOULD BE TAKEN WITH FOOD OR MILK. MEDICAL CHECKS: Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system. Macrodantin Capsules may interfere with the results of some tests for glucose in the urine. IF YOU TAKE MORE MACRODANTIN CAPSULES THAN YOU SHOULD: Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left over capsules with you, as well as the container and label, so that the medical staff knows what you have taken. IF YOU FORGET TO TAKE MACRODANTIN CAPSULES: Do not worry. If you remember later on that day, take that day’s dose as usual. If you miss a whole day’s dose take the normal dose on the next day. Do not take a double dose to make up for a forgotten capsule. If you are not sure ask your doctor or pharmacist. IF YOU STOP TAKING MACRODANTIN CAPSULES: Your doctor will tell you how long to take the treatment. Do not stop earlier than you are told, even if you feel better. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Macrodantin Capsules can cause side effects, although not ev Прочитать полный документ
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Macrodantin 50mg Capsules Nitrofurantoin 50mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nitrofurantoin capsules, Hard containing 50 mg Nitrofurantoin Ph Eur in macrocrystalline form. 3 PHARMACEUTICAL FORM The 50 mg hard gelatin capsule has an opaque yellow cap and opaque white body marked ‘Eaton 008’divided between the body and the cap. 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 DOSAGE: _ADULTS _ Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for seven days. Page 2 of 10 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. _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 25 kg 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 (Section 4.8). 4.3 CONTRAINDICATIONS Patients with known hypersensitivity to nitrofurantoin or other nitrofurans. Patients suffering from renal dysfunction with an eGFR of less than 45 ml/minute. Nitrofurantoin may be used with caution as short-course therapy only for the treatment of uncompl Прочитать полный документ