Nitrofurantoin Doc Generici

Package leaflet

NITROFURANTOINA DOC 100 mg capsules, 50 mg capsules

Nitrofurantoin
PHARMACOTHERAPEUTIC CATEGORY
Urinary tract antimicrobial chemotherapeutic agent.
THERAPEUTIC INDICATIONS
NITROFURANTOINA DOC is indicated for the treatment of urinary tract infections caused by susceptible strains of E. coli, Enterococci, S. aureus (it is not indicated for the treatment of concomitant cortical or perirenal renal abscesses), and certain strains of Klebsiella, Enterobacter, and Proteus.
Therapeutic indications: cystitis, pyelitis, pyelonephritis, postoperative infections of the genitourinary tract, particularly following instrumental examinations and after prostatectomy.
NITROFURANTOINA DOC is indicated for the treatment of urinary tract infections during pregnancy. Studies conducted on the fetus have shown that NITROFURANTOINA DOC does not increase the incidence of congenital abnormalities. This is supported by 25 years of clinical use of nitrofurantoin. However, it is known that the drug should always be administered with caution to pregnant patients (see Precautions and Warnings).
Prophylactic use: as a treatment for the prevention of infections during catheterization or instrumental procedures involving the urinary tract. For the prevention of recurrent infections in predisposed individuals.
CONTRAINDICATIONS
Anuria, oliguria (scant urine output), or significant renal function impairment (creatinine clearance less than 40 ml/min). The drug is contraindicated in pediatric patients and in pregnant women at term due to the risk of hemolytic anemia caused by immaturity of enzymatic systems (glutathione instability). The drug is also contraindicated in patients with known hypersensitivity to the product or to other nitrofuran derivatives. Known glucose-6-phosphate dehydrogenase deficiency.
PRECAUTIONS FOR USE
In patients with specific genetic characteristics (glucose-6-phosphate dehydrogenase deficiency), particularly among certain ethnic groups, predominantly of African descent and less frequently among Caucasian populations, nitrofuran derivatives, like many other therapeutic agents, may cause hemolysis. The appearance of this sign requires immediate discontinuation of treatment. Hemolysis ceases upon withdrawal of the drug.
Predisposing conditions such as renal impairment (creatinine clearance less than 40 ml/min), anemia, diabetes, electrolyte imbalance, vitamin B deficiency, and debilitating diseases may increase the likelihood of adverse effects.
In case of renal insufficiency, doses must be proportionally reduced and, above all, administrations spaced out. As with other antibacterial agents, superinfections may occur; however, with NITROFURANTOINA DOC these are limited to the genitourinary tract, since there is no suppression of normal bacterial flora in other body sites.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
No interactions of NITROFURANTOINA DOC with other drugs are known.
SPECIAL WARNINGS
In patients undergoing long-term treatment, the possibility of developing pulmonary reactions (diffuse interstitial pneumonia, pulmonary fibrosis, or both) requires periodic monitoring of these patients.
NITROFURANTOINA DOC is not a sulfonamide and therefore there is no need to increase fluid intake; abundant fluid intake would only dilute the antibacterial concentration in the urine. The urine of patients taking NITROFURANTOINA DOC may appear dark yellow or brown, but this occurrence is completely harmless.
Pregnancy and breastfeeding
The therapeutic safety of NITROFURANTOINA DOC during pregnancy and breastfeeding has not been definitively established. The use of this drug during suspected pregnancy requires that the expected benefit be weighed against the possible risks.
Consult your doctor or pharmacist before taking any medicine.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Therapeutic use: 1 capsule of 50 mg or 100 mg four times daily, according to the physician's judgment.
Prophylactic use: one-quarter to one-half of the therapeutic dose, according to the physician's judgment.
Method of administration: NITROFURANTOINA DOC may be taken with food or milk to further reduce any gastrointestinal disturbances.
As prescribed by a physician. Treatment should be continued for at least one week and for at least three days after sterile urine is achieved. Persistence of infection is an indication for re-evaluation of the case.
OVERDOSE
In case of overdose, gastric lavage is recommended. There is no known specific antidote for nitrofurantoin.
FOR ANY DOUBT ABOUT THE USE OF NITROFURANTOINA DOC, CONSULT YOUR
PHYSICIAN OR PHARMACIST
UNDESIRABLE EFFECTS
Like all medicines, NITROFURANTOINA DOC can cause undesirable effects, although not everybody experiences them.
Nausea or vomiting may occur, but this can be minimized or eliminated by taking the medicine with food or milk or by reducing the dosage.
With prolonged treatment at high doses and/or severe renal insufficiency, cases of peripheral neuropathy, headache, and other neurological disturbances have been observed. If numbness or paresthesia occurs in any part of the body, treatment must be suspended.
Hypersensitivity reactions such as skin rashes, pyrexia, or hepatitis have been reported with nitrofurantoin therapy. The hepatitis is of allergic type and may be associated with antinuclear factor and lymphocyte sensitization.
A respiratory syndrome with bronchospasm and/or dyspnea, cough, and sometimes chest pain has been described.
These symptoms have occasionally been associated with transient pulmonary infiltrate or pleural effusion. Rarely, hematological abnormalities (granulocytopenia, eosinophilia) have been reported.
Following the instructions contained in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsens, or if you notice any undesirable effect not listed in this leaflet, inform your doctor or pharmacist promptly.
EXPIRY DATE AND STORAGE
Expiry date: check the expiry date stated on the packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
No special storage precautions are required.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
Each capsule contains:
Active substance: Nitrofurantoin 100 mg or 50 mg; Excipients: Anhydrous lactose, maize starch, talc, gelatin, titanium dioxide (E 171).
PHARMACEUTICAL FORM AND CONTENT
NITROFURANTOINA DOC 100 mg: 20 oral capsules of approximately 448 mg containing 100 mg of active substance.
NITROFURANTOINA DOC 50 mg: 20 oral capsules of approximately 337 mg containing 50 mg of active substance.
MARKETING AUTHORIZATION HOLDER AND
MANUFACTURER
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.
Manufacturer:
La.Fa.Re. S.r.l.
Via Sacerdote Benedetto Cozzolino, 77
80056 Ercolano (NA)