Инструкция по применению NITROFURANTOINA DOK
NITROFURANTOINA DOC100 mg capsules
NITROFURANTOINA DOC50
mg capsules
Nitrofurantoina
PHARMACOTHERAPEUTIC CATEGORY
Antimicrobial chemotherapeutic agent for the urinary tract.
THERAPEUTIC INDICATIONS
NITROFURANTOINA DOC is indicated for the treatment of urinary tract infections
due to susceptible strains of E. coli, Enterococci, S. aureus (it is not indicated for the
treatment of concomitant cortical or perinephric renal abscesses) and to some strains of
Klebsiella, Enterobacter and Proteus.
Therapeutic indications: cystitis, pyelitis, pyelonephritis, post-operative infections of the
genitourinary tract, particularly after instrumental investigations and after prostatectomy.
NITROFURANTOINA DOC is indicated in the treatment of urinary tract infections in
pregnancy. Studies conducted on the fetus demonstrate that NITROFURANTOINA DOC does
not determine any increase in the incidence of congenital anomalies. This is confirmed by 25
years of clinical use of nitrofurantoin. It is nevertheless known that it must always be
administered with caution to pregnant patients (see Precautions and Warnings).
Preventive use: as a treatment for the prophylaxis of infections during
catheterization or instrumental maneuvers of the urinary tract. To prevent recurrent infections in
predisposed subjects.
CONTRAINDICATIONS
Anuria, oliguria (scarcity of urine) or significant impairment of renal function
(creatinine clearance less than 40 ml/min.). The drug is contraindicated in
pediatric age and in pregnant patients at term due to the possibility of hemolytic anemia
due to immaturity of enzymatic systems (glutathione instability). The drug is also
contraindicated in patients with a known hypersensitivity to the product or to other nitrofurans.
Known glucose-6-phosphate dehydrogenase deficiency.
PRECAUTIONS FOR USE
In patients with particular genetic characteristics (glucose-6-phosphate
dehydrogenase deficiency) typical of some ethnic groups, predominantly of black race and more rarely
of Caucasian populations, nitrofurans, like many other therapeutic agents, can
determine hemolysis. The appearance of this sign requires immediate interruption of
treatment. Hemolysis ceases upon discontinuation 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 can increase the likelihood of adverse effects.
In case of renal insufficiency, it is necessary to proportionally reduce the doses and above all
space out the administrations. Similarly to other antibacterial agents, superinfections can
overlap; however, with NITROFURANTOINA DOC these are limited to the
genitourinary tract, as there is no suppression of the normal bacterial flora in other
body districts.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines,
including those without a prescription.
No interactions with NITROFURANTOINA DOC with other drugs are known.
SPECIAL WARNINGS
In patients treated for a long time, the possibility of the onset of pulmonary reactions
(diffuse interstitial pneumonia or pulmonary fibrosis or both) requires periodic monitoring of these patients.
NITROFURANTOINA DOC is not a sulfonamide and therefore it is not necessary
to increase fluid intake; abundant fluid intake would only lead to
dilution of the antibacterial concentration in the urine. The urine of patients
taking NITROFURANTOINA DOC may present a dark yellow or
brown color, but this event is absolutely harmless.
Pregnancy and breastfeeding
The therapeutic safety of NITROFURANTOINA DOC during pregnancy and
breastfeeding has not been definitively established. The use of this drug in
presumed pregnancy requires that the expected benefit be compared with the possible risks
Ask your doctor or pharmacist for advice before taking any medicine
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Therapeutic use: 1 capsule of 50 mg or 100 mg four times a day according to the
doctor's judgment.
Preventive use: from one quarter to half of the therapeutic dose according to the doctor's judgment.
Method of use: NITROFURANTOINA DOC can be taken with food or milk to
further reduce any gastric discomfort.
As prescribed by your doctor. Therapy should be continued for at least one
week and for at least 3 days after achieving sterile urine. Persistence of the infection represents an indication for re-evaluation of the case.
OVERDOSE
In case of overdose, gastric lavage (gastric irrigation) is recommended. No
specific antidote is known for nitrofurantoin.
FOR ANY DOUBT ABOUT THE USE OF NITROFURANTOINA DOC, CONSULT YOUR
DOCTOR OR PHARMACIST
UNDESIRABLE EFFECTS
Like all medicines, NITROFURANTOINA DOC can cause side effects, although
not everyone 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 treatments at high doses and/or severe renal insufficiency, cases of
peripheral neuropathy, headache and other neurological alterations have been observed. If you experience
numbness or paresthesia in any part of the body, treatment should be discontinued.
Hypersensitivity reactions such as: skin rashes, fever or hepatitis have been reported,
associated with therapy with nitrofurantoin. Hepatitis is of an allergic type and may be associated
with antinuclear factor and lymphocytic sensitization.
A respiratory syndrome with bronchospasm and/or dyspnea, cough and
sometimes chest pain has been described.
These symptoms have been occasionally associated with transient pulmonary infiltrate or
pleural effusion. Rarely, hematological alterations have been described
(granulocytopenia, eosinophilia).
Following the instructions contained in the package leaflet reduces the risk of
side effects.
If any of these side effects worsen, or if you notice any other not listed in this leaflet, please inform your doctor or pharmacist immediately.
SHELF LIFE AND STORAGE
Shelf life: check the expiry date indicated on the packaging.
Caution: do not use the medicine after the expiry date indicated on the packaging
The expiry date refers to the product in intact packaging, correctly
stored.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
Each capsule contains:
Active ingredient: Nitrofurantoin 100 mg or 50 mg; Excipients: Anhydrous lactose, Corn starch,
Talc, Gelatin, Titanium dioxide (E 171).
PHARMACEUTICAL FORM AND CONTENT
NITROFURANTOINA DOC 100 mg: 20 capsules for oral use of approximately 448 mg containing
100 mg of active ingredient.
NITROFURANTOINA DOC 50 mg: 20 capsules for oral use of approximately 337 mg containing
50 mg of active ingredient.
MARKETING AUTHORISATION 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)

- Страна регистрации
- Форма выпускаHard capsule, <50 MG
- Код АТХJ01XE01
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги NITROFURANTOINA DOKФорма выпуска: Hard capsule, 50 MGДействующее вещество: нитрофурантоинаПроизводитель: TILLOMED ITALIA SRLОтпускается по рецептуФорма выпуска: Tablet, 50 MGДействующее вещество: нитрофурантоинаПроизводитель: S.F. GROUP S.R.L.Отпускается по рецептуФорма выпуска: Hard capsule, 50 MGДействующее вещество: нитрофурантоинаПроизводитель: GRUNENTHAL ITALIA S.R.L.Отпускается по рецепту
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NITROFURANTOINA DOK производится компанией DOC GENERICI SRL. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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