Active ingredients: Nitrofurantoin (Nitrofurantoin macrocrystals)
NEO FURADANTIN 50 mg hard capsules
NEO FURADANTIN 100 mg hard capsules
Why is Neo furadantin used? What is it for?
Neo Furadantin contains the active ingredient nitrofurantoin, which is an antibacterial used to treat urinary tract infections such as:
- cystitis (inflammation and infection of the bladder)
- pyelitis or pyelonephritis (inflammation and infection of the kidney)
- infections after a "genital and urinary tract operation, particularly after surgical removal of the prostate and after diagnostic procedures
- urinary tract infections during pregnancy
Neo Furadantin can be used to prevent urinary tract infections
- of people who have recurring infections
- due to the insertion of the catheter
- during diagnostic procedures
Contraindications When Neo furadantin should not be used
Do not take Neo Furadantin if
- you are allergic to nitrofurantoin or any of the other ingredients of this medicine
- if you suffer from urinary problems (anuria, oliguria) or severe kidney problems
- is under 18 years old
- it is in the final stages of pregnancy as there is a risk that it may affect the baby
- is deficient in an enzyme called G6PD (glucose-6-phosphate dehydrogenase).
Precautions for use What you need to know before taking Neo furadantin
Talk to your doctor or pharmacist before taking Neo Furadantin if you:
- are anemic (have a low red blood cell count which causes tiredness or weakness) or have a vitamin B deficiency
- have an electrolyte imbalance (altered levels of salts in the body)
- is diabetic
- your kidneys are functioning less than normal; in this case it is necessary to reduce the dose and above all to space out the doses
- has a debilitating disease
Treatment with Neo Furadantin can cause an enzyme called glucose-6-phosphate dehydrogenase to be reduced, which makes your red blood cells more easily damaged. If this happens, stop taking Neo Furadantin right away.
With prolonged use of Neo Furadantin, conditions affecting the lungs (diffuse hypersensitivity pneumonitis, pulmonary fibrosis) may occur. If this happens, consult your doctor.
While using Neo Furadantin the urine may turn a brownish color. This is normal and should not cause concern.
As with other antibacterial agents, superinfections (new infection overlapping an existing infection) limited to the genitourinary tract may overlap with the use of NEO FURADANTIN.
Children and adolescents
Neo Furadantin should not be used in children and adolescents under the age of 18.
Interactions Which drugs or foods can modify the effect of Neo furadantin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
There are no known interactions of NEO FURADANTIN with other medicines.
Neo furadantin with food and drink
Take Neo Furadantin with food or milk. This will reduce the risk of nausea and vomiting
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you are pregnant or have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Neo Furadantin can be taken to treat urinary tract infections during pregnancy. Neo Furadantin does not increase the incidence of congenital abnormalities in the fetus. However, Neo Furadantin should be taken with caution if you are pregnant or breastfeeding and only if your doctor thinks it is absolutely necessary.
Neo Furadantin should NOT be taken in late pregnancy as there is a risk that it may affect the baby.
Driving and using machines
If taken during the day, Neo Furadantin is unlikely to affect the ability to drive and use machines.
Neo Furadantin contains lactose
If you have been told by your doctor that you have "intolerance to some sugars, consult your doctor before taking this medicine.
Dose, Method and Time of Administration How to use Neo furadantin: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults is:
Treatment of the infection: 1 capsule of 50 mg or 100 mg 4 times a day according to the doctor's prescription.
Prevention of infection: 1 or 2 capsules per day according to the doctor's prescription.
Take Neo Furadantin for at least one week and at least 3 days after your urine is clear of infection; your doctor will inform you of this. If infection persists, consult your doctor immediately.
Use in children and adolescents
Neo Furadantin should not be used in children and adolescents under the age of 18.
Overdose What to do if you have taken an overdose of Neo furadantin
If you take more Neo Furadantin than you should
Tell your doctor or go to the nearest hospital as soon as possible, taking the pack with you if possible.
If you forget to take Neo Furadantin
Take a capsule as soon as you remember. If it is almost time for your next dose, wait until then and continue as normal. Do not take a double dose to make up for a forgotten capsule.
If you stop taking Neo Furadantin
Neo Furadantin should be taken for at least one week and for at least 3 days after the urine is clear of infection. You must complete the course of treatment, even if you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Neo furadantin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects described below occur, stop taking Neo Furadantin and consult your doctor:
- numbness or paraesthesia in any part of the body (changes in sensation such as tingling and numbness)
- Burning or numbness in the limbs (peripheral neuropathies) and other neurological disorders
- Headache
Side effects include nausea and vomiting
To minimize this possibility take Neo Furadantin with food or milk or by decreasing the dosage.
A respiratory reaction may occur while taking Neo Furadantin. This can cause difficulty in breathing (bronchospasm), shortness of breath, cough, chest pain, blood, pus or protein in the lungs and excess fluid in the space surrounding the lungs (pulmonary infiltrate or pleural effusion).
Other side effects include:
- Rash
- Fever
- Inflammation of the liver caused by the use of the medicine (allergic hepatitis)
- Blood disorders (granulocytopenia, eosinophilia, unusual increase or decrease in white blood cells).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or bottle after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Neo Furadantin contains
The active ingredient is macrocrystalline nitrofurantoin. Each hard capsule contains 50 mg or 100 mg of nitrofuranthin.
The other ingredients are: anhydrous lactose, corn starch, talc, yellow iron oxide (E172), titanium dioxide, gelatin.
What Neo Furadantin looks like and contents of the pack
Neo Furadantin capsules are packaged in aluminum blisters. Both 50 mg and 100 mg hard capsules are available in boxes of 20.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
NEO FURADANTIN HARD CAPSULES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule of 50 mg contains: nitrofurantoin macrocrystals 50 mg.
One 100 mg capsule contains: 100 mg macrocrystalline nitrofurantoin.
03.0 PHARMACEUTICAL FORM
Hard capsules.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
NEO FURADANTIN is indicated for the treatment of urinary tract infections due to susceptible strains of E.coli, enterococci, S. aureus (not indicated for the treatment of concomitant cortical or perirenal renal abscesses) and 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.
NEO FURADANTIN is indicated for the treatment of urinary tract infections in pregnancy. Studies on the fetus show that NEO FURADANTIN does not cause any increase in the incidence of congenital anomalies. This is confirmed by 25 years of clinical use of nitrofurantoin. However, it is known that it should always be administered with caution to pregnant patients.
Preventive use: as a treatment for the prophylaxis of infections during catheterization or instrumental maneuvers of the urinary tract. To prevent reinfection in predisposed individuals.
04.2 Posology and method of administration
Therapeutic use
1 capsule of 50 or 100 mg four times a day according to the doctor's judgment.
Preventive use: from one quarter to one half of the therapeutic dose according to the doctor's judgment.
How to use: NEO FURADANTIN can be taken with food or milk to further reduce any stomach upset. Therapy should be continued for at least one week and for at least three days after obtaining sterile urine. The persistence of the infection represents an indication for the re-examination of the case.
04.3 Contraindications
Anuria, oliguria or significant impairment of renal function (creatinine clearance less than 40 ml / min.). The drug is contraindicated in pediatric age and in full-term pregnant patients due to the possibility of haemolytic anemia due to immaturity of the enzyme systems (glutathione instability). The drug is also contraindicated in patients with known hypersensitivity to the product, or to other nitrofuran preparations. Known insufficiency of glucose-6-phosphate dehydrogenase.
04.4 Special warnings and appropriate precautions for use
In patients with particular genetic characteristics (glucose-6-phosphate dehydrogenase deficiency), typical of some ethnic groups, mainly black and more rarely Caucasian populations, nitrofuranics, like many other therapeutic agents, can cause hemolysis; the appearance of this sign requires the immediate interruption of the treatment. The haemolysis ceases when the drug is discontinued. In long-term treated patients, the possibility of developing pulmonary reactions (diffuse interstitial pneumonia or pulmonary fibrosis or both) requires periodic monitoring.
Predisposing conditions such as kidney damage (creatinine clearance less than 40 ml / min.), Anemia, diabetes, electrolyte imbalance, vitamin B deficiency and debilitating diseases may increase the chance of the occurrence of undesirable effects. In case of renal insufficiency, it is necessary to proportionally reduce the doses and above all to space out the administrations. Similarly to other antibacterial agents, superinfections can overlap; however with NEO FURADANTIN these are limited to the genitourinary tract, as there is no suppression of the normal bacterial flora in other parts of the body. FURADANTIN is not a sulfonamide and therefore it is not necessary to increase the ingestion of liquids: the abundant intake of liquids would only lead to a dilution of the antibacterial concentration in the urine. The urine of patients taking NEO FURADANTIN may have a dark yellow or brown color , but this event is absolutely harmless.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions of NEO FURADANTIN with other drugs.
04.6 Pregnancy and lactation
The therapeutic safety of NEO FURADANTIN during pregnancy and lactation has not been definitively ascertained. Use of this drug in presumed pregnancy requires that the anticipated benefit be compared with the possible risks.
The drug is contraindicated in full term pregnancy.
04.7 Effects on ability to drive and use machines
The use of NEO FURADANTIN, during the day, does not interfere with the waking state of the subject.
04.8 Undesirable effects
Nausea or vomiting may occur, but this can be minimized or eliminated by taking the drug with food or milk or by reducing the dosage. For prolonged treatments at high doses and / or severe renal insufficiency, cases of peripheral neuropathies, headache and other neurological alterations have been observed. If numbness or paraesthesia occurs in any part of the body, the treatment should be discontinued. Hypersensitivity reactions such as: rash, pyrexia or hepatitis associated with nitrofurantoin therapy have been reported. Hepatitis is allergic in type and may be associated with antinuclear factor and lymphocyte sensitization. A respiratory syndrome with bronchospasm and / or dyspnoea, cough and sometimes chest pain has been described. These symptoms have occasionally been associated with transient pulmonary infiltrate or pleural effusion. Haematological changes (granulocytopenia, eosinophilia) have been reported rarely.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: http://www.agenziafarmaco.gov.it/it/responsabili
04.9 Overdose
In case of overdose, gastrolusis is recommended. There is no known specific antidote for nitrofurantoin. It should be borne in mind that acidification of the urine increases the tubular reabsorption of nitrofurantoin.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC code: J01XE01
NEO FURADANTIN is a macro-crystal preparation of nitrofurantoin with a "broad spectrum antibacterial activity", particularly effective in the therapy and prophylaxis of urinary tract infections caused by Gram + and Gram- microorganisms. The proven antibacterial activity of NEO FURADANTIN is expressed by an inhibition of the anaerobic formation of Acetyl CoenzymeA from pyruvate in the microbial organism.
05.2 "Pharmacokinetic properties
The size of NEO FURADANTIN crystals undoubtedly has a fundamental effect on the rate of absorption (lower slope of the initial curve) and urinary recovery (replacement of the peak with a wider plateau). Following oral administration, the therapeutic urinary concentrations of NEO FURADANTIN, present after only 30 minutes, are maintained for approximately 6 hours. About 45% of the drug is excreted in the urine.
05.3 Preclinical safety data
Acute toxicity tests have shown a LD50 of 895 mg / kg per os in mice, and long-term studies, conducted on rats and dogs, have shown no signs of chronic toxicity, also certifying the non-carcinogenicity of the product. Furthermore, nitrofurantoin was neither teratogenic nor foetotoxic.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
50 mg and 100 mg capsules: anhydrous lactose, corn starch, talc, yellow iron oxide E172, titanium dioxide, gelatin.
06.2 Incompatibility
There are no known chemical-physical incompatibilities of nitrofurantoin towards other compounds.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
Given the stability of the product, NEO FURADANTIN does not require special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Blister in P.V.C. and aluminum
Pack sizes: 20 hard capsules of 50 mg
20 hard capsules of 100 mg
06.6 Instructions for use and handling
No special instructions for disposal.
07.0 MARKETING AUTHORIZATION HOLDER
GRÜNENTHAL ITALIA S.r.l. - Via Carlo Bo, 11 - 20143 Milan
08.0 MARKETING AUTHORIZATION NUMBER
"50 mg capsules", 20 capsules - A.I.C. n. 027320011
"100 mg capsules", 20 capsules - A.I.C. n. 027320023
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
1 September 1989
1 June 2010
10.0 DATE OF REVISION OF THE TEXT
11 April 2015
