Active ingredients: Metronidazole
FLAGYL 250 mg tablets
FLAGYL 500 mg ova
Why is Flagyl used? What is it for?
Pharmacotherapeutic group
Antiprotozoal Antiinfectives, gynecological antiseptics.
Therapeutic indications
FLAGYL 250 mg tablets:
- Trichomonas vaginalis symptomatic urethritis and vaginitis.
- Eradication of Helicobacter pylori (within the framework of an appropriate therapeutic protocol).
FLAGYL 500 mg ovules: Topical treatment of Trichomonas vaginalis vaginitis.
Contraindications When Flagyl should not be used
Hypersensitivity to the active substance (to other nitroimidazole derivatives) or to any of the excipients. Subjects with blood dyscrasias or with CNS diseases in active phase. Known or suspected pregnancy. Feeding time.
Precautions for use What you need to know before taking Flagyl
Use with caution in patients with severe hepatic and renal impairment. A clinical and laboratory control (complete blood count with leukocyte formula) is recommended if it is necessary to continue the treatment for more than 10 days.
Interactions Which drugs or foods can modify the effect of Flagyl
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Alcohol intake is not recommended during treatment as the combination with metronidazole may give rise to a disulfiram-like syndrome with nausea, vomiting and abdominal cramps.
Warnings It is important to know that:
To be used under strict medical supervision. During treatment, the urine may take on a reddish-brown color due to soluble drug pigments.
The product has shown carcinogenic properties in animals under particular experimental conditions.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. The product should not be administered in known or suspected pregnancy and during lactation.
Effects on ability to drive and use machines
The use of Flagyl does not affect the ability to drive or use machines.
Important information about some of the ingredients
Flagyl tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Flagyl: Posology
Trichomonas vaginalis symptomatic urethritis and vaginitis
Orally (in both women and men). Recent studies indicate that the administration of metronidazole in doses not exceeding 2 g, ie 8 tablets appropriately divided into 4 administrations in a single day, is preferable.
By vaginal route - 1 egg every evening introduced deeply, for 10 days, without interruptions even during the menstrual period. Topical use can be used as a complementary treatment and is effective in preventing relapses.
Eradication of Helicobacter pylori:
Adults
Metronidazole was effective and well tolerated when used as part of an appropriate therapeutic protocol (generally associated with proton pump inhibitors and other antibiotics), at dosages ranging from 1000 to 1500 mg (4-6 tablets) divided into 2-3 daily administrations and for periods between 7 and 14 days.
Overdose What to do if you have taken too much Flagyl
In case of accidental ingestion / intake of an excessive dose of Flagyl, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Flagyl, ask your doctor or pharmacist
Side Effects What are the side effects of Flagyl
Like all medicines, Flagyl can cause side effects, although not everybody gets them.
Gastro-intestinal disorders, anorexia, nausea, vomiting, impaned tongue, dry mouth, metallic taste, glossitis, stomatitis, headache, rash and, less frequently, drowsiness, dizziness, ataxia, depression, insomnia, nasal congestion.
Exceptionally urticaria, pruritus, angioedema and anaphylaxis, dysuria, cystitis, fever, polyuria, pyuria, decreased libido.
Sporadic cases of transient leukopenia or peripheral neuropathy have been reported following prolonged or intensive therapy.
The appearance of neurological symptoms implies the interruption of treatment.
Very rarely, cases of Stevens-Johnsons syndrome and Toxic Epidermal Necrolysis have been reported following administration of metronidazole.
The patient is invited to report any undesirable effect not described in the package leaflet to his doctor or pharmacist.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package. The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
Storage: Ovules: store at a temperature below 30 ° C and in the original packaging to protect the product from light.
Tablets: store in the original packaging to protect the product from light.
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 protect the environment.
Keep this medicine out of the sight and reach of children.
Composition
Each egg contains: 500 mg metronidazole.
Excipients: solid semisynthetic glycerides.
Each tablet contains: 250 mg metronidazole.
Excipients: corn starch; polyvinylpyrrolidone; microgranular cellulose; croscarmellose sodium; magnesium stearate; lactose.
Pharmaceutical form and content
Eggs: pack of 10 eggs
Tablets: pack of 20 tablets
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
FLAGYL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each egg contains: metronidazole 500 mg.
Each tablet contains: metronidazole 250 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Ovules
Tablets
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Flagyl 250 mg tablets:
• Trichomonas vaginalis symptomatic urethritis and vaginitis.
• Eradication of Helicobacter pylori (as part of an appropriate therapeutic protocol)
Flagyl 500 mg ova: Topical treatment of Trichomonas vaginalis vaginitis.
04.2 Posology and method of administration
Trichomonas vaginalis symptomatic urethritis and vaginitis :
Orally (in both women and men). Recent studies indicate that it is preferable to administer metronidazole in doses not exceeding 2 g, ie 8 tablets appropriately divided into 4 administrations in a single day.
By local vaginal route - 1 egg every evening introduced deeply, for 10 days, without interruptions even during the menstrual period. Topical use can be used as a complementary treatment and is effective in preventing relapses.
Eradication of Helicobacter pylori :
Adults
Metronidazole was effective and well tolerated when used as part of an appropriate therapeutic protocol (generally associated with proton pump inhibitors and other antibiotics), at dosages ranging from 1000 to 1500 mg (4-6 tablets) divided into 2-3 daily administrations and for periods between 7 and 14 days.
04.3 Contraindications
Hypersensitivity to the active substance (to other nitroimidazole derivatives) or to any of the excipients listed in section 6.1.
Subjects with blood dyscrasias or with CNS diseases in active phase. Known or suspected pregnancy.
Feeding time.
04.4 Special warnings and appropriate precautions for use
To be used under strict medical supervision.
During treatment, the urine may take on a reddish-brown color due to soluble drug pigments.
The product has shown carcinogenic properties in animals under particular experimental conditions.
Use with caution in patients with severe hepatic and renal impairment.
A clinical and laboratory control (complete blood count with leukocyte formula) is recommended if it is necessary to continue the treatment for more than 10 days.
Important information about some of the ingredients
Flagyl 250 mg tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose / galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Alcohol intake is not recommended during treatment as the combination with metronidazole may give rise to a disulfiram-like syndrome with nausea, vomiting and abdominal cramps.
04.6 Pregnancy and lactation
The product should not be administered in known or suspected pregnancy and during lactation.
04.7 Effects on ability to drive and use machines
The use of Flagyl does not affect the ability to drive or use machines.
04.8 Undesirable effects
Gastro-intestinal disorders, anorexia, nausea, vomiting, impaned tongue, dry mouth, metallic taste, glossitis, stomatitis, headache, rash and, less frequently, drowsiness, dizziness, ataxia, depression, insomnia, nasal congestion.
Exceptionally urticaria, pruritus, angioedema and anaphylaxis, dysuria, cystitis, fever, polyuria, pyuria, decreased libido.
Sporadic cases of transient leukopenia or peripheral neuropathy have been reported following prolonged or intensive therapy.
The appearance of neurological symptoms implies the interruption of treatment.
Very rarely, cases of Stevens-Johnsons syndrome and Toxic Epidermal Necrolysis have been reported following administration of metronidazole.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiprotozoans - nitroimidazole derivatives
ATC code: P01AB01
Pharmacotherapeutic group: Gynecological anti-infectives and antiseptics - imidazole derivatives
ATC code: G01AF01
Flagyl (metronidazole) synthetic chemotherapy for the treatment of Trichomonas vaginalis infections, has a marked trichomonicide activity but does not interfere with the useful vaginal flora (Doderlein bacillus).
Given its efficacy orally, Flagyl is also active in Trichomonas male urethritis.
Metronidazole is also known for its activities against anaerobic protozoa such as Giardia and Entamoeba; it is now also used successfully as an antibacterial in the treatment of infections caused by anaerobic microorganisms, both Gram-positive and Gram-negative.
05.2 Pharmacokinetic properties
The drug is very well absorbed in the intestine after oral administration and determines very high and persistent blood levels; after 0.5 g of metronidazole there is a blood peak of 15 mg / ml.
The high oral absorption allows to obtain a high concentration of chemotherapy which is not metabolized and therefore active in the urine. The flagellates that are found in the last urinary tract and that cannot be reached through local vaginal treatment alone can therefore also be attacked.
Metronidazole has a low bond with serum proteins (about 10%), diffuses well in almost all tissues and excellently overcomes the blood-liquor barrier (80%).
It is eliminated mainly by the kidney (70%), a fair amount is eliminated through vaginal secretion (15%), a small part is also excreted with saliva and milk.
The plasma half-life is approximately 8 hours after oral administration.
05.3 Preclinical safety data
Conventional studies of acute toxicity, repeated dose toxicity, and reproductive toxicity have shown that metronidazole poses no particular risk to humans.
Mutagenicity studies have shown that metronidazole is mutagenic in bacteria (positive in the Ames test) but not in animals.
Furthermore, metronidazole has shown carcinogenic properties in rodents only in particular experimental conditions (treatments at high doses and for prolonged periods).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
- Flagyl 500 mg ovules: solid semisynthetic glycerides.
- Flagyl 250 mg tablets: corn starch; polyvinylpyrrolidone; microgranular cellulose; croscarmellose sodium; magnesium stearate; lactose.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
Ovules: 2 years
Tablets: 3 years
06.4 Special precautions for storage
Ovules: store at a temperature below 30 ° C and in the original packaging to protect the product from light.
Tablets: store in the original packaging to protect the product from light.
06.5 Nature of the immediate packaging and contents of the package
• 10 eggs of 500 mg
• 20 tablets of 250 mg
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
ZAMBON ITALIA s.r.l. - Via Lillo del Duca, 10 - 20091 Bresso (MI)
08.0 MARKETING AUTHORIZATION NUMBER
• Flagyl 500 mg eggs - 10 eggs - AIC n. 018505040
• Flagyl 250 mg tablets - 20 tablets - AIC n. 018505038
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: February 27, 1961
Renewal: 1 June 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA resolution of 12 November 2013
