Active ingredients: Metronidazole
VAGILEN 500 mg ova
VAGILEN 250 mg hard capsules
Why is Vagilen used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antimicrobial, antiseptic with trichomonicide action.
THERAPEUTIC INDICATIONS
Treatment of symptomatic trichomoniasis in men and women.
Contraindications When Vagilen should not be used
VAGILEN is contraindicated in patients with hypersensitivity to any component of the preparations and in particular to metronidazole. It is also contraindicated - in the oral form - in cases with a clinical history of metronidazole hemodiscrasia and in those with active organic diseases of the central nervous system.
Since metronidazole passes the placental barrier and enters the fetal circulation, and since its effects on it are not definitively known, the use of VAGILEN is contraindicated in women who are pregnant or presumed to be pregnant.
Precautions for use What you need to know before taking Vagilen
The use of the product should be limited to cases of symptomatic trichomoniasis.
To be used under strict medical supervision.
The appearance of neurological signs implies the suspension of oral treatment.
Interactions Which drugs or foods may change the effect of Vagilen
Alcoholic beverages should be avoided during treatment with VAGILEN capsules as they can cause the mentioned side effects, particularly those affecting the gastrointestinal and urogenital systems (disulfiram-like syndrome).
Warnings It is important to know that:
A preventive oncological control is prudent for lymphomas or lung diseases or mastopathies, for which alterations have been observed in laboratory rodents undergoing experimental treatment with metronidazole.
Dose, Method and Time of Administration How to use Vagilen: Posology
For the woman: 1 or 2 eggs on site, per day. For the mixed treatment: 1 egg for local use and 2 capsules for oral use according to medical indication. However, the overall dose should not exceed 2 g to be administered in single concentrated doses.
Topical use can be used as a complementary treatment and is effective in preventing relapses.
For men: 1 or 2 capsules per day, according to medical indication.
Overdose What to do if you have taken too much Vagilen
There are no known effects that can be attributed to overdose of Vagilen.
Side Effects What are the side effects of Vagilen
With oral administration of metronidazole, the following may be observed: nausea sometimes accompanied by headache, anorexia and occasionally vomiting, diarrhea, epigastric pain, abdominal cramps; Constipation has also been reported. An unpleasant metallic taste is not uncommon.
Dirty tongue, glossitis and stomatitis have also been observed: these symptoms may refer to the development of Monilia during treatment, including in the vagina.
Moderate leukopenia may occur during treatment and can be expected to disappear upon completion. Other occasional possible side effects: dizziness and dizziness; incoordination and ataxia (rare); fleeting joint pains, confusion, irritability, depression, insomnia, weakness, modest erythema; hives, redness, dry mouth (or vagina and vulva), itching, dysuria, cystitis and a sense of pelvic pressure. In addition, and rarely, it has been observed: dyspareunia, fever, polyuria and incontinence, pyuria, decreased libido, nasal congestion, proctitis.
Dark urine is usually of no clinical significance, can almost certainly be a metabolite of metronidazole, and occurs if higher than recommended doses are used. Flattening of the electrocardiographic T wave may also be observed.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
The validity period is intended for the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
Keep this medicine out of the reach and sight of children.
Composition and pharmaceutical form
COMPOSITION
Ovules
One egg contains: Active ingredient: Metronidazole 500 mg.
Excipient: Mixture of mono, di, triglycerides of saturated fatty acids.
Hard capsules
One capsule contains: Active ingredient: Metronidazole 250 mg.
Excipients: Starch; Magnesium stearate; Talc; Jelly; Titanium dioxide.
PHARMACEUTICAL FORM AND CONTENT
Eggs - 10 eggs
Hard capsules - 20 capsules
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
VAGILEN®
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ovules
An egg contains:
Active ingredient: Metronidazole 500 mg.
Hard capsules
One capsule contains:
Active ingredient: Metronidazole 250 mg.
For excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Ovules
Hard capsules
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of symptomatic trichomoniasis in men and women.
04.2 Posology and method of administration
For the woman: 1 or 2 eggs on site, per day. For the mixed treatment: 1 egg for local use and 2 capsules for oral use according to medical indication. However, the overall dose should not exceed 2 g to be administered in single concentrated doses.
Topical use can be used as a complementary treatment and is effective in preventing relapses.
For man: 1 or 2 capsules per day, according to medical indication.
04.3 Contraindications
VAGILEN is contraindicated in patients with hypersensitivity to any component of the preparations and in particular to metronidazole. It is also contraindicated - in the oral form - in cases with a clinical history of metronidazole-induced hemodiscrasia and in those with active organic diseases of the central nervous system.
Since metronidazole passes the placental barrier and enters the fetus' circulation, and as its effects on it are not definitively known, the use of VAGILEN is contraindicated in women who are pregnant or presumed to be pregnant.
04.4 Special warnings and appropriate precautions for use
The use of the product should be limited to cases of symptomatic trichomoniasis.
The appearance of neurological signs implies the suspension of oral treatment.
To be used under strict medical supervision.
A preventive oncological control is prudent for lymphomas or lung diseases or mastopathies, for which alterations have been observed in laboratory rodents undergoing experimental treatment with metronidazole.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
Alcoholic beverages should be avoided during treatment with VAGILEN capsules as they may cause the side effects mentioned, particularly those affecting the gastrointestinal and urogenital systems (disulfiram-like syndrome).
04.6 Pregnancy and breastfeeding
Since metronidazole passes the placental barrier and enters the fetus' circulation, and as its effects on it are not definitively known, the use of VAGILEN is contraindicated in women who are pregnant or presumed to be pregnant.
04.7 Effects on ability to drive and use machines
No effects are described.
04.8 Undesirable effects
With oral administration of metronidazole, the following may be observed: nausea sometimes accompanied by headache, anorexia and occasionally vomiting, diarrhea, epigastric pain, abdominal cramps; Constipation has also been reported. An unpleasant metallic taste is not uncommon.
Dirty tongue, glossitis and stomatitis have also been observed: these symptoms may refer to the development of Monilia during treatment, including in the vagina.
Moderate leukopenia may occur during treatment and can be expected to disappear upon completion. Other occasional possible side effects: dizziness and dizziness; incoordination and ataxia (rare); fleeting joint pains, confusion, irritability, depression, insomnia, weakness, modest erythema; hives, redness, dry mouth (or vagina and vulva), itching, dysuria, cystitis and a sense of pelvic pressure. In addition, and rarely, it has been observed: dyspareunia, fever, polyuria and incontinence, pyuria, decreased libido, nasal congestion, proctitis.
Dark urine is usually of no clinical significance, can almost certainly be a metabolite of metronidazole, and occurs if higher than recommended doses are used. Flattening of the electrocardiographic T wave may also be observed.
04.9 Overdose
No overdose symptoms were reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Ovules
Pharmacotherapeutic group: Gynecological anti-infectives and antiseptics / Imidazole derivatives - ATC code: G01AF01.
Hard capsules
Pharmacotherapeutic group: Antiprotozoans / Nitroimidazole derivatives - ATC code: P01AB01.
The active ingredient of VAGILEN consists of metronidazole.
Metronidazole is a broad spectrum nitroimidazole derivative of antiprotozoal and antimicrobial action. It has a direct trichomonicide effect and is also active on anaerobic Gram-positive cocci, spore-forming bacilli, Gram-negative anaerobes. It exhibits marked activity on Gardnerella vaginalis. It is not active on the vaginal acidophilic flora.
05.2 Pharmacokinetic properties
Administered orally to experimental animals and humans, it is absorbed from the gastrointestinal tract and blood rates are related to the dose administered. It is eliminated either in the urine (60-80% of the dose) unchanged or in the form of several soluble metabolites of brown red color, both with the faeces (6-15% of the dose).
For topical vaginal application in women, metronidazole is absorbed in a percentage that varies between 10% and 20% of the administered dose.
Plasma protein binding is less than 20%.
It passes the placental barrier and is found in breast milk.
05.3 Preclinical safety data
Metronidazole is poorly toxic. High doses and many times higher than those used for human use do not induce any toxic phenomenon in experimental animals.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Ovules
Mixture of mono, di, triglycerides of saturated fatty acids.
Hard capsules
Starch; Magnesium stearate; Talc; Jelly; Titanium dioxide.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
VAGILEN ovules and hard capsules: 5 years in unopened packaging.
06.4 Special precautions for storage
None.
06.5 Nature of the immediate packaging and contents of the package
VAGILEN ovules- PVC-PE valves, box of 10 eggs.
VAGILEN hard capsules- PVC-Al blister, box of 20 capsules.
06.6 Instructions for use and handling
None in particular.
07.0 MARKETING AUTHORIZATION HOLDER
ALFA WASSERMANN S.p.A.
Registered office: Via E. Fermi, n. 1 - Alanno (PE)
Administrative office: Via Ragazzi del "99, n. 5 - Bologna
08.0 MARKETING AUTHORIZATION NUMBER
VAGILEN ovules: A.I.C. n. 020689016
VAGILEN hard capsules: A.I.C. n. 020689028
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
27.02.1973 / 01.06.2010
10.0 DATE OF REVISION OF THE TEXT
June 2010