Vagilen - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

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.

Further information on Vagilen can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER O 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS AND QUALITY CONTROLS

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

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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