VAGILEN 10 VAG VAG 500MG

VAGILEN

active ingredients

Ovuli An ovum contains: Active ingredient: Metronidazole 500 mg. Hard capsules One capsule contains: Active ingredient: Metronidazole 250 mg. For excipients, see 6.1.

Excellent

Ovuli: mix of mono, di, triglycerides of saturated fatty acids. Hard capsules: starch; magnesium stearate; talc; gelatin; titanium dioxide.

Therapeutic indications

Ovuli Treatment of symptomatic trichomoniasis in the woman. Hard capsules - Treatment of symptomatic trichomoniasis in man and woman; - Eradication of Helicobacter pylori (in the framework of an appropriate therapeutic protocol).

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. It is also contraindicated - in the oral form - in cases with 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 circle in the fetus, and since its effects on it are not definitively known the use of VAGILEN is contraindicated in pregnant women established or presumed (see paragraph 4.6). Nursing (see paragraph 4.6).

Population

Treatment of symptomatic trichomoniasis (ovuli and/or rigid capsules): For the woman: 1 or 2 eggs on site, per day. For 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 concentrated single doses. Topical use can be used as a complementary treatment, resulting in effective relapse prevention. For the man: 1 or 2 capsules per day, according to medical indication. Eradication of Helicobacter pylori (rigid capsules): Adults: The metronidazole was effective and well tolerated, when used in an appropriate therapeutic protocol (usually associated with protonic pump inhibitors and other antibiotics), doses between 1000 and 1500 mg (4-6 tablets) divided into 2-3 daily administrations and for periods between 7 and 14 days.

Conservation

None.

Warnings

The appearance of neurological signs implies the suspension of oral treatment. To be used under strict medical control. A preventive oncological control for lymphomas or pneumopathy or mastopatie is prudent, for which alterations have been observed in laboratory rodents in experimental treatment with metronidazole. With metronidazole-containing medicines for systemic use, severe hepatotoxicity/acute liver failure was reported, including cases with fatal outcome, with very quick start after treatment in patients with Cockayne syndrome. Therefore, in this metronidazole population it must be used after careful assessment of the risk-benefit ratio and only in the absence of alternative treatments. The analysis of liver function must be carried out just before the start of therapy, during and after the end of treatment, until the parameters of liver function are returned to the norm or the values will not be reached at the base. If the values of liver function analysis should increase significantly during treatment, the drug must be stopped. Patients suffering from Cockayne syndrome should be advised of the need to immediately report to the doctor any symptoms of potential liver injury and to stop treatment with metronidazole.

Interactions

During treatment with VAGILEN capsules should be avoided intake of alcoholic beverages because they can cause the mentioned side effects, especially those with gastrointestinal and urogenital systems (disulfiram-simile syndrome).

Effects

With oral administration of metronidazole, they can observe: nausea sometimes accompanied by headache, anorexia and occasionally vomiting, diarrhea, epigastric pain, abdominal cramps; has also been reported stipsi. An unpleasant metallic taste is not infrequent. It has also been observed dirty language, glossitis and stomatitis: these symptoms may refer to the development of Monilia undergoing treatment, even at the expense of the vagina. In course of treatment may have moderate leukopenia that you can wait for disappearance at the end of it. Other occasional side effects possible: dizziness and dizziness; incoordination and ataxia (rare); fugitive joint pains, confusion, irritability, depression, insomnia, fiacchezza, modest eritemi; hives, redness, dry mouth (or vagina and vulva), itching, dysuria, cystitis and pelvic pressure. Moreover, and rarely, it has been observed: dispareunia, fever, polyuria and incontinence, feathers, decreased libido, nasal congestion, proctitis. Dark Urine has not usually clinical meaning, it can almost certainly be a metabolite of metronidazole and occurs if higher doses than recommended ones are used. It can also be observed flattening of the electrocardiographic T wave. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction through the national reporting system: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

No overdose symptoms have been reported.

Since metronidazole passes the placental barrier and enters the circle in the fetus, and since its effects on it are not definitively known the use of VAGILEN is contraindicated in pregnant women established or presumed (see paragraph 4.3) and during nursing.

Source: Farmadati