Vagilen*10 Ovules Vag 500mg

NAME
VAGILEN

PHARMACOTHERAPEUTIC CATEGORY
Ovules: gynecological anti-infectives and antiseptics / imidazole derivatives. Rigid capsules: antiprotozoal / nitroimidazole derivatives.

ACTIVE PRINCIPLES
Metronidazole.

EXCIPIENTS
Ovules: mixture of mono, triglycerides and saturated fatty acids. Hard capsules: starch; magnesium stearate; talc; jelly; titanium dioxide.

INDICATIONS
Ovules: Treatment of symptomatic trichomoniasis in women. Hard capsules: treatment of symptomatic trichomoniasis in men and women; eradication of Helicobacter pylori (as part of an appropriate therapeutic protocol).

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. It is also contraindicated, in the oral form, in cases with a clinical history of metronidazole-induced haemodiscrasia and in those with active organic diseases of the central nervous system. Since metronidazole passes the placental barrier and enters the fetus, and since its effects on it are not definitively known, the use of the medicine is contraindicated in women who are pregnant or presumed to be pregnant.

DOSAGE
Treatment of symptomatic trichomoniasis (pessaries and / or hard capsules). 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. 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 humans: 1 or 2 capsules per day, according to medical indication. Eradication of Helicobacter pylori (hard capsules). Adults: metronidazole has been shown to be effective and well tolerated, when used as part of an appropriate therapeutic protocol (generally associated with proton pump inhibitors and other antibiotics), at dosages between 1000 and 1500 mg (4-6 tablets) divided into 2-3 daily administrations and for periods between 7 and 14 days.

STORAGE
None.

WARNINGS
The appearance of neurological signs implies the suspension of oral treatment. 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. Cases of severe hepatotoxicity / acute hepatic failure, including cases with a fatal outcome, with very rapid onset after initiation of treatment in patients with Cockayne syndrome have been reported with metronidazole-containing medicinal products for systemic use. Therefore, in this population metronidazole should be used after careful risk-benefit assessment and only in the absence of alternative treatments. Liver function tests should be performed just before the start of therapy, during and after the end of treatment, until liver function parameters have returned to normal or baseline values are reached. If liver function test values increase significantly during treatment, the drug should be discontinued. Patients with Cockayne syndrome should be advised of the need to immediately report to the physician any symptoms of potential liver injury and to discontinue treatment with metronidazole.

INTERACTIONS
During treatment with the drug, alcoholic beverages should be avoided because they can cause the mentioned side effects, particularly those affecting the gastrointestinal and urogenital systems (disulfiram-like syndrome).

SIDE 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. During treatment, moderate leukopenia may occur which can be expected to disappear at the end of it. Other occasional possible side effects: vertigo 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. Furthermore, it was rarely observed: dyspareunia, fever, polyuria and incontinence, pyuria, decreased libido, nasal congestion, proctitis. Dark urine usually has no clinical significance, it can almost certainly be a metabolite of metronidazole and occurs if doses higher than recommended are used. Flattening of the electrocardiographic T wave may also be observed. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
Since metronidazole passes the placental barrier and enters the fetus circulation, and given the lack of knowledge of its effects on it, the use of the product is contraindicated in women who are pregnant or presumed pregnant and during lactation.