VAGILEN "500 MG OVA" 10 OVA

Name
Vagilen 500 mg ovules
Metronidazole


What it is and what it is used for
Vagilen contains the active substance metronidazole, which belongs to the class of gynaecological anti-infectives and antiseptics/imidazole derivatives that are used for:

• treatment of a sexually transmitted infection (symptomatic trichomoniasis) manifested by inflammation of the genitals in women.


What you need to know before taking the medicine
DO NOT use Vagilen
• if you are allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6)
• during pregnancy and breastfeeding (see section "Pregnancy and breastfeeding").


Warnings and precautions
Stop treatment with Vagilen if you notice any symptoms affecting your nervous system.

Metronidazole, contained in Vagilen, is eliminated in the urine as soluble secondary products (metabolites) of reddish brown color. Therefore, the urine may appear dark, especially if higher doses than recommended are used.

Please note that your doctor may consider it prudent to perform a preventive check for the possible presence of tumors of the lymphoid tissue (lymphomas), lungs (pneumopathies) or breast (mastopathies).

Cases of liver toxicity (severe hepatotoxicity/acute liver failure), including cases resulting in death, have been reported with medicines containing metronidazole in patients with Cockayne syndrome.

If you suffer from Cockayne's syndrome, your doctor will also frequently monitor your liver function both during treatment with metronidazole and afterwards.

Tell your doctor immediately and stop taking metronidazole if you experience:
• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, soft, gray-green stools, or itching.

Take special care when using Vagilen :
Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with metronidazole. Stop using metronidazole and contact your doctor immediately if you experience any of the symptoms related to these serious skin reactions described in section 4.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking metronidazole and contact your doctor immediately if you notice any of the following symptoms:
- reddish, non-elevated patches on the trunk, target-shaped or circular, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
- a widespread, red, scaly rash with pustules under the skin and vesicles located mainly in the skin folds, trunk and upper limbs accompanied by fever (acute generalized exanthematous pustulosis).

Side effects that may occur with the use of Vagilen:
• dirty tongue, inflammation of the tongue (glossitis), inflammation of the mucous membrane of the mouth (stomatitis)
• inflammation of the vagina: these symptoms may refer to the development of fungi (Monilia) during treatment
• reduction in white blood cells (leukopenia)
• dizziness
• dizziness
• joint pain
• confusion
• irritability
• depression
• insomnia
• weakness
• inflammation and allergic reactions of the skin (erythema, urticaria, redness)
• dry mouth
• dryness of the vagina and vulva
• itching
• difficulty urinating (dysuria)
• inflammation of the urinary bladder (cystitis)
• feeling of pressure in the lower abdomen (pelvic pressure)

Other side effects that may rarely occur with the use of Vagilen:
• loss of muscle coordination (ataxia)
• pain in the vaginal area during sexual intercourse (dyspareunia)
• fever
• formation and elimination of an excessive amount of urine (polyuria)
• involuntary loss of urine (incontinence)
• presence of purulent material in the urine (pyuria)
• decreased sexual desire (libido)
• stuffy nose (nasal congestion)
• inflammation of the rectum (proctitis)
• dark urine (see also Warnings and precautions)
• alteration of the electrocardiography (flattening of the T wave)

Side effects that may occur with an unknown frequency (frequency cannot be estimated from the available data) with the use of Vagilen:
• inflammation of the pancreas (pancreatitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.