VAGILEN*10 VAGINAL SUPPOSITORIES 500MG

Vagilen 500 mg pessaries
Metronidazole

What it is and what it is used for
Vagilen contains the active ingredient metronidazole, which belongs to the class of anti-infectives and antiseptic gynecological / imidazole derivatives used for:

• the treatment of a sexually transmitted infection (symptomatic trichomoniasis) that manifests with 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
Discontinue treatment with Vagilen if you notice the appearance of symptoms affecting the nervous system.

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

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

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

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

Inform your doctor immediately and stop taking metronidazole in case of:
• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, soft and greenish-gray stools or itching.

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

Side effects that may occur with the use of Vagilen:
• coated tongue, inflammation of the tongue (glossitis), inflammation of the oral mucosa (stomatitis)
• vaginal inflammation: these symptoms may refer to the development of fungi (Monilia) during treatment
• reduction in white blood cells (leukopenia)
• dizziness
• lightheadedness
• joint pain
• confusion
• irritability
• depression
• insomnia
• weakness
• inflammations and allergic skin reactions (erythema, urticaria, redness)
• dry mouth
• dry 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 (also see Warnings and precautions)
• alteration of electrocardiography (flattening of the T wave)

Side effects that may occur with 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, including any not listed in this leaflet, talk to your doctor or pharmacist. 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.