EDENIL*VAG SOL 5FL 100ML0.1G

Edenil 0.1 g vaginal solution
Edenil 1 g powder for vaginal solution
Ibuprofen isobutanolammonium

What it is and what it is used for
Edenil contains the active ingredient ibuprofen, which belongs to a group of medicines called anti-inflammatory drugs.

This medicine is used to treat the symptoms of inflammation of the vulva and vagina (vulvovaginitis) characterized by small vaginal discharge, itching, irritation, burning, and vulvar pain.

Consult your doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
Do not use Edenil
- if you are allergic to ibuprofen isobutanolammonium, to substances chemically related to ibuprofen (such as other non-steroidal anti-inflammatory drugs) or to any of the other ingredients of this medicine (listed in paragraph 6);
- if you suffer from severe vulvovaginitis (severe inflammation of the vulva and vagina);
- if you are in the last 3 months of pregnancy.

If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Edenil if you are in the last 3 months of pregnancy. You should not use Edenil during the first 6 months of pregnancy unless strictly necessary and on your doctor's advice. If treatment is necessary during this period, the lowest dose should be used for the shortest possible time.

Oral forms (e.g., tablets) of ibuprofen can cause adverse effects in the fetus. It is not known whether the same risk applies to Edenil when used on the skin.

Warnings and precautions
Pay particular attention with Edenil:
Severe cutaneous reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Edenil and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

Consult your doctor or pharmacist before using Edenil.

Use Edenil exclusively for vaginal washes.
Prolonged use of this medicine can lead to allergic reactions (hypersensitivity).

In this case, discontinue treatment and consult your doctor to establish appropriate therapy.
If there is no response within 3 days of starting administration, do not persist with the treatment and consult your doctor.

In case of vaginal bleeding and/or leukorrhea (abundant whitish discharge), do not use Edenil without first consulting your doctor.

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

Stop treatment with ibuprofen and consult your doctor immediately if you notice any of the following symptoms:
• reddish, non-raised, target-shaped or circular patches on the torso, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Extensive rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• Extensive, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Irritation at the application site, erythema, urticaria (skin irritation) and itching have been reported with unknown frequency.
The skin becomes sensitive to light - frequency unknown.

Following the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.