Name
Edenil 0.1 g vaginal solution
Edenil 1 g powder for vaginal solution
Ibuprofen isobutanolammonium
What is it and what is it for?
Edenil contains the active ingredient ibuprofen which belongs to a group of medicines called anti-inflammatories.
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.
Contact 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 closely chemically related to ibuprofen (such as other non-steroidal anti-inflammatory drugs) or to any of the other ingredients of this medicine (listed in section 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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Edenil if you are in the last three months of pregnancy. You should not use Edenil during the first six months of pregnancy unless strictly necessary and on the advice of your doctor. If treatment is necessary during this period, the lowest dose should be used for the shortest possible duration.
Oral forms (e.g., tablets) of ibuprofen may 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
Take special care with Edenil:
Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and 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 serious skin reactions described in section 4.
Talk to your doctor or pharmacist before using Edenil.
Use Edenil exclusively for vaginal washes.
Use of this medicine for prolonged periods may give rise to allergic reactions (hypersensitization).
In this case, stop treatment and contact your doctor to establish an appropriate therapy.
If there is no response within 3 days of starting administration, do not continue treatment and consult your doctor.
In case of vaginal bleeding and/or leucorrhoea (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 taking ibuprofen and consult your doctor immediately if you notice any of the following symptoms:
• flat, target-shaped or circular reddish patches on the trunk, often with central vesicles, skin peeling, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Extensive skin rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• Extensive, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
Application site irritation, erythema, urticaria (skin irritation) and pruritus have been reported with unknown frequency.
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 experience 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.