Edenil

Patient Information Leaflet

Edenil 0.1 g vaginal solution, 1 g powder for vaginal solution

Ibuprofen isobutanolammonium
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects listed in this leaflet, or any that are not listed, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, or if your symptoms worsen after 3 days.

Contents of this leaflet:

1. What Edenil is and what it is used for
2. What you need to know before using Edenil
3. How to use Edenil
4. Possible side effects
5. How to store Edenil
6. Package contents and other information

1. What Edenil is and what it is used for.

Edenil contains the active substance ibuprofen, which belongs to a group of medicines called anti-inflammatory agents.
This medicine is used to treat symptoms of inflammation of the vulva and vagina (vulvovaginitis), characterized by minor vaginal discharge, itching, irritation, burning, and vulvar pain.
If you do not feel better or feel worse after 3 days, consult your doctor.

2. What you need to know before using Edenil

Do not use Edenil

• if you are allergic to ibuprofen isobutanolammonium, to substances chemically closely 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, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Edenil if you are in the last 3 months of pregnancy. You must not use Edenil during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest possible dose for the shortest possible duration should be used.
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 have been reported in association with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized acute exanthematous pustulosis (GEP). Stop using Edenil immediately and contact your doctor if you notice any of the symptoms related to these serious skin reactions described in section 4.
Consult your doctor or pharmacist before using Edenil.
Use Edenil exclusively for vaginal douching.
Prolonged use of this medicine may lead to allergic phenomena (hypersensitivity).
If this occurs, discontinue treatment and consult your doctor to establish appropriate therapy.
If there is no response within 3 days of starting treatment, do not continue treatment and consult your doctor.
If you experience vaginal bleeding and/or leucorrhoea (abundant whitish discharge), do not use Edenil without first consulting your doctor.

Other medicines and Edenil
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
No cases of interactions between Edenil and other medicines have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
The use of Edenil during pregnancy and breastfeeding is not recommended. If you are pregnant or breastfeeding, use Edenil only after consulting your doctor and only if strictly necessary.

Driving and using machines
Edenil does not impair the ability to drive vehicles or operate machinery.

Edenil 0.1 g vaginal solution contains parahydroxybenzoates and propylene glycol
The vaginal solution contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions), and propylene glycol, which may cause skin irritation.

3. How to use Edenil

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dose:
Edenil 0.1 g vaginal solution: 1 or 2 single-dose vials per day. Perform one or two vaginal washes per day.
Edenil 1 g powder for vaginal solution: 1–4 sachets per day. Perform one or two washes of the external genital area per day.

Instructions for use
Edenil 0.1 g vaginal solution: For each vaginal wash, use the entire ready-to-use medicinal solution contained in one single-dose vial. The solution can be used at room temperature or slightly warmed by placing the vial under a stream of warm water.

• Remove the tamper-evident seal and closure cap by pushing it sideways. (Fig. 1)
• After removing the seal, take the cannula out of its packaging and firmly attach it to the vial. (Fig. 2)
• The cannula ends with an applicator that has 3 openings at the tip for the solution to exit and 3 grooves for fluid drainage. (Fig. 3)
• Position yourself in a way that facilitates the cleansing and therapeutic action of the solution (e.g., squatting or sitting on the toilet).
• Gently insert only the upper part of the applicator into the vagina up to the indicated insertion limit shown in the figure. (Fig. 4)
• Squeeze the vial completely until it is empty. Retain the liquid in the vagina for a few minutes to allow the solution to exert its therapeutic effect.

Edenil 1 g powder for vaginal solution: Dissolve the contents of 1–2 sachets in 1 litre of water and use the resulting solution immediately after preparation for washing the external genital area.

If you use more Edenil than you should
If you have used more Edenil than recommended or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice regarding potential risks and necessary actions.
Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus (ringing in the ears), confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.

If you forget to use Edenil
Do not use a double dose to make up for a forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. 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:

• Flat, reddish patches, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• Widespread, red and scaly rash, with lumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).

Application site irritation, erythema, urticaria (skin irritation), and pruritus have been reported with
frequency not known.
Skin becomes sensitive to light – frequency not known.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or
pharmacist. You may also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Edenil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging, stored correctly.
Store Edenil 0.1 g vaginal solution at a temperature not exceeding 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Edenil contains
Edenil 0.1 g vaginal solution

• The active substance is ibuprofen isobutanolammonium. 100 ml contain 0.1 g of ibuprofen isobutanolammonium.
• The other components are: 2-phenoxyethanol, methyl p-hydroxybenzoate (E218), ethyl p-hydroxybenzoate (E214), propyl p-hydroxybenzoate (E216), butyl p-hydroxybenzoate, polysorbate 20, propylene glycol, floral essence, purified water.

Edenil 1 g powder for vaginal solution

• The active substance is ibuprofen isobutanolammonium. Each sachet contains 1 g of ibuprofen isobutanolammonium.
• The other components are: imidazolidinylurea, sodium chloride.

Description of the appearance of Edenil and package contents
Edenil 0.1 g is a vaginal solution contained in single-dose vials of 100 ml.
Pack sizes: 3 or 5 vials.
Edenil 1 g is a powder for vaginal solution contained in single sachets of 1 g.
Pack size: 10 sachets.

Marketing Authorization Holder and Manufacturer
TEOFARMA S.r.l. – Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)

Manufacturers
Edenil 0.1 g vaginal solution - 5 vials of 100 ml
SOFAR S.p.A. - Via Firenze 40 - 20060 Trezzano Rosa (MI)
Zambon S.p.A. - via della Chimica 9 - Vicenza
Officina Farmaceutica MITIM s.r.l. - Via Cacciamali 34-36-38 - 25125 Brescia
Laboratorio Chimico Farmaceutico A.Sella S.r.l. - Via Vicenza 67 - 36015 Schio (Vicenza)

Edenil 0.1 g vaginal solution - 3 vials of 100 ml
SOFAR S.p.A. - Via Firenze 40 - 20060 Trezzano Rosa (MI)
Officina Farmaceutica MITIM s.r.l. - Via Cacciamali 34-36-38 - 25125 Brescia
Laboratorio Chimico Farmaceutico A.Sella S.r.l. - Via Vicenza 67 - 36015 Schio (Vicenza)

Edenil 1 g powder for vaginal solution
Officina Farmaceutica MITIM s.r.l. - Via Cacciamali 34-36-38 - 25125 Brescia