EDENIL 0.1 G Roztwór dopochwowy

Treść ulotki

1. Edenil 0.1 g vaginal solution, 1 g powder for vaginal solution
   1. What is Edenil and what is it 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

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

Ibuprofen isobutanolammonium

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor

or pharmacist. See section 4.

• See a doctor if you do not feel better 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. Contents of the pack and other information

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

Edenil contains the active ingredient ibuprofen which belongs to a group of medicines called anti-inflammatory drugs.
This medicine is used for the treatment of symptoms of inflammation of the vulva and vagina
(vulvovaginitis) characterized by slight vaginal discharge, itching, irritation, burning and vulvar pain.
See your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using Edenil

Do not use Edenil

• if you are allergic to ibuprofen isobutanolammonium, to substances closely related chemically 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 are pregnant or are planning a pregnancy, or if you 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 under the advice of your doctor. If treatment is necessary during this period, it should
be used at the lowest dose 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 skin 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 the treatment with ibuprofen. Stop using Edenil and contact
your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in
section 4.
Consult your doctor or pharmacist before using Edenil.
Use Edenil exclusively for vaginal washes.
Use of this medicine for prolonged periods may lead to allergic reactions (hypersensitization).
In this case, stop treatment and consult your doctor to establish appropriate therapy.
In case of no response within 3 days from the start of administration, avoid persisting in 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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask
your doctor or pharmacist for advice 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 in cases of actual need.

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

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

3. How to use Edenil

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:
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 genitalia per day.

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

• Remove the guarantee and closure seal by pushing it sideways. (Fig. 1)
• Once the seal has been removed, extract the cannula from its packaging and position it firmly on the vial. (Fig. 2)
• The cannula ends with an applicator which at the end has 3 holes for the solution to exit and 3 grooves for the liquid to flow (Fig. 3).
• Assume a position that favors the cleansing and therapeutic action of the solution (squatting or sitting on the toilet).
• Gently insert only the upper part of the applicator into the vagina up to the insertion limit as shown in the figure. (Fig. 4)
• Compress the vial until completely empty. Hold the liquid in the vagina for a few minutes to allow the solution to perform its therapeutic action.

Edenil 1 g powder for vaginal solution:dissolve the contents of 1-2 sachets in 1 liter of water and use the resulting solution immediately after preparation for washing the external genitalia.

If you use more Edenil than you should
If you have taken more Edenil than you should or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital to obtain advice on the risk and what actions to take. Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness and dizziness, blood in the urine, a feeling of coldness in the body and breathing problems have been reported.

If you forget to use Edenil
Do not use a double dose to make up for a missed dose.
If you have any questions about using this medicine, ask 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 ibuprofene and consult your doctor immediately if you notice any of the following symptoms:

• Reddish, non-raised, target-shaped or circular patches on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genitals and eye sores. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high temperature and swollen lymph nodes (DRESS syndrome).
• Widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
You can 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 which is stated on the packaging. The expiry date refers
to the last day of that month. The expiry date refers to the product in intact packaging, correctly
stored.
Store Edenil 0.1 g vaginal solution at a temperature not exceeding 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines
that 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 ingredient is ibuprofen isobutanolammonium. 100 ml contain 0.1 g of ibuprofen isobutanolammonium.
• The other ingredients are: 2-phenoxyethanol, methylparaben(E218), ethylparaben(E214), propylparaben(E216), butylparaben, polysorbate 20, propylene glycol, floral essence, purified water.

Edenil 1 g powder for vaginal solution

• The active ingredient is ibuprofen isobutanolammonium. One sachet contains 1 g of ibuprofen isobutanolammonium.
• The other ingredients are: imidazolidinyl urea, sodium chloride.

Description of the appearance of Edenil and package contents
Edenil 0.1 g is presented as a vaginal solution contained in single-dose vials of 100 ml.
The package contains 3 or 5 vials.
Edenil 1 g is presented as a powder for vaginal solution contained in single sachets of 1 g.
The package contains 10 sachets.

Marketing authorisation holder and manufacturer
TEOFARMA S.r.l. – Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)

Manufacturer
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