EKZEM 250 MICROGRAMMI/ML Ушные капли, раствор

Содержание инструкции

1. Ekzem 250 microgrammes/ml ear drops, solution in single-dose containers
   1. What Ekzem is and what it is used for
   2. What you need to know before you use Ekzem
   3. How to use Ekzem
   4. Possible side effects
   5. How to store Ekzem
   6. Contents of the pack and other information

Ekzem 250 microgrammes/ml ear drops, solution in single-dose containers

Fluocinolone acetonide

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ekzem is and what it is used for
• 2. What you need to know before using Ekzem
• 3. How to use Ekzem
• 4. Possible side effects
• 5. How to store Ekzem
• 6. Contents of the pack and other information

1. What Ekzem is and what it is used for

Ekzem is a solution for use in the ear. It contains fluocinolone acetonide, a corticosteroid which
exerts an anti-inflammatory, anti-pruritic and vasoconstrictive action.
Ekzem is used for the treatment of auricular eczema in adults with an intact tympanic membrane.

2. What you need to know before you use Ekzem

Do not use Ekzem

• if you are allergic to fluocinolone acetonide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Prevent the medicine from entering the eyes.
• Consult your doctor before using Ekzem if your eardrum is or may be damaged (perforated).
• Immediately stop treatment and consult your doctor in case of hives, rash or any other allergic symptoms (e.g., sudden swelling of the face, throat or eyelids, or difficulty breathing). Severe hypersensitivity reactions require immediate emergency treatment.
• If your doctor has also diagnosed you with a bacterial or fungal infection, you will also need to use the additional treatment indicated for the treatment of the infection in order to prevent it from worsening. To reduce undesirable effects, use this medicine at the minimum dose and only for the period of time recommended by your doctor.

Contact your doctor if you experience blurred vision or other visual disturbances.

Use in children and adolescents
The use of fluocinolone acetonide for the treatment of auricular eczema has not been studied in children and
adolescents. Therefore, the use of this medicinal product is not recommended in these subgroups
of population.

Other medicines and Ekzem
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Adequate and well-controlled studies regarding the use of Ekzem by pregnant women are not available.
Therefore, during pregnancy, Ekzem should be taken with caution.
The same applies to the administration of Ekzem during breastfeeding, as it is not known whether fluocinolone
acetonide is secreted into breast milk.

Driving and operating machinery
Ekzem does not affect the ability to drive vehicles or operate dangerous machinery.

3. How to use Ekzem

Use the medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one single-dose container in the affected ear twice a day for 7 days.
Use Ekzem in both ears only on medical advice. Your doctor will inform you about the duration
of your treatment with Ekzem.

Instructions for administration
The person administering Ekzem should wash their hands.

• 1. Detach the single-dose container from the packaging (figure 1).
• 2. Warm the drops by holding the single-dose container in your hands (figure 2).
• 3. Remove the cap of the single-dose container (figure 3).
• 4. Tilt your head to the side so that the affected ear is facing upwards (figure 4).
• 5. Introduce the contents of one single-dose container into the ear (figure 5). Gently pull the earlobe upwards and outwards. This will allow the ear drops to flow into the ear canal.
• 6. Keep your head tilted for about one minute to allow the medicine to penetrate the ear (figure 6). Dispose of the single-dose container after administration.
• 7. If necessary, repeat in the other ear.

It is essential to follow these instructions to ensure the effectiveness of the medicine administered
in the ear. If the head is in a vertical position or moves too quickly at the time
of instilling the drops, some of the medicine may be lost, as the drops will run down the
face instead of penetrating deep into the ear canal.

If you use more Ekzem than you should
Symptoms of overdose are not known. In case of overdose or accidental ingestion of the
preparation, contact your doctor or pharmacist or the poison control center hotline immediately and
indicate the name of the product and the amount used. Alternatively, go to the nearest emergency room.

If you forget to use Ekzem
Do not use a double dose to make up for a missed application. Continue with the next dose.

If you stop using Ekzem
Do not stop using Ekzem without first talking to your doctor or pharmacist. It is very important
to use the ear drops for the entire time indicated by the doctor, even if the symptoms improve.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ekzem can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people) include: burning, itching,
irritation, dryness and discomfort at the application site.
Uncommon side effects (may affect up to 1 in 100 people) include: folliculitis
(inflammation of one or more hair follicles), acne, skin discoloration, dermatitis and contact dermatitis (skin inflammation/eczema).
Rare side effects (may affect up to 1 in 1,000 people) include: skin atrophy
(reduction in skin thickness), stretch marks (striae cutaneae), heat rash and
infection.
Frequency not known (the available data do not allow to estimate the frequency): blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell 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 Ekzem

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the single-dose container, the sachet and the box after "Exp". The expiry date refers to the last day of that month.
• Store at a temperature below 25 ºC and in the original packaging to protect the medicine from light.
• After first opening of the sachet: 3 months. Dispose of after 3 months from the first opening of the aluminium sachet.
• Dispose of the single-dose container after administration.

Do not use this medicine if you notice that the product does not have the appearance of a transparent solution from clear to
slightly yellow.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of medicines you no longer
use. This will help protect the environment.

6. Contents of the pack and other information

What Ekzem contains

• The active ingredient is fluocinolone acetonide.
• 1 ml of solution contains 250 micrograms of fluocinolone acetonide.
• Each single-dose container of 0.40 ml of solution contains 100 micrograms of fluocinolone acetonide.
• The other ingredients are polysorbate 80, glycerol, povidone K90F, lactic acid, 1N sodium hydroxide and purified water.

Description of the appearance of Ekzem and contents of the pack
Ekzem is a clear solution packaged in a single-dose plastic container of 0.40 ml. The
single-dose containers are in turn inserted into an aluminum wrapper and a cardboard box to
guarantee their integrity. Each single-dose container contains approximately 100 micrograms of fluocinolone
acetonide.
Each pack contains 15 or 30 single-dose containers. Not all pack sizes may be
marketed.

Marketing Authorisation Holder
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany

Distributor
Bruno Farmaceutici S.p.A.
Via delle Ande, 15
00144 Rome

Manufacturer responsible for batch release
Laboratorios Salvat, S.A.
Gall, 30-36 - 08950
Esplugues de Llobregat
Barcelona
Spain

This medicinal product is authorised in the Member States of the EEA with the following names:
SPAIN Ekzem 250 micrograms/ml eye/ear drops in solution in single-dose container
DENMARK Otazem
FINLAND Otazem 250 mcg/ml, ear drops, solution, single-dose pack
GERMANY OtoFlamm
ITALY Ekzem
NORWAY Otazem
PORTUGAL Ekzem, 0.1 mg/ 0.4 ml, ear drops, solution in single-dose container
SWEDEN Otazem 250 mcg/ml, ear drops, solution in single-dose container