Ekzem

PACKAGE INSERT

Package insert: information for the patient

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

Fluocinolone acetonide
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 that exerts anti-inflammatory, antipruritic, and vasoconstrictive effects.
Ekzem is used for the treatment of otic eczema in adults with an intact tympanic membrane.

2. What you need to know before using 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

• Avoid letting the medicine enter the eyes.
• Consult your doctor before using Ekzem if your eardrum is or may be damaged (perforated).
• Stop treatment immediately and consult your doctor if hives, rash, or any other allergic symptoms occur (e.g., sudden swelling of the face, throat, or eyelids, or breathing difficulties). Severe hypersensitivity reactions require immediate emergency treatment.
• If your doctor has also diagnosed a bacterial or fungal infection, you must use additional treatment indicated for the infection to prevent it from worsening. To reduce side effects, use this medicine at the lowest effective dose and only for the duration recommended by your doctor.

Contact your doctor if blurred vision or other visual disturbances occur.
Use in children and adolescents
The use of fluocinolone acetonide for the treatment of ear eczema has not been studied in children and adolescents. Therefore, the use of this medicinal product is not recommended in these population subgroups.
Other medicines and Ekzem
Inform 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, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Adequate and well-controlled studies on the use of Ekzem in pregnant women are not available. Therefore, Ekzem should be used with caution during pregnancy.
The same applies to administration of Ekzem during breastfeeding, as it is not known whether fluocinolone acetonide is excreted in breast milk.
Driving and using machines
Ekzem does not affect the ability to drive or operate machinery.

3. How to use Ekzem

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is one single-dose container administered into the affected ear twice daily for 7 days.
Use Ekzem in both ears only if specifically instructed by your doctor. Your doctor will advise you on how long to continue 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 from the single-dose container (Figure 3).
4. Tilt the head to the side so that the affected ear faces upward (Figure 4).
5. Instill the contents of one single-dose container into the ear (Figure 5). Gently pull the earlobe upward and outward to allow the ear drops to flow into the ear canal.
6. Keep the head tilted for about one minute to allow the medicine to penetrate the ear (Figure 6). Dispose of the single-dose container after use.
7. If necessary, repeat the procedure in the other ear.

It is essential to follow these instructions to ensure the effectiveness of the medicine administered into the ear. If the head is in an upright position or moves too quickly during instillation, part of the medicine may be lost, as the drops may run down the face instead of flowing deeply into the ear canal.

If you use more Ekzem than you should
Symptoms of overdose are unknown. In case of overdose or accidental ingestion of the product, contact your doctor, pharmacist, or poison control center immediately. Provide the product name 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 the missed dose. Continue with the next scheduled 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 full duration prescribed by your doctor, even if symptoms improve.

If you have further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ekzem can cause side effects, although not everyone experiences 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 unknown (data available do not allow estimation of frequency): blurred vision.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: 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, on the pouch, and on the carton after "Exp". The expiry date refers to the last day of that month.
• Store below 25 ºC and in the original packaging to protect the medicine from light.
• After first opening of the pouch: 3 months. Discard after 3 months from the first opening of the aluminium pouch.
• Discard the single-dose container after administration.

Do not use this medicine if you notice that the product does not appear as a clear to slightly yellowish transparent solution.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Ekzem contains

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

Description of the appearance of Ekzem and contents of the pack
Ekzem is a clear solution supplied in single-dose plastic containers of 0.40 ml. The single-dose containers are individually enclosed in an aluminum pouch and packed in a cardboard box to ensure integrity. Each single-dose container contains approximately 100 micrograms of fluocinolone acetonide.
Each package contains 15 or 30 single-dose containers. Not all pack sizes may be marketed.

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

Sales Licensee
Bruno Farmaceutici S.p.A.
Via delle Ande, 15
00144 Rome
Italy

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

This medicinal product is authorized in EEA Member States under the following names:
SPAIN Ekzem 250 microgramos/ml gotas óticas en solución en envase unidosis
DENMARK Otazem
FINLAND Otazem 250 mcg/ml, korvatipat, liuos, kerta-annospakkaus
GERMANY OtoFlamm
ITALY Ekzem
NORWAY Otazem
PORTUGAL Ekzem, 0.1 mg/ 0.4 ml, gotas auriculares, solução em recipiente unidose
SWEDEN Otazem 250 mcg/ml, örondroppar, lösning i endosbehållare