Package Insert: Information for the User

Ekzem 250 micrograms/ml Eye Drops in Single-Dose Containers

Fluocinolone Acetonide

Read this entire package insert carefully before starting to use this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What Ekzem is and for what it is used

2.What you need to know beforestarting touse Ekzem

3.How to use Ekzem

4.Possible adverse effects

5.Storage of Ekzem

6. Contents of the container and additional information

Ekzem is an ear drop solution. It containsfluocinolone acetonide, a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive action.

Ekzem is used for the treatment of otic eczema in adults with an intact tympanic membrane.

Do not use Ekzem

• if you are allergic to fluocinolone acetonide, to other corticosteroids or to any of the other components of this medication (listed in section 6).

Warnings and precautions

• This medication should not be applied to the eye.
• Consult your doctor before using Ekzem if you have or may have any perforation in the eardrum.
• If, once treatment has been started, you experience symptoms of urticaria (itching) or skin rash or any other allergic symptom (for example, sudden swelling of the face, throat or eyelids, difficulty breathing), stop treatment immediately and see your doctor. Severe hypersensitivity reactions may require immediate emergency treatment.
• If your doctor also diagnoses a bacterial or fungal infection, you will need to use additional treatment for the infection because, if not, it could worsen. To reduce the risk of adverse reactions, use this medication at the minimum dose and only for the time advised by your doctor.

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

Use in children and adolescents

Fluocinolone acetonide has not been studied for the treatment of otic eczema in children and adolescents, therefore Ekzem should not be used in this population.

Use of Ekzem with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

There are no adequate and well-controlled studies with Ekzem in pregnant women, therefore Ekzem should be used with caution during pregnancy.

Ekzem should also be used with caution in breastfeeding women since it is unknown whether fluocinolone acetonide is secreted in breast milk.

Driving and operating machinery

Ekzem does not affect the ability to drive vehicles or operate hazardous machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

The recommended dose is the contents of one ampule in the affected ear twice a day for seven days.

Only use Ekzem in both ears if your doctor has instructed you to do so. Your doctor will inform you about the duration of treatment with Ekzem.

Usage Recommendations

The person administering Ekzem must wash their hands before starting.

1. Separate one ampule from the strip of ampules contained in the package (image 1).
2. Warm the eye drops by holding the ampule in your hands (image 2).
3. Turn the dropper at the end of the ampule (image 3).
4. Tilt your head to one side so that the affected ear is facing upwards (image 4).
5. Deposit the entire contents of the ampule into the ear canal of the affected ear (image 5). Gently move the earlobe upwards and outwards. This will allow the eye drops to flow into the auditory canal.
6. Keep your head tilted for approximately 1 minute to allow the drops to penetrate the ear (image 6). Dispose of the ampule after administration.
7. Repeat, if necessary, in the other ear.

It is essential to follow these instructions to achieve a good outcome with this medication in your ear. Once the medication has been administered to the ear, it must be kept in place for 1 minute without placing the head in a vertical position or moving it too quickly. This could cause a loss of part of the administered medication, as the drops may fall onto the face and not penetrate the inner ear.

If you use more Ekzem than you should

No symptoms of overdose have been reported. In case of overdose or accidental ingestion, inform your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount administered or visit the nearest healthcare service.

If you forgot to use Ekzem

Do not use a double dose to compensate for the missed doses. Simply continue with the next dose.

If you interrupt treatment with Ekzem

Do not stop treatment with Ekzem without consulting your doctor or pharmacist. It is very important to use this medication for the time your doctor has indicated, even if your symptoms improve.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent (may affect up to 1 in 10 people):burning, itching, irritation, dryness, and discomfort in the application area.

Infrequent (may affect up to 1 in 100 people):folliculitis (inflammation of one or more hair follicles), acne, skin discoloration, dermatitis, and contact dermatitis (skin inflammation/eczema).

Rare (may affect up to 1 in 1,000 people):skin atrophy (decrease in skin thickness), skin striations, heat rash, and infection.

Unknown frequency (cannot be estimated from available data):blurred vision.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

• Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.
• Store below 25°C and in the original packaging to protect it from light.
• Do not use after 3 months of opening the aluminum protective cover. Keep unused single-dose vials in the protective cover within the box.
• Dispose of the vial after administration.

Do not use this medication if you observe that the product is not a transparent, slightly yellowish solution.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ekzem

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

Appearance of the product and contents of the package

Ekzem is a transparent solution packaged in single-dose plastic ampules of 0.40 ml. The single-dose ampules are packaged inside an aluminum protective pouch and a cardboard box for protection. Each ampule contains approximately 100 micrograms of fluocinolone acetonide.

Each package contains 15 or 30 ampules. Some package sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Salvat, S.A.

C/Gall, 30-36 - 08950

Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing

INFECTOPHARM GMBH

Von-Humboldt Strabe 1 – 64646

Heppenheim

Germany

or

Laboratorios Salvat, S.A.

C/Gall, 30 -36 – 08950

Esplugues de Llobregat

Barcelona – Spain

or

PHARMALOOP, S.L.

C/Bolivia, 15 – Polígono Industrial Azque

28806 Alcalá de Henares – Madrid (Spain)

This medicine is authorized in the member states of the European Economic Area with the following names:

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

DenmarkOtazem

FinlandOtazem 250 mcg/ml, ear drops, solution, single-dose package

GermanyOtoFlamm

ItalyEkzem

NorwayOtazem

PortugalEkzem, 0.1 mg/ 0.4 ml, ear drops, solution in single-dose container

SwedenOtazem 250 mcg/ml, ear drops, solution in endos container

Date of the last review of this leaflet:July 2019.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/