Ekzem 250 micrograms/ml otic solution in single-dose containers
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ekzem 250 micrograms/ml ear drops solution in single-dose containers
Fluocinolone acetonide
Read all of this leaflet carefully before you start 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 they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ekzem is and what it is used for
- What you need to know before using Ekzem
- How to use Ekzem
- Possible side effects
- How to store Ekzem
- Contents of the pack and other information
1. What Ekzem is and what it is used for
Ekzem is a solution for application in the ear. It contains fluocinolone acetonide, a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties.
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, to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- This medicine must not be applied to the eye.
- Consult your doctor before using Ekzem if you have or may have a perforation (hole) in the eardrum.
- If, after starting treatment, you develop symptoms of urticaria (itching) or skin rash, or any other allergic symptoms (for example, sudden swelling of the face, throat, or eyelids, difficulty breathing), stop treatment immediately and contact 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, as otherwise it could worsen. To minimize adverse reactions, use this medicine at the lowest effective dose and only for the duration 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 otic eczema has not been studied in children and adolescents; therefore, the use of Ekzem is not recommended in this population.
Use of Ekzem with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
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, as it is unknown whether fluocinolone acetonide is excreted in human breast milk.
Driving and using machines
Ekzem does not affect the ability to drive or operate machinery.
3. How to use Ekzem
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is the contents of one ampoule into the affected ear twice daily 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.
Instructions for use
The person administering Ekzem should wash their hands before starting.
- Detach one ampoule from the strip of ampoules contained in the sachet (image 1).
- Warm the ear drops by holding the ampoule in your hands (image 2).
- Turn the cap at the end of the ampoule one full turn (image 3).
- Tilt the head to one side so that the affected ear is facing upwards (image 4).
- Instil the entire contents of the ampoule into the ear canal of the affected ear (image 5). Gently pull the earlobe upward and outward. This will allow the ear drops to flow into the ear canal.
- Keep the head tilted for about 1 minute to allow the drops to penetrate into the ear (image 6). Discard the ampoule after administration.
- Repeat, if necessary, in the other ear.
It is important to follow these instructions to achieve a good treatment outcome with this medicine in your ear. After the medicine has been administered into the ear, the head should remain tilted for one minute without returning to an upright position or moving too quickly. Doing so too soon may result in loss of some of the administered medicine, as the drops may run out of the ear and down the face, failing to penetrate into the inner part of the ear.
If you use more Ekzem than you should
Symptoms related to overdose are not known. In case of overdose or accidental ingestion, inform your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount taken, or go to the nearest healthcare facility.
If you forget to use Ekzem
Do not use a double dose to make up for missed doses. Simply continue with the next dose as scheduled.
If you stop using Ekzem
Do not stop treatment with Ekzem without consulting your doctor or pharmacist. It is very important to use this medicine for the full duration prescribed by your doctor, even if symptoms improve.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Common (may affect up to 1 in 10 people): burning, itching, irritation, dryness, and discomfort at the application site.
Uncommon (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): cutaneous atrophy (reduction in skin thickness), skin striae (stretch marks), heat erythema, and infection.
Frequency not known (cannot be estimated from available data): blurred vision.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ekzem
Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.
- Store below 25°C and in the original packaging to protect from light.
- Do not use more than 3 months after opening the aluminium protective pouch. Keep unused unit-dose blisters inside the protective pouch within the carton.
- Dispose of the ampoule after administration.
Do not use this medicine if the product appears not to be a slightly yellowish, clear solution.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your usual pharmacy. If in doubt, please consult your pharmacist on how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ekzem
- The active substance is fluocinolone acetonide.
- 1 ml of solution contains 250 micrograms of fluocinolone acetonide.
- Each 0.40 ml single-dose vial 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 pack
Ekzem is a clear solution supplied in single-dose plastic vials containing 0.40 ml. The single-dose vials are packed in an aluminum protective pouch and an outer cardboard box for protection. Each vial contains approximately 100 micrograms of fluocinolone acetonide.
Each pack contains 15 or 30 vials. Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Salvat, S.A.
C/Gall, 30-36 - 08950
Esplugues de Llobregat
Barcelona - Spain
Manufacturer
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 medicinal product is authorized in the European Economic Area member states under the following names:
Spain Ekzem 250 micrograms/ml ear drops solution in single-dose containers
Denmark Otazem
Finland Otazem 250 mcg/ml, ear drops, solution, single-dose package
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
Date of the most recent review of this leaflet: July 2019.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/